Two-year-old Livia, the child of a Hong Kong mother and German father, is among patients in a London hospital as Britain grapples with a lockdown wrought by the coronavirus. But she is fighting a disease much rarer and even deadlier.

Livia was diagnosed in early March with acute myeloid leukaemia (AML). Because of the coronavirus pandemic, visits to her bedside have been restricted to reduce infection risks.

Only her father can stay with her. Her aunt and grandparents in Hong Kong cannot travel there for fear of exposing the child to more health risks.

Mother Olive Yu, who has been trying every means possible to save her daughter with access to donor registrations delayed during the lockdown told the Post in a phone interview: I still think that I'm in a really bad dream. I still find it very hard to accept that this is happening. Livia is everything to us because shes the only grandchild in the family, and our only child.

We need to be thinking about how we can help give her [as much time] as she can get

Olive Yu, mother

The family has called on those aged between 18 and 60 in Hong Kong to register as a bone marrow donor with the Hong Kong Bone Marrow Donor Registry, led by the Hong Kong Red Cross. The information is shared with the World Marrow Donor Association (WMDA), a global database of volunteer donors.

There are three options to save Livia, and the most ideal one is for a matching donor to be found and a bone marrow transplant to be conducted by June, according to Livias family.

Livias parents are appealing for bone marrow donors. Photo: Handout

Yu said: Everything takes time, especially now with the coronavirus. But the fact is, we are talking about the life of a two-year-old.

Everything is against us, but it doesn't mean that we should just stop and not do anything about it. So were going to try our best and do whatever we can to give her the best chance at life.

As of Wednesday, Britain had recorded more than 93,000 Covid-19 cases, with a death toll of over 12,000. Police enforced a lockdown on March 23, allowing people only to leave their homes for very limited purposes, such as for food and health reasons, and public gatherings of more than two people have been banned, while places such as restaurants, schools, pubs and gyms are closed.

In general, for bone marrow transplants, the donors human leucocyte antigens (HLA), proteins found on the surface of the blood and in tissue cells, must be closely matched so that the recipients body can accept the new stem cells into their bone marrow.

The second option is that the hospital also, at the same time, reaches out to stem cells from mothers who give birth and donate their umbilical cord, Yu added.

The third option is what they call a non-matching donor, which is either from the mother or father.

The blood samples of Livias parents are being analysed for matches, with results pending.

AML is a form of cancer involving the rapid growth of abnormal cells in the bone marrow and blood. This cancer type accounted for less than 1 per cent of all new cancer cases in Britain in 2017, and often occurs in adults, according to Cancer Research UK.

Livia, two, is now warded in a London hospital. Photo: Handout

A haematologist in Hong Kong, who spoke on condition of anonymity, said the incidence of cancer among children aged under 15 is around 1.2 per million. Fewer than 200 children are diagnosed with cancer in Hong Kong each year and about five out of the 200 have AML, according to him.

Story continues

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Coronavirus: We need bone marrow donors to save my baby girls life from leukaemia, Hong Kong mother of two-year-old pleads amid London lockdown -...

Bone Marrow Stem Cells Comments Off on Coronavirus: We need bone marrow donors to save my baby girls life from leukaemia, Hong Kong mother of two-year-old pleads amid London lockdown -… | April 16th, 2020

In 1994, I thought the biggest challenge in life would be finding a balance between a career as a Senior Trial Partner at a big Dallas firm and raising three children. In 1999, it became clear that the real challenge in my life was much more ominous. I was diagnosed with Multiple Sclerosis. There was no explanation as to why I contracted this devastating disease, what symptoms I would develop, or how fast I would become disabled. Would I be confined to a wheelchair or a bed? Would I become blind or simply have double vision? Would I have pain or just tingling? Would I die? I already had bladder problems, but would I also face bowel dysfunction? Over 2.5 million people are afflicted with MS, so why hasnt anyone found a cure? How could drug companies justify charging over $60,000 a year for medicines that dont improve a patients condition?

For the next fifteen years, I managed the kids and the disease with relative success. I learned what a bladder spasm is and the true definition of the word urgency. I learned that my husband really meant it when he said in sickness and health. I learned that pain from MS included the pain associated with doing a face plant into a door, and spilling boiling water on my leg but being unable to remove my pants before suffering 2nd degree burns. I learned that there were a few advantages to having MS, including speeding through airport security lines because I was in a wheelchair, and always being able to find a parking space.

In 2014 I fell and broke my leg. I was in a wheelchair for 6 weeks. It became obvious that it was time to become more aggressive with treatments. After scouring the internet for every treatment for MS in the world, I identified Dr. Dimitrios Karussis at Hadassah Medical Organization in Israel as my best hope. His approach was still experimental. He used the patients own stem cells, obtained through bone marrow extraction, grew the cells, and then infused the cells through a spinal tap.

After eight infusions the benefits of the treatment are unmistakable. Because I still walk with a walker, people realize that Im not cured. What they dont know is that I have my life back. Ive written three books, volunteer regularly at a hospital, travel around the country to raise awareness and financial support for the incredible work of Hadassah, the Womens Zionist Organization of America, Inc. (HWZOA) who operate Hadassah Hospital in Israel. I cook every week for my daughter in medical school. I have attended the graduation ceremonies of each of my three children from college, and I attended the wedding of my oldest son recently. This past year, we celebrated Thanksgiving at my house with 37 relatives.

Having MS has allowed me to stop sweating the small stuff. I have come to realize that what makes me happiest is making others happy. At the Dallas Childrens Hospital where I volunteer, my disability gives me the advantage of having an immediate connection to the kids. Making people smile is the best job at the hospital.

David Ben Gurion said: In Israel, in order to be a realist, you must believe in miracles.

I am a realist. I didnt simply wish to be cured of MS. I researched the possible options for treatment and used my best judgment to select one. Dr. Karussis is also a realist. Hes devoted over 30 years researching stem cell treatment of neurological diseases. He has published more than 120 peer reviewed scientific papers, given more than 150 lectures, served on editorial boards of major medical journals, was elected as the President of the Israeli Neuroimmunological Society and hosted an International Neurological Meeting. He has published the amazing results of the stem cell therapy he formulated for the treatment of MS and ALS.

I also believe in miracles. The miracle is that the people of Hadassah Hospital in Israel have given of their time, talent, and money to make this treatment possible and available to me. The miracle is that studies that I volunteered for twenty years ago in Dallas made me an attractive candidate for Dr. Karussis research. The miracle is that the Israeli Ministry of Health approved me to be treated in their Compassionate Care program. The miracle is that all MS patients can now have hope that an effective treatment is here and Hadassah Hospital is sharing it with the world.

VIDEO LINKS:

Watch MS patient Malia Litman dance at her sons wedding

Learn how MS patient Malia Litman got her life back

Learn more about Hadassah Medical Organization

Learn more about Dr. Dimitrios Karussis and his revolutionary stem cell treatment

CBS/Dallas News coverage of Malia Litmans MS treatment

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A Realist Who Believes in Miracles - Thrive Global

Bone Marrow Stem Cells Comments Off on A Realist Who Believes in Miracles – Thrive Global | April 16th, 2020

'), link: "https://www.rt.com/shows/documentary/486023-donors-blood-sisters-brothers/" }, events: { onReady: function () { if(ga && mediaMute === false) { ga('send', 'event', 'JWPLAYER-GA', 'CLICK PLAY', location.href); ga('send', 'event', 'JW Player Article', 'Ready', location.href); // } }, onPlay: function () { myStreamingTag.playVideoContentPart(metadata); if (ga) { if (mediaMute === false) { ga('send', 'event', 'JWPLAYER-GA', 'CLICK PLAY', location.href); ga('send', 'event', 'JW Player Article', 'Play', location.href); } } var playingVideoId = 'js-mediaplayer-5e985e5520302765572ed72c'; // id pauseMedia(playingVideoId); // if (recomedationBlock5e985e5520302765572ed72c) { recomedationBlock5e985e5520302765572ed72c.classList.remove('recomendation_active'); } if (mediaplayerContainer5e985e5520302765572ed72c) { mediaplayerContainer5e985e5520302765572ed72c.classList.add('mediaplayer_played'); } localStorage.setItem('canfixed', true); }, onPause: function () { myStreamingTag.stop(); if (mediaMute === false) { if (ga) ga('send', 'event', 'JWPLAYER-GA', 'CLICK PAUSE', location.href); } if (recomedationBlock5e985e5520302765572ed72c) { recomedationBlock5e985e5520302765572ed72c.classList.add('recomendation_active'); } }, onComplete: function () { myStreamingTag.stop(); if (ga && mediaMute === false) { ga('send', 'event', 'JWPLAYER-GA', 'COMPLETE', location.href); ga('send', 'event', 'JW Player Article', 'Complete', location.href); } if (recomedationBlock5e985e5520302765572ed72c) { recomedationBlock5e985e5520302765572ed72c.classList.add('recomendation_active'); } } } }); jwplayer("js-mediaplayer-5e985e5520302765572ed72c").addButton( "https://www.rt.com/static/libs/jwplayer/img/download.png", "Download", function () { window.location.href = "https://cdnv.rt.com/files/2020.04/5e985e5520302765572ed72c.mp4?download=1"; }, "download" ); function pauseMedia(playingMediaId) { var players = document.querySelectorAll('.jwplayer, object'); var fixPlayer = document.querySelector('.mediaplayer_fixed'); let shadowDiv = document.querySelector('.div_shadow'); var plId = playingMediaId.split('-')[2]; for (var i = 0, max = players.length; i

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You're my type: The donor lottery - RT

Bone Marrow Stem Cells Comments Off on You’re my type: The donor lottery – RT | April 16th, 2020

Researchers at Lund University in Sweden have succeeded in restoring mobility and sensation of touch in stroke-afflicted rats by reprogramming human skin cells to become nerve cells, which were then transplanted into the rats' brains. The study has now been published in the Proceedings of the National Academy of Sciences (PNAS).

