2 December 2019

Stem cell therapies may become redundant in repairing cardiac function after a heart attack, suggests a new study in mice.

It showed how stem cell treatments can heal hearts by triggering an immune response which can be achieved by using a chemical instead.

'This work is paradigm-shifting because it demonstrates a mechanism to explain a perplexing phenomenon that has intrigued cardiologists as a result of decades of cardiac stem cell trials,' Dr Jonathan Epstein at the University of Pennsylvania's Perelman School of Medicine in Philadelphia told The Scientist.

Stem cell therapies to repair damaged heart tissue are currently being tested in human clinical trials. In these treatments, human stem cells are injected into the heart and this leads to an improvement in heart function. However, how this works is not fully understood.

One possibility is that the injected stem cells are incorporated into the heart tissue and repair the damage. However, the latest study, published in the journal Nature, suggests that this may not be the case. Instead, the study indicated that the repair is actually a result of triggering the innate immune response.

Researchers injected different types of stem cell or a chemical inducer (zymosan) of the innate immune response into an experimental mouse model of heart disease. They saw improvement in heart function that was similar in all cases, and showed that this repair occurs via activation of macrophage cells of the innate immune system.

'The innate immune response acutely altered cellular activity around the injured area of the heart so that it healed with a more optimised scar and improved contractile properties,' said Dr Jeffery Molkentin at the University of Cincinnati and Cincinnati Children's Hospital Medical Centre, Ohio, who led the study. 'The implications of our study are very straightforward and present important new evidence about an unsettled debate in the field of cardiovascular medicine.'

The work could open up new possibilities for optimising the treatments currently in development, as well as alternative new therapies.

'If there is a chemical off-the-shelf, it would be a much more feasible therapy [than stem cell transplants],'Dr Kory Lavine at Washington University in St Louis, Missouri, told Nature News.

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Stem cells may trigger immune repair to mend hearts - BioNews

Cardiac Stem Cells Comments Off on Stem cells may trigger immune repair to mend hearts – BioNews | December 2nd, 2019

If are fasting intermittently or taking long food breaks, here's the news for you. A new study presented at the 2019 American Heart Association Scientific Sessions in Philadelphia has found the good health outcomes of intermittent fasting for cardiac catheterisation patients.The study showed that patients who practised intermittent fasting lived longer than those who didn't. In addition, they are less likely to be diagnosed with heart failure. Cardiac catheterisation is a procedure used to diagnose and treat certain cardiovascular conditions. "It is another example of how we're finding that regular fasting can lead to better health outcomes and longer lives," said the study's principal investigator Benjamin Horne, PhD, director of cardiovascular and genetic epidemiology at the Intermountain Healthcare Heart Institute.Researchers asked 2,001 intermountain patients undergoing cardiac catheterization from 2013 to 2015 a series of lifestyle questions, including whether or not they practised routine intermittent fasting. They then followed up with those patients 4.5 years later and found that routine intermittent fasters had a greater survival rate than those who did not.Because people who fast routinely also are known to engage in other healthy behaviours, the study also evaluated other parameters including demographics, socioeconomic factors, cardiac risk factors, comorbid diagnoses, medications and treatments, and other lifestyle behaviours like smoking and alcohol consumption.Correcting statistically for these factors, long-term routine fasting remained a strong predictor of better survival and lower risk of heart failure, according to researchers. While the study does not show that fasting is the causal effect for better survival, these real-world outcomes in a large population do suggest that fasting may be having an effect and urge continued study of the behaviour. "While many rapid weight loss fasting diets exist today, the different purposes of fasting in those diets and in this study should not be confused with the act of fasting," said Dr Horne. "All proposed biological mechanisms of health benefits from fasting arise from effects that occur during the fasting period or are consequences of fasting," he added.Why long-term intermittent fasting leads to better health outcomes is still largely unknown, though Dr Horne said it could be a host of factors. Fasting affects a person's levels of haemoglobin, red blood cell count, human growth hormone, and lowers sodium and bicarbonate levels, while also activating ketosis and autophagy - all factors that lead to better heart health and specifically reduce risk of heart failure and coronary heart disease. "With the lower heart failure risk that we found, which is consistent with prior mechanistic studies, this study suggests that routine fasting at a low frequency over two-thirds of the lifespan is activating the same biological mechanisms that fasting diets are proposed to rapidly activate," Dr Horne noted.Researchers speculate that fasting routinely over a period of years and even decades conditions the body to activate the beneficial mechanisms of fasting after a shorter length of time than usual.

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Can intermittent fasting help you live long? - Times of India

Cardiac Stem Cells Comments Off on Can intermittent fasting help you live long? – Times of India | November 29th, 2019

VANCOUVER, British Columbia, Nov. 26, 2019 (GLOBE NEWSWIRE) -- Novoheart (Novoheart or the Company) (TSXV: NVH; FWB: 3NH), a global stem cell biotechnology company, is pleased to announce a collaboration with global biopharmaceutical company AstraZeneca, in an effort to develop the worlds first human-specific in vitro, functional model of heart failure with preserved ejection fraction (HFpEF), a common condition especially among the elderly and in women, with the reported prevalence approaching 10% in women over the age of 80 years.1

Heart failure (HF) is a global pandemic with an estimated 64.3 million cases worldwide in 2017, with an increasing trend in prevalence2. The annual global economic burden of HF is estimated at over US$100 billion3. Accounting for approximately 50% of HF cases, HFpEF in particular is a major and growing public health problem worldwide, with its pathological mechanisms and diverse etiology poorly understood. Due to these complexities, models of the disease available to date, including various animal models, have limited ability to mimic the clinical presentation of HFpEF4. Therefore, drug developers lack an effective tool for preclinical testing of drug candidates for efficacy, and as a result, clinical outcomes for HFpEF have not improved over the last decades, with no effective therapies available.

In collaboration with the Cardiovascular, Renal and Metabolism therapy area of AstraZeneca, the initial phase of the project aims to establish a new in vitro model, leveraging Novohearts proprietary 3-D human ventricular cardiac organoid chamber (hvCOC) technology, that reproduces key phenotypic characteristics of HFpEF. Also known as human heart-in-a-jar, the hvCOC is the only human engineered heart tissue available on the market to date that enables clinically informative assessment of human cardiac pump performance including ejection fraction and developed pressure. Unlike animal models, engineered hvCOCs can be fabricated with specific cellular and matrix compositions, and patient-specific human induced pluripotent stem cells (iPSCs), that allow control over their physical and mechanical properties to mimic those observed in HFpEF patient hearts. Together with Novohearts proprietary hardware and software, this aims to provide a unique assay for understanding the mechanisms of HFpEF, identification of new therapeutic targets, and assessment of novel therapeutics for treating HFpEF patients. Novoheart will exclusively own the intellectual property rights to the newly developed HFpEF hvCOC model.

We are delighted to partner with AstraZeneca, an organization which has long invested in cardiovascular research and is committed to bringing new therapeutic solutions to patients with heart failure, said Novoheart CSO, Dr. Kevin Costa. We look forward to co-developing this new HFpEF hvCOC model into a powerful new tool in the worldwide battle against heart failure.

Regina Fritsche Danielson, Senior Vice President, Head of Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, said, There are significant unmet treatment needs in patients with heart failure with preserved ejection fraction. By combining Novohearts proprietary hvCOC model with our expertise in heart failure, we aim to create the first in vitro model reproducing phenotypic characteristics of heart failure with preserved ejection fraction. This could bridge the gap between in vivo animal models and clinical trials to help accelerate the drug discovery process by providing human-specific preclinical data.

1 Heart Fail Clin. 2014; 10(3):377388.2 Lancet. 2018; 392:1789-1858.3 Int J Cardiol. 2014; 171(3):368-76.4 JACC Basic Transl Sci. 2017; 2(6):770-789.

About Novoheart:

Novoheart is a global stem cell biotechnology company pioneering an array of next-generation human heart tissue prototypes. It is the first company in the world to have engineered miniature living human heart pumps that can revolutionize drug discovery, helping to save time and money for developing new therapeutics. Also known as 'human heart-in-a-jar', Novohearts bio-artificial human heart constructs are created using state-of-the-art and proprietary stem cell and bioengineering approaches and are utilized by drug developers for accurate preclinical testing of the effectiveness and safety of new drugs, maximizing the successes in drug discovery whilst minimizing costs and harm caused to patients. With the recent acquisition of Xellera Therapeutics Limited for manufacturing Good Manufacturing Product (GMP)-grade clinical materials, Novoheart is now developing gene- and cell-based therapies as well as next-generation therapeutics for cardiac repair or regeneration.

For further information, please contact:Ronald Li, CEOinfo@novoheart.com

For media enquiries or interviews, please contact:Media Relationsmedia@novoheart.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Forward-Looking Statements

Information set forth in this news release may involve forward-looking statements under applicable securities laws. Forward-looking statements are statements that relate to future, not past, events. In this context, forward-looking statements often address expected future business and financial performance, and often contain words such as "anticipate", "believe", "plan", "estimate", "expect", and "intend", statements that an action or event "may", "might", "could", "should", or "will" be taken or occur, or other similar expressions. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the risks identified in under the heading Risk Factors in Novohearts annual information form for the year ended June 30, 2019 or other reports and filings with the TSX Venture Exchange and applicable Canadian securities regulators. Forward-looking statements are made based on management's beliefs, estimates and opinions on the date that statements are made and the respective companies undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as required by applicable securities laws. Investors are cautioned against attributing undue certainty to forward-looking statements.

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Novoheart to Co-develop First of its Kind Human Heart-in-a-Jar Model of Heart Failure with AstraZeneca - GlobeNewswire

Cardiac Stem Cells Comments Off on Novoheart to Co-develop First of its Kind Human Heart-in-a-Jar Model of Heart Failure with AstraZeneca – GlobeNewswire | November 29th, 2019

Hailie and Treylin Hyman saw the bruising on their baby girls leg as a symbol that the active 1-year-old was getting to walk.

But as a blood test would following disclose and reveal, little Maci was suffering from an extremely unusual blood cancer that scared her life outwardly a risky treatment a practice nearly as serious as the disease.

At the start, it was very scary, Hailie Hyman told the reports.

Terrifying periods followed the diagnosis, punctuated by one crucial difficulty after another, starting the Boiling Springs couple to wonder if Maci would remain and survive or not.

The Hymans course started last February at Macis 1-year-old well-child checkup.

We had no clue anything was incorrect, her mom told. But they did a normal (blood test) and a few hours later, we attended a call telling her platelets were very low.

The Hymans was transferred to a hematologist who gained other abnormalities in Macis blood and listed a bone marrow biopsy to examine further.

During the treatment, the child endured an aneurysm in an artery and progressed into cardiac arrest. The medical team gave CPR for 20 minutes before she was steadied, her mom told.

Later, in the Emergency room, she underwent internal bleeding, too.

It was difficult, she told. There were many times that I would just pray and pray and pray.

Initially considering Maci had leukemia, doctors finally discovered she had myelodysplastic syndrome or MDS.

The situation occurs when abnormal cells in the bone marrow leave the patient weak and unable to make adequate blood.

In children, its more uncommon still. Most people are diagnosed in their 70s.

