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Stem Cell Therapy Market Grows on Back of Growing Awareness Regarding Regenerative Treatment Methods – TMR Research Blog

By daniellenierenberg

Lately, there has been rising awareness among people regarding the therapeutic potential of stem cells for disease management. This is one of the key factors contributing to growth of the global stem cell therapy market.

Further, identification of new stem cell lines, research and development of genome based cell analysis techniques, and investment inflow for processing and banking of stem cell are some of the significant factors augmenting expansion rate of the global stem cell therapy market.

Meanwhile, limitations associated with traditional organ transplantation such as immunosuppression risk, infection risk, and low acceptance rate of organ by body are few features leading to adoption of stem cell therapy. Moreover, high dependency on organ donors for organ transplantation is paving opportunities for growth of the stem cell therapy.

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Moreover, expanding pipeline and development of drugs for new applications are driving growth of the global stem cells market. Growing research activities focused on augmenting the application array of stem cell will also widen the horizon of stem cell market. Researchers are consistently trying to develop novel methods for creating human stem cell in order to comply with the rising demand for stem cell production to be used for disease management.

Development of Advanced Treatment Method Augmenting Market Growth

Lately, various new studies, development of novel therapies, and research projects have come into light in the global stem cell therapy market. Some of these treatment have been by approved by regulatory bodies, while others are still in pipeline for approval of the treatment.

In March 2017, Belgian based biotech firm TiGenix has announced that its latest development- cardiac cell therapy AlloCSC-01 has reached in its phase I/II successfully. It has shown positive results. Meanwhile, the U.S. FDA has also approved the treatment method. If this therapy is well-accepted among the patients, then approximately 1.9 million AMI patients could be treated using the therapy.

Likewise, another significant development that has been witnessed is development novel stem cell based technology for treatment of multiple sclerosis (MS) and similar concerns associated with nervous system. The treatment is developed by Israel-based Kadimastem Ltd. Also, the Latest development has been granted a patent by reputed regulatory body.

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

Some of these firms are following various growth strategies such as mergers and acquisitions, strategic alliances, and collaborations, and product development in order to strengthen their foothold in the global market for stem cell therapy.

Dermatology Segment Holds Prominence in Stem Cell Therapy Market

Stem cell therapy, primarily is a regenerative medicine. It encourages the reparative response of damaged, dysfunctional, or diseases tissue with the help of stem cells and associated derivatives. The treatment method is replacing the conventional transplant methods.

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Stem cell therapy method has wide array of application in the field of nervous system treatment, dermatology, bone marrow transplant, multiple sclerosis, osteoarthritis, hearing loss treatment, cerebral palsy, and heart failure. The method aids patients fight leukemia and similar blood related diseases.

Among all, dermatology segment is leading in the global stem cell therapy market. The segment is substantially contributing to growth of the market. Stem cell therapy reduces the after effects of general treatment for burns such as adhesion, infections, and scars among others.

Meanwhile, rising number of patient suffering from diabetes and increase in trauma surgery cases are anticipated to accelerate the adoption of stem cell therapy in the dermatology segment.

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As Head of Marketing at TMR Research, Rohit brings to the table over a decade of experience in market research and Internet marketing. His dedication, perseverance, and passion for perfection have enabled him to achieve immense success in his field. Rohit is an expert at formulating new business plans and strategies to help boost web traffic. His interests lie in writing news articles on technology,healthcare and business.View all posts by Rohit Bhisey

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June 13th, 2020

Coronavirus threat to global Good Growth Opportunities in Canine Stem Cell Therapy Market – Cole of Duty

By daniellenierenberg

The Canine Stem Cell Therapy Market research report enhanced worldwide Coronavirus COVID19 impact analysis on the market size (Value, Production and Consumption), splits the breakdown (Data Status 2014-2020 and 6 Year Forecast From 2020 to 2026), by region, manufacturers, type and End User/application. This Canine Stem Cell Therapy market report covers the worldwide top manufacturers like (VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics, Medivet Biologics, Okyanos, Vetbiologics, VetMatrix, Magellan Stem Cells, ANIMAL CELL THERAPIES, Stemcellvet) which including information such as: Capacity, Production, Price, Sales, Revenue, Shipment, Gross, Gross Profit, Import, Export, Interview Record, Business Distribution etc., these data help the consumer know about the Canine Stem Cell Therapy market competitors better. It covers Regional Segment Analysis, Type, Application, Major Manufactures, Canine Stem Cell Therapy Industry Chain Analysis, Competitive Insights and Macroeconomic Analysis.

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Canine Stem Cell Therapy Market report offers comprehensive assessment of 1) Executive Summary, 2) Market Overview, 3) Key Market Trends, 4) Key Success Factors, 5) Canine Stem Cell Therapy Market Demand/Consumption (Value or Size in US$ Mn) Analysis, 6) Canine Stem Cell Therapy Market Background, 7) Canine Stem Cell Therapy industry Analysis & Forecast 20202026 by Type, Application and Region, 8) Canine Stem Cell Therapy Market Structure Analysis, 9) Competition Landscape, 10) Company Share and Company Profiles, 11) Assumptions and Acronyms and, 12) Research Methodology etc.

Scope of Canine Stem Cell Therapy Market:The non-invasive stem cell obtaining procedure, augmented possibility of accomplishing high quality cells, and lower price of therapy coupled with high success rate of positive outcomes have collectively made allogeneic stem cell therapy a preference for veterinary physicians. Moreover, allogeneic stem cell therapy is 100% safe, which further supports its demand on a global level. Pet owners are identified to prefer allogeneic stem cell therapy over autologous therapy, attributed to its relatively lower costs and comparative ease of the entire procedure.

A rapidly multiplying geriatric population; increasing prevalence of chronic ailments such as cancer and cardiac disease; growing awareness among patients; and heavy investments in clinical innovation are just some of the factors that are impacting the performance of the global healthcare industry.

On the basis on the end users/applications,this report focuses on the status and outlook for major applications/end users, shipments, revenue (Million USD), price, and market share and growth rate foreach application.

Veterinary Hospitals Veterinary Clinics Veterinary Research Institutes

On the basis of product type, this report displays the shipments, revenue (Million USD), price, and market share and growth rate of each type.

Allogeneic Stem Cells Autologous Stem cells

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Geographically, the report includes the research on production, consumption, revenue, Canine Stem Cell Therapy market share and growth rate, and forecast (2020-2026) of the following regions:

Important Canine Stem Cell Therapy Market Data Available In This Report:

Strategic Recommendations, Forecast Growth Areasof the Canine Stem Cell Therapy Market.

Challengesfor the New Entrants,TrendsMarketDrivers.

Emerging Opportunities,Competitive Landscape,Revenue Shareof Main Manufacturers.

This Report Discusses the Canine Stem Cell Therapy MarketSummary; MarketScopeGives A BriefOutlineof theCanine Stem Cell Therapy Market.

Key Performing Regions (APAC, EMEA, Americas) Along With Their Major Countries Are Detailed In This Report.

Company Profiles, Product Analysis,Marketing Strategies, Emerging Market Segments and Comprehensive Analysis of Canine Stem Cell Therapy Market.

Canine Stem Cell Therapy Market ShareYear-Over-Year Growthof Key Players in Promising Regions.

What is the (North America, South America, Europe, Africa, Middle East, Asia, China, Japan)production, production value, consumption, consumption value, import and exportof Canine Stem Cell Therapy market?

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June 13th, 2020

Global Progenitor Cell Product Market 2020 with Coronavirus (COVID-19) Effect Analysis | likewise Industry is Booming Globally with Key Players …

By daniellenierenberg

Progenitor Cell Product Market Global and Outlook (2016 2026)

The report published onProgenitor Cell Productis an invaluable foundation of insightful data helpful for the decision-makers to form the business strategies related to R&D investment, sales and growth, key trends, technological advancement, emerging market and more.The COVID-19 outbreak is currently going the world over, this report covers the impact of the corona-virus on leading companies in the Progenitor Cell Product sector. This research report categorizes as the key players in the Progenitor Cell Product market and also gives a comprehensive study of Covid-19 impact analysis of the market by type, application and by regions like (Americas, APAC, and EMEA).

Click Here To Access The Free Sample PDF Report (including COVID19 Impact Analysis, full TOC, Tables and Figures):https://www.syndicatemarketresearch.com/market-analysis/progenitor-cell-product-market.html#sample

The global Progenitor Cell Product market report includes key facts and figures data which helps its users to understand the current scenario of the global market along with anticipated growth. The Progenitor Cell Product market report contains quantitative data such as global sales and revenue (USD Million) market size of different categories and subcategories such as regions, CAGR, market shares, revenue insights of market players, and others. The report also gives qualitative insights into the global Progenitor Cell Product market, which gives the exact outlook of the global as well as country level Progenitor Cell Product market.

Major Companies Profiled in the Global Progenitor Cell Product Market are:NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

The focus of the global Progenitor Cell Product market report is to define, categorized, identify the Progenitor Cell Product market in terms of its parameter and specifications/ segments for example by product, by types, by applications, and by end-users. This study also provides highlights on market trends, market dynamics (drivers, restraints, opportunities, challenges), which are impacting the growth of the Progenitor Cell Product market.

By Type, the Progenitor Cell Product market is segmented into:Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others

By Application, the Progenitor Cell Product market is segmented into:Medical care, Hospital, Laboratory

For Any Query Regarding the Progenitor Cell Product Market Report? Contact Us at:https://www.syndicatemarketresearch.com/inquiry/progenitor-cell-product-market

Progenitor Cell Product Market Regional Analysis

The Regions covered in this study are North America, Europe, Middle East & Africa, Latin America, and the Asia Pacific. It analyzes these regions on the basis of major countries in it. Countries analyzed in the scope of the report are the U.S., Canada, Germany, the UK, France, Spain, Italy, China, India, Japan, South Korea, Southeast Asian countries, Australia, Brazil, Mexico, GCC countries, Egypt, South Africa, and Turkey among others.

