BioRestorative Therapies (OTCMKTS:BRTX) and Livongo Health (NASDAQ:LVGO) are both medical companies, but which is the better stock? We will compare the two companies based on the strength of their risk, institutional ownership, profitability, earnings, valuation, analyst recommendations and dividends.

Institutional and Insider Ownership

0.1% of Livongo Health shares are owned by institutional investors. 17.9% of BioRestorative Therapies shares are owned by company insiders. Strong institutional ownership is an indication that hedge funds, endowments and large money managers believe a stock will outperform the market over the long term.

Analyst Recommendations

This is a breakdown of recent ratings and recommmendations for BioRestorative Therapies and Livongo Health, as reported by MarketBeat.

Livongo Health has a consensus target price of $44.30, indicating a potential upside of 71.17%. Given Livongo Healths higher probable upside, analysts plainly believe Livongo Health is more favorable than BioRestorative Therapies.

Profitability

This table compares BioRestorative Therapies and Livongo Healths net margins, return on equity and return on assets.

Valuation & Earnings

This table compares BioRestorative Therapies and Livongo Healths top-line revenue, earnings per share (EPS) and valuation.

BioRestorative Therapies has higher earnings, but lower revenue than Livongo Health.

Summary

Livongo Health beats BioRestorative Therapies on 7 of the 9 factors compared between the two stocks.

BioRestorative Therapies Company Profile

BioRestorative Therapies, Inc. develops therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells for the treatment of disc/spine disease and metabolic disorders. The company's lead cell therapy candidate is the BRTX-100, which focuses on providing non-surgical treatment for protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. It also develops the ThermoStem program, a pre-clinical program for the treatment of metabolic diseases, such as type 2 diabetes, obesity, hypertension, and other metabolic disorders, as well as cardiac deficiencies. In addition, the company provides curved needle device, a needle system with a curved inner cannula that allows access to difficult-to-locate regions for the delivery or removal of fluids and other substances. Further, it offers skin care products under the Stem Pearls brand name. BioRestorative Therapies, Inc. has a research and development agreement with Rohto Pharmaceutical Co., Ltd.; and a research agreement with Pfizer, Inc. and the University of Pennsylvania. The company was formerly known as Stem Cell Assurance, Inc. and changed its name to BioRestorative Therapies, Inc. in August 2011. BioRestorative Therapies, Inc. was incorporated in 1997 and is headquartered in Melville, New York.

Livongo Health Company Profile

Livongo Health, Inc. provides an integrated suite of solutions for the healthcare industry in North America. It solutions promote health behavior change based on real-time data capture supported by intuitive devices and insights driven by data science. The company offers a platform that provides cellular-connected devices, supplies, informed coaching, data science-enabled insights, and facilitates access to medications. Its products include Livongo for Diabetes, Livongo for Hypertension, Livongo for Prediabetes and Weight Management, and Livongo for Behavioral Health by myStrength. The company was formerly known as EosHealth, Inc. and changed its name to Livongo Health, Inc. in 2014. Livongo Health, Inc. was incorporated in 2008 and is headquartered in Mountain View, California.

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Financial Contrast: BioRestorative Therapies (OTCMKTS:BRTX) and Livongo Health (OTCMKTS:LVGO) - DFS Caller

Cardiac Stem Cells Comments Off on Financial Contrast: BioRestorative Therapies (OTCMKTS:BRTX) and Livongo Health (OTCMKTS:LVGO) – DFS Caller | November 12th, 2019

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Global Stem Cell Therapy Market: Overview

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

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

Know the Growth Opportunities in Emerging Markets

Global Stem Cell Therapy Market: Key Trends

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

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

Global Stem Cell Therapy Market: Market Potential

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

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

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

The regional analysis covers:

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Global Stem Cell Therapy Market: Regional Outlook

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

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

Global Stem Cell Therapy Market: Competitive Analysis

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

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

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Stem Cell Therapy Market Poised to Expand at a Robust Pace Over 2025 - Tech Admirers

Cardiac Stem Cells Comments Off on Stem Cell Therapy Market Poised to Expand at a Robust Pace Over 2025 – Tech Admirers | November 11th, 2019

US Stem Cell (OTCMKTS:USRM) and Auxly Cannabis Group (OTCMKTS:CBWTF) are both small-cap medical companies, but which is the superior business? We will contrast the two businesses based on the strength of their risk, earnings, analyst recommendations, valuation, profitability, dividends and institutional ownership.

Valuation & Earnings

This table compares US Stem Cell and Auxly Cannabis Groups gross revenue, earnings per share (EPS) and valuation.

US Stem Cell has higher revenue and earnings than Auxly Cannabis Group.

Risk & Volatility

US Stem Cell has a beta of 5.05, suggesting that its stock price is 405% more volatile than the S&P 500. Comparatively, Auxly Cannabis Group has a beta of 0.62, suggesting that its stock price is 38% less volatile than the S&P 500.

Analyst Ratings

This is a summary of current ratings for US Stem Cell and Auxly Cannabis Group, as provided by MarketBeat.com.

Institutional and Insider Ownership

0.0% of Auxly Cannabis Group shares are held by institutional investors. 16.7% of US Stem Cell shares are held by company insiders. Strong institutional ownership is an indication that large money managers, endowments and hedge funds believe a company will outperform the market over the long term.

Profitability

This table compares US Stem Cell and Auxly Cannabis Groups net margins, return on equity and return on assets.

Summary

US Stem Cell beats Auxly Cannabis Group on 6 of the 9 factors compared between the two stocks.

US Stem Cell Company Profile

U.S. Stem Cell, Inc., a biotechnology company, focuses on the discovery, development, and commercialization of autologous cellular therapies for the treatment of chronic and acute heart damage, and vascular and autoimmune diseases in the United States and internationally. Its lead product candidates include MyoCell, a clinical therapy designed to populate regions of scar tissue within a patient's heart with autologous muscle cells or cells from a patient's body for enhancing cardiac function in chronic heart failure patients; and AdipoCell, a patient-derived cell therapy for the treatment of acute myocardial infarction, chronic heart ischemia, and lower limb ischemia. The company's product development pipeline includes MyoCell SDF-1, an autologous muscle-derived cellular therapy for improving cardiac function in chronic heart failure patients. It is also developing MyoCath, a deflecting tip needle injection catheter that is used to inject cells into cardiac tissue in therapeutic procedures to treat chronic heart ischemia and congestive heart failure. In addition, the company provides physician and patient based regenerative medicine/cell therapy training, cell collection, and cell storage services; and cell collection and treatment kits for humans and animals, as well operates a cell therapy clinic. The company was formerly known as Bioheart, Inc. and changed its name to U.S. Stem Cell, Inc. in October 2015. U.S. Stem Cell, Inc. was founded in 1999 and is headquartered in Sunrise, Florida.