"Six months after the transplantation, we could see how the new cells had repaired the damage that a stroke had caused in the rats' brains," says Professor Zaal Kokaia, who together with senior professor Olle Lindvall and researcher Sara Palma-Tortosa at the Division of Neurology is behind the study.

Several previous studies from the Lund team and others have shown that it is possible to transplant nerve cells derived from human stem cells or from reprogrammed cells into brains of rats afflicted by stroke. However, it was not known whether the transplanted cells can form connections correctly in the rat brain in a way that restores normal movement and feeling.

"We have used tracking techniques, electron microscopy and other methods, such as light to switch off activity in the transplanted cells, as a way to show that they really have connected correctly in the damaged nerve circuits. We have been able to see that the fibres from the transplanted cells have grown to the other side of the brain, the side where we did not transplant any cells, and created connections. No previous study has shown this," says Zaal Kokaia, who, even though he and colleague Olle Lindvall have studied the brain for several decades, is surprised by the results.

"It is remarkable to find that it is actually possible to repair a stroke-damaged brain and recreate nerve connections that have been lost. The study kindles hope that in the future it could be possible to replace dead nerve cells with new healthy nerve cells also in stroke patients, even though there is a long way to go before achieving that," says Olle Lindvall.

The researchers have used human skin cells that have been reprogrammed in the laboratory to become nerve cells. They were then transplanted into the cerebral cortex of rats, in the part of the brain that is most often damaged after a stroke. Now the researchers will undertake further studies.

"We want to know more about how the transplanted cells affect the opposite hemisphere of the brain. We also want to take a closer look at how a transplant affects intellectual functions such as memory. In addition, we will study possible side effects. Safety is, of course, extremely important for cell transplantation if it is going to be used clinically in the future," says Zaal Kokaia.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Researchers Have Succeeded in Restoring Mobility and Sensation of Touch in Stroke-Afflicted Rats - Technology Networks

Skin Stem Cells Comments Off on Researchers Have Succeeded in Restoring Mobility and Sensation of Touch in Stroke-Afflicted Rats – Technology Networks | April 15th, 2020

NEW YORK, April 15, 2020 /PRNewswire/ -- The stem cell therapy market was valued at US$ 1,534.55 million in 2019 and is estimated to reach US$ 5,129.66 million by 2027; it is expected to grow at a CAGR of 16.7% from 2020 to 2027.

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The increasing awareness related to the stem cells therapy in effective disease management and growing demand for regenerative medicines are the key factor driving the stem cell therapy market. However, high cost related of the stem cell therapy limits the growth of the market.Stem cell research has been widely investigated globally for various medical applications, especially for the treatment of humans.This raises the importance of creating public awareness about stem cell research and its clinical potential.

The main role of stem cells is in the replacement of dying cells and reconstruction of damaged tissues. Based on the extensive stem cell research, many scientists have claimed that these cells could probably be used in the treatment of various diseases, including cancer and cardiovascular disease.There is a large number of potential treatment procedures that are undergoing clinical trials, and a notably few stem cell therapies have won FDA (i.e., US Food and Drug Administration) approval for clinical usage. For instance, in 2019, the FDA approved Fedratinib for the first-line treatment for myelofibrosis. Moreover, stem cell therapies are widely used in bone marrow transplantation, and these therapies have benefited thousands of people suffering from leukemia. Hematopoietic stem cells are used for treating more than 80 medical diseases, including immune system disorders, blood disorders, neurological disorders, metabolic disorders, genetic disorders, and several types of cancers, such as leukemia and lymphoma; this is also likely to boost the demand for this treatment procedure during the forecast period. Researchers are further investigating the use of stem cell therapies in the treatment of autoimmune disorders.

The global stem cell therapy market has been segmented on the basis of type, treatment, application type, and end user.Based on type, the market has been segmented into adult stem cell therapy, induced pluripotent stem cell therapy, embryonic stem cell therapy, and others.

The adult stem cell therapy held the largest share of the market in 2019; however, induced pluripotent stem cell therapy is estimated to register the highest CAGR in the market during the forecast period.Based on treatment, the stem cell therapy market has been segmented into allogeneic and autologous.

The allogeneic segment held a larger share of the market in 2019; however, the market for the autologous segment is expected to grow at a higher CAGR during the forecast period.Based on application type, the stem cell therapy market has been segmented into musculoskeletal, dermatology, cardiology, drug discovery and development, and other applications.

The musculoskeletal segment held the largest share of the stem cell therapy market in 2019, whereas the drug discovery and development segment is expected to report the highest CAGR during 20202027. Based on end user, the market has been segmented into academic and research institutes, and hospitals and specialty clinics. The academic & research institutes held the largest share of the market in 2019, and it is also expected to report the highest CAGR during the forecast period.Several essential secondary sources referred to for preparing this report are the FDA, World Health Organization (WHO), Organisation for Economic Co-operation and Development, National Institutes of Health, Spanish Agency for Medicines (AEMPS), Japanese Society for Regenerative Medicine, and Indian Council of Medical Research, among others.

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Stem Cell Therapy Market to 2027 - Global Analysis and Forecasts by Type; Treatment; Application; End User, and Geography - Yahoo Finance

Bone Marrow Stem Cells Comments Off on Stem Cell Therapy Market to 2027 – Global Analysis and Forecasts by Type; Treatment; Application; End User, and Geography – Yahoo Finance | April 15th, 2020

EL SEGUNDO, Calif.--(BUSINESS WIRE)-- NantKwest, Inc. (NASDAQ: NK) and ImmunityBio, Inc., clinical-stage immunotherapy companies within the NantWorks family of companies, today announced they are in active discussions with the U.S. Food and Drug Administration (FDA) for vaccines and therapeutics to combat COVID-19.

Leveraging ImmunityBios expertise in vaccine development and natural killer cell activation, with a broad platform of immunomodulators currently in clinical trials for cancer and infectious diseases, and NantKwests extensive experience in off-the-shelf, cell-based therapeutics, the companies are combining their resources to design and develop therapeutics and vaccines for COVID-19.

Were in a race against time, but I am confident that, as a result of the incredible hard work the NantKwest, ImmunityBio, and the global scientific communities are undertaking, we will find effective therapeutics and vaccines against this coronavirus, said Patrick Soon-Shiong, M.D., Chairman & CEO of NantKwest and ImmunityBio.

Therapeutics:

The biological, immunological, and physiological status of the patients medical state should inform the treatment strategy to reverse the infectivity and tissue damage caused by this virus. ImmunityBio and NantKwest have developed immunomodulator regimens for COVID-19 based on the biological stage of the patients infection - from the mild, moderate to the severe or critically ill state.

In the mild-to-moderate stage of infection, we believe that the patients infection and viral load could be mitigated with natural killer (NK) and T cell stimulation. Hence, in this early-moderate stage of the disease, we are proposing clinical trials of N-803 alone, and a second trial of haNK alone, or haNK combined with convalescent plasma, said Dr. Soon-Shiong.

Investigational New Drug (IND) applications with the FDA for these trials are pending. ImmunityBios Il-15 superagonist N-803 is currently being used in clinical trials for other indications and has achieved Breakthrough Therapy Designation from the FDA[1] for the treatment of BCG-unresponsive non-muscle invasive bladder carcinoma in situ (NMIBC-CIS) patients. It has also demonstrated encouraging results in lowering the viral load in SHIV-infected monkeys[2], as announced last month at the Annual Conference on Retroviruses and Opportunistic Infections (CROI)[3].

In patients requiring ventilatory support in the severe state of COVID-19 disease, we are exploring the use of bone marrow-derived allogenic mesenchymal stem cells (BM-Allo-MSC) to mitigate the cytopathic storm, said Dr. Soon-Shiong.

NantKwest has proprietary isolation and expansion methods for growing MSCs and is using ImmunityBios automated, closed system (GMP-in-a-Box) to safely and rapidly grow these stem cells from a bone marrow cell bank in approximately 7-9 days. NantKwest has filed an IND with the FDA and anticipates beginning trials in Q2 2020.