Maci had to produce regular blood transfusions, antibiotics, and other medicines to struggle the MDS, Bryant stated. But the only support for a remedy was a stem cell transplant.

The transplant is very risky.

Its also laden with possibly life-threatening difficulties, including graft vs. host disease, which happens when immune cells from the donor strike the patients body, Bryant told. Other difficulties incorporate permanent kidney damage and gastrointestinal problems.

There were so many moments during her initial months that it appeared like she would not survive, Bryant stated. So the fact that she is here is a miracle.

Macis family got an anonymous donor by the National Marrow Donor Program, participating many individuals to register in the process, Bryant told.

Maci was admitted to MUSC on June 5 and discharged on Oct. 14.

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Toddler Bravely Cheats Death After He Survived Rare Cancer And Its Treatment - The Digital Weekly

Cardiac Stem Cells Comments Off on Toddler Bravely Cheats Death After He Survived Rare Cancer And Its Treatment – The Digital Weekly | November 29th, 2019

HONG KONG, Nov. 26, 2019 /PRNewswire/ --Novoheart("Novoheart" or the "Company") (TSXV: NVH; FWB: 3NH), a global stem cell biotechnology company, is pleased to announce a collaboration with global biopharmaceutical company AstraZeneca, in an effort to develop the world's first human-specific in vitro, functional model of heart failure with preserved ejection fraction (HFpEF), a common condition especially among the elderly and in women, with the reported prevalence approaching 10% in women over the age of 80 years.[1]

Heart failure (HF) is a global pandemic with an estimated 64.3 million cases worldwide in 2017, with an increasing trend in prevalence[2]. The annual global economic burden of HF is estimated at over US$100 billion[3]. Accounting for approximately 50% of HF cases, HFpEF in particular is a major and growing public health problem worldwide, with its pathological mechanisms and diverse etiology poorly understood. Due to these complexities, models of the disease available to date, including various animal models, have limited ability to mimic the clinical presentation of HFpEF[4]. Therefore, drug developers lack an effective tool for preclinical testing of drug candidates for efficacy, and as a result, clinical outcomes for HFpEF have not improved over the last decades, with no effective therapies available.

In collaboration with the Cardiovascular, Renal and Metabolism therapy area of AstraZeneca, the initial phase of the project aims to establish a new in vitro model, leveraging Novoheart's proprietary 3-D human ventricular cardiac organoid chamber (hvCOC) technology, that reproduces key phenotypic characteristics of HFpEF. Also known as "human heart-in-a-jar", the hvCOC is the only human engineered heart tissue available on the market to date that enables clinically informative assessment of human cardiac pump performance including ejection fraction and developed pressure. Unlike animal models, engineered hvCOCs can be fabricated with specific cellular and matrix compositions, and patient-specific human induced pluripotent stem cells (iPSCs), that allow control over their physical and mechanical properties to mimic those observed in HFpEF patient hearts. Together with Novoheart's proprietary hardware and software, this aims to provide a unique assay for understanding the mechanisms of HFpEF, identification of new therapeutic targets, and assessment of novel therapeutics for treating HFpEF patients. Novoheart will exclusively own the intellectual property rights to the newly developed HFpEF hvCOC model.

"We are delighted to partner with AstraZeneca, an organization which has long invested in cardiovascular research and is committed to bringing new therapeutic solutions to patients with heart failure," said Novoheart CSO, Dr. Kevin Costa. "We look forward to co-developing this new HFpEF hvCOC model into a powerful new tool in the worldwide battle against heart failure."

Regina Fritsche Danielson, Senior Vice President, Head of Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, said, "There are significant unmet treatment needs in patients with heart failure with preserved ejection fraction. By combining Novoheart's proprietary hvCOC model with our expertise in heart failure, we aim to create the first in vitro model reproducing phenotypic characteristics of heart failure with preserved ejection fraction. This could bridge the gap between in vivo animal models and clinical trials to help accelerate the drug discovery process by providing human-specific preclinical data."

[1] Heart Fail Clin. 2014; 10(3):377-388.

[2] Lancet. 2018; 392:1789-1858.

[3] Int J Cardiol. 2014; 171(3):368-76.

[4]JACC Basic Transl Sci. 2017; 2(6):770-789.

About Novoheart:

Novoheartis a global stem cell biotechnology company pioneering an array of next-generation human heart tissue prototypes. It is the first company in the world to have engineered miniature living human heart pumps that can revolutionize drug discovery, helping to save time and money for developing new therapeutics. Also known as 'human heart-in-a-jar', Novoheart's bio-artificial human heart constructs are created using state-of-the-art and proprietary stem cell and bioengineering approaches and are utilized by drug developers for accurate preclinical testing of the effectiveness and safety of new drugs, maximizing the successes in drug discovery whilst minimizing costs and harm caused to patients. With the recent acquisition of Xellera Therapeutics Limited for manufacturing Good Manufacturing Product (GMP)-grade clinical materials, Novoheart is now developing gene- and cell-based therapies as well as next-generation therapeutics for cardiac repair or regeneration.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Forward-Looking Statements

Information set forth in this news release may involve forward-looking statements under applicable securities laws. Forward-looking statements are statements that relate to future, not past, events. In this context, forward-looking statements often address expected future business and financial performance, and often contain words such as "anticipate", "believe", "plan", "estimate", "expect", and "intend", statements that an action or event "may", "might", "could", "should", or "will" be taken or occur, or other similar expressions. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the risks identified in under the heading "Risk Factors" in Novoheart's annual information form for the year ended June 30, 2018 or other reports and filings with the TSX Venture Exchange and applicable Canadian securities regulators. Forward-looking statements are made based on management's beliefs, estimates and opinions on the date that statements are made and the respective companies undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as required by applicable securities laws. Investors are cautioned against attributing undue certainty to forward-looking statements.

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Novoheart to Co-develop First of its Kind Human Heart-in-a-Jar Model of Heart Failure with AstraZene - PharmiWeb.com

Cardiac Stem Cells Comments Off on Novoheart to Co-develop First of its Kind Human Heart-in-a-Jar Model of Heart Failure with AstraZene – PharmiWeb.com | November 28th, 2019

A handful of biotech companies have been laboring for years to turn stem cells into treatments that can repair damaged tissue after a heart attack, but with limited success. A team from the Cincinnati Children's Hospital Medical Center tracked stem cells injected into the hearts of mice, and what they found could explain why this particular attempt at regenerative medicine has not proven effectiveand inspire new ideas for repairing damaged heart tissue.

The researchers injected both live and dead heart stem cells into mice with damaged hearts and discovered that the procedure touched off extreme inflammation. That inflammatory response generated a healing process, which in turn improved the mechanical properties of the injured area, they reported in the journal Nature.

During the study, the scientists used two types of stem cells that have been tested for the treatment of damaged heart tissue in clinical trials: cardiac progenitor cells and bone marrow mononuclear cells. They also tried injecting the chemical zymosan, which has been shown to prompt an immune response that can promote healing.

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All three treatments activated macrophage cells from the immune system, which helped the animals hearts heal with a more optimized scar and improved contractile properties, said lead investigator Jeffery Molkentin, Ph.D., director of Molecular Cardiovascular Microbiology at Cincinnati Children's Hospital Medical Center and professor at the Howard Hughes Medical Institute, in a statement.

Problem is, the initial goal of injecting stem cells into patients with damaged hearts was to regenerate cardiomyocytes. The Cincinnati team had previously reported that c-kit+ cardiac progenitor cells only produce tiny amounts of new cardiomyocytesnot nearly enough to provide any therapeutic value.

This new study validated that finding, leading Molkentin and colleagues to propose that cardiac researchers re-evaluate the current planned cell therapy based clinical trials to ask how this therapy might really work.

Whats more, the researchers found that stem cells and zymosan were only effective if they were injected directly into mouse hearts in the areas where the damage had occurred. This approach is at odds with most stem cell clinical trials, which involve infusing cells into the circulatory system.

Our results show that the injected material has to go directly into the heart tissue flanking the infarct region. This is where the healing is occurring and where the macrophages can work their magic, Molkentin said.

RELATED: Stem cell combo repairs damaged hearts in rats

The findings from the Cincinnati team could prove valuable in a field that has seen its share of disappointments. Australia-based Mesoblast, for one, released results from a phase 2 trial last year that showed patients who received injections of mesenchymal precursor cells did not improve to the point where they could stop using their left ventricular assist devices.

And the National Heart, Lung, and Blood Institute of the National Institutes of Health had to halt a trial testing c-kit+ cells and mesenchymal stem cells in patients with heart failure because of safety concerns.

The Cincinnati Children's Hospital researchers believe their findings could inspire new regenerative approaches to treating heart disease. They are now planning further studies focused on harnessing the healing power of macrophages.

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Stem cells don't repair injured hearts, but inflammation might, study finds - FierceBiotech

Cardiac Stem Cells Comments Off on Stem cells don’t repair injured hearts, but inflammation might, study finds – FierceBiotech | November 28th, 2019

Hailie Hyman holds her daughter Maci, 1, before an appointment at the Prisma Health Pediatric Hematology Oncology Center Monday, Nov. 4, 2019.(Photo: JOSH MORGAN/Staff)

GREENVILLE, S.C.Hailie and Treylin Hyman saw the bruising on their baby girls leg as a sign that the active 1-year-old was learning to walk.

But as a blood test would later reveal, little Maci was actually suffering from an extremely rare blood cancer that threatened her life without a risky treatment - atreatmentalmost as dangerous as the disease.

In the beginning, it was very scary, Hailie Hyman told The Greenville News.

I couldnt think of anything but the bad things, she confessed. It was all about the statistics. And the statistics arent good.

Terrifying months followed the diagnosis, punctuated by one critical complication after another, leaving the Boiling Springs couple to wonder if Maci would survive.

Somehow, though, the blue-eyed toddler pulled through.And now her family is looking forward to a special Thanksgiving with much to be grateful for.

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The Hymans journey began last February atMacis 1-year-old well-child checkup.

We had no idea anything was wrong, her mom said.But they did a routine (blood test) and a couple of hours later, we got a call saying her platelets were very low.

The Hymans were referred to a hematologist who found other abnormalities in Macis blood and scheduled a bone marrow biopsy to investigate further.

Hailie Hyman holds her daughter Maci, 1, before an appointment at the Prisma Health Pediatric Hematology Oncology Center Monday, Nov. 4, 2019.(Photo: JOSH MORGAN/Staff)

During the procedure, the child suffered an aneurysm in an artery and went into cardiac arrest. The team performed CPR on her for 20 minutes before she was stabilized, her mom said.

Later, in the pediatric intensive care unit, she suffered internal bleeding, too.

It was really hard, she said. There were many nights that I would just pray and pray and pray.

Initially believing Maci had leukemia, doctors subsequently determined she had myelodysplastic syndrome, or MDS.

The condition occurs when abnormal cells in the bone marrow leave the patient unable to make enough blood, according to the American Cancer Society.

Its rare, afflicting as few 10,000 Americans a year, though the actual number is unknown.

Maci Hyman, 1, interacts with hospital staff before an appointment at the Prisma Health Pediatric Hematology Oncology Center Monday, Nov. 4, 2019.(Photo: JOSH MORGAN/Staff)

In children, its rarer still. Most people arediagnosed in their 70s.