Auxly Cannabis Group Company Profile

Auxly Cannabis Group Inc. operates as a cannabis streaming company. It provides funding for cannabis production; and holds contractual rights and minority equity interest relating to the operation of cannabis facilities. The company was formerly known as Cannabis Wheaton Income Corp. and changed its name to Auxly Cannabis Group Inc. in June 2018. Auxly Cannabis Group Inc. was incorporated in 1987 and is headquartered in Vancouver, Canada.

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Reviewing US Stem Cell (OTCMKTS:USRM) and Auxly Cannabis Group (OTCMKTS:CBWTF) - Riverton Roll

Cardiac Stem Cells Comments Off on Reviewing US Stem Cell (OTCMKTS:USRM) and Auxly Cannabis Group (OTCMKTS:CBWTF) – Riverton Roll | November 11th, 2019

Scientists from Dystrogen Therapeutics Corp. published data supporting cardioprotective effects of the Companys therapy for muscular dystrophy disorders. Cardiomyopathy is the most devastating cause of morbidity and mortality in Duchenne Muscular Dystrophy (DMD) patients and affects 30% of patients by 14years of age and 50% of patients by 18years of age. Heart failure in these patients is the result of cardiac myocyte death and fibrosis, leading to both diastolic and systolic dysfunction.

Dystrogen Therapeutics Corp has developed an engineered chimeric cell therapy which has been previously shown to restore muscle function in pre-clinical studies. For Duchennes muscular dystrophy, the company has developed dystrophin expressing chimeras DECs. Using the companys proprietary technology, DECs are created by an ex vivo fusion of allogeneic human myoblast from a healthy donor with autologous human myoblast received from DMD patient. DECs have been shown to maintain the ability to express normal dystrophin protein in previously published pre-clinical studies.

The new study published in theOctober 15th, 2019online edition of the journalStem Cell Reports and Reviewsconfirmed the protective effect of DEC on cardiac function after intraosseous delivery shown by increased values of both ejection fraction and fractional shortening, which at 90days revealed a rebound effect when compared to the vehicle injected controls and mice receiving not-chimeric cell therapy. Moreover, these functional improvements correlated with restoration of dystrophin expression in cardiac muscle at 90days post-DEC treatment.

These findings are potentially significant for the treatment of DMD, said Dr. Maria Siemionow, MD, PhD Dystrogen Therapeutics Corp chief scientific officer and the therapys inventor. This study establishes DEC as a promising new option for cardiac protection and potential amelioration of DMD related cardiac pathology.

These data add to the growing body of literature supporting the potential of our chimeric cell platform to restore systemic muscle function, with less potential side effects then gene therapy-based approaches, said Dr. Kris Siemionow, MD, PhD Dystrogen Therapeutics Corp CEO. We are very pleased to have these data published in a highly relevant journal for the field and look forward to further exploring this opportunity.

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Dystrogen Therapeutics Announces That Treatment With DEC Cells Improves Cardiac Function Cardiology2.0 - Cardiology2.0

Cardiac Stem Cells Comments Off on Dystrogen Therapeutics Announces That Treatment With DEC Cells Improves Cardiac Function Cardiology2.0 – Cardiology2.0 | November 11th, 2019

Home News Going into Space Changes the Human Heart Cells, but What Happens When They Get Back on Earth?

Commonly, astronauts stay in space for a more extended period of time, and NASA is planning longer missions to the Moon and Mars. Researchers say that we need to understand better the effects that microgravity has on the heart.

Studies have shown that spaceflight can reduce heart rate and the lower arterial pressure, and can also increase cardiac output. However, new research shows how microgravity zero gravity has an impact on the human heart when it comes to the cellular level.

Scientists have been able to check the health of astronauts while they were in space, which was a great way to understand the molecular cell changes. This comes from Joseph C. Wu, from Stanford Universitys School of Medicine. He is the author of the study.

The health of humans can be sustained for about a year in space, says NASA. When trying to answer this, researchers from Stanford University have taken a look at the cardiac function and at the gene expression in the human heart cells from three people. The cells did not come from biopsies, but they were made by reprogramming a sample of blood into the human stem cells. Then, the heart cells were cultured abroad the International Space Station for around 5 weeks. This is the first study of this kind.

Scientists found that the exposure to microgravity changed the expression of 2.635 genes, which was a temporary change in the RNA, that is made from DNA. Most of them returned to the normal patterns of gene expression in about 10 days after coming back to Earth. RNA is a temporary and handwritten copy of the DNA. So the gene expression was temporarily changed by the environment microgravity. The changes were subtle, but they were still significant.

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Going into Space Changes the Human Heart Cells, but What Happens When They Get Back on Earth? - Henri Le Chat Noir

Cardiac Stem Cells Comments Off on Going into Space Changes the Human Heart Cells, but What Happens When They Get Back on Earth? – Henri Le Chat Noir | November 10th, 2019

Science Foundation Ireland 2019 Science Awards recognise key leaders in the Irish Research Community

Associate Professor Dr Eilish McLoughlin has been honoured with a prestigious 2019 Science Foundation (SFI) award announced today at the annual SFI Science Summit in Athlone attended by over 300 leading members of Irelands research community who gathered to celebrate the significant contributions made over the past year to Science, Technology, Engineering and Maths (STEM) in Ireland.

Dr McLoughlin was presented with the SFI Outstanding Contribution to STEM Communication in recognition of her incredible contribution to the popularisation of science and her sterling efforts in raising public awareness of the value of science to human progress.

Dr McLoughlin is Director of the Research Centre for the Advancement of STEM Teaching and learning (CASTeL) at DCU. She obtained her BSc in Applied Physics and PhD in Surface Physics from DCU.

A firm believer in the mantra that science is for all, she has led several large-scale national initiatives to widen participation in STEM including Physics Busking, Science on Stage, Improving Gender Balance (all 3 have been funded by SFI) and the STEM Teacher Internship.

Her significant contributions to STEM engagement have resulted in many awards, especially the prestigious Institute of Physics Lise Meitner Medal in 2018 and the DCU President's Award for Engagement in 2017.

She has led several EU collaborations in STEM Education including coordinator of ESTABLISH, Co-Coordinator SAILS and is currently National Coordinator of the H2020 Open Schools for Open Societies project.

Speaking about her award Dr McLoughlin said:

I would like to thank Science Foundation Ireland for presenting me with this award.

I really appreciate their on-going support for STEM education and public engagement activities that allow me to engage with members of the public and teachers and students in schools across Ireland and share my passion for physics.

I hope that my interaction with young people and their parents will encourage more students to choose physics and follow a career in STEM.

Young girls need role models to encourage them to follow their interests and achieve their potential in physics. I hope by winning this award, more young people will realise that physics is a rewarding pathway to follow.

Dr McLoughlin was among ten award winners including a new award for Mentorship which was introduced to celebrate the important role mentors play in providing guidance, motivation and emotional support in our research system.

Acknowledging the award winners, Minister for Training, Skills, Innovation and Research and Development, John Halligan TD, said:

The Science Foundation Ireland Awards recognise the breadth and depth that research encompasses from industry collaborations to public engagement and the innovative breakthroughs that are leading research globally in the areas of Immunology, Biomaterials, Cancer research and much more.