Vaccines: Developing a platform for both initial immunizations and subsequent booster injections

First generation Adenovirus platforms (Ad5) currently in use are disadvantaged by inducing adenovirus neutralizing antibodies, thus limiting multiple doses and reducing the immune response to the antigen of interest. ImmunityBio has overcome this obstacle through the development of a second generation Ad5 platform. Through multiple deletions in the adenovirus genome, this next generation platform establishes a vector that is immunologically quiet as it relates to adenovirus protein production in the host dendritic cell and enables this same Ad5 vector to serve both as a prime and a boost treatment, even in patients with pre-existing adenovirus immunity. This second-generation Ad5 [E1-, E2b-, E3- deleted] platform has demonstrated safety in Phase I and Phase II studies in immunosuppressed cancer patients.

Furthermore ImmunityBio has extensive infectious disease experience with this second generation Ad5 platform and has published several peer-reviewed articles on studies demonstrating humoral and cell mediated immunity in H1N1 Influenza[4], HIV[5], SIV[6], Lassa Fever[7], Chikungunya, and Zika virus infections.

While development of therapies is urgently needed in this crisis, as urgent is the need to develop a vaccine with long-lasting cell-mediated immunity. Developing vaccines in the time of pandemics requires novel approaches and the use of modernized genomics, molecular dynamics, and vectors that are proven to induce cell-mediated immunity, with mass scale production capabilities. In 2009, with the H1N1 crisis, the scientific team developing this second generation Ad5 platform demonstrated that such a vaccine for the H1N1 pandemic could be developed in six weeks from identification of the H1N1 sequence. This experience in 2009 allows ImmunityBio to respond as rapidly as possible to the COVID-19 pandemic, continued Dr. Soon-Shiong. I view the spike (S) protein and the nucleocapsid (N) protein as the equivalent of a neoantigen in cancer. A recent study by the National Cancer Institute (NCI) in patients with advanced cancer, published in The Oncologist[8] reported positive evidence that this platform could induce antigen-specific T cell immunity, even in the face of previous adenoviral immunity, said Dr. Soon-Shiong. Together with our scientific collaborators at the NCI, we have recently published evidence[9] that the Ad5 platform can successfully induce cell-mediated immunity following the administration of Ad5-Neoantigens, with total remission of the tumor in pre-clinical models. Based on these findings, we are hopeful that the Ad platform could induce a similar immune response to this novel Coronavirus antigen.

About NantKwest

NantKwest (NASDAQ: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized, activated NK cellsas well as their activity against a broad range of cancershas been tested in phase I clinical trials in Canada and Europe, as well as in multiple phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com

haNK is a registered trademark of NantKwest, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that NantKwest will be successful in improving the treatment of cancer. Risks and uncertainties related to this endeavor include, but are not limited to, obtaining FDA approval of NantKwests NK cells as well as other therapeutics as part of the NANT Cancer Vaccine platform as a cancer treatment.

Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

These and other risks regarding NantKwests business are described in detail in its Securities and Exchange Commission filings, including in NantKwests Annual Report on Form 10-K for the year ended December 31, 2019. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

About ImmunityBio

ImmunityBio, Inc. is a privately-held immunotherapy company with a broad portfolio of biological molecules at clinical stages of development. The companys goals are to employ this portfolio to activate endogenous natural killer and CD8+ T cells in the fields of cancer and infectious disease. Specifically, ImmunityBios goal is to develop a memory T-cell cancer vaccine to combat multiple tumor typeswithout the use of high-dose chemotherapy. Regarding infectious disease, ImmunityBio is addressing HIV, influenza, and the coronavirus.

ImmunityBios first-in-human platform of technologies has enabled it to achieve one of the most comprehensive, late-stage clinical pipelines, activating both the innate (natural killer cell) and adaptive immune systems. The product pipeline includes an albumin-linked chemotherapeutic (Aldoxorubicin), a novel IL-15 cytokine superagonist (N-803), checkpoint inhibitors, macrophage polarizing peptides, bi-specific fusion proteins targeting TGFb and IL-12, adenovirus, and yeast vaccine therapies targeting tumor-associated antigens and neoepitopes.

In December 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to N-803 for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). Other indications currently at registration-stage trials include BCG-unresponsive papillary bladder cancer, first- and second-line lung cancer, and metastatic pancreatic cancer.

ImmunityBios goal is to develop therapies, including vaccines, for the prevention and treatment of HIV, influenza, and the coronavirus SARS-CoV-2.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that ImmunityBio will be successful in improving the treatment of various diseases, including, but not limited to the novel coronavirus and cancer. Risks and uncertainties related to this endeavor include, but are not limited to, the companys beliefs regarding the success, cost and timing of its development activities and clinical trials.

Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

[1]: ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in NMIBC December 4, 2019 https://www.businesswire.com/news/home/20191204005300/en/ImmunityBio-Granted-FDA-Breakthrough-Therapy-Designation-N-803

[2]: ImmunityBio Announces Durable Virus Control of SHIV Without Anti-Retroviral Therapy (ART) by Activating NK and Memorty T Cells with N-803, an IL-15 Superagonist March 10, 2020 https://immunitybio.com/immunitybio-announces-durable-virus-control-of-shiv-without-anti-retroviral-therapy-by-activating-nk-and-memory-t-cells-with-n-803-an-il-15-superagonist/

[3]: Combination IL-15 Therapy in a SHIV NHP Model Presented at Conference on Retroviruses and Opportunistic Infections (CROI) March 8-11, 2020 Boston, Massachusetts http://www.croiconference.org/sessions/combination-il-15-therapy-shiv-nhp-model

[4]: Prevention of Influenza Virus Shedding and Protection from Lethal H1N1 Challenge Using a Consensus 2009 H1N1 HA and NA Adenovirus Vector Vaccine. Vaccine. 2011 Sep 16; 29(40): 70207026. Published 2011 Aug 5. doi: 10.1016/j.vaccine.2011.07.073

[5]: Induction and Comparison of SIV Immunity in Ad5 Nave and Ad5 Immne Non-Human Primates Using an Ad5 [E1-, E2b-] Based Vaccine. Vaccine. 2011 Oct 19;29(45):8101-7. doi: 10.1016/j.vaccine.2011.08.038. Epub 2011 Aug 22.

[6]: Control of SIV Infection and Subsequent Induction of Pandemic H1N1 Immunity in Rhesus Macaques Using an Ad5 [E1-, E2b-] Vector Platform.Vaccine. 2012 Nov 26; 30(50): 72657270. Published 2012 Oct 2. doi: 10.1016/j.vaccine.2012.09.058

[7]: Adenoviral Vector-Based Vaccine is Fully Protective Against Lethal Lassa Fever Vhallenge in Hartley Guinea Pigs. Vaccine..2019 Oct 23;37(45):6824-6831. doi: 10.1016/j.vaccine.2019.09.030. Epub 2019 Sep 24.

[8]: A Phase I Trial Using a Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury)Based Immunotherapy Vaccine Regimen in Patients with Advanced Cancer. The Oncol. doi:10.1634/theoncologist.2019-0608

[9]: Efficient Tumor Clearance and Diversified Immunity Through Neoepitope Vaccines and Combinatorial Immunotherapy. Cancer Immunology Research July 2019 DOI: 10.1158/2326-6066.CIR-18-0620

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NantKwest and ImmunityBio Announce Therapeutics and Vaccines for Combatting COVID-19; Clinical Trials Anticipated to Begin This Quarter - BioSpace

Bone Marrow Stem Cells Comments Off on NantKwest and ImmunityBio Announce Therapeutics and Vaccines for Combatting COVID-19; Clinical Trials Anticipated to Begin This Quarter – BioSpace | April 15th, 2020

News Release

Wednesday, April 15, 2020

NIH-funded study offers new path to modeling eye disease, advancing therapies

Researchers have discovered a technique for directly reprogramming skin cells into light-sensing rod photoreceptors used for vision. The lab-made rods enabled blind mice to detect light after the cells were transplanted into the animals eyes. The work, funded by the National Eye Institute (NEI), published April 15 in Nature. The NEI is part of the National Institutes of Health.

Up until now, researchers have replaced dying photoreceptors in animal models by creating stem cells from skin or blood cells, programming those stem cells to become photoreceptors, which are then transplanted into the back of the eye. In the new study, scientists show that it is possible to skip the stem-cell intermediary step and directly reprogram skins cells into photoreceptors for transplantation into the retina.

This is the first study to show that direct, chemical reprogramming can produce retinal-like cells, which gives us a new and faster strategy for developing therapies for age-related macular degeneration and other retinal disorders caused by the loss of photoreceptors, said Anand Swaroop, Ph.D., senior investigator in the NEI Neurobiology, Neurodegeneration, and Repair Laboratory, which characterized the reprogrammed rod photoreceptor cells by gene expression analysis.

Of immediate benefit will be the ability to quickly develop disease models so we can study mechanisms of disease. The new strategy will also help us design better cell replacement approaches, he said.