Main Highlights and Significant aspects of the Reports:

A comprehensive look at the Progenitor Cell Product Industry Changing business trends in the global Progenitor Cell Product market Historical and forecast size of the Progenitor Cell Product market in terms of Revenue (USD Million) Detailed market bifurcation analysis at a various level such as type, application, end-user, Regions/countries Current industry growth and market trends Player positioning analysis and Competitive Landscape analysis for the Progenitor Cell Product market Key Product presents by Major players and business strategies used Niche and Potential segments (ex. types, applications, and regions/countries) predicted to revealed promising growth Key challenges encountered by operating players in the market space Analysis of major risks linked with the market operations

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Overview:This segment offers an overview of the report to provide an idea regarding the contents and nature of the research report along with a wide synopsis of the global Progenitor Cell Product Market.

Analysis of Leading Players Strategies:Market top players can utilize this analysis to increase the upper hand over their rivals in the market.

Study on Major Market Trends:This segment of the report delivers a broad analysis of the most recent and future market trends.

Forecasts of the Market:The report gives production, consumption, sales, and other market forecasts. Report Buyers will approach exact and approved evaluations of the total market size in terms of value and volume.

Analysis of Regional Growth:This report covered all major regions and countries. The regional analysis will assist market players to formulate strategies specific to target regions, tap into unexplained regional markets, and compare the growth of all regional markets.

Analysis of the Segment:This report provides a reliable and accurate forecast of the market share of important market segments. This analysis can be used by market participants for strategic development so that they can make significant growth in the Progenitor Cell Product market.

The main questions given in the report include:

1.What will be the market size and growth rate in 2026 with COVID-19 Impact Analysis?2.What are the major market trends impacting the growth of the global market with COVID-19 impact analysis?3.Who are the major players operating in the worldwide market?4.What are the important factors driving the worldwide Progenitor Cell Product market?5.What are the challenges to market growth?6.What are the opportunities and threats faced by the vendors in the international market?7.What are the trending factors affecting the market shares of the Americas, APAC, and EMEA?8.What are the major effects of the five forces analysis of the global Progenitor Cell Product market?

Note In order to provide a more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.(*If you have any special requirements, please let us know and we will offer you the report as you want.)

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June 13th, 2020

The Country Is Reopening. Im Still on Lockdown – WIRED

By daniellenierenberg

For millions of Americans, though, keeping normalcy at bay for such a long time is a luxury they cant afford. People need to hold onto their jobs. Or find new ones. The streets are filling up with Americans who are responding to one national crisisthat of police brutality and systemic racismin the midst of another. And the economy is in cardiac arrest.

Just last week, to address this, the governor of my state announced an accelerated reopening. In the last weeks, there were about 1,500 new coronavirus cases in our region, an increase of 37 percent. In all these headlines, I can see cracks in the walls Ive built around my mom and my partner. How do we bubble people stay safe as the world moves ahead? In some ways people who are immunocompromised have lived their lives in preparation for all of this, Mamjunder told me.

Not long ago, in response to WIRED's Covid-19 coverage, the publication got an email from a woman named Brandy Stephens whod been diagnosed with acute lymphoblastic leukemia in 2014, when she was 26. She and her husband had a 1-year-old daughter. Her treatment put her in the hospital for 165 days, 35 of them on a ventilator. During that time a mere houseplant could have killed me, she wrote. I had multi-organ failure, my bone marrow died, I had pulmonary embolisms, a partially collapsed lung. Then, a stem cell transplant built her a new immune system. In July 2019, at the five-year mark, Stephens was finally able to be reimmunized, against the scary things that babies are immunized for.

Most of the world does not know we exist, she wrote.

I called her to ask about how she did it. I needed to know how to shepherd my mom and partner through a reopened world. I couldn't eat takeout for a year post-transplant. I carry sanitizer, gloves, masks, Lysol with me. She added, My husband is my rock. It has become second nature to have real quirks, to, say, go to family gatherings but not get close to anyone. She knows how to do this. I feel for people who never have had to isolate before, she added, I went through that struggle. (Immunocompromised people have figured out how to protest too.)

We are lucky to live in an area that has kept the overall coronavirus numbers low, yet the steady tick of reminders about potential Covid-19 resurgences haunt me. For everyone in this pandemic, its hard right now to accurately see a future beyond quarantine. Will we return to normal this year? What does normal mean? Something different for all of us, of course.

Last Friday afternoon I was working at Moms house, and I took a break. We were sitting in her living room, on her lovely blue couches. The dog tucked his head under her arm. Mom asked me what I was looking forward to.

The question jolted me. In pre-corona times, I tried to keep things on the calendar to look forward to. But over the past two months I have shut that instinct down.

Now, my mind ricocheted. Restaurants. Could I look forward to eating at our favorite pizza joint? My partners brother: He just added a new floor at the top of the house, a big glorious room with sliding glass doors that open to a porch overlooking the Pacific. He wants to have parties in that big, cheerful space. Will we be there?

Here are the things I hope to put on my calendar someday soon: dinner at our friends house. Driving with Mom for a day at our favorite beach, without worrying about crowds. Those parties at my partners brothers house, in that big, cheerful space. And if need be, flights to a different city if the new treatments we need for my partners cancer arrive, via a trial, somewhere else.

I hope I can put all of those things on the calendar, for the time we have left together.

I thought it was just a rash but rare cancer now covers 90% of my skin splitting my hands and feet open – The Sun

By daniellenierenberg

WHEN Tony Ferreira developed a small skin rash on his lower back - he assumed it would be gone in a few days.

And given the dad-of-one, 40, had always been fit and healthy, the last thing to cross his mind was that it could be cancer.

However, Tony's worst fears became a reality when the rash rapidly spread across his body - causing his feet and hands to split open.

Doctors soon diagnosed the gardener, from Jersey, with a rare form of non-Hodgkin lymphoma called Sezary syndrome - which has now affected about 90 per cent of his body.

Desperate to keep her husband alive, Tony's wife Osvalda is now pleading for a stem cell donor to come forward and save his life.

She said: "We pray that a stranger will help us to continue our lives together for many years to come."

We pray that a stranger will help us to continue our lives together for many years to come

Tony's nightmare first begun in 2012, when he noticed a small rash on his lower back which did not go away.

The rash quickly developed - causing his hands and feet would split open - and Tony then noticed lumps in his groin and under his arms.

Five years on, in 2017, medics diagnosed Tony, originally from Madeira, with a rare form of non-Hodgkin lymphoma called Sezary syndrome.

The condition causes white blood cells to become cancerous and aggressively attack the skin.

About 90 per cent of Tony's body is now affected by the rare cancer, and his best chance of survival is blood stem cell donation.

His wife is now desperately hoping a stem cell donor will come forward.

The charity DKMS is co-ordinating the worldwide search for a donor, but Tony's Portuguese heritage is making it much more difficult for him to find a match.

Tony's parents and four siblings have been checked as a potential match, but none are suitable.

In March, Tony's doctors decided to treat him with a new anti-cancer chemotherapy drug (mogamulizumab) but the trial was then delayed due to the Covid-19 pandemic.

Osvalda, who worked as a housekeeper for a care home in Jersey, had been keeping the family afloat financially, but was then advised to take temporary leave due to the risk she might contract Covid-19 and pass it on to her husband.

She said: "Tony's condition is bad enough, but for thousands of patients living with cancer in the UK, Covid-19 has delayed many treatments.

"We're not sure yet when we can begin travelling to London for treatment or what the new normal will look like.

"I long to hold Tony's hands again, without his protective gloves on.

What is Sezary syndrome?

Sezary syndrome is an aggressive form of cutaneous T-cell lymphoma which is a group of disorders that occur when T-cells (a type of white blood cell) become cancerous and affect the skin.

It is characterised by a widespread red rash that may cover most of the body, the presence of cancerous T cells (called Sezary cells) in the blood, and abnormally enlarged lymph nodes.

Although Sezary syndrome can affect people of all ages, it is most commonly diagnosed in adults over age 60.

The signs and symptoms of this condition can vary but may include:

Affected people may also have an increased risk of developing anotherlymphomaor other type ofcancer.

The exact cause of Sezary syndrome is currently unknown.

Source: Rare Diseases

Treatment varies based on the signs and symptoms present in each person and the severity of the condition.

"Tony has been wearing his blue plastic gloves so long now that I've almost forgotten how his hands feel without them.

"He has such strong hands and holding them would reassure me that everything is going to be all right."

Jonathan Pearce, chief executive officer at DKMS UK, said the charity had seen a 50 per cent drop in the number of people coming forward to be donors due to coronavirus.

He added: "We are hugely concerned about the impact Covid-19 is having on those who rely on a blood stem cell donor.

"While many stem cell transplants are still going ahead, the logistics around supporting blood stem cell donors to travel to hospital, and then arranging the transport of the stem cells to the transplant centre, have become much more challenging and complex.

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"There are also transplants that have been delayed, but once the pandemic is over we know there will be a backlog of patients in urgent need of an unrelated blood stem cell donor.

"Sadly though, in some of those cases there's a risk that the disease could progress further, and a transplant may no longer be possible once this is all over."

People can register for a swab kit here.

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I thought it was just a rash but rare cancer now covers 90% of my skin splitting my hands and feet open - The Sun

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June 13th, 2020

A definitive ranking of who will win MasterChef Australia 2020. – Mamamia

By daniellenierenberg

We are down to top nine of MasterChefAustralia 2020. That may seem like an odd point at which to call the winner. But hey, we're just that invested.

Below, I have compiled a list of whose unbalanced/under-seasoned/shallow-flavoured dish is going to send them home next; from Sunday night's all-in street-food elimination, right through to the finale.

No matter what happens on Masterchef, we'll always have Katy Perry. Relive the magic of her episode below. (Post continues.)

'Based on what?' I hear you ask.

Good question.

I could walk you through some highly advanced modelling based on past performance and predictive analytics, but I didn't actually do any of that.

Instead, I used a mix of womanly instinct, unashamed favouritism and a few spoilersfrom The Daily Mail.

So here we go. In a very particular order...

A forensic analysis of the promo for Sunday night's episode has led me to conclude that Khanh is going home next.

By which I mean they're setting it up to look like Emelia is going which means she definitely isn't, and there are lingering shots of Khanh, and the words 'fan favourite' are used.

AND the tabloids have reported that he doesn't make the top six... and... and... I just have a hunch.

Tessa is probably the most versatile cook in the joint.