We were told that just four out of 1 million children get it every year, Hailie Hyman said.

That made the diagnosis elusive at first, said Dr. Nichole Bryant, a pediatric hematologist-oncologist with Prisma Health-Upstate, formerly Greenville Health System.

Shes the only one Ive seen in my career, she said.

Maci had to have regular blood transfusions, antibiotics and other medications to fight the MDS, Bryant said. But the only hope for a cure was a stem cell transplant at the Medical University of South Carolina in Charleston.

When they said that was the only treatment plan for MDS, I of course went to Google, Hailie Hyman said. I read about transplant patients and ...all the complications. It was terrifying. But no matter how many bad things I saw, we had to do it. There is no other option.

The transplantis extremely risky.

Hailie Hyman looks at a fish tank with her daughter Maci, 1, before an appointment at the Prisma Health Pediatric Hematology Oncology Center Monday, Nov. 4, 2019.(Photo: JOSH MORGAN/Staff)

First, high doses of chemotherapy are given to destroy the diseased bone marrow, leaving the patient without an immune system, so fighting infections becomes a challenge. Then healthy donor marrow is infused.

Its also fraught with potentially life-threatening complications, including graft vs. host disease, which occurs when immune cells from the donor attack the patients body, Bryant said. Other complications include permanent kidney damage and gastrointestinal problems.

They have to go to hell and back, she said. But its the only option for long-term survival.

Maci had a really rough start, suffering lots and lots and lots of complications, Bryant said.

Her kidneys failed, so she wound up on dialysis. When she couldnt breathe on her own, she was put on a ventilator. And because she couldnt eat, she had to be tube fed.

Hailie Hyman looks at a fish tank with her daughter Maci, 1, before an appointment at the Prisma Health Pediatric Hematology Oncology Center Monday, Nov. 4, 2019.(Photo: JOSH MORGAN/Staff)

She had blistering sores in her mouth and throughout her GI tract, her mom said. Because her liver wasnt functioning properly, her abdomen filled up with fluid that had to be drained. She was bleeding so profusely in her lungs that one of them collapsed.

Maci, who was sedated through much of it, was put on full life support, she said.

That night we almost lost her, her mom said. We were in the hallway crying our eyes out. We didnt know what do to or think. It was pretty scary for a while.

Somehow, Maci made it.

There were so many times during her first months that it seemed like she would not survive, Bryant said. So the fact that she is here ... is really a miracle.

Macis family found an unrelated donor through the National Marrow Donor Program, enlisting hundreds of other people to join the registry in the process, Bryant said.

Nichole Bryant, M.D.(Photo: Provided)

It was an important part of their journey that maybe didnt directly benefit Maci, she said. But if everybody did that, we wouldnt have difficulty finding a donor for anybody.

Doctors have no explanation for why Maci got MDS. She didnt carry the genetic mutation for it and there is no family history.

She is a rare child - and not in a good way, her mom said, adding,Youve got to laugh sometimes or youre going to cry.

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Maci was admitted to MUSC on June 2 and released on Oct. 14.

The Hymans, both 22, spent the entire time in Charlestonwhile Hailies mom cared for their older daughter, Athena, now 2.

Treylins employer held his welding job open for him. And other friends and family members did what they could to help.

We had many, many people very generously donate to us to cover expenses at home and living expenses where we were, Hailie Hyman said.

We are thankful for everyone who helped us through it the cards, the gifts, the donations. Every single cent is greatly appreciated.

Maci's doing well, but recovery from a transplant can take months to years, Bryant said.

Her kidneys are functioning again so she was able to come off dialysis. But she still must take many medications, including anti-rejection drugs that suppress her immune system and leaveher at risk for infection. And she still must be tube fed.

She is miles ahead of where she was two months ago, Bryant said. But she still has a long way to go. Its a long, long road.

Macis mom says she can be up and playing one day and flopped over on the couch another. She still experiences a lot of nausea and vomiting, but is doing well compared to where she was.

Hailie Hyman pulls her daughter Maci, 1, in a wagon in the hallway before an appointment at the Prisma Health Pediatric Hematology Oncology Center Monday, Nov. 4, 2019.(Photo: JOSH MORGAN/Staff)

So as the nation pauses to give thanks this Thanksgiving, she says the family will be countingtheir many blessings family andfriends, Gods mercy, andthe doctors and nurses who saved Macis life.

She has battled a lot and overcome a lot, she said. I have no doubt she will be able to get through.

Want to know more about becoming a marrow donor? Go to bethematch.org.

Follow Liv Osby on Twitter:@livgnews

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South Carolina toddler survives rare cancer and the risky procedure used to treat it - USA TODAY

Cardiac Stem Cells Comments Off on South Carolina toddler survives rare cancer and the risky procedure used to treat it – USA TODAY | November 28th, 2019

Recently, a new study that appears in the journal Nature, focuses on stem cell therapy and shows unexpected ways in which it may be helpful in recovering the health of the heart. Stem cell therapy has become popular in the past few years due to its benefits for a big number of health conditions.

Currently, there is major ongoing research on stem cells since they are responsible for the regeneration of new cells and may play a fundamental role in understanding the development of a variety of different diseases as well as their potential treatments.

Some of the recent discoveries of medical science include using stem cells as regenerative medicine as they can be turned into particular types of cells that may be able to replace tissues damaged as a result of health issues and thereby control the disease.

Read also:New Study Reveals Hydromethylthionine Slows Cognitive Decline and Brain Atrophy

The therapy can be specifically useful for people with conditions such as type 1 diabetes, spinal cord injuries, Alzheimers disease, Parkinsons disease, stroke, cancer, burns, amyotrophic lateral sclerosis, heart disease, and osteoarthritis.

At the moment, the most successful procedure that involves stem cell therapy is performing a bone marrow transplant. This surgical operation replaces the cells which have been damaged during chemotherapy by programmed stem cells. People are usually able to maintain and live a normal life after recovery from the surgery.

Furthermore, stem cell usage in clinical trials designed for testing the effectiveness, safety, and potential negative impact of new drugs. To do so, the stem cells can be programmed into becoming the type of cells that the drug aims to target.

The new study, which was led by Jeffery Molkentin who is a professor of the Howard Hughes Medical Institute (HHMI) and the director of Molecular Cardiovascular Microbiology a Cincinnati Childrens Hospital Medical Center, takes data from a study from the same journal, Nature, from the years 2014 which was conducted by the same medical team.

In the new paper, the team with Molkentin as the principal investigator found some unexpected results. There were two types of stem cells in the clinical trial cardiac progenitor cells and bone marrow mononuclear cells.

The main objective of the new trial was to re-evaluate the results of the 2014 study, which showed that injecting c-kit positive heart stem in the heart does not help in the regeneration of cardiomyocytes, to see how the cell therapy can be made to be effective.

It was instead discovered that injecting an inert chemical called zymosan, which is designed particularly for inducing an innate immune response, or dead stem cells can also be beneficial for the recovery of heart as they may speed up the healing procedure.

Injecting either dead stem cells or zymosan led to a reduction in the development of cellular matrix connective tissue in the areas which had been damaged in the heart. In addition, the mechanical properties of the targeted scar also improved.

Another important finding was that chemical substances such as zymosan are required to be injected directly into the heart for optimum results. In previous clinical trials, direct injections were avoided for safety reasons.

Molkentin and the team state that follow-up studies and trials on this new discovery are imminent as they may be important for developing therapies in the future.

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Stem Cell Therapy May Improve Heart Health In New Ways - TheHealthMania

Cardiac Stem Cells Comments Off on Stem Cell Therapy May Improve Heart Health In New Ways – TheHealthMania | November 28th, 2019

Appiah rang Leukaemia Cares helpline from the point of diagnosis until well after the end of her daughters life. Sometimes Id call them as a means of support, she says, when things got really rough, when her medications were really powerful, and the chemo made her so unwell. She rang when she had panic attacks; an NHS psychologist had told her that these were likely, and that she should breathe into a brown paper bag, but Appiah found speaking to a person more soothing.

With a laugh, Appiah notes that shed ring the helpline at other times, too: Sometimes Id be out with Imogin, and shed be in the pram, being naughty, and all of my patience was going down the drain, and Id phone Leukaemia Cares nurses, and say: Look, Im feeling so depressed, my daughters shouting, I dont know what to do!

But I might also say: Nurse, Im actually feeling good today.

Appiah says the support of an independent person was invaluable: When your child is so ill, you need to speak to someone who doesnt know your name you need an outsider you can unload to. I didnt want anyone thinking: Here Sheila comes again!

You become self-conscious about your situation and dont want to be a burden on your friends and family. With the helpline, you wont be judged: they just listen. You get it out of your system and then go do the shopping at Sainsburys.

When Imogin was well, shed go to school. But she also spent weeks at a time in isolation in St Georges Hospital, with her mother by her side. Once, she had a bad reaction to a medication and went into cardiac arrest. She was crying and saying, Please, please! and they were giving her all sorts of medicine. The doctors were battling to keep her stable and I dived into the bed with her and told her: Youre going to be OK. I lay down with her and I started singing with her. And then, once she stabilised, she said: Now can I watch High School Musical?"

Appiah shakes her head, laughing: Thats what she was like: I was on thedoor of death, but I have something else planned. I want to watch my video and none of you are going to stop me!

Charities sent the pair to Disneyland Paris twice. The first time was fantastic, says Appiah, the second time Imogin was in and out of consciousness. But they said we should go, to make memories, Appiah explains. Imogin got to be a celebrity for a day and went to Hamleys in a limousine to get anything she wanted.

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'My daughter's death took me to the darkest place, but I've learned it's possible to come back' - Telegraph.co.uk

Cardiac Stem Cells Comments Off on ‘My daughter’s death took me to the darkest place, but I’ve learned it’s possible to come back’ – Telegraph.co.uk | November 28th, 2019

Stem Cell Assay Market: Snapshot

Stem cell assay refers to the procedure of measuring the potency of antineoplastic drugs, on the basis of their capability of retarding the growth of human tumor cells. The assay consists of qualitative or quantitative analysis or testing of affected tissues and tumors, wherein their toxicity, impurity, and other aspects are studied.

With the growing number of successful stem cell therapy treatment cases, the global market for stem cell assays will gain substantial momentum. A number of research and development projects are lending a hand to the growth of the market. For instance, the University of Washingtons Institute for Stem Cell and Regenerative Medicine (ISCRM) has attempted to manipulate stem cells to heal eye, kidney, and heart injuries. A number of diseases such as Alzheimers, spinal cord injury, Parkinsons, diabetes, stroke, retinal disease, cancer, rheumatoid arthritis, and neurological diseases can be successfully treated via stem cell therapy. Therefore, stem cell assays will exhibit growing demand.

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Another key development in the stem cell assay market is the development of innovative stem cell therapies. In April 2017, for instance, the first participant in an innovative clinical trial at the University of Wisconsin School of Medicine and Public Health was successfully treated with stem cell therapy. CardiAMP, the investigational therapy, has been designed to direct a large dose of the patients own bone-marrow cells to the point of cardiac injury, stimulating the natural healing response of the body.

Newer areas of application in medicine are being explored constantly. Consequently, stem cell assays are likely to play a key role in the formulation of treatments of a number of diseases.