Scientists have studied induced pluripotent stem (iPS) cells with intense interest over the past decade. IPSCs are developed in a lab from adult cells rather than fetal tissue and can be used to make nearly any type of replacement cell or tissue. But iPS cell reprogramming protocols can take six months before cells or tissues are ready for transplantation. By contrast, the direct reprogramming described in the current study coaxed skin cells into functional photoreceptors ready for transplantation in only 10 days. The researchers demonstrated their technique in mouse eyes, using both mouse- and human-derived skin cells.

Our technique goes directly from skin cell to photoreceptor without the need for stem cells in between, said the studys lead investigator, Sai Chavala, M.D., CEO and president of CIRC Therapeutics and the Center for Retina Innovation. Chavala is also director of retina services at KE Eye Centers of Texas and a professor of surgery at Texas Christian University and University of North Texas Health Science Center (UNTHSC) School of Medicine, Fort Worth.

Direct reprogramming involves bathing the skin cells in a cocktail of five small molecule compounds that together chemically mediate the molecular pathways relevant for rod photoreceptor cell fate. The result are rod photoreceptors that mimic native rods in appearance and function.

The researchers performed gene expression profiling, which showed that the genes expressed by the new cells were similar to those expressed by real rod photoreceptors. At the same time, genes relevant to skin cell function had been downregulated.

The researchers transplanted the cells into mice with retinal degeneration and then tested their pupillary reflexes, which is a measure of photoreceptor function after transplantation. Under low-light conditions, constriction of the pupil is dependent on rod photoreceptor function. Within a month of transplantation, six of 14 (43%) animals showed robust pupil constriction under low light compared to none of the untreated controls.

Moreover, treated mice with pupil constriction were significantly more likely to seek out and spend time in dark spaces compared with treated mice with no pupil response and untreated controls. Preference for dark spaces is a behavior that requires vision and reflects the mouses natural tendency to seek out safe, dark locations as opposed to light ones.

Even mice with severely advanced retinal degeneration, with little chance of having living photoreceptors remaining, responded to transplantation. Such findings suggest that the observed improvements were due to the lab-made photoreceptors rather than to an ancillary effect that supported the health of the hosts existing photoreceptors, said the studys first author Biraj Mahato, Ph.D., research scientist, UNTHSC.

Three months after transplantation, immunofluorescence studies confirmed the survival of the lab-made photoreceptors, as well as their synaptic connections to neurons in the inner retina.

Further research is needed to optimize the protocol to increase the number of functional transplanted photoreceptors.

Importantly, the researchers worked out how this direct reprogramming is mediated at the cellular level. These insights will help researchers apply the technique not only to the retina, but to many other cell types, Swaroop said.

If efficiency of this direct conversion can be improved, this may significantly reduce the time it takes to develop a potential cell therapy product or disease model, said Kapil Bharti, Ph.D., senior investigator and head of the Ocular and Stem Cell Translational Research Section at NEI.

Chavala and his colleagues are planning a clinical trial to test the therapy in humans for degenerative retinal diseases, such as retinitis pigmentosa.

The work was supported by grants EY021171, EY025667, EY025905, and EY025717 and NEI Intramural Research Program grants ZIAEY000450, ZIAEY000474 and ZIAEY000546.

The University of North Texas has a patent pending on the chemical reprogramming method reported in this paper. CIRC Therapeutics is a start-up company that plans to commercialize treatments using the technology.

This press release describes a basic research finding. Basic research increases our understanding of human behavior and biology, which is foundational to advancing new and better ways to prevent, diagnose, and treat disease. Science is an unpredictable and incremental process each research advance builds on past discoveries, often in unexpected ways. Most clinical advances would not be possible without the knowledge of fundamental basic research.

NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Mahato B, Kaya KD , Fan Y, Sumien N, Shetty RA, Zhang W, Davis D, Mock T , Batabyal S, Ni A, Mohanty S, Han Z, Farjo R, Forster M, Swaroop A and Chavala SH. Pharmacologic fibroblast reprogramming into photoreceptors restores vision. Published online April 15, 2020 in Nature.http://dx.doi.org/10.1038/s41586-020-2201-4

###

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Researchers restore sight in mice by turning skin cells into light-sensing eye cells - National Institutes of Health

IPS Cell Therapy Comments Off on Researchers restore sight in mice by turning skin cells into light-sensing eye cells – National Institutes of Health | April 15th, 2020

Advance Market Analyticsreleased the research report ofGlobal Liver CirrhosisMarket, offers a detailed overview of the factors influencing the global business scope.Global Liver Cirrhosis Market research report shows the latest market insights with upcoming trends and breakdown of the products and services.The report provides key statistics on the market status, size, share, growth factors of the Global Liver Cirrhosis.This Report covers the emerging players data, including: competitive situation, sales, revenue and global market share of top manufacturers are F. Hoffmann-La Roche AG (Switzerland), Merck & Co., Inc (United States), Abbott Laboratories (United States), Novartis International AG (Switzerland), Bristol Myers Squibb Company (United States), Gilead Sciences, Inc (United States), Conatus Pharmaceuticals (United States), GlaxoSmithKline plc (United Kingdom), Grifols, S.A. (Spain), GWOXI Stem Cell Applied Technology Co., Ltd (China), Hepion Pharmaceuticals (United States), Intercept Pharmaceuticals, Inc. (United States) and Lepu Medical Technology (Beijing) Co., Ltd. (China).

Free Sample Report + All Related Graphs & Charts @ https://www.advancemarketanalytics.com/sample-report/63193-global-liver-cirrhosis-market

The liver cirrhosis means the condition that causes scar tissue of the liver to replace healthy liver tissue cells, it happens over the period due to the chronic infection or alcohol addiction. It is diagnosed by various radiology tests such as computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), needle biopsy of the liver. A new imaging technique called elastography, which can be performed with ultrasound or MRI, can also diagnosis cirrhosis.

Market Trend

Market Drivers

Opportunities

Restraints

Challenges

The Global Liver Cirrhosisis segmented by following Product Types:

Type (Alcoholic Cirrhosis, Atrophic Cirrhosis, Biliary Cirrhosis, Cardiac Cirrhosis, Cryptogenic Cirrhosis), Application (Hospitals, Specialty Clinics, Others), Treatment (Self-care, Medications {Diuretic, Ammonia Reducer, Beta Blocker, Antibiotics, Antiviral Drug}, Medical procedure {Rubber Band Ligation, Therapeutic Endoscopy, and Transjugular Intrahepatic Portosystemic Shunt}, Surgery {Liver transplantation}), Stages (Stage 1, Stage 2, Stage 3, Stage 4), Tests (Computed Tomography (CT), Ultrasound, Magnetic Resonance Imaging (MRI), Needle Biopsy)

Region Included are: North America, Europe, Asia Pacific, Oceania, South America, Middle East & Africa

Country Level Break-Up: United States, Canada, Mexico, Brazil, Argentina, Colombia, Chile, South Africa, Nigeria, Tunisia, Morocco, Germany, United Kingdom (UK), the Netherlands, Spain, Italy, Belgium, Austria, Turkey, Russia, France, Poland, Israel, United Arab Emirates, Qatar, Saudi Arabia, China, Japan, Taiwan, South Korea, Singapore, India, Australia and New Zealand etc.Enquire for customization in Report @:https://www.advancemarketanalytics.com/enquiry-before-buy/63193-global-liver-cirrhosis-market

Strategic Points Covered in Table of Content of Global Liver Cirrhosis Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Global Liver Cirrhosis market

Chapter 2: Exclusive Summary the basic information of the Global Liver Cirrhosis Market.

Chapter 3: Displayingthe Market Dynamics- Drivers, Trends and Challenges of the Global Liver Cirrhosis

Chapter 4: Presenting the Global Liver Cirrhosis Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying the by Type, End User and Region 2013-2018

Chapter 6: Evaluating the leading manufacturers of the Global Liver Cirrhosis market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile

Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions.

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source

Finally, Global Liver Cirrhosis Market is a valuable source of guidance for individuals and companies.

Data Sources & Methodology

The primary sources involves the industry experts from the Global Liver Cirrhosis Market including the management organizations, processing organizations, analytics service providers of the industrys value chain. All primary sources were interviewed to gather and authenticate qualitative & quantitative information and determine the future prospects.

In the extensive primary research process undertaken for this study, the primary sources Postal Surveys, telephone, Online & Face-to-Face Survey were considered to obtain and verify both qualitative and quantitative aspects of this research study. When it comes to secondary sources Companys Annual reports, press Releases, Websites, Investor Presentation, Conference Call transcripts, Webinar, Journals, Regulators, National Customs and Industry Associations were given primary weight-age.

Get More Information: https://www.advancemarketanalytics.com/reports/63193-global-liver-cirrhosis-market

Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Asia.

About Author:

Advance Market Analytics is Global leaders of Market Research Industry provides the quantified B2B research to Fortune 500 companies on high growth emerging opportunities which will impact more than 80% of worldwide companies revenues.