Technically skilled, intuitive, knowledgeable. I don't anticipate a major stuff up sending her home.

She will likely only be felled by someone else pulling, as Andy would say, "a really cracking plate of food" out of their backside.

...will still be happy when he leaves, because he's Callum.

The mums of Australia, meanwhile, will be very sad because "he just seems like such a nice boy".

Sweet, Brendan. You are too good for reality television.

Run, run far away. (Preferably towards my house, say, around dinner time...)

This one will hurt most of all.

But at least we will get an uplifting montage of his best moments; like that time he hid beneath his bench when Katy Perry approached, and that time he won two challenges in a row and someone said, "It's Reece week" and he replied "Oh my god, it IS Reece week."

That was fun.

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A definitive ranking of who will win MasterChef Australia 2020. - Mamamia

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June 13th, 2020

Ancient crocodiles used to walk on two feet, new footprints reveal – News Landed

By daniellenierenberg

A new finding in South Korea reveals that the ancestors to the modern crocodile walked on two legs. The 106-million-year-old fossilized foot impressions of the crocodylomorph suggest that the ancient reptile was 2 to 3 meters long, as the researchers published in the journal Scientific Reports.

Professor Kyung Soo Kim and his team from the Chinju National University of Education found the footprints and skin traces at the Sacheon Jahye-ri site of theJinju Formation. The team was able to conclude that the creatures must have been bi-pedal, as there were no hand impressions or front feet impressions present at the site.

The footprints were initially thought to be made by a giant bipedal pterosaur walking on the mudflat, we now understand that these were bipedal crocodile prints, said University of Queenslands Dr. Anthony Romilio. The footprints measure around 21 cm, suggesting the track-makers had legs about the same height as human adult legs. These were long animals that we estimate were over 3 m in length. Source: Sci News.

Read Also: Human embryo model grown from stem cells by scientists for the first time

The newly found tracks were named Batrachopus grandis, in comparison to the smaller Batrachopus type tracks.

Previous discoveries have also hinted that ancient crocodiles could have been bi-pedal. One example was the skeletal reconstructions ofCarnufex carolinensis, an ancient croc that walked 231 million years ago, according to Science News. However, these footprints are concrete proof that ancient crocodiles used to walk on two limbs.

These types of findings are crucial in learning about past life on our planet, even helping us better interpret other dinosaur fossils.

Do you want to publish on Apple News, Google News, and more?Join our writing community,improve your writing skills, and be read by hundreds of thousands around the world!

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June 13th, 2020

Exosome Therapeutic Market 2020 Analysis, Trends, Opportunity, Size And Segment | Leading Players evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE…

By daniellenierenberg

Global Exosome Therapeutic Market report is of huge importance when it is about building business strategy by identifying the high growth and attractive market categories. This report assists to design capital investment strategies based on forecasted high potential segments. With this market report, it becomes simple and easy to develop competitive strategy based on competitive landscape. Moreover, potential business partners, acquisition targets and business buyers can be identified by using this Exosome Therapeutic Market research report. To plan for a new product launch and inventory in advance, this business report provides several useful insights.

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Market Analysis and Insights:Global Exosome Therapeutic Market

Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

The major players covered in the Exosome Therapeutic Market report are evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global. Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Get Full TOC, Tables and Figures of Market Report @https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market&rp

Exosomes are used to transfer RNA, DNA, and proteins to other cells in the body by making alteration in the function of the target cells. Increasing research activities in exosome therapeutic is augmenting the market growth as demand for exosome therapeutic has increased among healthcare professionals.

Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.

This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

Global Exosome Therapeutic Market Scope and Market Size

Global exosome therapeutic market is segmented of the basis of type, source, therapy, transporting capacity, application, route of administration and end user. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Based on type, the market is segmented into natural exosomes and hybrid exosomes. Natural exosomes are dominating in the market because natural exosomes are used in various biological and pathological processes as well as natural exosomes has many advantages such as good biocompatibility and reduced clearance rate compare than hybrid exosomes.

Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process. The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.

Rising demand of exosome therapeutic across the globe as exosome therapeutic is expected to be one of the most prominent therapies for autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases treatment, according to clinical researches exosomes help to processes regulation within the body during treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases. This factor has increased the research activities in exosome therapeutic development around the world for exosome therapeutic. Hence, this factor is leading the clinician and researches to shift towards exosome therapeutic. In the current scenario the exosome therapeutic are highly used in treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases and as anti-aging therapy as it Exosomes has proliferation of fibroblast cells which is significant in maintenance of skin elasticity and strength.

Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. Mesenchymal stem cells are dominating in the market because mesenchymal stem cells (MSCs) are self-renewable, multipotent, easily manageable and customarily stretchy in vitro with exceptional genomic stability. Mesenchymal stem cells have a high capacity for genetic manipulation in vitro and also have good potential to produce. It is widely used in treatment of inflammatory and degenerative disease offspring cells encompassing the transgene after transplantation.

Based on therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. Chemotherapy is dominating in the market because chemotherapy is basically used in treatment of cancer which is major public health issues. The multidrug resistance (MDR) proteins and various tumors associated exosomes such as miRNA and IncRNA are include in in chemotherapy associated resistance.

Based on transporting capacity, the market is segmented into bio macromolecules and small molecules. Bio macromolecules are dominating in the market because bio macromolecules transmit particular biomolecular information and are basically investigated for their delicate properties such as biomarker source and delivery system.

Based on application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. Oncology segment is dominating in the market due to rising incidence of various cancers such as lung cancer, breast cancer, leukemia, skin cancer, lymphoma. As per the National Cancer Institute, in 2018 around 1,735,350 new cases of cancer was diagnosed in the U.S. As per the American Cancer Society Inc in 2019 approximately 268,600 new cases of breast cancer diagnosed in the U.S.

Based on route of administration, the market is segmented into oral and parenteral. Parenteral route is dominating in the market because it provides low drug concentration, free from first fast metabolism, low toxicity as compared to oral route as well as it is suitable in unconscious patients, complicated to swallow drug etc.

The exosome therapeutic market, by end user, is segmented into hospitals, diagnostic centers and research & academic institutes. Hospitals are dominating in the market because hospitals provide better treatment facilities and skilled staff as well as treatment available at affordable cost in government hospitals.

Exosome therapeutic Market Country Level Analysis

The global exosome therapeutic market is analysed and market size information is provided by country by type, source, therapy, transporting capacity, application, route of administration and end user as referenced above.

The countries covered in the exosome therapeutic market report are U.S. and Mexico in North America, Turkey in Europe, South Korea, Australia, Hong Kong in the Asia-Pacific, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua, Uruguay as part of Latin America.

Country Level Analysis, By Type

North America dominates the exosome therapeutic market as the U.S. is leader in exosome therapeutic manufacturing as well as research activities required for exosome therapeutics. At present time Stem Cells Group holding shares around 60.00%. In addition global exosomes therapeutics manufacturers like EXOCOBIO, evox THERAPEUTICS and others are intensifying their efforts in China. The Europe region is expected to grow with the highest growth rate in the forecast period of 2019 to 2026 because of increasing research activities in exosome therapeutic by population.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

Huge Investment by Automakers for Exosome Therapeutics and New Technology Penetration

Global exosome therapeutic market also provides you with detailed market analysis for every country growth in pharma industry with exosome therapeutic sales, impact of technological development in exosome therapeutic and changes in regulatory scenarios with their support for the exosome therapeutic market. The data is available for historic period 2010 to 2017.

Competitive Landscape and Exosome Therapeutic Market Share Analysis

Global exosome therapeutic market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, concept cars, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companys focus related to global exosome therapeutic market.

Many joint ventures and developments are also initiated by the companies worldwide which are also accelerating the global exosome therapeutic market.

For instance,

Partnership, joint ventures and other strategies enhances the company market share with increased coverage and presence. It also provides the benefit for organisation to improve their offering for exosome therapeutics through expanded model range.

Customization Available:Global Exosome Therapeutic Market

Data Bridge Market Researchis a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customised to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analysed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Factbook) or can assist you in creating presentations from the data sets available in the report.

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Exosome Therapeutic Market 2020 Analysis, Trends, Opportunity, Size And Segment | Leading Players evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE...

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June 13th, 2020

Exosome Therapeutic Market 2020 to Show Tremendous Growth | Leading Players evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United…

By daniellenierenberg

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Market Analysis and Insights:Global Exosome Therapeutic Market

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Global Exosome Therapeutic Market Scope and Market Size

Exosome therapeutic Market Country Level Analysis

Country Level Analysis, By Type

Huge Investment by Automakers for Exosome Therapeutics and New Technology Penetration

Competitive Landscape and Exosome Therapeutic Market Share Analysis

Many joint ventures and developments are also initiated by the companies worldwide which are also accelerating the global exosome therapeutic market.

For instance,

Customization Available:Global Exosome Therapeutic Market

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Exosome Therapeutic Market 2020 to Show Tremendous Growth | Leading Players evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United...

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June 13th, 2020

EHA25Virtual: Combined Irradiation and Chemotherapy Better Prepares Children for Stem Cell Transplantation than Chemotherapy Alone – P&T Community

By daniellenierenberg

THE HAGUE, Netherlands, June 12, 2020 /PRNewswire/ -- Treatment of childhood cancer is a success story, particularly for acute lymphoblastic leukemia (ALL). More than 90% of ALL patients below 18 years of age are rescued with contemporary chemotherapy. However, the remaining 10% have resistant or reoccurring leukemia and require alternative treatment regimens. One of the most powerful leukemia therapies is hematopoietic stem cell transplantation from a donor (allogeneic HSCT). Approximately 50-80% of pediatric ALL patients that receive allogeneic HSCT are cured, 20% experience leukemic reoccurrence (relapse), and 10% die from complications.

Allogeneic HSCT is a multistep procedure:

For high-risk leukemia, the gold standard conditioning procedure is a combination of total body irradiation (TBI) and high dose chemotherapy. This approach is very effective in controlling leukemia in the conditioning step, but patients may experience highly negative consequences of this procedure later in life: sterility, growth retardation, lung problems, and secondary cancer.