I would like to congratulate each awardee on their achievements, which illustrate the invaluable knowledge and resource that Irelands research community offers.

I am also pleased to see mentorship amongst the awards this year, highlighting the importance of supporting the next generation of researchers and enriching our growing research community.

Professor Mark Ferguson, Director General of Science Foundation Ireland and Chief Scientific Adviser to the Government of Ireland, also congratulated the award winners, saying:

On behalf of Science Foundation Ireland, I would like to congratulate the award winners on their success and recognise their dedication in realising their ambitions and in doing so, building Irelands reputation as a global research leader.

We are very proud of the excellent quality of research that our funding enables, and the SFI Awards are an important acknowledgement of the collective achievements of the Irish research community, which continue to be impactful, inspirational and world-leading.

The 2019 Recipients are as follows:

SFI Researcher of the Year 2019

The SFI Researcher of the Year Award recognises the accomplishments of an SFI funded researcher who has contributed significantly to the Irish research community in the year of the award and/or throughout their career.

The successful researcher has achieved exceptional scientific and engineering research outputs combined with a clear demonstration of the ability to communicate their research.

Recipient: Professor Kevin OConnor, Director of the BEACON SFI Bioeconomy Research Centre, University College Dublin

Professor Kevin OConnor received his BSc degree and PhD from University College Cork.

He is a Professor of Microbial biotechnology in the School of Biomolecular and Biomedical Science at UCD and an investigator in the UCD Earth Institute.

As Director of the BEACON SFI Bioeconomy Research Centre, Professor OConnor is leading blue skies and industry focused research to build and support the development of Irelands bioeconomy.

He is shaping the European Bioeconomy Strategy through his chairmanship of the Scientific Committee for the Bio-based Industries Joint Undertaking (BBIJU), a 3.7 billion Public-Private Partnership.

His research work is seminal in the area of circular economy (plastics to biodegradable plastics), circular bioeconomy (dairy processing by-product to value-added chemical) and biotechnology (hydroxytyrosol production by a biocatalyst).

Collaborating with industry, Professor OConnor developed technology to convert a dairy by-product into an organic acid, which was patented and licensed to industry.

It is now being scaled and implemented in a world first second generation dairy biorefinery, which has received over 30 million in EU funding.

He has published extensively and patented technologies on the conversion of waste plastics to biodegradable plastic and the biotechnological production of hydroxytyrosol (a health promoting molecule) and founded two spin-out companies Bioplastech and Nova Mentis.

Commenting on receiving the Award Professor Kevin OConnor stated:

I am delighted and honoured to receive this prestigious SFI award.

It is a recognition of the dedication of the many researchers and industry partners with whom I work and collaborate with, across multiple scientific fields and sectors, at UCD, across Ireland and internationally.

Through these collaborations we are creating knowledge and translating this knowledge into innovative technological solutions to address global and societal bioeconomy challenges.

I would especially like to acknowledge and thank SFI for their funding, and UCD, BEACON centre members and my wife and family for all their support.

SFI Early Career Researcher of the Year

The SFI Early Career Researcher Award recognises outstanding early career research talent and in recognition of the high calibre of nominations in 2019, there are two individual recipients of the Early Career Researcher of the Year Award:

Recipient: Associate Professor Lydia Lynch, Trinity College Dublin

An Associate Professor at Trinity College Dublin (TCD), in the School of Biochemistry and Immunology, Dr Lydia Lynch established and runs the Lynch Laboratory.

She graduated from University College Dublin with a BSc in Cell Biology and Genetics and a PhD in Immunology and went onto receive a Newman Fellowship for her early post-doctoral studies in St. Vincents University Hospital, where she helped establish the Immunology and Obesity Lab.

Here she discovered adipose iNKT cells and demonstrated that their activation could help manage obesity and metabolic disease.

Dr Lynch is also the recipient of the prestigious LOreal-UNESCO International Women in Science Award and a Marie Curie International Fellowship, which allowed her to move to Harvard Medical School in 2013 and continue studying immunometabolism.

Whilst at Harvard, she was a recipient of the inaugural Innovation Evergreen Fund award. She is also the holder of an American Diabetes Association Award and a Cancer Research Institute Award as well as a European Research Council (ERC) Starting grant and SFI President of Ireland Future Research Leader Award and currently leads an international team in immunometabolism at TCD.

Recipient: Dr Orla OSullivan, APC Microbiome Ireland SFI Research Centre and Vistamilk SFI Research Centre, Teagasc

Dr Orla OSullivan completed her degree in Biochemistry and PhD in Bioinformatics in UCC. She went on to complete a postdoctoral fellowship at the Conway Institute UCD and then joined Teagasc, where she focuses on profiling the microbiome and where she has worked on the ELDERMET project amongst many others.

Dr OSullivan is a funded investigator within the APC Microbiome Ireland SFI Research Centre and Vistamilk SFI Research Centre.

In 2014, Dr OSullivan was awarded an SFI Starting Investigator Research Grant to allow her to establish herself as an independent scientist.

In the same year she was awarded the APC Junior Scientist of the Year.

She is committed to communicating science to all and actively participates in a number of outreach programmes such as BIG STEM communicators, BT Young Scientist, Fota Mad Scientist and World Microbiome Day.

Her research focuses on the microbiome and her studies have established that healthy and protein-rich athlete diets result in a more diverse gut microbiota than standard diets.

She aims to utilise outputs from this research to holistically manage chronic illnesses associated with the gut microbiome, thereby addressing a number of critical societal health challenges.

In 2018, Dr OSullivan was named by Clarivate Analytics as a Highly Cited Researcher placing her in the top 1% of researchers worldwide.

SFI Industry Partnership Award

The SFI Industry Partnership Award celebrates a collaboration between an SFI-funded academic research group and industry.

Recipient: Professor Danny Kelly, AMBER SFI Research Centre for Advanced Materials and BioEngineering Research, Trinity College Dublin, for collaboration with Johnson & Johnson Services, Inc.

Professor Danny Kelly is a Professor of Biomedical Engineering and is Director of the Trinity Centre for Biomedical Engineering where he leads a large multidisciplinary orthopaedic tissue engineering group.

He holds the Chair of Tissue Engineering at TCD and has received three prestigious European Research Council (ERC) awards. Professor Kelly is at the forefront of tissue regeneration using 3D bioprinting strategies.

Through his position at AMBER he has led the Johnson & Johnson partnership on the TRANSITION programme, funded under SFIs Spokes programme to develop a new class of 3D-printed biological implants that will regenerate, rather than replace, diseased joints.

TRANSITION is a shared vision and expands upon AMBERs long-standing collaboration with DePuy Ireland Unlimited Company.

TRANSITION, led by Professor Danny Kelly, brings together Principal Investigators and researchers from four AMBER partners (DCU, RCSI, TCD & UCD) and scientists and engineers from Johnson & Johnsons 3D Printing Centre of Excellence and DePuy Synthes.