Our Analyst is tracking high growth study with detailed statistical and in-depth analysis of market trends & dynamics that provide a complete overview of the industry. We follow an extensive research methodology coupled with critical insights related industry factors and market forces to generate the best value for our clients. We Provides reliable primary and secondary data sources, our analysts and consultants derive informative and usable data suited for our clients business needs. The research study enable clients to meet varied market objectives a from global footprint expansion to supply chain optimization and from competitor profiling to M&As.

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Liver Cirrhosis Market Projected to Gain Significant Value by 2024 - Science In Me

Cardiac Stem Cells Comments Off on Liver Cirrhosis Market Projected to Gain Significant Value by 2024 – Science In Me | April 15th, 2020

The coronavirus pandemic has gripped all countries and infected more than half a million people around the world, so far. Some 100,000 people have also lost their lives to the virus. In Iran, too, all national plans have been drawn up while taking the epidemic into consideration.

The Royan Research Institute, which is a distinguished scientific centre in Iran, is naturally expected to adopt innovative measures in order to boost the societys health at a time when the country is gripped by the coronavirus outbreak. One of the measures for which the research centre is known is its cell-therapy capacity. Recently, Royan has taken action to tap into its cell-therapy potential to fight COVID-19.

Head of the research centre Abdolhossein Shahverdi has, in an interview, weighed in on the measures adopted by the institute to fight the coronavirus, namely the establishment of a molecular diagnostic laboratory.

The Royan Institute has good experience in the field of cell science, he said.

Given that the Royan Research Centre has the necessary infrastructure, we felt that we should tap into its potentialities to help tackle the ordeal which has gripped the country, he added.

Of course, treatments offered by the Royan Institute has, so far, been mostly related to infertility or cell-therapy for hardly curable diseases; however, there was good infrastructure at Roya, and with reliance on this very infrastructure, we began to put into service a molecular diagnosis lab in cooperation with the Ministry of Health and Medical Education to serve as a backup coronavirus diagnosis laboratory, he said.

One of the problems that develop in patients infected with the coronavirus is that their lungs are affected, and these problems may result in subsequent complications. So far, good treatment methods have been used for COVID-19 patients in Iran by drawing on Chinas experience in fighting the coronavirus as well as the findings of medical institutes inside Iran. In addition, a large percentage of patients have recovered using these very methods and returned to the bosom of their families.

he Royan Research Institute has experience in the field of cell therapy and using Mesenchymal stem cells (MSCs). The institute has a record of treating different illnesses using cell therapy. Mesenchymal stem cells are among good cells used in cell therapy and play a role in moderating reactions by the immune system and healing damaged tissue. The research institute has received initial licenses from the Ministry of Health and Medical Treatment to use MSCs. By drawing on its experience in cell therapy and its treatment record in that regard, the Royan Institute has taken the first step in developing a treatment for coronavirus patients through cell therapy and stem cells in cooperation with other hospitals and the Tehran University of Medical Sciences.

In this treatment method, MSCs are used. One of the sources of these cells are umbilical cord blood cells or marrow cells, he noted.

In the past, we had used these cells to treat some incurable illnesses such as cartilage and bone diseases, and we achieved good results, said the director of the institute.He expressed hope the treatment method will successfully pass the stage of clinical tests and prove useful in treating coronavirus patients.

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Stem-Cell-Therapy Proves Effective in Treating COVID-19 - Iran Front Page - IFP News

Bone Marrow Stem Cells Comments Off on Stem-Cell-Therapy Proves Effective in Treating COVID-19 – Iran Front Page – IFP News | April 14th, 2020

In this special edition of the CURE Talks Cancer podcast, we teamed up with our sister publication OncLive on Air to speak with a patient-doctor duo on myeloproliferative neoplasms.

BY Kristie L. Kahl and Gina Columbus

MPNS essential thrombocythemia, myelofibrosis and polycythemia vera begin with an abnormal change, or mutation, in a stem cell in the bone marrow, which leads to an overproduction of any combination of white cells, red cells and platelets.

In this special edition of the CURE Talks Cancer podcast, we teamed up with our sister publication OncLive on Air to speak with a patient-doctor duo on the disease.

Learn more from Dr. Ruben A. Mesa, director of the Mays Cancer Center at UT Health San Antonio MD Anderson, and Antje Hjerpe, a patient diagnosed with essential thrombocythemia in 1992. The pair discuss myeloproliferative neoplasms what they are, how theyre treated and how patients can talk to their doctors to be their own best advocates.

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Patient-Doctor Duo: The Basics of Myeloproliferative Neoplasms - Curetoday.com

Bone Marrow Stem Cells Comments Off on Patient-Doctor Duo: The Basics of Myeloproliferative Neoplasms – Curetoday.com | April 14th, 2020

captionStress may cause gray hair prematurely.sourceManop_Phimsit/Shutterstock

Stress can affect the body in many different ways. And while it seems that stressful life events like being president may cause gray hair, the truth is a bit more complicated.

Gray hair is likely caused by a combination of genetics, aging, and hormones, and there is some research to suggest that stress can turn hair gray prematurely. Heres what you need to know.

When youre born, your hair color is determined by natural pigments in your skin called melanin.

Human hair follicles contain two types of melanin: eumelanin and pheomelanin, says Leann Poston, MD, a licensed physician. The wide diversity of possible hair colors comes from the production ratio of these two types of melanin.

Melanin is created from melanocytes, which are the cells found in your skin and hair follicles. When melanocytes stop producing melanin, your hair color changes to gray.

Melanocytes often stop producing melanin as you age, which is why gray hair is so common among the elderly. However, its common for hair to start turning gray around age 35.

Overall, Poston says that a combination of factors such as genetics, hormones, and your environment will determine exactly when your hair turns gray.

Though stress alone will not cause gray hair, there is some research that suggests it may speed up the graying process.

For example, a 2020 study published by the journal Nature found that when mice were exposed to stress, they lost melanocyte cells and gained gray hair as a result.

This is an interesting study that links stress to an abnormal conversion of stem cells to a more differentiated form, melanocytes, Poston says.

Melanocyte stem cells typically decrease in numbers as you age. But premature activation, associated with increases in a stress hormone called norepinephrine (or noradrenaline), actually caused these cells to decline more quickly in mice leading to the gray hair that researchers observed.

Poston says she doesnt believe this animal study is enough to definitively say that the same is true for humans. But other research has also suggested that stress can accelerate graying.

For example, a 2018 study in the International Journal of Trichology observed an increase in oxidative stress as a result of psychological stress and higher levels of oxidative stress, which contributes to a complicated biological imbalance in humans, are associated with an increased risk of many chronic diseases as well as premature aging.

The study suggests that premature gray hair, or the graying of hair by age 20, is linked with higher levels of oxidative stress, which may increase with more of your everyday psychological stressors like a difficult job or the pressure to provide for your family.

In addition, cigarette smoking and vitamin deficiencies which can also increase oxidative stress have been associated with early graying.

Overall, genetics and aging are likely to be more determinate for when your hair turns gray. But, as some research has suggested, psychological stress and other unhealthy risk factors may accelerate this graying process.

Read more:
Does stress cause gray hair? It may lead to premature graying - Business Insider

Skin Stem Cells Comments Off on Does stress cause gray hair? It may lead to premature graying – Business Insider | April 14th, 2020

More than 25 EINDs approved by FDA for leronlimab use in COVID-19 patients

Phase 2 trial - As of last week, 12 patients enrolled from 2 sites; 3 more sites to initiate enrollment this week, for a total of 5 sites

Phase 2b/3 trial - First hospital cleared to enroll patients beginning today

VANCOUVER, Washington, April 13, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today a comprehensive update and overview of the therapeutic indications from over 30 COVID-19 patients recently treated with leronlimab in over 4 hospitals and clinics throughout the country. More than 25 hospitals, to date, have requested participation in the Companys trials.

Patient enrollment in the Companys two clinical trials and Emergency Investigational New Drug (EIND) is as follows:

-- More than 25 patients have been administered leronlimab under EINDs authorized by the U.S. Food and Drug Administration (FDA). -- Rate of response in mild-to-moderate patients under EIND has been very promising with the first five patients treated being removed from oxygen. -- As of last week, 12 patients have been treated in the Phase 2 trial for mild-to-moderate COVID-19 indications and, because it is a double-blinded, placebo-controlled trial, results are not yet available. -- First site cleared to enroll patients in Phase 2b/3 beginning today.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, We continue to coordinate around the clock with healthcare professionals across the country to deliver leronlimab to patients and we are in regular contact with the FDA to ensure they receive current patient data. We are planning to rapidly enroll 75 patients and report the results to the FDA as quickly as possible.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

Continued here:
Southern California Patients Treated with Leronlimab for COVID-19 under Emergency IND: 4 Patients with Moderate Indications Removed from Oxygen; 3...

Bone Marrow Stem Cells Comments Off on Southern California Patients Treated with Leronlimab for COVID-19 under Emergency IND: 4 Patients with Moderate Indications Removed from Oxygen; 3… | April 13th, 2020

SUZHOU, Chinaand SHANGHAI, April 13, 2020 /PRNewswire/ -- Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell and gene therapy company, is pleased to announce that their first-in-human phase I data of Universal TruUCAR GC027 in relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) was accepted for plenary oral presentation at the America Association for Cancer Research (AACR) Annual Meeting.