Therefore, a large consortium of pediatric transplant experts initiated a global study to investigate whether chemotherapy-based conditioning could substitute TBI. The study is called FORUM (For Omitting Radiation Under Majority Age) and had to be stopped because chemotherapy-based conditioning had significantly poorer outcomes (i.e., lower overall survival rates) than the combination of TBI and chemotherapy. The researchers will now perform prospective monitoring to better define the advantages and limitations of various conditioning approaches.

Presenter:Dr Christina PetersAffiliation:Stem Cell Transplantation Unit, St. Anna Children's Hospital, Vienna, AustriaAbstract:#S102 TBI OR CHEMOTHERAPY BASED CONDITIONING FOR CHILDREN AND ADOLESCENTS WITH ALL: A PROSPECTIVE RANDOMIZED MULTICENTER-STUDY "FORUM" ON BEHALF OF THE AIEOP-BFM-ALL-SG, IBFM-SG, INTREALL-SG AND EBMT-PD-WP

Embargo: Please note that our embargo policy applies to all selected abstracts in the Press Briefings. For more information click here.

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June 13th, 2020

Westerleigh resident is alive because of stem cell therapy by his doctor — for free. Heres his story. – SILive.com

By daniellenierenberg

Stephen Raffone had difficulty breathing. He coughed up sputum and was wheezing. Doctors told him he had chronic obstructive pulmonary disease (COPD), a condition that causes blocked airflow from the lungs.

As a result, he was being treated for stage 4 COPD.

His doctor was also treating him for cellulitis, an inflammatory and painful bacterial skin infection where extremities appear red and swollen and the area can feel hot and tender to the touch, as well as poor circulation.

My legs were beginning to get ulcerated and they were breaking down, said Raffone.

He was administered the Roman Catholic Churchs Last Rites three times several years ago when he was a patient in Richmond University Medical Center.

Raffone, who is now 63, was in need of a lung transplant.

He was a heavy smoker and it took its toll. However, because he was in a weakened state due to other serious health conditions, doctors told him hed never survive the surgery.

The Westerleigh resident, who has been in need of 24-hour care for the last several years, requires the assistance of two nurses who rotate 12-hour shifts.

One, a close family friend, suggested Raffone see a medical specialist who performs stem cell therapy, a procedure where the patients own stem cells are removed, treated and returned to his or her own body after a conditioning regimen.

She contacted Dr. Alexandre M. Scheer of Scheer Medical Wellness and he agreed to see Raffone.

Dr. Alexandre M. Scheer (Courtesy/Stephen Raffone)Staten Island Advance

But since Raffone was unable to leave his home, Scheer visited Raffone for a consultation and to evaluate his condition.

Fast forward a year and a half and Scheer has continued with those visits almost every Saturday free of charge also underwriting the cost for treatments, as well as Uber rides from Manhattan to Staten Island, in order to perform the stem cell procedure.

RAFFONES NURSE SPEAKS

One of Raffones nurses recounted Raffones journey.

She explained that when they started to explore stem cell therapy she placed calls to several doctors, but the biggest thing that jumped out at her was the astronomical cost.

But there was something about Dr. Scheer. And I just knew he was the right one, said the registered nurse for more than 30 years. "He wasnt interested in money. His goal is his patients outcome. Stephen did pay for the first set of treatments, but since then, Dr. Scheer has not taken a dime.

When the patient began treatments, the first therapy was a tremendous boost and then every week after that he was treated for seven weeks. In the beginning, the doctor visited every week and brought whatever supplies was needed. The PRP (platelet rich plasma) treatments are daily.

I draw the blood, I spin the blood," she said. We have a small centrifuge here so it separates the blood. The PRP is given by a nebulizer. It takes about 30 minutes. And once a week he gets a protein enriched plasma, which takes about a half hour, she added.

He has chronic venous ulcerations of the both lower extremities from the knee down, she said.

Raffone has end stage COPD. But since he started the treatments, hes gone to the hospital only once. And he has tested negative for antibody COVID-19.

RAFFONES TREATMENT BEGINS

Raffone was required to install the centrifuge machine with needles and plasma tube, a laboratory device used for the separation of fluids, gas or liquid, based on density. Separation is achieved by spinning a vessel containing material at high speed.

Initially, Dr. Scheer sent a plastic surgeon to my home to perform liposuction, a type of fat-removal procedure used in plastic surgery, where they separate the fat and preserve the stem cells, Raffone said. They did this four times weekly at the beginning. Dr. Scheer has been visiting my home pretty much each week since Sept. 22, 2018. But right now the stem cell therapy is done once a month."

They draw blood out and spin it. Its all done through IV. Right now stem cell infusion is done once a month and daily through a nebulizer. Dr. Scheer does it on Saturday and my nurse and dear friend to Dr. Scheer does it during the week. My house looks like a hospital. Dr. Scheer is keeping me alive and everything is healing up so well, said Raffone.

Stephen Raffone's left leg before stem cell treatment. (Courtesy/Stephen Raffone)Staten Island Advance

Raffone says he wanted to come forward with his account at this time because hes so grateful and especially today when so many negative stories are in the news.

We need some good stories. There are very few people like Dr. Scheer, especially now during the COVID-19 crisis, he said.

My nurse draws the blood and puts it in a centrifuge when the doctor cant make it from the city. But Dr. Scheer is still coming to my house in spite of the COVID-19 crisis," Raffone continued.

Raffone has been confined to a bed one that he says turns you from side to side and upside down. But Dr. Scheer is confident that when restrictions are lifted and physical therapy sessions resume, Raffone will be able to walk.

The stem cell therapy is not only helping to combat Raffones COPD, but it has also helped him with cellulitis on his leg.

Stephen's Raffone healed left leg after stem cell therapy. (Courtesy/Stephen Raffone)Staten Island Advance

Scheer, a staunch supporter of stem cell therapy, has a background in neurosurgery and regenerative medicine. He performs surgery at several surgical centers in Manhattan.

It has to do with the amount of cells your bone marrow," he said. What we do is . . . saturate the body with stem cells. It suppresses the inflammatory response. COVID-19 also is an inflammatory disease. The COVID-19 kills the lungs. So you dont have oxygen going through. The stem cells protect, so you have continual oxygen transfer.

Dr. Scheer, who practices at Sheer Medical Wellness in Manhattan, says you can regenerate yourself.

I want my patients to be fine. I will pay for the patient. Im happy Stephens alive. And then my life is made. Stephen will now be able to walk after physical therapy. He was on 12 liters of oxygen daily. Hes now on two liters. I know his nurse very well and thats how we connected. The stem cell treatment is the appropriate treatment for him. I pay out of pocket because I know the right treatment for his condition," he added.

Dr. Scheer points out in China and in Israel stem cell therapy is the treatment they use for COVID- 19.

Its where you take Eastern and Western medicine and put it together. The patients body and will to live and having the right outlook on life has a lot to do with proper health. Our group is so big. We have 40 different doctors in my practice. Im the medical director, he said. Stem cell treatment is the future of medicine. At $10,000 a treatment, its very expensive. And the number depends on the issue at hand.

THE INITIAL CALL

When Scheer spoke to Raffone, He said I cant get out of bed,' the doctor said. "I drove to Staten Island and I got to know Stephen and his family very well. Its not a one-time treatment. Im seeing him on a weekly basis. There is a relationship that occurs. And thats what matters and thats what keeps people alive. Hope is what keeps them alive. And Im doing this since 2001. The treatment involves platelet enriched plasma that suppresses inflammatory reactions in the lungs. Whats happening is youre able to suppress the inflammatory reaction. His legs and his heart are getting better as well. This is a treatment until we can get him walking.

Scheer says Raffone must undergo physical therapy in oder for him to walk around freely.

And hell be able to travel to my office. Im not giving up on him. Im paying out of pocket. A quarter of my patients, I pay for. Stephen has gone through so much. Hes alive because of stem cell therapy. And due to his lung condition with COVID, he has not contracted it."

Scheer says its been a team effort, with multiple doctors coming into play.

Stephen is keeping himself alive. Im just the tool that can help. I just do the best I can for as many people as I can.

Originally posted here:
Westerleigh resident is alive because of stem cell therapy by his doctor -- for free. Heres his story. - SILive.com

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June 13th, 2020

New CRISPR, gene therapy results strengthen potential for treatment of blood diseases – BioPharma Dive

By daniellenierenberg

Three people with the inherited blood diseases sickle cell and beta thalassemia remain free of burdensome blood transfusions and their worst symptoms, months after receiving an infusion of genetically modified stem cells.

One of the three, a young woman with a severe form of beta thalassemia, has now been followed for over a year since she was treated, while the second, a woman in her 30s with sickle cell disease, is more than nine months removed from her infusion. They are the first two patients in pioneering studies of a therapy, developed by CRISPR Therapeutics and Vertex, that's based on the gene editing technology known as CRISPR.

Both patients continue to respond to treatment, bolstering evidence of genetic medicine's potential to permanently alter the course of devastating hereditary conditions like sickle cell and transfusion-dependent beta thalassemia. A gene therapy developed by Bluebird Bio has shown similar potential.

First results from the two studies, disclosed last November, were "taking the promise of CRISPR and turning that into a reality," said Samarth Kulkarni, CRISPR Therapeutics' CEO, in an interview. The additional data and follow-up now available "show these effects can be long-lasting and durable."

And in beta thalassemia, the first patient's experience is now supported by results from another patient who was treated about five months ago. This individual has also been able to stop receiving blood transfusions.

Taken together, the two patients responses are "proof of concept," CRISPR Therapeutics and Vertex claim, that their approach to treating beta thalassemia has the potential to be curative.

In sickle cell, the companies are also hopeful. The one patient for whom they have data has not had a vaso-occlusive crisis, a painful episode caused by the disease's characteristic sickling of red blood cells, since her treatment.

"The clinical manifestation of the disease is different, but we see consistent outcomes across both diseases," said Bastiano Sanna, Vertex's head of cell and genetic therapies, in an interview.

Three other beta thalassemia patients and one other sickle cell disease patient have been treated in the two studies of CRISPR Therapeutics and Vertex's therapy, dubbed CTX001. If results continue to look positive, CTX001 could be another powerful way to help people for whom treatment options have long been limited.