Global Stem Cell Assay Market: Overview

The increasing investment in research and development of novel therapeutics owing to the rising incidence of chronic diseases has led to immense growth in the global stem cell assay market. In the next couple of years, the market is expected to spawn into a multi-billion dollar industry as healthcare sector and governments around the world increase their research spending.

The report analyzes the prevalent opportunities for the markets growth and those that companies should capitalize in the near future to strengthen their position in the market. It presents insights into the growth drivers and lists down the major restraints. Additionally, the report gauges the effect of Porters five forces on the overall stem cell assay market.

Global Stem Cell Assay Market: Key Market Segments

For the purpose of the study, the report segments the global stem cell assay market based on various parameters. For instance, in terms of assay type, the market can be segmented into isolation and purification, viability, cell identification, differentiation, proliferation, apoptosis, and function. By kit, the market can be bifurcated into human embryonic stem cell kits and adult stem cell kits. Based on instruments, flow cytometer, cell imaging systems, automated cell counter, and micro electrode arrays could be the key market segments.

In terms of application, the market can be segmented into drug discovery and development, clinical research, and regenerative medicine and therapy. The growth witnessed across the aforementioned application segments will be influenced by the increasing incidence of chronic ailments which will translate into the rising demand for regenerative medicines. Finally, based on end users, research institutes and industry research constitute the key market segments.

The report includes a detailed assessment of the various factors influencing the markets expansion across its key segments. The ones holding the most lucrative prospects are analyzed, and the factors restraining its trajectory across key segments are also discussed at length.

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Global Stem Cell Assay Market: Regional Analysis

Regionally, the market is expected to witness heightened demand in the developed countries across Europe and North America. The increasing incidence of chronic ailments and the subsequently expanding patient population are the chief drivers of the stem cell assay market in North America. Besides this, the market is also expected to witness lucrative opportunities in Asia Pacific and Rest of the World.

Global Stem Cell Assay Market: Vendor Landscape

A major inclusion in the report is the detailed assessment of the markets vendor landscape. For the purpose of the study the report therefore profiles some of the leading players having influence on the overall market dynamics. It also conducts SWOT analysis to study the strengths and weaknesses of the companies profiled and identify threats and opportunities that these enterprises are forecast to witness over the course of the reports forecast period.

Some of the most prominent enterprises operating in the global stem cell assay market are Bio-Rad Laboratories, Inc (U.S.), Thermo Fisher Scientific Inc. (U.S.), GE Healthcare (U.K.), Hemogenix Inc. (U.S.), Promega Corporation (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), STEMCELL Technologies Inc. (CA), Cell Biolabs, Inc. (U.S.), and Cellular Dynamics International, Inc. (U.S.).

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Stem Cell Assay Market Demand with Leading Key Players and New Investment Opportunities Emerge To Augment Segments in Sector By 2025 - The Denton...

Cardiac Stem Cells Comments Off on Stem Cell Assay Market Demand with Leading Key Players and New Investment Opportunities Emerge To Augment Segments in Sector By 2025 – The Denton… | November 28th, 2019

Injections of stem cellseither a patients own or from a donorinto the hearts of people with cardiac conditions has been shown in some cases to improve heart function. How the cells help has been a mystery. A paper in Nature today (November 27) shows that activation of an innate immune response can explain, and even recapitulate, the beneficial effects of stem cell transplants in the hearts of mice.

The findings suggest stem cells may not be required to boost cardiac repair, but some researchers argue that, by finally providing a mechanistic explanation, the study supports the use of cell therapy.

This work is paradigm-shifting because it demonstrates a mechanism to explain a perplexing phenomenon that has intrigued cardiologists as a result of decades of cardiac stem cell trials, writes cardiologist Jonathan Epstein of the University of Pennsylvanias Perelman School of Medicine in an email to The Scientist. Now the focus can shift from injecting cells into the heart to understanding how to modulate the immune system so that heart function is improved, continues Epstein, who was not involved in the study.

The idea of applying stem cells, derived from the bone marrow or elsewhere, to the heart to fix damage caused by myocardial infarction or cardiovascular disease has been the subject of intense pre-clinical and clinical investigations for the best part of two decades, and yet the field is highly controversial. Aside from the retractions of fraudulent papers that misguided the larger heart regeneration community for years, the observed benefits of cell transplant therapies are generally modest and, because the underlying mechanism of repair is unknown, there is a lack of consensus about which of the many types of stem cells and delivery approaches might work best, as well as which types of patients may benefit.

A better knowledge of the mechanism would drive better clinical trial design, says Jeffery Molkentin, a cardiovascular biologist at Cincinnati Children's Hospital Medical Center who led the latest project. Indeed, he says, if mechanistic studies had been done up-front then we would have been much further along in the clinical trials [at this point].

For transplanted cells to produce functional benefits in the heart, its likely the cells would need to remain there after injection. So Molkentins team studied a variety of stem cell types injected into mice to see if any of them ever engrafted in the heart, he says. We had a list of five of the most prominent ones and none of the five ever engrafted, and they were all cleared within less than two weeks and sometimes within five or six days. But, the team did spot something else happening. In all [cases], he says, there was this really noticeable inflammatory response.

The team then showed that whether they injected live stem cells, dead stem cells, or zymosana potent activator of the innate immune systeminto the hearts of mice that had been given an experimental myocardial infarction, functional improvement of the heart occurred. By contrast, an injection of cyclosporinewhich suppresses the innate immune systemafter the cell delivery eliminated the beneficial effects.

The team went on to show that in the injured hearts of mice that received cell therapy or zymosan treatment there was evidence of improved muscle mechanical properties as well as scar remodeling and reduction. Both treatments recruited certain subtypes of macrophages that experiments indicated were driving this remodeling.

A heart attack triggers innate immunity automatically, prompting the essential scarring without which the heart would rupture, says Molkentin. The cell therapy (or zymosan treatment), being delayed by one week, does not exacerbate this initial inflammation, he says, but instead somehow realigns the healing process and makes for a better scar.

It seems like it optimize[s] the properties of the area around the scar and the contractility of that area, Molkentin says, but we dont know exactly why yet. . . . Were trying to figure this out.

Whatever the precise mechanism, the study shows the importance of the immune system, says Paul Riley of the University of Oxford who studies regenerative medicine but was not involved in the research. Its certainly very important for the field to be aware of this [finding], he continues. It will stimulate further interest in targeting or modulating, or thinking about the way the immune response . . . can effect more optimal function and repair after acute myocardial infarction.

If the results hold true in humans, it could have implications for any future trials in which patients might receive immunosuppression to prevent cell rejection, suggests Riley. Although its not thought any such trials are currently underway, according to Molkentin and Joshua Hare, a cardiologist and stem cell researcher at the University of Miami who was not involved in the study, if embryonic stem cells were ever approved for trial they would require immunosuppressives, Hare says.

Hare has been involved in a number of stem cell therapy trials and sees the paper not as evidence that the stem cells themselves arent necessary, but instead as a mechanistic explanation for the fact that they do work. It is often the case in medicine, he says, that once a treatment is in use, we change our perspective on how they work. Fundamentally, he says, we know that the cells are working, and that theyre safe. He therefore thinks the paper supports the field and . . . substantiates that we were on the right track. That said, he adds, If someone takes these findings and comes up with a better approach, a safer approach, a more efficacious approach, thats great.

R.J. Vagnozzi et al., An acute immune response underlies the benefit of cardiac stem-cell therapy,Nature, doi:10.1038/s41586-019-1802-2,2019.

Ruth Williams is a freelance journalist based in Connecticut. Email her atruth@wordsbyruth.comor find her on Twitter @rooph.

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Activation of the Immune System Underlies Cardiac Cell Therapies - The Scientist

Cardiac Stem Cells Comments Off on Activation of the Immune System Underlies Cardiac Cell Therapies – The Scientist | November 27th, 2019

Transparency Market Research (TMR)has published a new report on the globalcell separation technology marketfor the forecast period of 20192027. According to the report, the global cell separation technology market was valued at ~US$ 5 Bnin 2018, and is projected to expand at a double-digit CAGR during the forecast period.

Overview

Cell separation, also known as cell sorting or cell isolation, is the process of removing cells from biological samples such as tissue or whole blood. Cell separation is a powerful technology that assists biological research. Rising incidences of chronic illnesses across the globe are likely to boost the development of regenerative medicines or tissue engineering, which further boosts the adoption of cell separation technologies by researchers.

Expansion of the global cell separation technology market is attributed to an increase in technological advancements and surge in investments in research & development, such asstem cellresearch and cancer research. The rising geriatric population is another factor boosting the need for cell separation technologies Moreover, the geriatric population, globally, is more prone to long-term neurological and other chronic illnesses, which, in turn, is driving research to develop treatment for chronic illnesses. Furthermore, increase in the awareness about innovative technologies, such as microfluidics, fluorescent-activated cells sorting, and magnetic activated cells sorting is expected to propel the global cell separation technology market.

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North America dominated the global cell separation technology market in 2018, and the trend is anticipated to continue during the forecast period. This is attributed to technological advancements in offering cell separation solutions, presence of key players, and increased initiatives by governments for advancing the cell separation process. However, insufficient funding for the development of cell separation technologies is likely to hamper the global cell separation technology market during the forecast period. Asia Pacific is expected to be a highly lucrative market for cell separation technology during the forecast period, owing to improving healthcare infrastructure along with rising investments in research & development in the region.

Rising Incidences of Chronic Diseases, Worldwide, Boosting the Demand for Cell Therapy

Incidences of chronic diseases such as diabetes, obesity, arthritis, cardiac diseases, and cancer are increasing due to sedentary lifestyles, aging population, and increased alcohol consumption and cigarette smoking. According to the World Health Organization (WHO), by 2020, the mortality rate from chronic diseases is expected to reach73%, and in developing counties,70%deaths are estimated to be caused by chronic diseases. Southeast Asia, Eastern Mediterranean, and Africa are expected to be greatly affected by chronic diseases. Thus, the increasing burden of chronic diseases around the world is fuelling the demand for cellular therapies to treat chronic diseases. This, in turn, is driving focus and investments on research to develop effective treatments. Thus, increase in cellular research activities is boosting the global cell separation technology market.

Increase in Geriatric Population Boosting the Demand for Surgeries

The geriatric population is likely to suffer from chronic diseases such as cancer and neurological disorders more than the younger population. Moreover, the geriatric population is increasing at a rapid pace as compared to that of the younger population. Increase in the geriatric population aged above 65 years is projected to drive the incidences of Alzheimers, dementia, cancer, and immune diseases, which, in turn, is anticipated to boost the need for corrective treatment of these disorders. This is estimated to further drive the demand for clinical trials and research that require cell separation products. These factors are likely to boost the global cell separation technology market.

According to the United Nations, the geriatric population aged above 60 is expected to double by 2050 and triple by 2100, an increase from962 millionin 2017 to2.1 billionin 2050 and3.1 billionby 2100.

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Productive Partnerships in Microfluidics Likely to Boost the Cell Separation Technology Market

Technological advancements are prompting companies to innovate in microfluidics cell separation technology. Strategic partnerships and collaborations is an ongoing trend, which is boosting the innovation and development of microfluidics-based products. Governments and stakeholders look upon the potential in single cell separation technology and its analysis, which drives them to invest in the development ofmicrofluidics. Companies are striving to build a platform by utilizing their expertise and experience to further offer enhanced solutions to end users.