Gracell Logo (PRNewsfoto/Gracell)

This year's AACR presentations are moved to be held virtually to allow sharing the data in a timely fashion. A series of online sessions featuring presentations will be provided. Gracell will report the clinical safety and efficacy of GC027, an off-the-shelf CAR-T product based on Gracell's TruUCAR technology, for treatment of adult T-ALL patients.

"We are very pleased that AACR has accepted the phase I results of GC027, a first-in-human off-the-shelf TruUCAR product for plenary oral presentation. Gracell's proprietary TruUCAR platform was protected with patents of novel designs and unique features. Remarkably, GC027 derived from HLA unmatched donor's cells, is a monotherapy without co-administration of other immunosuppressive drug." said Dr. William CAO, founder and CEO of Gracell. "We are pleased to share thefirst-in-human phase I data with the scientific community."

Presentation: Safety and efficacy clinical study of TruUCART GC027: the first-in-human, universal CAR-T therapy for relapsed/refractory T-cell acute lymphoblastic leukemiaAbstract #9564Online live section: Apr. 27-28, EDT

About GC027GC027 was manufactured fromT cells of human leukocyte antigen (HLA) unmatched healthy donors using TruUCAR technology. TruUCAR allows the allogeneic CAR-T cells to proliferate and persist in HLA-unmatched patients (recipients) with minimized risk of graft-versus-host-disease (GvHD). GC027 is currently being developed as an investigational, off-the-shelf CAR-T cell therapy for treatment of T cell malignancies. The use of HLA unmatched healthy donor's cells may improve efficacy and reduce production time, available for off-the-shelf use in a timely manner.

About TruUCARTruUCAR is Gracell's proprietary and patented platform technology, with selected genes being edited to avoid GvHD and immune rejection without using strong immunosuppressive drugs. In addition to T-ALL antigen, the platform technology can also be implemented for other targets of hematological malignancies.

About T-ALLT - Lymphoblastic Leukemia (T-ALL) is an aggressive form of acute lymphoblastic leukemia, with a diffuse invasion of bone marrow and peripheral blood. In 2015, T-ALL affected around 876,000 people globally and resulted in 110,000 deaths worldwide. T-ALL compromises about 15%-20% of all children and adult acute lymphoblastic leukemia[1].Current standard of care therapies for T-ALL are chemotherapy and stem cell transplantation. 40-50% of patients will experience relapse within two years following front line therapy with limited treatment options available[2] [3]. Treatment of relapsed and refractory T-ALL remains a high unmet medical need.

About GracellGracell Biotechnologies Co., Ltd. ("Gracell") is a clinical-stage biotech company, committed to developing highly reliable and affordable cell gene therapies for cancer. Gracell is dedicated to resolving the remaining challenges in CAR-T, such as high production costs, lengthy manufacturing process, lack of off-the-shelf products, and inefficacy against solid tumors. Led by a group of world-class scientists, Gracell is advancing FasTCAR, TruUCAR (off-the-shelf CAR), Dual CAR and Enhanced CAR-T cell therapies for leukemia, lymphoma, myeloma, and solid tumors.

Story continues

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Gracell to Present the First-in-human, Universal TruUCAR GC027 Therapy for Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia at the AACR...

Bone Marrow Stem Cells Comments Off on Gracell to Present the First-in-human, Universal TruUCAR GC027 Therapy for Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia at the AACR… | April 13th, 2020

Stress can affect the body in many different ways. And while it seems that stressful life events like being president may cause gray hair, the truth is a bit more complicated.

Gray hair is likely caused by a combination of genetics, aging, and hormones, and there is some research to suggest that stress can turn hair gray prematurely. Here's what you need to know.

When you're born, your hair color is determined by natural pigments in your skin called melanin.

"Human hair follicles contain two types of melanin: eumelanin and pheomelanin," says Leann Poston, MD, a licensed physician. "The wide diversity of possible hair colors comes from the production ratio of these two types of melanin."

Melanin is created from melanocytes, which are the cells found in your skin and hair follicles. When melanocytes stop producing melanin, your hair color changes to gray.

Melanocytes often stop producing melanin as you age, which is why gray hair is so common among the elderly. However, it's common for hair to start turning gray around age 35.

Overall, Poston says that a combination of factors such as genetics, hormones, and your environment will determine exactly when your hair turns gray.

Though stress alone will not cause gray hair, there is some research that suggests it may speed up the graying process.

For example, a 2020 study published by the journal Nature found that when mice were exposed to stress, they lost melanocyte cells and gained gray hair as a result.

"This is an interesting study that links stress to an abnormal conversion of stem cells to a more differentiated form, melanocytes," Poston says.

Melanocyte stem cells typically decrease in numbers as you age. But premature activation, associated with increases in a stress hormone called norepinephrine (or noradrenaline), actually caused these cells to decline more quickly in mice leading to the gray hair that researchers observed.

Poston says she doesn't believe this animal study is enough to definitively say that the same is true for humans. But other research has also suggested that stress can accelerate graying.

For example, a 2018 study in the International Journal of Trichology observed an increase in oxidative stress as a result of psychological stress and higher levels of oxidative stress, which contributes to a complicated biological imbalance in humans, are associated with an increased risk of many chronic diseases as well as premature aging.

The study suggests that premature gray hair, or the graying of hair by age 20, is linked with higher levels of oxidative stress, which may increase with more of your everyday psychological stressors like a difficult job or the pressure to provide for your family.

In addition, cigarette smoking and vitamin deficiencies which can also increase oxidative stress have been associated with early graying.

Overall, genetics and aging are likely to be more determinate for when your hair turns gray. But, as some research has suggested, psychological stress and other unhealthy risk factors may accelerate this graying process.

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Does stress cause gray hair? It may lead to premature graying - Insider - INSIDER

Skin Stem Cells Comments Off on Does stress cause gray hair? It may lead to premature graying – Insider – INSIDER | April 13th, 2020

Theres no doubt that as we get older, our skin's wants and needs begin to change. Whileskincare routines of our late teens andearly twenties might have focused heavily on oil-absorbing products that worked to keepbreakouts in check, as we enter our thirties, its likely that other, more pressingskin issues start cropping up. For instance, spots of pigmentation might start surfacing, fine lines may begin to form and skin that was once plump andglowing could appear lacklustre and dull.

The sorry truth is that as we enter our thirties, all of the stuff that makes our skin naturally healthy starts to deteriorate. By the time we get to our thirties, we have around 50% collagen left in our skin.Hyaluronic acid production also slows down and cellular turnover only hits us around every four to six weeks. Everything starts to slow down, says celebrity facialist, Michaella Bolder.

So what exactly does all of this mean? And how can we help minimise the affects of ageing on our skin? To help decode everything there is to know about caring for skin in your thirties, I caught up with some of the top skincare experts in the business. Unsurprisingly, I found that, for the most part, they all preached the same message: As we make our way into our thirties, certainingredients simply cannot be compromised on.

Keeping scrolling for the six products they seriously recommend and to shop the best formulas out there.

As we enter our thirties, its understandable to assume that well start experiencing less breakouts as natural oil production starts to decline. However, thats not to say that regularexfoliation isnt necessary anymore.

Just because breakouts are most associated with teenage years, acne can still occur well into our thirties. In my clinical practice I frequently see patients in their thirties with adult onset acne, says Dr Catherine Borysiewicz, Consultant Dermatologist at the Cadogan Clinic. Data suggests women are more frequently affected by adult acne compared with men. The exact reason for this is unknown, but felt to be related to fluctuating hormone levels: during periods or from birth control pills, and also during and following pregnancy. The role of stress is also becoming more apparent, she warns.

Not only do regular acid treatments encourage cell turnover (something that starts slowing down in our thirties), they can also help to exfoliate for a clearer, more radiant complexion. Just remember, only exfoliate once or twice a week and always follow up with SPF.

REN Clean Skincare Ready Steady Glow Daily AHA Tonic (27)

Medik8 Blemish Control Pads (26)

Paula's Choice Resist Advanced Smoothing Treatment 10% AHA (37)

This Works Morning Expert Multi-Acid Pads (33)

Weve heard it time and time again, but its true that no skincare routine is complete without some sort ofvitamin C product, especially if youre in your thirties. But what exactly is it, and what does it do? To start with, vitamin C is a very powerful antioxidant that works against skin-damaging free radicals such as pollution and UV. And unfortunately, by the time we reach our thirties, the effects of free radical damage start to become more and more evident. Vitamin C eradicates free radicals that have hidden within our skin cells that start to diminish our healthy cells, turning them into unhealthy, broken ones. It basically eats free radicals up like Pacman, says Bolder.

On top of that, vitamin C is great for treating pigmentation and lightening dark spots without altering normal skin tone. Leading aesthetic doctor and surgeon,Dr Mayoni also warns, In our thirties, pigment cells can start to become overactive and so the skin starts to look less plump, less hydrated and with more areas of pigmentation appearing.