A significant milestone was realised earlier this year with the establishment of the Collaborative Bioprinting Laboratory in TCDs Trinity Biomedical Sciences Institute, which co-locates researchers from both sides of the partnership.

SFI Best International Engagement Award

This award recognises the accomplishments of a Science Foundation Ireland-funded researcher/group specifically in the context of their international activities.

Recipient: Professor Abhay Pandit, Scientific Director, CRAM SFI Research Centre for Medical Devices, NUI Galway

Professor Abhay Pandit is Professor of Biomaterials at NUI Galway and Scientific Director of CRAM SFI Research Centre for Medical Devices.

Professor Pandit has been an elected member on the Council for both the Tissue Engineering and Regenerative Medicine International Society and European Society for Biomaterials Society.

He was the first Irish academic to be inducted as an International Fellow in Biomaterials Science and Engineering by the International Union of Societies for Biomaterials Science and Engineering and elected as a Fellow of the Tissue Engineering and Regenerative International Society.

He was also elected to the American Institute of Medical and Biological Engineering (AIMBE) College of Fellows.

Professor Pandit has published more than 250 papers in peer-reviewed journals, filed numerous patent applications and has licensed four technologies to medical device companies.

He has coordinated four EU grants to date and has generated research contracts from industry and government funding agencies totalling 90 million.

Throughout his career, his work has been outward facing, from engaging in international collaborations and hosting international conferences, to supporting trade missions and championing residency programs for leaders in the community (artists, filmmakers, teachers) to empower them with the STEM message.

SFI Entrepreneurship Award

The SFI Entrepreneurship Award celebrates an entrepreneurial achievement by SFI supported researchers.

Recipient: Professor William Gallagher, University College Dublin

Professor William Gallagher is Director of the UCD Conway Institute of Biomolecular and Biomedical Research and Professor of Cancer Biology in the UCD School of Biomolecular & Biomedical Science at University College Dublin.

He was also the Director of the first Irish Cancer Society Collaborative Cancer Research Centre, BREAST-PREDICT, which completed its ground-breaking six year programme in September 2019. Professor Gallagher co-founded the molecular diagnostics company OncoMark in 2007 and is currently its Chief Scientific Officer.

OncoMark focuses on the development and application of biomarker panels which address critical unmet needs for cancer patients.

A major focus of Professor Gallaghers research work is the identification and validation of candidate biomarkers of breast and other cancers, particularly those which guide treatment decision making.

He has received a number of awards to date, including the BACR/AstraZeneca Young Scientist Frank Rose Award in 2004, the St. Luke's Silver Medal Award in 2008, the NovaUCD Innovation Award in 2011 and the inaugural IACR Award for 'Outstanding Contribution to Cancer Medicine and Research' in 2017.

Professor Gallagher has led multiple EU networks under EU programmes, he has had many collaborations with a variety of industrial partners throughout his research, and has filed multiple patents.

SFI Outstanding Contribution to STEM Communication (There are two recipients of this award, including Dr McLoughlin)

Recipient: Dr Muriel Grenon, NUI Galway

Dr Muriel Grenon is a lecturer in Biochemistry, School of Natural Sciences, NUI Galway and the founding Director of the Cell EXPLORERS science outreach programme.

Dr Grenon started out the programme in 2012 with a team of 10 undergraduate science students in NUI Galway and has built Cell EXPLORERS into a national network comprising 13 partner teams with members from 15 Higher Education Institutions in Ireland.

Between 2012 and 2018 Cell EXPLORERS involved 1,187 team members, visited 471 classrooms in 280 schools and reached 32,000 members of the public.

Cell EXPLORERS has also successfully integrated science outreach projects into the final year of the Biochemistry undergraduate course at NUI Galway allowing the creation of potential novel science outreach resources each semester.

Dr Grenon is also involved in driving science communication internationally: Cell EXPLORERS is part of Scientix, the community for Science Education in Europe.

The programme has also started a collaboration with the University of Kwatzulu-Natal in South Africa, where a team is currently piloting the Fantastic DNA school visits.

Dr Grenons contribution and dedication to the popularisation of STEM has been recognised by the Outstanding Contribution to STEM award at the 2013 Galway Science and Technology Festival, the 2017 NUI Galway President Award for Societal Impact and being made Knight of the Order of the Palmes Acadmiques by the French Ministry of Education in 2019.

SFI Mentorship Award

This inaugural award recognises outstanding mentorship provided by a researcher funded by Science Foundation Ireland.

Recipient: Dr Fatima Gunning, IPIC SFI Research Centre and Tyndall National Institute

Dr Fatima Gunning completed her BSc in Physics and PhD in Optoelectronics from Pontifcia Universidade Catlica do Rio de Janeiro (PUC-Rio), Brazil before joining IPIC SFI Research Centre, hosted by Tyndall National Institute after a brief two year period at Corning.

Currently serving as Head of Graduate Studies at Tyndall National Institute and a PI at IPIC SFI Research Centre, she is looking at novel photonics technologies for the Internet of the future.

She has also led many diversity and inclusion programmes that are directly targeted at improving the deficit of diverse talent and gender balance in the field including Empowering Women@Tyndall and being a key advocate for Tyndall to apply for Athena SWAN by 2020.

Dr Gunning has been selected to become Vice President of Membership and Outreach of the IEEE Photonics Society starting January 2020 to expand the diversity, inclusion and mentorship efforts to an international scale.

Dr Gunning believes that all students are different, are driven by different motivations and develop their research in different ways.

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Dr Eilish McLoughlin honoured by SFI for Outstanding Contribution to STEM Communication - Dublin City University

Cardiac Stem Cells Comments Off on Dr Eilish McLoughlin honoured by SFI for Outstanding Contribution to STEM Communication – Dublin City University | November 9th, 2019

The thought of spaceflight may make the heart skip a beat, but actually travelling beyond Earth could alter the organs cells.

With extended stays aboard the International Space Station (ISS) commonplace, and the likelihood of humans spending longer periods in space increasing, there is a need to better understand the effects of micro-gravity on cardiac function.

New research suggests heart muscle cells derived from stem cells have a remarkable ability to adapt to their environment during and after spaceflight.

Scientists examined cell-level cardiac function and gene expression in human heart cells cultured aboard the International Space Station for five-and-a-half weeks.They found that exposure to micro-gravity changed the expression of thousands of genes, but largely normal patterns reappeared within 10 days after returning to Earth.

Read more about the body in space:

Senior study author, Joseph Wu, of Stanford University School of Medicine, said: Our study is novel because it is the first to use human induced pluripotent stem cells to study the effects of spaceflight on human heart function.

Micro-gravity is an environment that is not very well understood, in terms of its overall effect on the human body, and studies like this could help shed light on how the cells of the body behave in space, especially as the world embarks on more and longer space missions such as going to the Moon and Mars.