Stem Cell Research to Account for a Prominent Share

Stem cell is a prominent cell therapy utilized in the development of regenerative medicine, which is employed in the replacement of tissues or organs, rather than treating them. Thus, stem cell accounted for a prominent share of the global market. The geriatric population is likely to increase at a rapid pace as compared to the adult population, by 2030, which is likely to attract the use of stem cell therapy for treatment. Stem cells require considerably higher number of clinical trials, which is likely to drive the demand for cell separation technology, globally. Rising stem cell research is likely to attract government and private funding, which, in turn, is estimated to offer significant opportunity for stem cell therapies.

Biotechnology & Pharmaceuticals Companies to Dominate the Market

The number of biotechnology companies operating across the globe is rising, especially in developing countries. Pharmaceutical companies are likely to use cells separation techniques to develop drugs and continue contributing through innovation. Growing research in stem cell has prompted companies to own large separate units to boost the same. Thus, advancements in developing drugs and treatments, such as CAR-T through cell separation technologies, are likely to drive the segment.

As per research, 449 public biotech companies operate in the U.S., which is expected to boost the biotechnology & pharmaceutical companies segment. In developing countries such as China, China Food and Drug Administration(CFDA) reforms pave the way for innovation to further boost biotechnology & pharmaceutical companies in the country.

Global Cell Separation Technology Market: Prominent Regions

North America to Dominate Global Market, While Asia Pacific to Offer Significant Opportunity

In terms of region, the global cell separation technology market has been segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America dominated the global market in 2018, followed by Europe. North America accounted for a major share of the global cell separation technology market in 2018, owing to the development of cell separation advanced technologies, well-defined regulatory framework, and initiatives by governments in the region to further encourage the research industry. The U.S. is a major investor in stem cell research, which accelerates the development of regenerative medicines for the treatment of various long-term illnesses.

The cell separation technology market in Asia Pacific is projected to expand at a high CAGR from 2019 to 2027. This can be attributed to an increase in healthcare expenditure and large patient population, especially in countries such as India and China. Rising medical tourism in the region and technological advancements are likely to drive the cell separation technology market in the region.

Launching Innovative Products, and Acquisitions & Collaborations by Key Players Driving Global Cell Separation Technology Market

The global cell separation technology market is highly competitive in terms of number of players. Key players operating in the global cell separation technology market include Akadeum Life Sciences, STEMCELL Technologies, Inc., BD, Bio-Rad Laboratories, Inc., Miltenyi Biotech, 10X Genomics, Thermo Fisher Scientific, Inc., Zeiss, GE Healthcare Life Sciences, PerkinElmer, Inc., and QIAGEN.

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Cell Separation Technology Market Size Projected to Rise Lucratively During 2019 2027 - News Description

Cardiac Stem Cells Comments Off on Cell Separation Technology Market Size Projected to Rise Lucratively During 2019 2027 – News Description | November 27th, 2019

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA, Mercks anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China in combination with carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). This new indication was granted full approval based on overall survival (OS) findings from the pivotal Phase 3 KEYNOTE-407 trial, including interim data from an extension of the global study in Chinese patients. With this third first-line approval in NSCLC in less than one year, KEYTRUDA is now the first anti-PD-1 therapy approved in China in combination with chemotherapy for the first-line treatment of squamous and nonsquamous NSCLC, as well as in the monotherapy setting for appropriate patients with NSCLC (tumor proportion score [TPS] 1%).

In KEYNOTE-407, KEYTRUDA in combination with chemotherapy significantly improved both overall survival and progression-free survival in patients with metastatic squamous non-small cell lung cancer, said Prof. Ying Cheng, director of Jilin Cancer Hospital. Lung cancer is the leading cause of cancer death in China, so this approval represents an important milestone for the patients and families facing this difficult-to-treat disease.

In KEYNOTE-407, data from a pre-specified interim analysis showed that KEYTRUDA in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) resulted in a statistically significant improvement in OS and progression-free survival (PFS), the dual primary endpoints, compared to chemotherapy alone. Specifically, KEYTRUDA in combination with chemotherapy reduced the risk of death by 36% compared to chemotherapy alone (HR=0.64 [95% CI, 0.49-0.85]; p=0.0017). KEYTRUDA in combination with chemotherapy also demonstrated an improvement in PFS, with a reduction in the risk of progression or death by 44% compared to chemotherapy alone (HR=0.56 [95% CI, 0.45-0.70]; p<0.0001). In the extension of the global study in Chinese patients, KEYTRUDA in combination with chemotherapy reduced the risk of death by 56% compared to chemotherapy alone (HR=0.44 [95% CI, 0.24-0.81]). The China extension study also demonstrated an improvement in PFS, with a reduction in the risk of progression or death by 68% compared to chemotherapy alone (HR=0.32 [95% CI, 0.21-0.49]). Additional findings from the KEYNOTE-407 China extension study were recently presented at the European Society for Medical Oncology (ESMO) Asia 2019 Congress.

This approval expands our current lung cancer indications in China to include KEYTRUDA in combination with chemotherapy in patients with squamous cell carcinoma, a particularly difficult-to-treat type of lung cancer, said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. Importantly, KEYTRUDA provides a foundation for the treatment of lung cancer in China and now more patients with non-small cell lung cancer may have the opportunity to benefit from combination therapy with KEYTRUDA.

In less than one year, we have received three first-line approvals for KEYTRUDA, in combination with chemotherapy or as monotherapy, in non-small cell lung cancer, said Joseph Romanelli, president of MSD in China. KEYTRUDA, in combination with chemotherapy or as monotherapy, has demonstrated a significant survival benefit versus chemotherapy and we will continue to work closely with the external stakeholders to bring this important treatment option to patients.

About Lung Cancer in China

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death in China and worldwide. Each year, more than 787,000 new cases of lung cancer are diagnosed in China and more than 631,000 deaths result from the disease. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. There are several subtypes of NSCLC, including adenocarcinoma (accounting for 40% of lung cancers), squamous cell carcinoma (25 to 30%) and large cell carcinoma (10 to 15%).

About KEYTRUDA (pembrolizumab) Injection

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,000 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected Indications for KEYTRUDA (pembrolizumab) in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for the treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [CPS 10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grade 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%), receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid function (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or 4 hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including cHL, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with HCC were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 3-4) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent of which (1%) included hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%). The most common adverse reactions (>1%) resulting in permanent discontinuation of KEYTRUDA, axitinib or the combination were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). When KEYTRUDA was used in combination with axitinib, the most common adverse reactions (20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

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Merck's KEYTRUDA (pembrolizumab) Now Approved in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in...

Cardiac Stem Cells Comments Off on Merck’s KEYTRUDA (pembrolizumab) Now Approved in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in… | November 26th, 2019

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Stem Cell Therapy Market: Snapshot

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

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One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

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Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Stem Cell Therapy Market Segmentation, Assessment and Growth Opportunities by Forecast 2025 - Tech Admirers

Cardiac Stem Cells Comments Off on Stem Cell Therapy Market Segmentation, Assessment and Growth Opportunities by Forecast 2025 – Tech Admirers | November 26th, 2019

Stem cells are incredible. Science is only starting to scratch the surface of how these amazing cells can help people suffering from heart failure and other cardiovascular issues. Heres some information on what stem cells are, and how they may help heart attack patients and others who have problems involving their heart tissue.

There are more than 200 kinds of cells in the body, and each type is specifically structured for the job its supposed to do. There are skin cells, nerve cells, and cells that form heart tissue and other tissues in the body.1

Theyre found in bone marrow, blood vessels, the liver, the brain, and other parts of the body. Stem cells are even found in the umbilical cord. These sophisticated cells change over time as the body matures. Some of them disappear shortly after youre born, while others stay with you for a lifetime.2

There are three main types of stem cells tissue-specific (adult stem cells), embryonic stem cells, and induced pluripotent (iPS) stem cells. Heres a quick look at each type:

These typically reside in a specific organ, generating other cells to support the health of that organ. They replace those that are lost through injury, or through everyday living.3

Embryonic stem cells form about three to five days after a sperm fertilizes an egg. These are also known as pluripotent cells. This simply means they can develop into any sort of cell the body needs to develop.4

Embryonic cells have been the source of a massive controversy. The main reason is that harvesting these cells destroys the embryo.5 Scientists are working to develop iPS cells that come from adult stems cells rather than embryonic cells. Early research indicates that these cells may share many of the same characteristics of embryonic cells. But there are differences between the two, and there is more work to be done before scientists know exactly what those differences are.6

Research is ongoing into the potential use of stem cells for heart health. For example, work is being done to see if stem cells can help improve heart attack survival rates. Scientists are also looking into the potential for giving a patient their own cardiac stem cells after a heart attack, or even giving patients non-cardiac stem cells from a donor after an attack takes place.7

The goal of this research is to eventually provide cardiac patients with stem cells that can regenerate heart tissue that has been damaged. Some researchers feel that these advances are imminent, while others believe there is a great deal of work yet to be done.8

Early results from ongoing clinical trials involving stem cells for heart health are extremely promising. In one study, a group of 109 patients suffering from heart failure received either stem cell therapy or a placebo. According to the results, the patients who received stem cells were at significantly lower risk of hospitalization or death due to a sudden worsening of their condition.9

Heart failure affects more than 5 million people in the U.S.10 It occurs when the heart gradually weakens to the point to where it cant pump enough blood to meet the needs of the rest of the body. For those with severe heart failure, the only options are either to have a heart transplant or have a device planted to help the heart continue pumping. And even this is only a temporary measure theyll still need a transplant.11

Another study involved the use of stem cells from the umbilical cord. This trial involved 30 heart failure patients. Like the previous study, one group received stem cells while the other received a placebo. The umbilical cords were donated by healthy mothers whose babies were delivered through cesarean section.12

According to the results, the hearts of patients who received the umbilical cord stem cells pumped better than those of the placebo group. The stem cell patients also showed improved quality of life and day-to-day functioning. In addition, the stem cell group did not report any adverse effects, such as immune system reactions.13

As you can see, the use of stem cells to treat heart patients shows great promise. But this is still an extremely young scientific field, and a great deal more research must be performed. Many questions have to be answered, such as what approaches to stem cell harvesting will work the best and what types of side effects are possible from stem cell treatment.

However, this research does bring hope. And hope is something that is incredibly important to many of those suffering from severe cardiac illnesses.

Learn More:How Cardio Can Change Your Brain (And Why Thats Good News!)NEWS: A Vaccine For Arthritis Is Closer Than You ThinkAre Organ Donors At Risk of Becoming Obsolete?