Drunk Elephant C-Firma Day Serum (67)

Kiehl's Powerful-Strength Line-Reducing Concentrate (52)

La Roche-Posay Pure Vitamin C10 Serum (38)

SkinCeuticals C E Ferulic Serum (140)

As a rule, it tends to be that the older we get, the more potent and active our skincare needs to be. However, there is one particular product that we can never have too much of. Although it sounds scary, hyaluronic acid isnt actually an acid in the way that you might think. Whereas most acids work to exfoliate, hyaluronic acid is a powerful moisture-binder that occurs naturally in our skin.

What is a moisture-binder, I hear you ask? Able to retain up to x1000 its own weight in water, hyaluronic acid is able to hold onto any moisture and hydration in order to keep skin looking plump and supple. The bad news is that as we enter our thirties, our hyaluronic acid supplies start declining. Upon reaching our thirties, our natural stores of hyaluronic acid decrease, warns Rowan Hall-Farrise, Head of Global Education at QMS Medicosmetics. Not only does the amount that our skin naturally produces start to diminish, but years of exposure to free radicals also begins to wear our existing supplies down, hence why vitamin C is important. Are you keeping up?

Using a hyaluronic acid serum twice a day is essential and be sure to apply it 10 minutes before you use any retinol, advises Bolder.

Zelens Z Hyaluron Hyaluronic Acid Complex Serum Drops (55)

The INKEY List Hyaluronic Acid Serum (6)

Vichy Mineral 89 (25)

Eucerin Hyaluron-Filler Ultra Light Moisture Booster Gel-Cream (25)

Collagen might just be one of the most-mentioned words in beauty advertising, but its actually quite a complex thing. A naturally-occurring protein, collagen is the stuff that really helps hold everything together and support the skin, making it healthy, plump and bouncy. Just like hyaluronic acid, free radicals and ageing start to impact our collagen production as we get into our thirties. From the age of 25, our collagen production starts to decrease. Our late twenties and early thirties is when we should start incorporating collagen treatments into our regimens, says Hall-Farrise.

However, despite what beauty brands might tell you, supplementing collagen isn't as easy as slapping on a collagen-infused face cream - the molecules are far too big to be absorbed by the skin. Luckily, there are ways to encourage the bodys natural collagen production, but were warning you that they dont come cheap. The professional treatment of microneedling helps to stimulate collagen, but you can also use stem cell products at home. The stem cells are there to encourage collagen stimulation and preserve the collagen that we have left in our skin, says Bolder.

If you can't justify the expense, don't worry too much, keeping on top of your hyaluronic acid serums twice a day should be enough to keep skin looking plump and firm in the short term.

Augustinus Bader The Cream (205)

QMS Medicosmetics Collagen System Sensitive (199)

Sarah Chapman Skinesis Stem Cell Collagen Activator Duo (149)

Indie Lee Stem Cell Serum (127)

You knew this was coming, right? While its all too easy to switch off the minute you hear the word retinol (seriously, do we ever stop talking about it?), experts warn that now is actually the time to start paying attention. In fact, Bolder actually advises against using retinol any time before your mid-thirties. Retinol should not be in your early thirties, but in your mid to late thirties I recommend starting to use a retinol at around 1%, she says.

If youre totally out of the loop with exactly what retinol does and why its beautys ingredient du jour, let me explain. A form of vitamin A (dont be fooled by the word vitamin, this stuff is seriously powerful), retinol increases cell turnover and is thought to be one of the only skincare ingredients that can actually help reverse the signs of ageing. Dr Laura Hamilton, aesthetic doctor and founder ofVictor & Garth explains, Retinol can really do wonders for your skin. It can improve skin texture, reduce pore size and minimise the appearance of fine lines and wrinkles. In our thirties, most of us will see results with retinol.

But be warned, its not always fun and games. Side effects of redness and peeling can take some getting used to, so start with a lower strength twice a week at night time only and build up, says Dr Hamilton.

La Roche-Posay Retinol B3 Serum (39)

Sunday Riley A+ High-Dose Retinoid Serum (70)

Origins Plantscription Overnight Moisturiser (49)

Elizabeth Arden Retinol Ceramide Line Erasing Night Serum Capsules X 30 (38)

Sure, the importance of SPF application might not be specific to any one decade of your life, but its crucial to reiterate that it should always feature in your daily skincare routine if you want to protect your skin from sun damage and ageing. While daily sun cream application might have been considered a more preventative measure in your twenties, in your thirties you might be starting to notice the physical damage that prolonged sun exposure can cause. Sun damage starts to come through in your thirties. So while vitamin C and retinol are needed to help reduce the damage already caused, SPF every single day will help prevent any further sun damage, says Bolder.

The Body Shop Skin Defence Multi-Protection Lotion SPF 50+ (18)

Institut Esthederm Adaptasun Sensitive Skin Face Cream Strong Sun (30)

Medik8 Advanced Day Total Protect (55)

Shiseido Expert Sun Ageing Protection Lotion SPF30 (35)

Next up, I've done my research, and these are the best anti-ageing products.

This article originally appeared on Who What Wear

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The 6 Skin Products Experts Say Every 30-Something Should Have in Their Routine - Yahoo Style

Skin Stem Cells Comments Off on The 6 Skin Products Experts Say Every 30-Something Should Have in Their Routine – Yahoo Style | April 13th, 2020

Coronavirus (Image source: U.S. Department of State)

In my February column, I wrote about the fact that I had a stem cell transplant in early December 2019, about a month before I heard for the first time about the coronavirus.

The transplant entailed getting an unrelated donors stem cells to replace mine; then, if all went according to plan, these cells would grow into a new immune system to seek and destroy my cancer cells.

As a result of the transplant, all of my childhood vaccinations became ineffective. I was instructed to stay in isolation for at least four months in order to avoid infectious and possibly deadly diseases like influenza. Consequently, I have been quarantined since December.

Just a day before writing this, a friend told me that Im a trendsetter.

I knew very little about viruses before the coronavirus came alongonly that they were microscopic infectious organisms that invade living cells and then reproduce. In an effort to review what I had been (mostly unconsciously) protected from before transplant, I Googled the Centers for Disease Control and Prevention (CDC) and found a piece entitled, Vaccines for children: Diseases you almost forgot about.

I was reminded that most of us had vaccines as children for some of the nastiest viruses, including polio, which invades the brain and spinal cord and leads to paralysis; tetanus, a potentially fatal disease that causes lockjaw; whooping cough, which can lead to violent coughing that makes it difficult to breathe; and many more.

Most older adults are familiar with chicken pox, mumps and measles. I had two of them as a young teenager. One that I forgot about is diphtheria, which affects breathing or swallowing and can lead to heart failure, paralysis and death. There are several more.

I imagined the panic that parents must have felt and the pain that young children must have experienced before vaccines were discovered to prevent these horrible infectious diseases.

For the time being, I cannot replace my old vaccines. I must wait for at least one year while my new immune system gets stronger.

The idea of being in isolation and maintaining a safe social distance for a few months post-transplant made sense to me. I was well prepared by doctors and nurses and I knew my wife would be a great caregiver, so I thought I could do the time.

And then, the coronavirus came along.

For me, being quarantined was an old hat by the time a national emergency was declared and everything started to shut down. I learned that this new virus main target was the lungs and people older than 60 years with underlying health conditions were its primary targets.

I fit the bill and knew that Id have to do more time: at least another three months, my transplant doctor told me. The only difference is that this time, hundreds of millions of people would be joining me.

I was well-prepared before and after my transplant. I knew why I had to self-isolate and for how long. No one, including me, was prepared for COVID-19 and the mass quarantine that it now requiresnot only to protect oneself and ones family, but also to protect strangers. Mostly older strangers like me.

Scientists and other health professionals were the heroes of viral epidemics gone by. I do believe we will get through this, with people like immunologist Dr. Anthony Fauci leading the way.

Still, the unknown is what is most frightening. We all want answers, yet some remain illusive at the moment. This is an opportunity for all of us to strengthen our tolerance for ambiguity.

When will this end? No clue. Will it come back? No idea.

Although my new immune system needs more time to protect me, I just found out after a PET scan that Im in complete remission from my cancer.

Will it come back? No idea.

We are all in the same boat, living in uncertainty, whether young or old, healthy or unwell. As Plato said, Be kind, for everyone you meet is fighting a harder battle.

Andrew Malekoff is the executive director of North Shore Child and Family Guidance Center. To find out more, call 516-626-1971 or visit http://www.northshorechildguidance.org.

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A Quarantine Trendsetter - Long Island Weekly News

Spinal Cord Stem Cells Comments Off on A Quarantine Trendsetter – Long Island Weekly News | April 13th, 2020

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.

Know the Growth Opportunities in Emerging Markets

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.

The regional analysis covers:

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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.