Until now, most studies on how the heart reacts to micro-gravity have been conducted in either non-human models or at tissue, organ or systemic level.To address this, the beating cells were launched to the ISS aboard a SpaceX spacecraft as part of a commercial resupply service mission.Simultaneously, they were also cultured on Earth for comparison purposes.

When they returned to the planet, the cells showed normal structure and morphology.However, they did adapt by modifying their beating pattern and calcium recycling patterns.

Immunofluorescence imaging of the cells grown in micro-gravity aboard the International Space Station Joseph Wu lab, Stanford University School of Medicine/PA

Researchers sequenced the cells harvested at four-and-a-half weeks aboard the ISS, and 10 days after returning to Earth.Results showed that 2,635 genes were differentially expressed among flight, post-flight, and ground control samples.

Most notably, gene pathways related to mitochondrial function were expressed more in the space-flown cells, according to the research published in the Stem Cells Reports journal.

A comparison of the samples revealed the space cells adopted a unique gene expression pattern during spaceflight, which reverted to one that is similar to ground-side controls upon return to normal gravity.

Dr Wu added: Were surprised about how quickly human heart muscle cells are able to adapt to the environment in which they are placed, including micro-gravity.

These studies may provide insight into cellular mechanisms that could benefit astronaut health during long-duration spaceflight, or potentially lay the foundation for new insights into improving heart health on Earth.

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Space travel affects heart cells, but only temporarily - BBC Focus Magazine

Cardiac Stem Cells Comments Off on Space travel affects heart cells, but only temporarily – BBC Focus Magazine | November 9th, 2019

JERUSALEM & PARSIPPANY, N.J. & INCHEON, South Korea--(BUSINESS WIRE)--Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), Celltrion, Inc., (KRX KRX:068270) and Celltrion Healthcare, Co., Ltd. (KRX KOSDAQ:091990), today announced that TRUXIMA (rituximab-abbs) injection is the first biosimilar to the reference product Rituxan1 (rituximab) now available in the United States with a full oncology label. TRUXIMA is currently indicated for the treatment of adult patients with non-Hodgkins Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL):

We are excited about the first FDA-approved biosimilar to rituximab in the U.S., stated Brendan OGrady, Executive Vice President and Head of North America Commercial at Teva. Tevas commitment to biosimilars is focused on the potential to create lower healthcare costs and increased price competition. This focus is consistent with Tevas mission of making accessible medications to help improve the lives of patients.

TRUXIMA was approved by the U.S. Food and Drug Administration (FDA) as the first rituximab biosimilar. The approval was based on a review of a comprehensive data package inclusive of foundational and extensive analytical characterization, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data. In May 2019, the FDA approved TRUXIMA to match all of the reference products oncology indications for NHL and CLL. In light of a patent settlement with Genentech, Celltrion and Teva have a pending FDA submission for rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA), and a license from Genentech to expand the TRUXIMA label to include these indications in Q2 2020.

We are pleased to announce the launch of the first rituximab biosimilar, TRUXIMA, with our marketing partner Teva in the U.S. said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. We believe that the introduction of TRUXIMA into the U.S. market will contribute to addressing unmet needs of U.S. patients as well.

The Wholesale Acquisition Cost (WAC or list price) for TRUXIMA will be 10 percent lower than the reference product. TRUXIMA is being made available through primary wholesalers at a WAC of $845.55 for 100mg vial and $4227.75 for 500mg vial. Actual costs to individual patients and providers for TRUXIMA are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patients insurance payer and eligibility for participation in the assistance program.

Dedicated patient support services are also available from Teva through the Comprehensive Oncology Reimbursement Expertise (CORE) program. CORE is available to help eligible patients, caregivers and healthcare professionals navigate the reimbursement process. CORE offers a range of services, including benefits verification and coverage determination, support for precertification and prior authorization, assistance with coverage guidelines and claims investigation, and support through the claims and appeals process. A savings program is also available for eligible commercially insured patients. To learn more, please visit TevaCORE.com. For healthcare professionals seeking additional information, there is also a dedicated site at TRUXIMAhcp.com.

Celltrion and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 to commercialize TRUXIMA in the U.S. and Canada.

Please see the Important Safety Information below including the Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. For more information, please visit the full prescribing information.

Important Safety Information

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Infusion-Related Reactions - Administration of rituximab products, including TRUXIMA, can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue TRUXIMA infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions

Severe Mucocutaneous Reactions - Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products

Hepatitis B Virus (HBV) Reactivation - HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with TRUXIMA. Discontinue TRUXIMA and concomitant medications in the event of HBV reactivation

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products

Warnings and Precautions

Infusion-Related Reactions - Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes. Rituximab product-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death.

Premedicate patients with an antihistamine and acetaminophen prior to dosing. Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Depending on the severity of the infusion-related reaction and the required interventions, temporarily or permanently discontinue TRUXIMA. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved. Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (>25,000/mm3)

Severe Mucocutaneous Reactions - Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab products. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these reactions has been variable and includes reports with onset on the first day of rituximab exposure. Discontinue TRUXIMA in patients who experience a severe mucocutaneous reaction. The safety of re-administration of rituximab products to patients with severe mucocutaneous reactions has not been determined.

Hepatitis B Virus Reactivation - Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs] positive).

HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases increase in bilirubin levels, liver failure, and death can occur.

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with TRUXIMA. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during TRUXIMA treatment.

Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following TRUXIMA therapy. HBV reactivation has been reported up to 24 months following completion of rituximab therapy.

In patients who develop reactivation of HBV while on TRUXIMA, immediately discontinue TRUXIMA and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming TRUXIMA treatment in patients who develop HBV reactivation. Resumption of TRUXIMA treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV.

Progressive Multifocal Leukoencephalopathy (PML) - JC virus infection resulting in PML and death can occur in rituximab product-treated patients with hematologic malignancies. The majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. Most cases of PML were diagnosed within 12 months of their last infusion of rituximab.

Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture.

Discontinue TRUXIMA and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML.

Tumor Lysis Syndrome (TLS) - Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 12-24 hours after the first infusion of rituximab products in patients with NHL. A high number of circulating malignant cells (>25,000/mm3) or high tumor burden, confers a greater risk of TLS.

Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated.

Infections - Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab product-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure). New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue TRUXIMA for serious infections and institute appropriate anti-infective therapy. TRUXIMA is not recommended for use in patients with severe, active infections.

Cardiovascular Adverse Reactions - Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of TRUXIMA for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina.

Renal Toxicity - Severe, including fatal, renal toxicity can occur after rituximab product administration in patients with NHL. Renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and TRUXIMA is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue TRUXIMA in patients with a rising serum creatinine or oliguria.

Bowel Obstruction and Perforation - Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1-77) days in patients with NHL. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur.

Immunization - The safety of immunization with live viral vaccines following rituximab product therapy has not been studied and vaccination with live virus vaccines is not recommended before or during treatment.

Embryo-Fetal Toxicity - Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. Advise pregnant women of the risk to a fetus. Females of childbearing potential should use effective contraception while receiving TRUXIMA and for 12 months following the last dose of TRUXIMA.