Sources1.https://askabiologist.asu.edu/questions/human-cell-types2.https://www.medicalnewstoday.com/info/stem_cell3.http://www.closerlookatstemcells.org/learn-about-stem-cells/types-of-stem-cells4.https://stemcells.nih.gov/info/basics/3.htm5.http://www.cnn.com/2013/07/05/health/stem-cells-fast-facts/index.html6.http://www.closerlookatstemcells.org/learn-about-stem-cells/types-of-stem-cells#induced-pluripotent7.https://my.clevelandclinic.org/health/diseases/17508-stem-cell-therapy-for-heart-disease8.https://www.health.harvard.edu/heart-health/repairing-the-heart-with-stem-cells9.https://www.ncbi.nlm.nih.gov/pubmed/2705988710.https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm11.http://www.heart.org/HEARTORG/Conditions/HeartFailure/TreatmentOptionsForHeartFailure/Devices-and-Surgical-Procedures-to-Treat-Heart-Failure_UCM_306354_Article.jsp#.WleO-yMrJ3k12.https://www.medicalnewstoday.com/articles/319552.php13.http://circres.ahajournals.org/content/early/2017/09/15/CIRCRESAHA.117.310712

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Stem Cells For Heart Health: What The Current Research ...

Cardiac Stem Cells Comments Off on Stem Cells For Heart Health: What The Current Research … | November 25th, 2019

Cardiol Therapeutics Inc. is pleased to announce the formation of the Clinical Steering Committee for a Phase 2 international trial.

Cardiol Therapeutics Inc. (TSX:CRDL, OTCQX:CRTPF) (Cardiol or the Company), a leader in the production of pharmaceutical cannabidiol (CBD) products and in the development of innovative cannabidiol medicines for heart disease, is pleased to announce the formation of the Clinical Steering Committee (CSC) for a Phase 2 international trial in acute myocarditis using the Companys CardiolRx100 cannabidiol formulation.

The CSC, which comprises key opinion leaders in acute myocarditis from North America and Europe, recently met during the American Heart Associations Scientific Sessions in Philadelphia held November 16thto 18th. The role of the CSC is to advise on the trial design, provide overall supervision of the trial, and ensure that it is being conducted in accordance with the principles of Good Clinical Practice. The CSC has oversight of the protocol, any protocol amendments, and provides advice to the investigators on all aspects of the trial.

Acute myocarditis is characterized by inflammation of the heart muscle (myocardium). The most common cause is viral infection of the heart tissue which is initially responsible for the inflammation. In a significant number of cases, perhaps due to an autoimmune process, the inflammation persists with ongoing myocardial damage and depressed heart function. Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is the most common cause of sudden cardiac death in people less than 35 years old. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Symptoms include chest pain, fatigue, shortness of breath, and arrhythmias. Because of the progressive damage to heart cells, heart failure develops (defined as the inability of the heart to pump sufficient blood to meet the needs of the body). The study will use left ventricular ejection fraction (LVEF) as one measure of heart function.

CardiolRx100 is Cardiol Therapeutics pure pharmaceutically (cGMP) produced high concentration cannabidiol formulation that is THC free (<10ppm). Based on the large body of experimental evidence of the anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease, Cardiol believes there is an opportunity to develop a potential breakthrough therapy for acute myocarditis that would be eligible for designation as an orphan drug. In the United States, an orphan drug designation is granted for pharmaceuticals being developed to treat medical conditions affecting fewer than 200,000 people. These conditions are referred to as orphan diseases. In the U.S. and the European Union, orphan drugs are eligible for accelerated marketing approvals and companies developing orphan drugs typically receive other incentives, including a prolonged period of market exclusivity that can extend over seven years, during which the drug developer has sole rights to market the drug.

Cardiol has assembled eight highly distinguished thought leaders in cardiology from North America and Europe to oversee and guide our acute myocarditis trial that is being planned at world leading heart institutes, including the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, and Charit University Medicine Berlin, stated David Elsley, President and CEO of Cardiol Therapeutics. The U.S. orphan drug program was successfully utilized to accelerate the first FDA approval of cannabidiol for the treatment of two pediatric epilepsy orphan diseases. We see a similar opportunity with our international trial in acute myocarditis to fast track the development of our CardiolRx formulation for a serious cardiovascular orphan disease for which there is currently no accepted standard of care.

Members of Cardiols Acute Myocarditis CSC include:

Dennis M. McNamara, MD (Chair)

Dr. Dennis McNamara is a Professor of Medicine at the University of Pittsburgh. He is also the Director of the Heart Failure/Transplantation Program at the University of Pittsburgh Medical Center. Dr. McNamara received his undergraduate/graduate education at Yale University, New Haven, Connecticut, and Harvard Medical School, Boston, Massachusetts, respectively. He completed his internship, residency, and cardiology fellowship at Massachusetts General Hospital in Boston. McNamaras current research interests include etiology and pathogenesis of dilated cardiomyopathies; inflammatory syndromes of cardiovascular disease; myocardial recovery in recent onset non-ischemic primary cardiomyopathy; etiology and management of peripartum cardiomyopathy; and genetic modulation of outcomes in cardiovascular disease.

Leslie T. Cooper, Jr., MD (Co-Chair)

Dr. Leslie T. Cooper, Jr., is a general cardiologist and the chair of the Mayo Clinic Enterprise Department of Cardiovascular Medicine, as well as chair of the Department of Cardiovascular Medicine at the Mayo Clinic in Florida. Dr. Coopers clinical interests and research focus on clinical and translational studies of rare and undiagnosed cardiomyopathies, myocarditis, and inflammatory cardiac and vascular diseases, such as giant cell myocarditis, cardiac sarcoidosis, eosinophilic myocarditis, and Takayasus arteritis. He has published over 130 original peer-reviewed papers, as well as contributing to and editing books on myocarditis. In addition to his clinical and research work, Dr. Cooper is a fellow of the American College of Cardiology, the American Heart Association, the European Society of Cardiology Heart Failure Association, the International Society for Heart and Lung Transplantation, and the Society for Vascular Medicine and Biology. He is also the founder and former president of the Myocarditis Foundation and continues to serve on its Board of Directors.

Arvind Bhimaraj, MD

Dr. Arvind Bhimaraj is a specialist in Heart Failure and Transplantation Cardiology and is Assistant Professor of Cardiology, Institute for Academic Medicine, at Houston Methodist and at Weill Cornell Medical College, NYC. He has been Co-Director of the Heart Failure Research Laboratory at Houston Methodist since 2016. His area of focus is anti-fibrotic mechanisms and how to promote recovery of a damaged heart. Dr. Bhimaraj was a Heart Failure Fellow at the Cleveland Clinic from July 2010 to September 2011. Dr. Bhimaraj also specializes in Interventional Cardiology, is board certified in Cardiovascular Disease, and the author of numerous cardiovascular publications.

Matthias Friedrich, MD

Dr. Matthias Friedrich is Full Professor with the Departments of Medicine and Diagnostic Radiology at the McGill University in Montreal and Chief, Cardiovascular Imaging at the McGill University Health Centre. He is also Professor of Medicine at Heidelberg University in Germany. Dr. Friedrich earned his MD at the Friedrich-Alexander-University Erlangen-Nrnberg, Germany. He completed his training as an internist and cardiologist at the Charit University Medicine Center, Humboldt University in Berlin. Dr. Friedrich founded one of the first large Cardiovascular Magnetic Resonance centres in Germany at the Charit University Hospital in Berlin. After his move to Canada, from 2004 to 2011, he was Director of the Stephenson Cardiovascular MR Centre at the Libin Cardiovascular Institute of Alberta and Professor of Medicine within the Departments of Cardiac Sciences and Radiology at the University of Calgary, Canada. From 2011 to 2015, he directed the Philippa and Marvin Carsley Cardiovascular MR Centre at the Montreal Heart Institute and was Michel and Renata Hornstein Chair in Cardiac Imaging at the Universit de Montral.

Peter Liu, MD

Dr. Peter Liu is the Chief Scientific Officer and Vice President, Research, of the University of Ottawa Heart Institute, and Professor of Medicine and Physiology at the University of Toronto and University of Ottawa. He was the former Scientific Director of the Institute of Circulatory and Respiratory Health at the Canadian Institutes of Health Research, the major federal funding agency for health research in Canada. Prior to that role, he was the inaugural Director of the Heart & Stroke/Lewar Centre of Excellence in Cardiovascular Research at University of Toronto. Dr. Liu received his MD from the University of Toronto, and postgraduate training at Harvard University. His laboratory investigates the causes and treatments of heart failure, the role of inflammation, and the identification of novel biomarkers and interventions in cardiovascular disease. Dr. Liu has published over 300 peer-reviewed articles in high impact journals and received numerous awards in recognition of his research and scientific accomplishments.

Wai Hong Wilson Tang, MD

Dr. Wai Hong Wilson Tang is the Advanced Heart Failure and Transplant Cardiology specialist at the Cleveland Clinic in Cleveland, Ohio. Dr. Tang is also the Director of the Cleveland Clinics Center for Clinical Genomics; Research Director, and staff cardiologist in the Section of Heart Failure and Cardiac Transplantation Medicine in the Sydell and Arnold Miller Family Heart & Vascular Institute at the Cleveland Clinic. He attended and graduated from Harvard Medical School in 1996, having over 23 years of diverse experience, especially in Advanced Heart Failure and Transplant Cardiology. Dr. Tang is affiliated with many hospitals including the Cleveland Clinic and cooperates with other doctors and physicians in medical groups including The Cleveland Clinic Foundation.

Barry Trachtenberg, MD

Dr. Barry H. Trachtenberg is a cardiologist specializing in heart failure and cardiac transplantation. He is also the director of the Michael DeBakey Cardiology Associates Cardio-Oncology program, an evolving field devoted to prevention and management of cardiovascular complications of cancer therapies such as chemotherapy and radiation. His clinical experience includes heart failure and heart transplantation, mechanical support pumps, and cardio-oncology. He has contributed to multiple publications related to advanced heart failure, cardiac transplantation, regenerative therapies, and ventricular assist devices. Dr. Trachtenberg is a member of the American Heart Association, the International Society for Heart and Lung Transplantation, the Heart Failure Society of America, and the International CardiOncology Society of North America.

Carsten Tschpe, MD

Dr. Carsten Tschpe is Professor of Medicine and Cardiology and Vice Director of the Department of Internal Medicine and Cardiology, Charit University Medicine Berlin. He received his doctorate in medicine in 1993 and has over 140 peer-reviewed publications, including overview and book articles, and 120 international original articles. His research interests include inflammatory cardiomyopathy, diabetic cardiopathy, and ischemic cardiopathy. He also includes diastolic dysfunction, endothelial dysfunction, peptide systems, and experimental and clinical studies in cardiology and stem cells in his research studies. For his outstanding research work, Dr. Tschpe was awarded the prestigious Arthur Weber Prize by the German Cardiac Society Cardiovascular Research.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (TSX: CRDL)(OTCQX: CRTPF) is focused on producing pharmaceutical cannabidiol (CBD) products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure. The Companys lead product, CardiolRx, is designed to be one of the safest and most consistent CBD formulations on the market. CardiolRx is pharmaceutically produced, cGMP certified, and is THC free. The Company plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and is also pursuing distribution opportunities in Europe and Latin America.

In heart failure, Cardiol is planning an international clinical study of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary nanotechnology to uniquely deliver pharmaceutical CBD and other anti-inflammatory drugs directly to sites of inflammation in the heart that are associated with heart failure. Heart failure is the leading cause of death and hospitalization in North America with associated healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visitwww.cardiolrx.com.