CRISPR, an easy-to-use method of genetic surgery that's derived from a bacterial defense system, has become a mainstay in labs across the world for all types of experiments. Its potential use as a human therapeutic has drawn closer as companies harnessing the technology CRISPR Therapeutics, Editas Medicine and Intellia Therapeutics have advanced their research. CRISPR Therapeutics is the first of the three to deliver results from a clinical trial.

CRISPR and Vertex unveiled their updated results at the European Hematology Association's virtual meeting on Friday. Also being presented were the latest data from Bluebird's gene therapy, known as LentiGlobin.

Bluebird is much further along, having treated 60 patients with beta thalassemia and 37 with sickle cell disease across six different studies.

Updated results from three of those studies showed 23 of 27 evaluable patients with beta thalassemia were transfusion independent for at least a year following treatment. And in sickle cell, no serious vaso-occlusive crises were observed in the 18 patients who had at least six months of follow-up. An episode was previously reported in one patient several months after LentiGlobin treatment, but was judged to be non-serious.

One sickle cell patient died suddenly 20 months following infusion with LentiGlobin, Bluebird reported Friday. Both the treating physician and an independent study committee concluded the death, ruled to be cardiovascular in nature, was unlikely to be related to the gene therapy.

Both beta thalassemia and sickle cell are diseases caused by mutations in the beta globin gene, faulty DNA that results in either absent or warped hemoglobin. Without enough hemoglobin, patients' red blood cells can't carry needed oxygen throughout the body. And those with sickle cell have abnormal hemoglobin that makes red blood cells fragile and stiff, causing them to stick in blood vessels.

Both diseases require chronic blood transfusions, and can lead to organ damage and reduced lifespans. Treatment options are limited, although that's now changing. The Food and Drug Administration, over the past few years, has approved Reblozyl, for beta thalassemia, and Oxbryta and Adakveo, for sickle cell.

Adakveo reduces the frequency of vaso-occlusive crises, while Reblozyl and Oxbryta are chronic medicines meant to boost patients' hemoglobin levels.

CRISPR Therapeutics and Vertex, along with Bluebird, are trying to accomplish the same goal but in more dramatic fashion: raising hemoglobin levels high enough so patients can stop blood transfusions and, in sickle cell, avoid pain crises altogether.

CRISPR and Vertex use CRISPR/cas9 gene editing to modify the DNA of stem cells extracted from a patient's bone marrow. The cells are engineered to produce a type of hemoglobin that's present at birth but normally replaced soon after. Once returned to the body and engrafted in the bone marrow, these CRISPR'd cells substitute this so-called fetal hemoglobin for the missing adult hemoglobin.

In the three patients treated so far, that appears to be what's happened. Both beta thalassemia patients are producing hemoglobin at levels considered normal. The sickle cell patient now has enough fetal hemoglobin to dilute the effects of sickled hemoglobin, potentially helping to preserve red blood cells.

Crucially, CRISPR and Vertex shared data for the first time indicating a high percentage of edited cells are present in each patient's bone marrow, supporting their confidence that the effects of treatment might last.

Bluebird, by contrast, doesn't edit the DNA of extracted stem cells, but rather inserts a modified gene into those cells. Once infused and engrafted in a patient, the cells can produce gene therapy-derived hemoglobin.

In most beta thalassemia and sickle cell patients treated with Bluebird's LentiGlobin, hemoglobin levels rose to normal or near-normal levels.

LentiGlobin is already approved for certain beta thalassemia patients in Europe as Zynteglo. In the U.S., Bluebird has hit delays and pushed back when it expects to submit an application to the middle of next year. A filing for an accelerated approval in sickle cell would likely follow sometime in the second half of 2021.

CRISPR and Vertex, meanwhile, plan to enroll more patients into their two studies, which they hope could serve as sufficient for an approval application if positive, Kulkarni said.

Original post:
New CRISPR, gene therapy results strengthen potential for treatment of blood diseases - BioPharma Dive

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June 13th, 2020

Regenerative Therapy Options for Horses With Osteoarthritis – TheHorse.com

By daniellenierenberg

Biologic, or regenerative, therapies have altered the way many equine veterinarians treat problematic joints. Some of the most mainstream and popular modalities they currently use to manage osteoarthritis (OA) in horses are autologous conditioned serum, autologous protein solution, platelet-rich plasma, and mesenchymal stem cells.

Most biologic therapies involve collecting and concentrating the horses natural anti-inflammatory and regenerative proteins or cells so they can be injected into an area of pathology (disease or damage) in the same horse.

Autologous conditioned serum is a cell-free extract of whole blood that has been processed to contain high concentrations of interleukin-1 receptor antagonist protein (IRAP), a naturally occurring anti-inflammatory protein within the body. It is marketed under the trade names IRAP and IRAP II.

When preparing ACS, veterinarians collect venous blood in a proprietary syringe system that encourages porous glass beads to bind with white blood cells. During an incubation process the bound white cells release high concentrations of IRAP. The veterinarian then draws the serum off into small portions and freezes it for future injection into arthritic joints. In clinical studies of ACS, researchers have reported improved synovial membrane (joint surface lining) health, stimulation of natural IRAP production, and improved lameness.

Platelet rich plasma is blood plasma thats been centrifuged or filtrated to have a higher concentration of platelets than whole blood. Many horse owners are familiar with PRP and its use in tendon and ligament injuries; however, veterinarians are using it more regularly for treating joint disease.

One of platelets roles in the body is to modulate tissue healing. They do so by releasing growth factors and signaling molecules that initiate repair and promote anabolic (supporting tissue growth) effects. Veterinarians have capitalized on this ability by injecting high concentrations of platelets directly into damaged or inflamed regions. Because many PRP systems allow for stallside preparation, it is a convenient option for immediate treatment without the hassle of incubation or culturing in the lab, as is the case with ACS and stem cell preparation, respectively.

Historically, equine veterinarians have primarily used PRP to help treat soft tissue injuries. More recent work has led to intra-articular (in the joint) use with promising results. Although researchers have demonstrated how platelet-derived products work in vitro (in the lab) and veterinarians have seen promising anecdotal results in vivo (in the live horse), theyve yet to produce evidence-based confirmation of its clinical efficacy.

Mark Revenaugh, DVM, owner of Northwest Equine Performance, in Mulino, Oregon, says the main factors standing between researchers ability to gather objective data and establish a consensus on PRPs efficacy are the high variability among preparation systems, individual patient reactivity to the product, and an unknown ideal concentration of platelets for particular injuries.

Most practitioners cant always check how many platelets are being used, he says. Depending on the system, one veterinarian may be using 100,000 platelets/milliliter and another veterinarian may be using 1 billion platelets/milliliter. These are not the same treatments, even though both are called PRP. I would love to see an industry standard develop.

Overall, PRPs positive anecdotal results and relatively easy preparation make it a useful option for treating osteoarthritis (OA) in horses.

Autologous protein solution (marketed under the trade name Pro-Stride) is essentially a hybrid of ACS and PRP. Its two-step stallside preparation process involves separating whole blood and sequestering white blood cells and platelets in a small fraction of plasma. The veterinarian then concentrates the separate blood components by filtration, leaving a solution of white blood cells, platelets, and serum proteins that provides the anti-inflammatory mediators of IRAP and the platelet-derived growth factors of PRP.

In a 2014 study out of The Ohio State University, researchers revealed that an intra-articular APS injection can significantly improve lameness, weight-bearing symmetry, and range of joint motion in horses that dont have severe lameness or significant compromise to the joint structure.

Mesenchymal stems cells are adult stem cells that can direct regeneration and repair of damaged tissue. Veterinarians have used this type of stem cell as a treatment strategy for equine soft tissue injury for some time; its only recently that veterinarians have begun using them to treat OA, and its not fully clear how they work in this capacity. Researchers working on early stem cell studies hoped to establish evidence that stem cells injected into regions of injury would develop into the respective tissue. While this hypothesis proved to be incorrect, continued research has revealed that these cells might instead have anti-inflammatory effects and the ability to recruit other stem cells to the area that could, in fact, heal damaged tissue.

The two most common forms of mesenchymal stem cells are adipose (fat)-derived and bone-marrow-derived. Some study results have shown that bone marrow sources yield smaller concentrations thanbut are superior toadipose sources in their ability to differentiate into musculoskeletal tissue. Some encouraging data supporting the use of mesenchymal stem cells for treating OA exists, but researchers have only published a small number of studies with promising results. Equine veterinarians have used MSCs to treat intra-articular soft tissue injury (meniscal and cruciate damagecartilaginous tissues and ligaments that support the stifle), with successful anecdotal results. Theyve reported more variable outcomes when using it for primary intra-articular injuries.

Carter Judy, DVM, Dipl. ACVS, staff surgeon at Alamo Pintado Equine Medical Center, in Los Olivos, California, says he currently prefers to use PRP and APS for OA treatment over MSCs. However, he admits there is much to be discovered. What will be interesting to see is how manipulating the cells and providing them with different signals and markers can make their efficacy much more potent and focused, he says.

When weighing treatment options for horses with OA, veterinarians should base their decision to use a certain biologic modality on its cost, availability, and how a horse has responded previously.

Our knowledge base of how the biologics work is improving, but we are in the infancy of understanding, Judy says. Much of the use is based on the clinical response as much as is it on the scientific data.

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June 13th, 2020

COVID 19 to Lead the Sales of Myelofibrosis Treatment to Register Stellar Growth in the Next 10 Years – Cole of Duty

By daniellenierenberg

Myelofibrosis or osteomyelofibrosis is a myeloproliferative disorder which is characterized by proliferation of abnormal clone of hematopoietic stem cells. Myelofibrosis is a rare type of chronic leukemia which affects the blood forming function of the bone marrow tissue. National Institute of Health (NIH) has listed it as a rare disease as the prevalence of myelofibrosis in UK is as low as 0.5 cases per 100,000 population. The cause of myelofibrosis is the genetic mutation in bone marrow stem cells. The disorder is found to occur mainly in the people of age 50 or more and shows no symptoms at an early stage. The common symptoms associated with myelofibrosis include weakness, fatigue, anemia, splenomegaly (spleen enlargement) and gout. However, the disease progresses very slowly and 10% of the patients eventually develop acute myeloid leukemia. Treatment options for myelofibrosis are mainly to prevent the complications associated with low blood count and splenomegaly.