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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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Stem Cell Therapy Market Set to Witness an Uptick during 2017 to 2025 - Science In Me

Cardiac Stem Cells Comments Off on Stem Cell Therapy Market Set to Witness an Uptick during 2017 to 2025 – Science In Me | April 13th, 2020

it would be a good thing!

There are oodles of old rules in Cardiology. The provocateur in me loves it when dogma falls.

Niftier even, is when one can invoke the biology of newts to explain how yet another certainty was proven wrong.

As it turns out, those funny-looking mud-lovers possess a property that may revolutionize the treatment of heart disease. Unlike humans, newts can regrow damaged organs, including the heart! The newts organs contain cells that arent fully committed (biologists say terminally differentiated) to function.

Thats different than humans. Our organs, the heart among them, once damaged, do not recover. In humans, scar tissue replaces dead cells and the organ is diminished. This is how heart attacks result in heart failure: non-contracting scar tissue replaces the blood-starved (infarcted) muscle. This leads to a weaker pump (congestive heart failure) and susceptibility to rhythm problems (sudden death). Sadly, this process takes only an hour or so to occur. Hence the rush in stenting open a blocked artery.

Millions of heart patients suffer from weak hearts due to heart muscle damage. Until recently, most doctors held to the old belief that self-renewal of heart muscle is impossible. All doctors can do is micro-manage medicines and maybe implant risky defibrillators. The heart remains weak, the patient limited. The wordirreversibility.

Until recently that is.

New and emerging data reveals that our hearts may indeed have progenitor (stem) cells capable of growing into mature squeezing muscle cells. Call them, newt-like if you will.

Here goes the thinking: Unlike the newt, we humans cant signal heart stem cells to grow new muscle. But imagine if we could? Scar could be replaced with beating muscle, thereby restoring pump function. Heart attacks and heart muscle problems (cardiomyopathy), once thought permanently disabling, could be reversed like skin infections. Its like a fantasy.

Stem cells? Yes. I think its possible that cardiac stems cells may be the key that opens the treasure chest of the next generation of cardiac care. And how neat is it that my hometown, Louisville KY, happens to be at the epicenter of stem cell research?

Dr Roberto Bolli, a hard-working, self-made research scientist from Italy, who now chairs the Department of Cardiology at the University of Louisville has broken exciting new ground. His teams work, published in the journal, Lancet, has brought new momentum to the dreamy possibility of using cardiac stem cells to regrow damaged heart muscle.

Dr Bollis study (called SCIPIO) was the first in-man study of heart-derived stem cells. Previous stem cell studies used animal models, or those done in humans used bone marrow cells rather than heart cells.

Heres my brief synopsis of the Lancet study:

The U of L researchers enrolled patients with prior heart attacks and weakened hearts that were referred for bypass surgery. During surgery, a sample of the heart was cut out, sent to Boston where the cardiac stem cells were isolated. (This process involves serious biochemistry, above my pay grade; I like to think of the sample as being juiced down to the stem cells.). At four months, time enough for improvement from bypass to have occurred, one group (16 patients) underwent heart cath where a balloon angioplasty catheter was used to infuse a syringe full of the patients own (1 million) stem cells. The control group (7 patients) had standard bypass but no stem cell infusions.

The results were striking:

Compared to the control subjects who showed no improvement in heart function during the follow-up period (1 year), those who received stem cells sustained significant improvements in heart function, physical capacity and scored better on quality of life questionnaires. Most remarkably, ultrasound and MRI imaging revealed the areas where stem cells were infused showed the most improvement, and the enhanced squeezing function continued over the year. There were no safety issues with stem cell infusions.

These findings led the authors to conclude that cardiac stem cells induced regeneration of heart muscle.

Wow.

I have to admit that my knee-jerk reaction tended towards naysaying. No way could this work, I thought. The study involved only 16 patients followed for only a year. Lots of limitations. Very preliminary.

But after spending a couple of hours reading about the biology of stem cells, Im pretty excited about the Louisville research. For instance, I learned that injected stem cells might not have to en-graft themselves into the scar, rather they may signal the native heart to repair itself. Biologists call this a paracrine function.

Dr Bolli told our local paper that he has been besieged with letters from desperate patients with weakened hearts. Promising press reports on very early research tend to amplify hope. Rightly, Dr Bolli emphasizes the preliminary nature of this work. He adds that the SCIPIO study is ongoing and more data is forthcoming.

Its surely way too early to speculate on whether this novel approach evolves into Cardiologys Facebook or iPhone.

We will see. But let it be known that I am marking this post with a new category, Cardiac stem cells. Im keeping my eye on this exciting topic.

Put me down as optimistic and hopefulthe heart-healthy outlook.

JMM

Disclosure: I dont own Baxter stock.

h/t to Larry Husten (@cardiobrief)

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Cardiac Stem CellsHope for Congestive Heart Failure

Cardiac Stem Cells Comments Off on Cardiac Stem CellsHope for Congestive Heart Failure | April 12th, 2020

Supplemental Biologics License Application (sBLA) Accepted for KEYTRUDA Monotherapy in Patients Whose Tumors Are Tumor Mutational Burden-High (TMB-H) Who Have Progressed Following Prior Treatment

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck's anti-PD-1 therapy. The application seeks accelerated approval of KEYTRUDA monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) 10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 16, 2020.

"From the start, biomarker research has been a critical aspect of our clinical program evaluating KEYTRUDA monotherapy," said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. "TMB has been an area of scientific interest to help identify patients most likely to benefit from KEYTRUDA. We look forward to working with the FDA throughout the review process to help bring KEYTRUDA monotherapy to patients with cancer in the second-line or higher treatment setting, where options remain limited."

The application was based in part on results from the Phase 2 KEYNOTE-158 trial, which also supported Merck's 2017 FDA approval for KEYTRUDA as the first cancer treatment based on a biomarker, regardless of cancer type, in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. MSI-H is on the highest end of the TMB spectrum. Data from KEYNOTE-158 on the TMB-H patient population were presented at the European Society for Medical Oncology (ESMO) 2019 Congress.

About KEYNOTE-158

KEYNOTE-158 (NCT02628067) is a multicenter, multi-cohort, non-randomized, open-label trial evaluating KEYTRUDA (200 mg every three weeks) in patients with solid tumors. Tissue TMB status was determined using the Foundation Medicine, Inc. FoundationOneCDx assay. Tumor response was assessed every nine weeks per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent, central, blinded radiographic review. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR) according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body's 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 industry's largest immuno-oncology clinical research program. There are currently more than 1,200 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 patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

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 1 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 head and neck squamous cell carcinoma (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 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 [combined positive score (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 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.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

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 (MCC). 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 Grades 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 adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). 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 adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or 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 classical Hodgkin lymphoma, 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-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

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 with advanced NSCLC; 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%).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those 2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%).

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 hepatocellular carcinoma (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%).

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Grace Mitchell cant wait to get on the road again.

And when she hits the road this time, shell be bound for Anchorage, Alaska, to take part in the Mayors Midnight Sun Marathon on June 17.

Grace will be participating in a 26.2 mile walk, sponsored by the Leukemia Society of America.

I completed the Honolulu Marathon in December of 1998, Grace said. I raised almost $5,000.

This is Graces second year as part of the Leukemia Societys Team in Training program. Money raised during the marathon is given to researchers at the Mayo Clinic, Hughs Institute and the University of Minnesota. Research funded in the past by the Leukemia Society has helped to develop new treatments for other cancers as well. Funds raised this year will be used to fight leukemia, myeloma, lymphoma, and Hodgkins disease. Grace and her husband own a summer cabin on Mille Lacs Lake and have been coming to the area for many years.

Inspired by his story in the Messenger, Grace is walking this year in honor of Abel Vanderpoel, son of Mary Jo and Keith Vanderpoel of Onamia.

Abel Vanderpoel was diagnosed with leukemia in September. He recently received stem cells from his sister Betsy and is undergoing treatment at Fairview Medical Center in the Twin Cities.

Grace will also be walking in memory of Patrick Kluck, who passed away in July of 1990 from leukemia.

Although not official honorees this year, in my heart, I will also be walking in memory of Catherine Malmquist and to honor Tanner Mielke, she said.

Two years ago, Grace was diagnosed with myelodysplastic syndrome, a pre-luekemia disease.

This is a cancer that attacks the bone marrow that produces the red blood cells, she said. At the present time, they do not know what causes the disease, and there is no cure. Thanks to tremendous prayer support, my disease is stable. My hope and prayer is that by the time my disease progresses, a treatment an cure will be found through continuing research.

Teams in training began in 1968 in New York when a woman named Lucy Duffy wanted to do something positive in response to her husbands struggle with leukemia. As a runner in the New York City Marathon, she passed out pledge forms to solicit donations for each mile she completed in the race. Her husband lost his battle two months after she ran the marathon, but she had raised $22,000 in his honor. Last year, over 23,000 runners, walkers and cyclists participated in the worlds major marathons on behalf of the Leukemia Society of America.

The Minnesota Team in Training began in 1994 and has raised nearly $2 million for research and patient aid in Minnesota, South and North Dakota.

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