For further information, please contact:

David Elsley, President & CEO+1.289.910.0850david.elsley@cardiolrx.com

Trevor Burns, Investor Relations+1.289.910.0855trevor.burns@cardiolrx.com

Cautionary statement regarding forward-looking information:

This news release contains forward-looking information within the meaning of applicable Canadian securities laws. All statements, other than statements of historical fact, that address activities, events or developments that Cardiol Therapeutics Inc. (Cardiol) believes, expects or anticipates will, may, could or might occur in the future are forward- looking information. Forward-looking information is frequently identified by the use of words such as plans, expects, projects, intends, believes, anticipates, forecasts, and other similar words and phrases, including variations (and negative variations) of such words and phrases, or may be identified by statements to the effect that certain actions, events or conditions may, could, should, would, or will be taken, occur or be achieved. Forward-looking information contained herein may include, but is not limited to, statements with respect to: future events; the future performance or the intended business strategy of Cardiol, including, but not limited to, the plan to commercialize CardiolRx100 and the planning of an international clinical study of CardiolRx in acute myocarditis; the potential for Cardiols licensed drug encapsulation and delivery technologies to enhance the bioavailability of pharmaceuticals; managements expectations regarding estimated future pharmaceutical research and development opportunities, collaborations and prospects; the success and proposed timing of Cardiols product development activities; the ability of Cardiol to develop its product candidates; Cardiols plans to research, discover, evaluate and develop additional products; Cardiols proposed future collaborations to advance Cardiols lead nanoformulations into clinical development; and the potential for Cardiols cannabinoid-based products to provide sources of future revenue. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information. These risks and uncertainties and other factors include that the success of Cardiols product candidates will require significant capital resources and years of clinical development efforts; the results of clinical testing and trial activities of Cardiols products; Cardiols ability to obtain regulatory approval and market acceptance of its products; Cardiols ability to raise capital and the availability of future financing; Cardiols lack of operating history; unforeseeable deficiencies in the development of Cardiols product candidates; uncertainties relating to the availability and costs of financing needed in the future for Cardiols research and development initiatives; Cardiols ability to manage its research, development, growth and operating expenses; the potential failure of clinical trials to demonstrate acceptable levels of safety and efficacy of Cardiols product candidates; Cardiols ability to retain key management and other personnel; risks related to fluctuations in medicinal cannabinoid markets in Canada and worldwide; uncertainties regarding Cardiols ongoing collaborative and manufacturing partnerships; uncertainties regarding results of researching and developing products for human use; Cardiol competes in a highly competitive and evolving industry; Cardiols ability to obtain and maintain current and future intellectual property protection; and other risks and uncertainties and factors. These risks, uncertainties and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events or results or otherwise. Although Cardiol believes that the expectations reflected in the forward-looking information are reasonable, they do involve certain assumptions, risks, and uncertainties and are not (and should not be considered to be) guarantees of future performance. It is important that each person reviewing this news release understands the significant risks attendant to the operations of Cardiol.

Click here to connect with Cardiol Therapeutics Inc. (TSX:CRDL) for an Investor Presentation.

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Cardiol Therapeutics Announces Clinical Steering Committee for Phase 2 International Trial in Acute Myocarditis Using CardiolRx(TM) 100 | INN -...

Cardiac Stem Cells Comments Off on Cardiol Therapeutics Announces Clinical Steering Committee for Phase 2 International Trial in Acute Myocarditis Using CardiolRx(TM) 100 | INN -… | November 25th, 2019

An artist rendering of a new generation of biobots developed by researchers at the University of Illinois--soft robotic devices powered by skeletal muscle tissue stimulated by on-board motor neurons. (Image source: Michael Vincent)

The next-generation of medical treatment and diagnosis likely will include tiny robots that can explore inside the human body and perform appointed tasks.

To drive this technological aim, researchers at the University of Illinois have developed soft, biological robotic devices that are self-driven using light-stimulated neuromuscular tissue and have intelligence, memory, and learning ability. The work brings researchers a step closer toward the development of autonomous biobots.

This is the first milestone towards intelligent biorobots that make themselves through self assembly, project leader Taher Saif, a mechanical science and engineering professor from the University of Illinois, told Design News.

Muscle cells mixed with an extra cellular matrix is dropped on the tail part, where muscle cells form the muscle tissue by self assembly, Saif told Design News. Neurons are placed on the head part of the swimmer from where they spread out and form junctions with the muscle. These neurons then fire and make the muscle contract.

The researchers published a paper on their recent work in the journal Proceedings of the National Academy of Sciences.

The recent work is a continuation of Saifs research on similar technology. In 2014, research teams led by Saif and a colleague, bioengineering professor Rashid Bashir, developed the first self-propelled biohybrid robots that could swim and walk, powered by beating cardiac muscle cells derived from rats.

While those robots could move on their own using biomaterials, they couldnt sense the environment or make decisions, Saif said.

The current work takes this technology a step further with biobots powered by skeletal muscle tissue and stimulated by on-board motor neurons, he said. The neurons have optogenetic properties derived from mouse stem cells; when exposed to light, they fire to actuate the muscle tissue.

Neurons make connections between each other forming a neural network, Saif explained. Some of the neurons form junctions with the muscle. The neurons fire and stimulate the muscle.

Once the muscle is stimulated, it contracts and moves the tails of the swimming biobot, Saif said. This motion of the tails make the swimmer propel forward.

Once the researchers ensured that the neuromuscular tissue used in the biobots was compatible with the synthetic biobot skeletons, they then set about to optimize the abilities of the swimming device. In particular, they aimed for the bot to be able to respond intelligently to environment cues by integrating neural units within biohybrid systems.

Given our understanding of neural control in animals, it may be possible to move forward with biohybrid neuromuscular design by using a hierarchical organization of neural networks, Saif said in a press statement.

Once these smart biobots are optimized, Saif and his team believe they can be used for various applications in bioengineering, medicine, and self-healing materials and technologies.

In the future, it is possible that such intelligent micro biorobots may swim towards a target tissue inside the body and deliver drugs on an on-demand basis, Saif told Design News.

The team plans to continue its work by exploring the use of multiple types of neurons in the biobot as well as to test the robots ability to sense and fire when a threshold signal such as a chemical gradient is exceeded.

Elizabeth Montalbano is a freelance writer who has written about technology and culture for more than 20 years. She has lived and worked as a professional journalist in Phoenix, San Francisco and New York City. In her free time she enjoys surfing, traveling, music, yoga and cooking. She currently resides in a village on the southwest coast of Portugal.

January 28-30:North America's largest chip, board, and systems event,DesignCon, returns to Silicon Valleyfor its 25th year!The premier educational conference and technology exhibition, this three-day event brings together the brightest minds across the high-speed communications and semiconductor industries, who are looking to engineer the technology of tomorrow. DesignCon is your rocket to the future. Ready to come aboard?Register to attend!

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Biobots are hybrid machines that have muscles and nerves - DesignNews

Cardiac Stem Cells Comments Off on Biobots are hybrid machines that have muscles and nerves – DesignNews | November 23rd, 2019

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved CALQUENCE (acalabrutinib) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The US approval was granted under the FDAs Real-Time Oncology Review and newly established Project Orbis programs.

The approval is based on positive results from the interim analyses of two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL. Together, the trials showed that CALQUENCE in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease progression or death versus the comparator arms in both 1st-line and relapsed or refractory CLL. Across both trials, the safety and tolerability of CALQUENCE were consistent with its established profile.

Dave Fredrickson, Executive Vice President, Oncology Business Unit said: With over 20,000 new cases anticipated this year in the US alone, todays approval of CALQUENCE provides new hope for patients with one of the most common types of adult leukemia, offering outstanding efficacy and a favorable tolerability profile. The chronic lymphocytic leukemia patient population is known to face multiple comorbidities, and tolerability is a critical factor in their treatment.

Dr. Jeff Sharman, Director of Research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for The US Oncology Network, and a lead author of the ELEVATE-TN trial, said: Tolerability remains an issue in the current treatment landscape of chronic lymphocytic leukemia, which may require ongoing therapy for many years. In the ELEVATE-TN and ASCEND trials comparing CALQUENCE to commonly used treatment regimens, CALQUENCE demonstrated a clinically meaningful improvement in progression-free survival in patients across multiple settings, while maintaining its favorable tolerability and safety profile.

The results of the interim analysis of the ELEVATE-TN trial will be presented at the upcoming American Society of Hematology congress.

The trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with either CALQUENCE in combination with obinutuzumab or CALQUENCE monotherapy versus chlorambucil chemotherapy plus obinutuzumab, a current standard-of-care combination used in the control arm.

In the CALQUENCE combination arm, risk of disease progression or death was reduced by 90% (HR 0.10; 95% CI, 0.06-0.17, p<0.0001) and in the monotherapy arm it was reduced by 80% (HR 0.20; 95% CI, 0.13-0.30, p<0.0001).

The median time to disease progression for patients treated with CALQUENCE in combination with obinutuzumab or as a monotherapy has not yet been reached vs. 22.6 months (95% CI, 20-28) for chlorambucil plus obinutuzumab.

ELEVATE-TN safety overview (most common ARs*, 15%):

Adverse reaction

CALQUENCE plus obinutuzumab(n=178)

CALQUENCE monotherapy(n=179)

Chlorambucil plus obinutuzumab(n=169)

Any

Grade 3

Any

Grade 3

Any

Grade 3

Infection

69%

22%

65%

14%

46%

13%

Neutropenia

53%

37%

23%

13%

78%

50%

Anemia

52%

12%

53%

10%

54%

14%

Thrombocytopenia

51%

12%

32%

3.4%

61%

16%

Headache

40%

1.1%

39%

1.1%

12%

0

Diarrhea

39%

4.5%

35%

0.6%

21%

1.8%

Musculoskeletal pain

37%

2.2%

32%

1.1%

16%

2.4%

Fatigue

34%

2.2%

23%

1.1%

24%

1.2%

Bruising

31%

0

21%

0

5%

0

Rash

26%

2.2%

25%

0.6%

9%

0.6%

Arthralgia

22%

1.1%

16%

0.6%

4.7%

1.2%

Dizziness

20%

0

12%

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CALQUENCE Approved in the US for Adult Patients With Chronic Lymphocytic Leukemia - Business Wire

Cardiac Stem Cells Comments Off on CALQUENCE Approved in the US for Adult Patients With Chronic Lymphocytic Leukemia – Business Wire | November 23rd, 2019

Surgeons in the operating room. Researchers at the University of Maryland believe rapidly cooling the body could put patients into a state of suspended animation.

A team of surgeons at the University of Maryland School of Medicine have placed a human patient in "suspended animation" for the first time, according to a report by New Scientist on Wednesday. The procedure is intended to prolong the time surgeons have to fix traumatic injuries by deliberately lowering patients' body temperatures.

The Emergency Preservation and Resuscitation (EPR) for Cardiac Arrest From Trauma (EPR-CAT) trial has been in the works since 2010 and intends to rapidly cool the body of patients presenting with extreme trauma -- like a gunshot or knife wound. The prognosis for this type of trauma is grim: Due to rapid blood loss, these patients go into cardiac arrest. With the heart stopped, there's only minutes for surgeons to stem the bleeding and get the heart pumping again before damage occurs. The odds of survival are between 2 to 5%.