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The global market for myelofibrosis treatment is expected to grow moderately due to low incidence of a disease. However, increasing incidence of genetic disorders, lifestyle up-gradation and rise in smoking population are the factors which can boost the growth of global myelofibrosis treatment market. The high cost of therapy will the growth of global myelofibrosis treatment market.

The global market for myelofibrosis treatment is segmented on basis of treatment type, end user and geography:

As myelofibrosis is considered as non-curable disease treatment options mainly depend on visible symptoms of a disease. Primary stages of the myelofibrosis are treated with supportive therapies such as chemotherapy and radiation therapy. However, there are serious unmet needs in myelofibrosis treatment market due to lack of disease modifying agents. Approval of JAK1/JAK2 inhibitor Ruxolitinib in 2011 is considered as a breakthrough in myelofibrosis treatment. Stem cell transplantation for the treatment of myelofibrosis also holds tremendous potential for market growth but high cost of therapy is foreseen to limits the growth of the segment.

On the basis of treatment type, the global myelofibrosis treatment market has been segmented into blood transfusion, chemotherapy, androgen therapy and stem cell or bone marrow transplantation. Chemotherapy segment is expected to contribute major share due to easy availability of chemotherapeutic agents. Ruxolitinib is the only chemotherapeutic agent approved by the USFDA specifically for the treatment of myelofibrosis, which will drive the global myelofibrosis treatment market over the forecast period.

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Geographically, global myelofibrosis treatment market is segmented into five regions viz. North America, Latin America, Europe, Asia Pacific and Middle East & Africa. Northe America is anticipated to lead the global myelofibrosis treatment market due to comparatively high prevalence of the disease in the region.

Some of the key market players in the global myelofibrosis treatment market are Incyte Corporation, Novartis AG, Celgene Corporation, Mylan Pharmaceuticals Ulc., Bristol-Myers Squibb Company, Eli Lilly and Company, Taro Pharmaceuticals Inc., AllCells LLC, Lonza Group Ltd., ATCC Inc. and others.

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June 13th, 2020

Majority of Evaluable Patients Across Genotypes Achieve Transfusion Independence and Maintain It with Near-Normal Hemoglobin Levels in Phase 3 Studies…

By daniellenierenberg

CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced that new data from ongoing Phase 3 studies of betibeglogene autotemcel (beti-cel; formerly LentiGlobin for -thalassemia gene therapy) show pediatric, adolescent and adult patients with a range of genotypes of transfusion-dependent -thalassemia (TDT) achieve and maintain transfusion independence with hemoglobin (Hb) levels that are near-normal (10.5 g/dL). These data are being presented at the Virtual Edition of the 25th European Hematology Association (EHA25) Annual Congress.

With more than a decade of clinical experience evaluating gene therapy in patients with transfusion dependent -thalassemia across a wide range of ages and genotypes, we have built the most comprehensive understanding of treatment outcomes in the field, said David Davidson, M.D., chief medical officer, bluebird bio. Seeing patients achieve transfusion independence and maintain that positive clinical benefit over time with robust hemoglobin levels reflects our initial vision of the potential of beti-cel. The accumulating long-term data demonstrating improvements in bone marrow histology, iron balance and red cell biology support the potential of beti-cel to correct the underlying pathophysiology of transfusion-dependent -thalassemia.

A total of 60 pediatric, adolescent and adult patients across genotypes of TDT have been treated with beti-cel in the Phase 1/2 Northstar (HGB-204) and HGB-205 studies, and the Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies as of March 3, 2020. In studies of beti-cel, transfusion independence is defined as no longer needing red blood cell transfusions for at least 12 months while maintaining a weighted average Hb of at least 9 g/dL.

TDT is a severe genetic disease caused by mutations in the -globin gene that results in significantly reduced or absent adult hemoglobin (HbA). In order to survive, people with TDT maintain Hb levels through lifelong, chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload.

Patients with transfusion-dependent -thalassemia do not make enough healthy red blood cells and cannot live without chronic transfusions; for patients that means a lifetime of necessary visits to a hospital or clinic and reliance on an often unreliable blood supply, which compounds the challenges of managing this disease, said presenting study author Professor John B. Porter, MA, M.D., FRCP, FRCPath, University College London Hospital, London, UK. These results showing patients free from transfusions and maintaining near-normal hemoglobin levels after treatment with beti-cel is a positive outcome for people living with transfusion-dependent -thalassemia. In addition, we now have more data that provide further evidence that most of these patients have a measurable improvement in markers of healthy red blood cell production.

Beti-cel is a one-time gene therapy designed to address the underlying genetic cause of TDT by adding functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). This means there is no need for donor HSCs from another person, as is required for allogeneic HSC transplantation (allo-HSCT). Once a patient has the A-T87Q-globin gene, they have the potential to produce HbAT87Q, which is gene therapy-derived Hb, at levels that eliminate or significantly reduce the need for transfusions.

Northstar-2 (HGB-207) Efficacy

As of March 3, 2020, all 23 patients in HGB-207 were treated and have been followed for a median of 19.4 months. These patients ranged in age from four to 34 years, including eight pediatric (<12 years of age) and 15 adolescent/adult (>12 years of age) patients. Only 19 patients were evaluable for transfusion independence; four additional patients do not yet have sufficient follow-up to be assessed for transfusion independence.

Eighty-nine percent of evaluable patients (17/19) achieved transfusion independence, with median weighted average total Hb levels of 11.9 g/dL (min-max: 9.4 12.9 g/dL) over a median of 19.4 months of follow-up to date (min-max: 12.3 31.4 months). These 17 patients previously required a median of 17.5 transfusions per year (min-max: 11.5 37 transfusions per year).

Improved iron levels, as measured by serum ferritin and hepcidin levels (proteins involved in iron storage and homeostasis), were observed and trends toward improved iron management were seen. Over half of patients stopped chelation therapy, which is needed to reduce excess iron caused by chronic blood transfusions. Seven out of 23 patients began using phlebotomy for iron reduction.

Analysis of Healthy Red Blood Cell Production

In exploratory analyses, biomarkers of ineffective erythropoiesis (red blood cell production) were evaluated in patients who achieved transfusion independence in HGB-207.

The myeloid to erythroid (M:E) ratio in bone marrow from patients who achieved transfusion independence increased from a median of 1:3 (n=17) at baseline to 1:1.2 (n=16) at Month 12. Improvement of the M:E ratio, the ratio of white blood cell and red blood cell precursors in the bone marrow, suggests an improvement in mature red blood cell production. Images illustrating the bone marrow cellularity at baseline, Month 12 and Month 24 are available in the EHA25 presentation (abstract #S296): Improvement in erythropoiesis in patients with transfusion-dependent -thalassemia following treatment with betibeglogene autotemcel (LentiGlobin for -thalassemia) in the Phase 3 HGB-207 study.

Additionally, biomarkers of erythropoiesis continue to demonstrate a trend toward normalization in patients who achieved transfusion independence, including improved levels over time of erythropoietin, a hormone involved in red blood cell production; reticulocytes, immature red blood cells; and soluble transferrin receptor, a protein measured to help evaluate iron status. The continued normalization of red blood cell production over time among some patients who achieved transfusion independence supports the disease-modifying potential of beti-cel in patients with TDT.

Northstar-3 (HGB-212) Efficacy

As of March 3, 2020, 15 patients (genotypes: 9 0/0, 3 0/ +IVS1-110, 3 homozygous IVS-1-110 mutation) were treated and had a median follow-up of 14.4 months (min-max: 1.124.0 months). Median age at enrollment was 15 (min-max: 4 33 years).

Six of eight evaluable patients achieved transfusion independence, with median weighted average total Hb levels of 11.5 g/dL (min-max: 9.5 13.5 g/dL), and continued to maintain transfusion independence for a median duration of 13.6 months (min-max: 12.2 21.2 months) as of the data cutoff.

Eighty-five percent of patients (11/13) with at least seven months of follow-up had not received a transfusion in more than seven months at time of data cutoff. These 11 patients previously required a median of 18.5 transfusions per year (min-max: 11.0 39.5 transfusions per year). In these patients, gene therapy-derived HbAT87Q supported total Hb levels ranging from 8.814.0 g/dL at last visit.

Betibeglogene autotemcel Safety

Non-serious adverse events (AEs) observed during the HGB-207 and HGB-212 trials that were considered related or possibly related to beti-cel were tachycardia, abdominal pain, pain in extremities, leukopenia, neutropenia and thrombocytopenia. One serious event of thrombocytopenia was considered possibly related to beti-cel.

In HGB-207, serious events post-infusion in two patients included three events of veno-occlusive liver disease and two events of thrombocytopenia. In HGB-212, serious events post-infusion in two patients included two events of pyrexia.

Additional AEs observed in clinical studies were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan, including SAEs of veno-occlusive disease.

In both Phase 3 studies, there have been no deaths, no graft failure, no cases of vector-mediated replication competent lentivirus or clonal dominance, no leukemia and no lymphoma.

The presentations are now available on demand on the EHA25 website:

About betibeglogene autotemcel

The European Commission granted conditional marketing authorization (CMA) for betibeglogene autotemcel (beti-cel; formerly LentiGlobin gene therapy for -thalassemia), marketed as ZYNTEGLO gene therapy, for patients 12 years and older with transfusion-dependent -thalassemia (TDT) who do not have a 0/0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate, but a human leukocyte antigen (HLA)-matched related HSC donor is not available. On April 28, 2020, the European Medicines Agency (EMA) renewed the CMA for ZYNTEGLO, supported by data from 32 patients treated with ZYNTEGLO, including three patients with up to five years of follow-up.

TDT is a severe genetic disease caused by mutations in the -globin gene that result in reduced or significantly reduced hemoglobin (Hb). In order to survive, people with TDT maintain Hb levels through lifelong chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload.

Beti-cel adds functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). Once a patient has the A-T87Q-globin gene, they have the potential to produce HbAT87Q, which is gene therapy-derived hemoglobin, at levels that may eliminate or significantly reduce the need for transfusions.

Non-serious adverse events (AEs) observed during clinical studies that were attributed to beti-cel included abdominal pain, thrombocytopenia, leukopenia, neutropenia, hot flush, dyspnea, pain in extremity and non-cardiac chest pain. Two serious adverse events (SAE) of thrombocytopenia was considered possibly related to beti-cel.