Most common adverse reactions in clinical trials of NHL (>25%) were: infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia

Most common adverse reactions in clinical trials of CLL (>25%) were: infusion-related reactions and neutropenia

Nursing Mothers - There are no data on the presence of rituximab in human milk, the effect on the breastfed child, or the effect on milk production. Since many drugs including antibodies are present in human milk, advise a lactating woman not to breastfeed during treatment and for at least 6 months after the last dose of TRUXIMA due to the potential for serious adverse reactions in breastfed infants.

About TRUXIMA

TRUXIMA (rituximab-abbs) is a U.S. Food and Drug Administration (FDA)-approved biosimilar to RITUXAN (rituximab) for the treatment of adult patients with CD20-positive, B-cell NHL to be used as a single agent or in combination with chemotherapy or CLL in combination with fludarabine and cyclophosphamide (FC).

TRUXIMA has the same mechanism of action as Rituxan and has demonstrated biosimilarity to Rituxan through a totality of evidence.

About Celltrion Healthcare, Co. Ltd.

Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcares products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines.

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacturing of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA approval for TRUXIMA (rituximab-abbs) and HERZUMA (trastuzumab-pkrb) in 2018.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve peoples lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at http://www.tevapharm.com.

Teva's Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding TRUXIMA, which are based on managements current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

and other factors discussed in our Quarterly Reports on Form 10-Q for the first and second quarter of 2019 and in our Annual Report on Form 10-K for the year ended December 31, 2018, including in the sections captioned "Risk Factors and Forward Looking Statements. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

1 RITUXAN is a registered trademark of Genentech and Biogen.

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Teva and Celltrion Announce the Availability of TRUXIMA (rituximab-abbs) Injection, the First Biosimilar to Rituxan (rituximab) in the United States -...

Cardiac Stem Cells Comments Off on Teva and Celltrion Announce the Availability of TRUXIMA (rituximab-abbs) Injection, the First Biosimilar to Rituxan (rituximab) in the United States -… | November 8th, 2019

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE:TAK) today announced that it will present a total of 29 company-sponsored abstracts at the 61st American Society of Hematology (ASH) Annual Meeting on December 7-10, 2019 in Orlando, FL, highlighting the companys commitment to advancing the treatment of hematologic cancers and bleeding disorders.

Pursuing Breakthrough, Patient-Centric Innovation in Oncology and Bleeding Disorders

Takeda will present 29 scientific updates on the companys investigational and early-stage therapies, which demonstrates its investment in new compounds to address patient needs, as well as data from Phase 3 trials and real-world evidence findings, in disease states including multiple myeloma, lymphoma and leukemia.

We are presenting notable data on several clinical programs at ASH, highlighting our deep oncology pipeline and our commitment to developing innovative therapies that may address unmet needs for blood cancer patients, said Phil Rowlands, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. In particular we look forward to sharing data from the Phase 3 clinical trial of ixazomib in amyloidosis patients, data from the US MM-6 study, which evaluates an in-class transition from parenteral bortezomib to oral ixazomib in multiple myeloma, further analyses from the Phase 3 ECHELON-2 trial of ADCETRIS in peripheral T-cell lymphoma, as well as early stage data from several of our pipeline programs.

In hematology, Takeda will present real-world evidence from studies of its portfolio of treatments across bleeding disorders, including hemophilia A, hemophilia B and von Willebrand disease. The company will also present scientific updates related to its hemophilia A and hemophilia B gene therapy programs and adeno-associated virus (AAV) gene therapy platform.

Understanding real-world evidence is critical as Takeda continues to provide patients with innovative therapies for hemophilia A and hemophilia B while broadening our research and development efforts in von Willebrand disease and other bleeding disorders, said Daniel Curran, M.D., Head, Rare Diseases Therapeutic Area Unit, Takeda. Also at ASH, we look forward to providing an update on our gene therapy programs in hemophilia and the optimization of Takedas AAV gene therapy platform, particularly for patients with pre-existing immunity to AAV serotypes.

Accepted oncology abstracts include:

Note: all times listed are in Eastern Standard Time

NINLARO (ixazomib) and Multiple Myeloma

ADCETRIS (brentuximab vedotin) and Lymphoma

ICLUSIG (ponatinib)

Pipeline (multiple myeloma, lymphoma, chronic lymphocytic leukemia, acute myeloid leukemia)

Accepted hematology abstracts include:

Note: all times listed are in Eastern Standard Time

ADYNOVATE (Antihemophilic Factor (Recombinant), PEGylated) and Hemophilia A

FEIBA (Anti-Inhibitor Coagulant Complex)

von Willebrand Disease

Pipeline (hemophilia A, hemophilia B and gene therapies)

About ADCETRISADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics' proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression in 2017, adults with pcALCL or CD30-expressing MF who have had prior systemic therapy in 2018, and for previously untreated Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (5) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD.

ADCETRIS has received marketing authorization by regulatory authorities in more than 70 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.

ADCETRIS is being evaluated broadly in more than 70 clinical trials, including a Phase 3 study in first-line Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in first-line CD30-positive peripheral T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-positive malignancies.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

ADCETRIS (brentuximab vedotin) Important Safety Information (European Union)Please refer to Summary of Product Characteristics (SmPC) before prescribing.

CONTRAINDICATIONS

ADCETRIS is contraindicated for patients with hypersensitivity to brentuximab vedotin and its excipients. In addition, combined use of ADCETRIS with bleomycin causes pulmonary toxicity.

SPECIAL WARNINGS & PRECAUTIONS

Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients treated with ADCETRIS. PML has been reported in patients who received ADCETRIS after receiving multiple prior chemotherapy regimens. PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal.

Closely monitor patients for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV. A negative JCV PCR does not exclude PML. Additional follow up and evaluation may be warranted if no alternative diagnosis can be established Hold dosing for any suspected case of PML and permanently discontinue ADCETRIS if a diagnosis of PML is confirmed.

Be alert to PML symptoms that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms).

Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Closely monitor patients for new or worsening abdominal pain, which may be suggestive of acute pancreatitis. Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures. Hold ADCETRIS for any suspected case of acute pancreatitis. ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.

Pulmonary Toxicity: Cases of pulmonary toxicity, some with fatal outcomes, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), have been reported in patients receiving ADCETRIS. Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. Promptly evaluate and treat new or worsening pulmonary symptoms (e.g., cough, dyspnoea) appropriately. Consider holding dosing during evaluation and until symptomatic improvement.

Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteremia, sepsis/septic shock (including fatal outcomes), and herpes zoster, and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Carefully monitor patients during treatment for emergence of possible serious and opportunistic infections.

Infusion-related reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis, have been reported with ADCETRIS. Carefully monitor patients during and after an infusion. If anaphylaxis occurs, immediately and permanently discontinue administration of ADCETRIS and administer appropriate medical therapy. If an IRR occurs, interrupt the infusion and institute appropriate medical management. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions. IRRs are more frequent and more severe in patients with antibodies to ADCETRIS.

Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumor and high tumor burden are at risk of TLS. Monitor these patients closely and manage according to best medical practice.

Peripheral neuropathy (PN): ADCETRIS treatment may cause PN, both sensory and motor. ADCETRIS-induced PN is typically an effect of cumulative exposure to ADCETRIS and is reversible in most cases. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay and a dose reduction or discontinuation of ADCETRIS.

Hematological toxicities: Grade 3 or Grade 4 anemia, thrombocytopenia, and prolonged (equal to or greater than one week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Monitor complete blood counts prior to administration of each dose.

Febrile neutropenia: Febrile neutropenia has been reported with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose of treatment. Closely monitor patients for fever and manage according to best medical practice if febrile neutropenia develops.

When ADCETRIS is administered in combination with AVD, primary prophylaxis with G-CSF is recommended for all patients beginning with the first dose.

Stevens-Johnson syndrome (SJS): SJS and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. Fatal outcomes have been reported. Discontinue treatment with ADCETRIS if SJS or TEN occurs and administer appropriate medical therapy.

Gastrointestinal (GI) Complications: GI complications, some with fatal outcomes, including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorrhage, have been reported with ADCETRIS. Promptly evaluate and treat patients if new or worsening GI symptoms occur.

Hepatotoxicity: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been reported with ADCETRIS. Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk. Test liver function prior to treatment initiation and routinely monitor during treatment. Patients experiencing hepatotoxicity may require a delay, dose modification, or discontinuation of ADCETRIS.

Hyperglycemia: Hyperglycemia has been reported during trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. Closely monitor serum glucose for patients who experiences an event of hyperglycemia. Administer anti-diabetic treatment as appropriate.

Renal and Hepatic Impairment: There is limited experience in patients with renal and hepatic impairment. Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations.

CD30+ CTCL: The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence. In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Szary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology. These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes. Carefully consider the benefit-risk per patient and use with caution in other CD30+ CTCL patient types.

Sodium content in excipients: This medicinal product contains 13.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

INTERACTIONSPatients who are receiving a strong CYP3A4 and P-gp inhibitor, concomitantly with ADCETRIS may have an increased risk of neutropenia. If neutropenia develops, refer to dosing recommendations for neutropenia (see SmPC section 4.2). Co-administration of ADCETRIS with a CYP3A4 inducer did not alter the plasma exposure of ADCETRIS, but it appeared to reduce plasma concentrations of MMAE metabolites that could be assayed. ADCETRIS is not expected to alter the exposure to drugs that are metabolized by CYP3A4 enzymes.

PREGNANCY: Advise women of childbearing potential to use two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment. There are no data from the use of ADCETRIS in pregnant women, although studies in animals have shown reproductive toxicity. Do not use ADCETRIS during pregnancy unless the benefit to the mother outweighs the potential risks to the fetus.

LACTATION (breast-feeding): There are no data as to whether ADCETRIS or its metabolites are excreted in human milk, therefore a risk to the newborn/infant cannot be excluded. With the potential risk, a decision should be made whether to discontinue breast-feeding or discontinue/abstain from therapy with ADCETRIS.

FERTILITY: In nonclinical studies, ADCETRIS treatment has resulted in testicular toxicity, and may alter male fertility. Advise men being treated with ADCETRIS not to father a child during treatment and for up to 6 months following the last dose.

Effects on ability to drive and use machines: ADCETRIS may have a moderate influence on the ability to drive and use machines.

UNDESIRABLE EFFECTS

Monotherapy: The most frequent adverse reactions (10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnoea, weight decreased, myalgia and abdominal pain. Serious adverse drug reactions occurred in 12% of patients. The frequency of unique serious adverse drug reactions was 1%. Adverse events led to treatment discontinuation in 24% of patients.

Combination Therapy: In the study of ADCETRIS as combination therapy with AVD in 662 patients with previously untreated advanced HL, the most common adverse reactions ( 10%) were: neutropenia, nausea, constipation, vomiting, fatigue, peripheral sensory neuropathy, diarrhoea, pyrexia, alopecia, peripheral motor neuropathy, decreased weight, abdominal pain, anaemia, stomatitis, febrile neutropenia, bone pain, insomnia, decreased appetite, cough, headache, arthralgia, back pain, dyspnoea, myalgia, upper respiratory tract infection, alanine aminotransferase increased. Serious adverse reactions occurred in 36% of patients. Serious adverse reactions occurring in 3% of patients included febrile neutropenia (17%), pyrexia (6%), and neutropenia (3%). Adverse events led to treatment discontinuation in 13% of patients.

ADCETRIS (brentuximab vedotin) Important Safety Information (U.S.)

BOXED WARNINGPROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

Administer G-CSF primary prophylaxis beginning with Cycle 1 for patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL.

Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.

Most Common (20% in any study) Adverse ReactionsPeripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, and mucositis.

Drug InteractionsConcomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific PopulationsModerate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

For additional Important Safety Information, including BOXED WARNING, please see the full Prescribing Information for ADCETRIS at http://www.seattlegenetics.com or http://www.ADCETRIS.com.

ADYNOVATE Professional Important Information

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information

Indications and Limitation of UseADYNOVATE is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

ADYNOVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

CONTRAINDICATIONSPrior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).

WARNINGS & PRECAUTIONSHypersensitivity ReactionsHypersensitivity reactions are possible with ADYNOVATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with other recombinant antihemophilic factor VIII products, including the parent molecule, ADVATE. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.

Neutralizing AntibodiesFormation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.

ADVERSE REACTIONSThe most common adverse reactions (1% of subjects) reported in the clinical studies were headache and nausea.

Click here for Full Prescribing Informationhttps://www.shirecontent.com/PI/PDFs/ADYNOVATE_USA_ENG.pdf

FEIBA [Anti-Inhibitor Coagulant Complex] Indications and Detailed Important Risk Information

Indications for FEIBA

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.

Detailed Important Risk Information for FEIBA

WARNING: EMBOLIC AND THROMBOTIC EVENTS

CONTRAINDICATIONS

FEIBA is contraindicated in patients with:

WARNINGS AND PRECAUTIONS

Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur, particularly following the administration of high doses (>200 units/kg/day) and/or in patients with thrombotic risk factors.

Patients with DIC, advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with recombinant factor VIIa have an increased risk of developing thrombotic events due to circulating tissue factor or predisposing coagulopathy. Potential benefit of treatment should be weighed against potential risk of these thromboembolic events.

Infusion should not exceed a single dose of 100 units/kg and daily doses of 200 units/kg. Maximum injection or infusion rate must not exceed 2 units/kg/minute. Monitor patients receiving >100 units/kg for the development of DIC, acute coronary ischemia and signs and symptoms of other thromboembolic events. If clinical signs or symptoms occur, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain, discontinue FEIBA and initiate appropriate diagnostic and therapeutic measures.