Even if patients survive, the lack of oxygen caused by the injuries can result in permanent damage to the brain.

Samuel Tisherman, who is overseeing the EPR-CAT trial, suspects that rapid cooling or "induced hypothermia" can buy trauma patients extra time.

The clinical trial aims to alter the body's temperature by about 27 degrees Celsius, dropping it below 10 degrees Celsius (50 degrees Fahrenheit) with an ice-cold saline solution. In computing parlance, the idea is that induced hypothermia puts the body into a sort of "standby" mode. Metabolic processes slow down, our cells don't need as much oxygen and so cell damage is prevented. When the wounds are repaired, the system can be rebooted -- hopefully with no long-lasting effects to the hardware.

There's sound scientific reason to believe rapid cooling can achieve such miraculous feats.

The New York Times reported a similar trial in dogs (with the somewhat alarming headline "Zombie Dogs") in December 2005, where canines ventured into the afterlife and back again. After having their blood drained and going into cardiac arrest, the dogs were pumped full of a cool saline solution. Clinically, doctors would say the dogs were dead, but after three hours, the saline solution was replaced with blood and the dogs were warmed. They survived. Importantly, they didn't seem to suffer from any severe neurological deficits.

A cohort of 20 patients will be enrolled in the study -- 10 will receive EPR, 10 will not. Trauma patients can not consent to taking part in the trial, but the US Food and Drug Administration approved the trial on the proviso there is no alternative treatment, while also consulting with members of the community and allowing anyone to opt out, should they choose.

No results have been released but Tisherman discussed the trial at a symposium at the New York Academy of Sciences on Monday, revealing his team had trialed the suspended animation technique in one patient. The expected completion date is December 2019, with full results expected by the end of 2020.

Originally published 3:43 p.m PT

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Suspended animation induced in humans for the first time - CNET

Cardiac Stem Cells Comments Off on Suspended animation induced in humans for the first time – CNET | November 22nd, 2019

NORTH CHICAGO, Ill., Nov. 21, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that more than 40 abstracts, including 18 oral presentations, will be presented during the upcoming American Society of Hematology (ASH) Annual Meeting & Exposition, December 7-10, in Orlando, FL. New data include presentations on Ibrutinib (IMBRUVICA) plus venetoclax (VENCLEXTA/VENCLYXTO) among others.

"At this year's ASH Annual Meeting, AbbVie will showcase the latest scientific progress from our portfolio spanning various hematologic malignancies," said Mohamed Zaki, M.D., Ph.D., Head of Hematology Oncology, AbbVie. "We look forward to sharing the new data from our clinical development programs for ibrutinib and venetoclax, which continue to demonstrate the potential to transform care and improve the lives of people living with various difficult-to-treat blood cancers."

Data from two studies of ibrutinib combination regimens in the first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) will be featured in the CLL Therapy Oral Session. A new minimal residual disease (MRD)-guided analysis from the Phase 2 CAPTIVATE study (PCYC-1142) of ibrutinib in combination with venetoclax will be presented (Abstract #35), as well as longer-term outcomes data from the Phase 3 E1912 study of ibrutinib in combination with rituximab, which served as the basis of a recent U.S. Food and Drug Administration (FDA) sNDA submission (Abstract #33). In addition, extended follow-up data of up to 7.5 years in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) supporting the long-term disease control and tolerability with ibrutinib (Abstract #1538) and a four-year updated analysis from the Phase 3 MURANO trial of venetoclax in combination with rituximab will be shared (Abstract #355).

These new data will provide insights on the ongoing evaluation of ibrutinib (IMBRUVICA) and venetoclax (VENCLEXTA/VENCLYXTO)use among a variety of CLL patients.

Details about presentations are as follows:

Abstract

Presentation Timing

Ibrutinib

Ibrutinib Plus Venetoclax for First-line Treatment of CLL/SLL: Results from the MRD Cohort of Phase 2 CAPTIVATE Study (PCYC-1142); Tam et al.; Abstract #35

Saturday, December 7

Oral Session: 7:30 a.m. 9:00 a.m. ET

Oral Presentation: 8:30 a.m. ET

Ibrutinib and Rituximab Compared to FCR in Younger Patients with CLL: Extended Follow-Up from the E1912 Trial; Shanafelt et al.; Abstract #33*

Saturday, December 7

Oral Session: 7:30 a.m. 9:00 a.m. ET

Oral Presentation: 8:00 a.m. ET

Long-Term Outcomes with Ibrutinib Versus the Prior Regimen: A Pooled Analysis in Relapsed/Refractory MCL with up to 7.5 Years of Extended Follow-up (MCL2001, MCL3001, CAN3001, PCYC-1104); Ruleet al.; Abstract #1538

Saturday, December 7

Poster Session: 5:30 p.m. 7:30 p.m. ET

Planned Analysis of the Phase 1/2 CIRLL Trial for CLL and MCL of Cirmtuzumab in Combination with Ibrutinib; Choi et al.; Abstract #1755

Saturday, December 7

Poster Session: 5:30 p.m. 7:30 p.m. ET

Clinical Impact of Ibrutinib with R-CHOP in UntreatedNon-GCB DLBCL Co-Expressing BCL2 and MYC Genes in the Phase 3 PHOENIX Trial; Johnson et al.; Abstract #354**

Sunday, December 8

Oral Session: 7:30 a.m. 9:00 a.m. ET

Oral Presentation: 8:45 a.m. ET

Using Ibrutinib in Earlier Lines of Treatment in CLL/SLL (RESONATE/RESONATE-2); Barr et al.; Abstract #3054

Sunday, December 8

Poster Session: 6:00 p.m. 8:00 p.m. ET

Phase 2 Results of the iR2 Regimen (Ibrutinib, Lenalidomide, and Rituximab) in Patients with Relapsed/Refractory Non-germinal Center B CellLike (Non-GCB) Diffuse Large B-Cell Lymphoma (DLBCL) (PCYC-1123); Ramchandren et al.; Abstract #761

Monday, December 9

Oral Session: 2:45 p.m. 4:15 p.m. ET

Oral Presentation: 3:45 p.m. ET

Venetoclax

Ibrutinib (Ibr) Plus Venetoclax (Ven) for First-Line Treatment of Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL): Results from the MRD Cohort of the Phase 2 CAPTIVATE Study

Saturday, December 7

Oral Session: 7:30 a.m. 9:00 a.m. ET

Oral Presentation: 8:30 a.m. ET

Quantitative Analysis of Minimal Residual Disease (MRD) Shows High Rates of Undetectable MRD After Fixed-Duration Chemotherapy-Free Treatmentand Serves as Surrogate Marker for Progression-Free Survival: A Prospective Analysis of the Randomized CLL14 trial

Saturday, December 7

Oral Session: 7:30 a.m. 9:00 a.m. ET

Oral Presentation: 8:45 a.m. ET

T(11;14) and High BCL2 Expression are Predictive Biomarkers of Response to Venetoclax in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Biomarker Analyses from the Phase 3 BELLINI Study

Saturday, December 7

Oral Session: 9:30 a.m. 11:00 a.m. ET

Oral Presentation: 10:15 a.m. ET

Identification of Recurrent Genomic Alterations in the Apoptotic Machinery in CLL Patients Treated with Venetoclax Monotherapy

Saturday, December 7

Oral Session: 12:00 p.m. 1:30 p.m. ET

Oral Presentation: 12:45 p.m. ET

Updated Results from the Venetoclax (Ven) in Combination with Idasanutlin (Idasa) Arm of a Phase 1b Trial in Elderly Patients (Pts) with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)Ineligible for Cytotoxic Chemotherapy

Saturday, December 7

Oral Session: 2:00 p.m. 3:30 p.m. ET

Oral Presentation: 2:00 p.m. ET

Outcomes After Stem Cell Transplant in Older Patients with Acute Myeloid Leukemia Treated with Venetoclax-Based Therapies

Saturday, December 7

Oral Session: 2:00 p.m. 3:30 p.m. ET

Oral Presentation: 3:15 p.m. ET

Safety and Efficacy of Venetoclax in Combinationwith Navitoclax in Adult and Pediatric Relapsed/Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

Saturday, December 7

Oral Session: 4:00 p.m. 5:30 p.m. ET

Oral Presentation: 4:30 p.m. ET

Four-Year Analysis of MURANO Study Confirms Sustained Benefit of Time-Limited Venetoclax-Rituximab (VenR) in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)

Sunday, December 8

Oral Session: 7:30 a.m. 9:00 a.m. ET

Oral Presentation: 7:30 a.m. ET

Genome and Exome-Wide Studies Reveal Potential Predictive Efficacy Markers for Venetoclax andRituximab (VenR) in Relapsed/Refractory Chronic Lymphocytic Leukemia (R/R CLL): Subgroup Analyses of the MURANO Trial

Sunday, December 8

Oral Session: 7:30 a.m. 9:00 a.m. ET

Oral Presentation: 7:45 a.m. ET

A Phase 1b Study Evaluating the Safety and Efficacy of Venetoclax as Monotherapy or in Combination with Azacitidine for the Treatment of Relapsed/Refractory Myelodysplastic Syndrome

Monday, December 9

Oral Session: 7:00 a.m. 8:30 a.m. ET

Oral Presentation: 7:00 a.m. ET

A Phase 1b Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Treatment-Nave Patients with Higher-Risk Myelodysplastic Syndrome

Monday, December 9

Oral Session: 7:00 a.m. 8:30 a.m. ET

Oral Presentation: 7:45 a.m. ET

Biomarker Modulation by Mivebresib (ABBV-075) +/ Venetoclax in Relapsed/Refractory Acute MyeloidLeukemia

Monday, December 9

Oral Session: 7:00 a.m. 8:30 a.m. ET

Oral Presentation: 8:00 a.m. ET

Response to Venetoclax in Combination with LowIntensity Therapy (LDAC or HMA) in Untreated Patients with Acute Myeloid Leukemia Patients with IDH, FLT3 and Other Mutations and Correlations with BCL2 Family Expression

Monday, December 9

Oral Session: 7:00 a.m. 8:30 a.m. ET

Oral Presentation: 8:15 a.m. ET

First Analysis from a Phase 1/2 Study of Venetoclaxin Combination with Daratumumab and Dexamethasone, +/- Bortezomib, in Patients with Relapsed/Refractory Multiple Myeloma

Monday, December 9

Oral Session: 6:15 p.m. 7:45 p.m. ET

Oral Presentation: 6:15 p.m. ET

Phase 1/2 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Dexamethasone as Targeted Therapy for Patients with t(11;14) Relapsed/Refractory Multiple Myeloma

Monday, December 9

Oral Session: 6:15 p.m. 7:45 p.m. ET

Oral Presentation: 6:30 p.m. ET

Navitoclax

Results from a Phase 2 Study of Navitoclax in Combination with Ruxolitinib in Patients with Primary or Secondary Myelofibrosis

Monday, December 9

Oral Session: 10:30 a.m. 12:00 p.m. ET

Oral Presentation: 11:30 a.m. ET

*Abstract was submitted by the National Cancer Institute

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AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting - P&T Community

Cardiac Stem Cells Comments Off on AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting – P&T Community | November 22nd, 2019