Additional AEs observed in clinical studies were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan, including SAEs of veno-occlusive disease.

The CMA for beti-cel is valid in the 27 member states of the EU as well as UK, Iceland, Liechtenstein and Norway. For details, please see the Summary of Product Characteristics (SmPC).

The U.S. Food and Drug Administration (FDA) granted beti-cel orphan drug designation and Breakthrough Therapy designation for the treatment of transfusion-dependent -thalassemia. Beti-cel is not approved in the U.S.

Beti-cel continues to be evaluated in the ongoing Phase 3 Northstar-2 and Northstar-3 studies. For more information about the ongoing clinical studies, visit http://www.northstarclinicalstudies.com or clinicaltrials.gov and use identifier NCT02906202 for Northstar-2 (HGB-207) and NCT03207009 for Northstar-3 (HGB-212).

bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of betibeglogene autotemcel or LentiGlobin for SCD. For more information visit: https://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

ZYNTEGLO, LentiGlobin, and bluebird bio are trademarks of bluebird bio, Inc.

bluebird bio Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the COVID-19 pandemic and resulting impact on our operations and healthcare systems will affect the execution of our development plans or the conduct of our clinical studies; the risk that the efficacy and safety results observed in the patients treated in our prior and ongoing clinical trials of beti-cel may not persist; and the risk that the efficacy and safety results from our prior and ongoing clinical trials will not continue or be repeated with additional patients in our ongoing or planned clinical trials or in the commercial context; the risk that the FDA will require additional information regarding beti-cel, resulting in a delay to our anticipated timelines for regulatory submissions, including submission of our BLA. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

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June 13th, 2020

Market Analysis and Technological Opportunities of Cell Therapy Manufacturing Market till 2030 – Medic Insider

By daniellenierenberg

Prophecy Market Insights Cell Therapy Manufacturing market research report provides a comprehensive, 360-degree analysis of the targeted market which helps stakeholders to identify the opportunities as well as challenges. The research report study offers keen competitive landscape analysis including key development trends, accurate quantitative and in-depth commentary insights, market dynamics, and key regional development status forecast 2020-2029. It incorporates market evolution study, involving the current scenario, growth rate, and capacity inflation prospects, based on Porters Five Forces and DROT analyses.

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An executive summary provides the markets definition, application, overview, classifications, product specifications, manufacturing processes; raw materials, and cost structures.

Market Dynamics offers drivers, restraints, challenges, trends, and opportunities of the Cell Therapy Manufacturing market

Segment Level Analysis in terms of types, product, geography, demography, etc. along with market size forecast

Regional and Country- level Analysis different geographical areas are studied deeply and an economical scenario has been offered to support new entrants, leading market players, and investors to regulate emerging economies. The top producers and consumers focus on production, product capacity, value, consumption, growth opportunity, and market share in these key regions, covering

The comprehensive list of Key Market Players along with their market overview, product protocol, key highlights, key financial issues, SWOT analysis, and business strategies. The report dedicatedly offers helpful solutions for players to increase their clients on a global scale and expand their favour significantly over the forecast period. The report also serves strategic decision-making solutions for the clients.

Competitive landscape Analysis provides mergers and acquisitions, collaborations along with new product launches, heat map analysis, and market presence and specificity analysis.

Segmentation Overview:

Cell Therapy ManufacturingMarket Key Companies:

harmicell, Merck Group, Dickinson and Company, Thermo Fisher, Lonza Group, Miltenyi Biotec GmBH, Takara Bio Group, STEMCELL Technologies, Cellular Dynamics International, Becton, Osiris Therapeutics, Bio-Rad Laboratories, Inc., Anterogen, MEDIPOST, Holostem Terapie Avanazate, Pluristem Therapeutics, Brammer Bio, CELLforCURE, Gene Therapy Catapult EUFETS, MaSTherCell, PharmaCell, Cognate BioServices and WuXi AppTec.

The Cell Therapy Manufacturing research study comprises 100+ market data Tables, Graphs & Figures, Pie Chat to understand detailed analysis of the market. The predictions estimated in the market report have been resulted in using proven research techniques, methodologies, and assumptions. This Cell Therapy Manufacturing market report states the market overview, historical data along with size, growth, share, demand, and revenue of the global industry.

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The study analyses the manufacturing and processing requirements, project funding, project cost, project economics, profit margins, predicted returns on investment, etc. This report is a must-read for investors, entrepreneurs, consultants, researchers, business strategists, and all those who have any kind of stake or are planning to foray into the Cell Therapy Manufacturing industry in any manner.

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Market Analysis and Technological Opportunities of Cell Therapy Manufacturing Market till 2030 - Medic Insider

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June 13th, 2020

Aprea Therapeutics Presents Results From French Phase Ib/II Clinical Trial of APR-246 (Eprenetapopt) and Azacitidine in Patients with TP53 Mutant…

By daniellenierenberg

BOSTON, June 12, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc.(Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced the oral presentation of updated data from its French Phase 1b/2 clinical trial at the 25th European Hematology Association Annual Meeting (EHA). The trial is evaluating the safety and efficacy of APR-246 (eprenetapopt) in combination with azacitidine (AZA) for the treatment of TP53 mutant myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). The clinical trial is sponsored by the Groupe Francophone des Mylodysplasies (GFM).

As of the April 1, 2020 data cutoff, the overall response rate (ORR) in 28 evaluable MDS patients was 75%, with a 57% complete remission (CR) rate, by International Working Group (IWG) criteria. With a median duration of follow-up of 9.7 months, the median overall survival (OS) for all enrolled patients (n=52) was 12.1 months and in MDS patients (n=34) was 12.1 months. For patients who remained on treatment for 3 or more cycles of treatment the median OS was higher at 13.7 months versus 2.8 months for patients who were on treatment for fewer than 3 cycles. Relative to baseline, mutant TP53 variant allele frequency (VAF) was decreased in responding patients by 3 cycles of treatment, including 20 (51%) patients who achieved mutant TP53 negativity by next-generation sequencing (NGS).

The data from this ongoing trial of eprenetapopt with azacitidine continue to be very encouraging in these most difficult-to-treat TP53 mutant MDS and AML patients, who not only have at least one TP53 mutation but the majority of whom also have high risk cytogenetic abnormalities, said Thomas Cluzeau, M.D., co-lead investigator for the GFM trial. We continue to observe ORR and CR rates in these patients that are substantially higher than the GFMs experience with azacitidine monotherapy. Furthermore, with increased duration of follow-up, we now also see the emergence of highly encouraging overall survival that appears to be better than azacitidine alone or in combination with others agents in this very high-risk molecular group of patients with a TP53 mutation.

Details of the on-demand oral presentation are as follows:

Title: APR-246 Combined with Azacitidine in TP53 Mutated Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia. A Phase 2 Study by the Groupe Francophone des Mylodysplasies (GFM)

Oral Abstract Session: Novel treatments for MDS I

Abstract: S181

About the Clinical Trial

Eligible patients in the Phase Ib/II clinical trial include hypomethylating agent (HMA) nave, TP53 mutated MDS and AML. All enrolled patients were to receive APR-246 as a 4,500 mg fixed dose IV daily for 4 days and AZA over 7 days in 28-day cycles. The primary endpoint of the trial is CR rate.

AboutAprea Therapeutics, Inc.

Aprea Therapeutics, Inc.is a biopharmaceutical company headquartered inBoston, Massachusettswith research facilities inStockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivatemutant tumor suppressor protein, p53. The Companys lead product candidate is APR-246 (eprenetapopt), a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer. For more information, please visit the company website atwww.aprea.com.

The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) represents a spectrum of hematopoietic stem cell malignancies in which bone marrow fails to produce sufficient numbers of healthy blood cells. Approximately 30-40% of MDS patients progress to acute myeloid leukemia (AML) and mutation of the p53 tumor suppressor protein is thought to contribute to disease progression. Mutations in p53 are found in up to 20% of MDS and AML patients and are associated with poor overall prognosis.

About p53 and APR-246 (eprenetapopt)

The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50% of all human tumors. These mutations are often associated with resistance to anti-cancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.

APR-246 (eprenetapopt) is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein by restoring wild-type p53 conformation and function and thereby induce programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed with APR-246 in a wide variety of solid and hematological cancers, including MDS, AML, and ovarian cancer, among others. Additionally, strong synergy has been seen with both traditional anti-cancer agents, such as chemotherapy, as well as newer mechanism-based anti-cancer drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase 1/2 clinical program with APR-246 has been completed, demonstrating a favorable safety profile and both biological and confirmed clinical responses in hematological malignancies and solid tumors with mutations in the TP53 gene.

Forward-Looking StatementCertain information contained in this press release includes forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, related to our clinical trials, regulatory submissions and projected cash position. We may, in some cases use terms such as predicts, believes, potential, continue, anticipates, estimates, expects, plans, intends, targeting, confidence, may, could, might, likely, will, should or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward looking statements are subject to risks and uncertainties including risks related to the success and timing of our clinical trials or other studies, risks associated with the coronavirus pandemic and the other risks set forth in our filings with theU.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Source:Aprea Therapeutics, Inc.

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Aprea Therapeutics Presents Results From French Phase Ib/II Clinical Trial of APR-246 (Eprenetapopt) and Azacitidine in Patients with TP53 Mutant...

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June 13th, 2020

Exploring the Therapeutic Potential of ST266 Against Numerous Diseases Including COVID-19 – Technology Networks

By daniellenierenberg

Noveome Biotherapeutics is a clinical-stage company focused on developing therapies for the regenerative repair of tissues. Their product ST266, a first-of-its-kind, multi-targeted, non-cellular platform biologic comprised of a complex mixture of biomolecules, is currently being evaluated as a potential treatment for the severe inflammatory response observed in the lungs of some COVID-19 patients.Technology Networks recently spoke with William J. Golden, Noveome Biotherapeutics Founder, Chairman and CEO, who explains the underlying basis for investigating ST266s potential against COVID-19. Golden also elaborates on many of the other indications for which ST266 is being developed to treat.Laura Lansdowne (LL): Could you provide our readers with a brief overview of Noveome Biotherapeutics?William J. Golden (WJG): Noveome is a clinical-stage biotherapeutics company located in Pittsburgh, PA. The company was founded in 2000 by Bill Golden and Lancet Capital. The group was interested in exploring non-embryonic stem cells and identified a technology at the University of Pittsburgh that was using cells derived from human amnion, a membrane that closely covers the fetus during development. The company, named Kytaron Technologies, Inc. at the time, licensed that amnion cell technology but, ultimately, Noveome scientists were able to discover, develop and patent their own unique population of cells, called Amnion-derived Multipotential Progenitor (AMP) cells, using a proprietary culture method that follows current Good Manufacturing Practice (cGMP) regulations. These novel cells were used to produce our product, ST266.LL: What is ST266? Could you elaborate on its mechanism of action in relation to the healing process?WJG: Noveomes product, ST266, is the secretome produced by the AMP cells. It is a completely cell-free solution and is comprised of hundreds of biologically active molecules, including cytokines and growth factors. Interestingly, these cytokines and growth factors exist at very low physiological levels ranging from pg/mL ng/mL concentrations.1 The fact that such low concentrations of these molecules are biologically active is quite remarkable when you consider that traditional protein-based therapies are usually administered at concentrations that are orders of magnitude greater than the concentrations found in ST266.Because the composition of ST266 is so complex, its multiple mechanisms of action have only been partially elucidated. Clinical and preclinical studies have shown ST266 to be anti-inflammatory,2,3 promote wound healing,4,5 reduce apoptosis, reduce vascular permeability (manuscript in preparation), and restore cellular homeostasis.3 Preclinical studies have also shown ST266 to be neuroprotective. In a traumatic brain injury model, ST266 significantly protected against reactive gliosis, suggesting potent anti-inflammatory activity, and resulted in significant recovery of rotarod motor function.6,7 In another study, ST266 was tested in the experimental autoimmune encephalopathy (EAE) mouse model of multiple sclerosis (MS). In this model, the mice develop optic neuritis, which is among the presenting symptoms of MS in humans. ST266 was administered to the nares of mice 15 or 22 days after disease induction. ST266 is absorbed via capillary action along the olfactory nerves which bypasses the blood-brain barrier. This unique route of administration allows for the delivery of high molecular weight biologics to the optic nerve of the eye and the central nervous system. ST266 attenuated visual dysfunction, prevented retinal ganglion cell (RGC) loss, reduced inflammation, and decreased the rate of demyelination of the optic nerve in EAE mice.3Mechanistically, ST266 simultaneously acts on multiple cell receptor-activated and intracellular signaling pathways. For example, in the EAE MS model, neuroprotective effects involved oxidative stress reduction, SIRT1-mediated mitochondrial function promotion, and pAKT signaling.3 In a Phase 2 UV light burn study, ST266 reduced erythema and DNA damage and increased the expression of XPA DNA repair proteins.2Importantly, ST266 has a proven clinical safety profile. It has been administered to 243 patients by various routes of administration (topical skin, topical ocular, topical oral, targeted intranasal), and no drug-related serious adverse events have been reported. Preclinical studies of systemically administered ST266 have also yielded no drug-related safety concerns.LL: For what indications is ST266 currently being evaluated as a treatment?WJG: We refer to ST266 as a platform biologic. By this, we mean that ST266 is one product that has the potential to treat numerous and varied diseases. In the clinic, we have shown anti-inflammatory activity when ST266 is applied topically to UV light-burned the skin2 and topical application to the gums of patients with gingivitis and periodontitis showed a reduction in proinflammatory cytokines in the patients crevicular fluid (manuscript in preparation). We are currently conducting a Phase 2 open label trial of ST266 to treat persistent corneal epithelial defects (PEDs) when applied topically to the eye. Results from this trial will be published soon. We are currently planning a Phase 2b multi-center, randomized, double-masked trial to further evaluate the safety and efficacy of ST266 in this indication. Finally, we are conducting a Phase 1 study in patients at risk for developing glaucoma. This study is using the intranasal route of delivery described above in combination with a novel delivery device. The goal is to deliver ST266 directly to the optic nerve, where it can protect the RGCs that are damaged in glaucoma. We envision this route of delivery will be applicable to central nervous system and other back-of-the eye indications.We also have several ongoing preclinical programs that are evaluating systemically administered ST266 for more generalized inflammatory conditions. These data are not yet published but combined with the data we have compiled in preclinical and clinical studies of topical skin, topical oral and topical ocular administration, we believe ST266 has the potential to be an effective therapy for numerous systemic inflammatory conditions.LL: Could you elaborate on the underlying basis for your evaluation of ST266 as a potential treatment for COVID-19?WJG: As you know, a major complication of COVID-19 is the severe inflammatory response seen in the lungs of some patients. This response is called cytokine storm or cytokine release syndrome. As the pandemic continues and more data have become available, it is now known that the cytokine storm does not just affect the lungs. Multi-organ damage occurs in many of these patients. We believe that systemic delivery of ST266 and its anti-inflammatory activity has the potential to calm the storm. Our as-yet-unpublished preclinical studies with intravenous ST266 support this hypothesis and we are moving rapidly to initiate intravenous ST266 in a Phase 1 study. Once safety in humans is established by this route of administration, we will commence Phase 2 studies in COVID-19 patients.William J. Golden was speaking to Laura Elizabeth Lansdowne, Senior Science Writer for Technology Networks.References

1. Steed, DL, C Trumpower, D Duffy, C Smith, V Marshall, R Rupp, and M Robson. (2008). Amnion-Derived Cellular Cytokine Solution: A Physiological Combination of Cytokines for Wound Healing. Eplasty 8: 15765.

2. Guan, Linna, Amanda Suggs, Emily Galan, Minh Lam, and Elma D. Baron. (2017). Topical Application of ST266 Reduces UV-Induced Skin Damage. Clinical, Cosmetic and Investigational Dermatology. DOI: https://doi.org/10.2147/CCID.S147112.

3. Khan, Reas S, Kimberly Dine, Bailey Bauman, Michael Lorentsen, Lisa Lin, Helayna Brown, Leah R Hanson, et al. (2017). Intranasal Delivery of A Novel Amnion Cell Secretome Prevents Neuronal Damage and Preserves Function In A Mouse Multiple Sclerosis Model. Scientific Reports. DOI: https://doi.org/10.1038/srep41768.

4. Bergmann, Juri, Florian Hackl, Taro Koyama, Pejman Aflaki, Charlotte a Smith, Martin C Robson, and Elof Eriksson. (2009). The Effect of Amnion-Derived Cellular Cytokine Solution on the Epithelialization of Partial-Thickness Donor Site Wounds in Normal and Streptozotocin-Induced Diabetic Swine. Eplasty 9: e49.

5. Franz, Michael G, Wyatt G Payne, Liyu Xing, D K Naidu, R E Salas, Vivienne S Marshall, C J Trumpower, Charlotte A Smith, David L Steed, and M C Robson. (2008). The Use of Amnion-Derived Cellular Cytokine Solution to Improve Healing in Acute and Chronic Wound Models. Eplasty 8: e21.

6. Deng-Bryant, Ying, Zhiyong Chen, Christopher van der Merwe, Zhilin Liao, Jitendra R Dave, Randall Rupp, Deborah a Shear, and Frank C Tortella. (2012). Long-Term Administration of Amnion-Derived Cellular Cytokine Suspension Promotes Functional Recovery in a Model of Penetrating Ballistic-like Brain Injury. The Journal of Trauma and Acute Care Surgery DOI: https://doi.org/10.1097/TA.0b013e3182625f5f.

7. Deng-Bryant, Ying, Ryan D. Readnower, Lai Yee Leung, Tracy L. Cunningham, Deborah A. Shear, and Frank C. Tortella. (2015). Treatment with Amnion-Derived Cellular Cytokine Solution (ACCS) Induces Persistent Motor Improvement and Ameliorates Neuroinflammation in a Rat Model of Penetrating Ballistic-like Brain Injury. Restorative Neurology and Neuroscience. DOI: https://doi.org/10.3233/RNN-140455.

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Exploring the Therapeutic Potential of ST266 Against Numerous Diseases Including COVID-19 - Technology Networks

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June 12th, 2020

‘I found these 4 affordable winter skin saviours in the chemist beauty aisles.’ – Mamamia

By daniellenierenberg

The light, non-greasy, dermatologically tested formula contains Vitamin B3 to help hydrate and support the skin barrier, and SPF30 for added sun protection. It alsosits beautifully under your regular SPF you'll have on, and makeup.

It won't clog your pores and doesn't include common irritants like fragrance or colour. The no-fuss formula also won't mess with the rest of your skincare, making it the easy to slot into your existing routine. Done!

(*Side note:Always read the label. Follow the directions for use. Avoid prolonged sun exposure and wear protective clothing, hats and eyewear to further reduce risk. Frequent re-application is required.)

Anyone else get dry lips in winter? This lip balm is brilliant for a few reasons.

A) It's super affordable and accessible - you'll find it at most pharmacies.

B) It has SPF50+ broad spectrum protection.

C) The texture isn't too thick or too thin, it's just right.

And D) You can wear the clear formula over the top of alip stain or lip liner.

Just don't leave it in the car, OK?

(And yes, you know the drill:Always read the label. Follow the directions for use. Avoid prolonged sun exposure and wear protective clothing, hats and eyewear to further reduce risk. Frequent re-application is required.)

See the article here:
'I found these 4 affordable winter skin saviours in the chemist beauty aisles.' - Mamamia

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June 12th, 2020

EHA25Virtual: Combined Irradiation and Chemotherapy Better Prepares Children for Stem Cell Transplantation than Chemotherapy Alone – PR Newswire UK

By daniellenierenberg

Allogeneic HSCT is a multistep procedure:

Embargo: Please note that our embargo policy applies to all selected abstracts in the Press Briefings. For more information click here.

Logo - http://mma.prnewswire.com/media/622259/EHA_Logo.jpg

SOURCE European Hematology Association (EHA)

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EHA25Virtual: Combined Irradiation and Chemotherapy Better Prepares Children for Stem Cell Transplantation than Chemotherapy Alone - PR Newswire UK

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June 12th, 2020

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