Safety and efficacy of FEIBA for breakthrough bleeding in patients receiving emicizumab has not been established. Cases of thrombotic microangiopathy (TMA) were reported in a clinical trial where subjects received FEIBA as part of a treatment regimen for breakthrough bleeding following emicizumab treatment. Consider the benefits and risks with FEIBA if considered required for patients receiving emicizumab prophylaxis. If treatment with FEIBA is required for patients receiving emicizumab, the hemophilia treating physician should closely monitor for signs and symptoms of TMA. In FEIBA clinical studies TMA has not been reported.

Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur. Symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. Reactions can be severe and systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported. If signs and symptoms of severe allergic reactions occur, immediately discontinue FEIBA and provide appropriate supportive care.

Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

FEIBA contains blood group isohemagglutinins (anti-A and anti-B). Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, D, may interfere with some serological tests for red cell antibodies, such as antiglobulin test (Coombs test).

ADVERSE REACTIONS

Most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.

Serious adverse reactions seen are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

DRUG INTERACTIONS

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Takeda to Highlight Expanded Portfolio of Products Across Oncology and Hematology at 61st American Society of Hematology (ASH) Annual Meeting -...

Cardiac Stem Cells Comments Off on Takeda to Highlight Expanded Portfolio of Products Across Oncology and Hematology at 61st American Society of Hematology (ASH) Annual Meeting -… | November 8th, 2019

Updated safety and efficacy results from ongoing Phase 1 CRB-402 study of bb21217 in relapsed/refractory multiple myeloma

Updated results from ongoing Phase 1/2 (HGB-206) study of LentiGlobin gene therapy for patients with sickle cell disease

New data from ongoing Phase 3 studies of LentiGlobin gene therapy for -thalassemia in pediatric, adolescent and adult patients

CAMBRIDGE, Mass. bluebird bio, Inc. (Nasdaq: BLUE) announced today that new and updated data from its investigational gene and cell therapy programs for multiple myeloma, sickle cell disease (SCD) and transfusion-dependent -thalassemia (TDT) will be presented at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida, December 7 10.

bluebird bio will present updated safety and efficacy data from the ongoing Phase 1 clinical study (CRB-402) of bb21217. bb21217 is an investigational BCMA-targeted chimeric antigen receptor (CAR) T cell therapy being studied, in partnership with Celgene, in patients with relapsed/refractory multiple myeloma (RRMM).

In addition, data from clinical studies of LentiGlobin gene therapy for -thalassemia, including results up to 61 months from the long-term follow-up study (LTF-303) and updated results from the completed Phase 1/2 Northstar (HGB-204) study, will be presented at ASH. The company will also present new data from the ongoing Phase 3 Northstar-2 (HGB-207) study in pediatric, adolescent and adult patients who do not have a 0/0 genotype and from the ongoing Phase 3 Northstar-3 (HGB-212) study in pediatric, adolescent and adult patients who have 0/0 genotype or an IVS-I-110 mutation at both alleles of the -globin gene.

New data from the companys Phase 1/2 HGB-206 study of LentiGlobin gene therapy for SCD will include additional patients treated in the study and updated data for those previously reported. The company will also present data from exploratory assays designed to assess the relationship between drug product characteristics and red blood cell physiology in patients treated with LentiGlobin for SCD.

Updated Data from Ongoing Phase 1 Clinical Study (CRB-402) of bb21217

Updated Results from an Ongoing Phase 1 Clinical Study of bb21217 Anti-BCMA CAR T Cell Therapy Presenting Author: Jesus G. Berdeja, M.D., Sarah Cannon Center for Blood Cancers, Nashville, Tenn. Date & Time: Oral #927, Monday, December 9, 2019, 6:45 p.m. ET

bb21217, an investigational BCMA-targeted CAR T cell therapy being developed in partnership with Celgene, is one of bluebird bios lead oncology programs. bb21217 uses the idecabtagene vicleucel CAR molecule (formerly referred to as bb2121) and is manufactured with a process intended to increase the in vivo persistence of CAR T cells.

This presentation will include updated data from the Phase 1 CRB-402 study, the first-in-human study of bb21217 in patients with RRMM, designed to assess the primary endpoint of safety as well as other pre-defined endpoints including efficacy and pharmacokinetics measurements. CRB-402 is a two-part (dose escalation and dose expansion), open-label, multi-site Phase 1 study of bb21217 in adults with RRMM with a projected final enrollment of 74 patients.

Data in the abstract include results as of the data cutoff date of April 20, 2019 for 22 patients who have received bb21217 at three dose levels (12 at 150 x 106 CAR+ T cells; six at 300 x 106 CAR+ T cells; and four at 450 x 106 CAR+ T cells). These patients had a median of seven prior lines of therapy (min-max: 4 17 lines), 18 patients had a prior autologous stem cell transplant, 19 patients received daratumumab and 13 patients received prior treatment with bortezomib, lenalidomide, carfilzomib, pomalidomide and daratumumab.

As of the data cutoff, the adverse events observed were consistent with known toxicities of CAR T therapies. Thirteen of 22 patients developed cytokine release syndrome (CRS); five Grade 1, seven Grade 2, and one Grade 3 case. All 13 patients responded to supportive care, tocilizumab and/or corticosteroids. Five of 22 patients developed neurotoxicity; one Grade 1, two Grade 2, one Grade 3 (vertigo/dizziness), and one Grade 4 (encephalopathy, previously reported). For the one patient previously reported with Grade 4 neurotoxicity, Grade 3 CRS was also reported, and both have resolved.

Eighteen patients were evaluable for clinical response with > two months of follow-up or progressive disease within two months. Eighty-three percent (n=15/18) of evaluable patients demonstrated clinical response per the International Myeloma Working Group Uniform Response Criteria for multiple myeloma. As of the data cutoff, with the median follow-up after bb21217 infusion of five months (min-max: <1 18 months), nine patients remained in response, including two patients with ongoing response at 15 and 18 months.

Evidence of myeloma in the bone marrow, known as minimal residual disease, was undetectable by next-generation sequencing at a sensitivity level of 10-5 or better in all responders who had evaluable bone marrow samples (n=10) at Month 1. CAR T cell persistence was observed in six of eight patients evaluable at six months and in two of two patients evaluable at 12 months.

This study is ongoing to evaluate the potential safety and efficacy of treatment with bb21217, and updated results, including early clinical and CAR T cell persistence data, will be shared at the ASH conference.

Multiple Myeloma Presentations at ASH

Markers of Initial and Long-Term Responses to Idecabtagene Vicleucel (Ide-Cel; bb2121) in the CRB-401 Study in Relapsed/Refractory Multiple Myeloma Presenting Author: Ethan G. Thompson, Ph.D., Celgene, Seattle, Wash. Date & Time: Poster #4328, Monday, December 9, 2019, 6:00 8:00 p.m. ET

Updated Results from an Ongoing Phase 1 Clinical Study of bb21217 anti-BCMA CAR T Cell Therapy Presenting Author: Jesus G. Berdeja, M.D., Sarah Cannon Center for Blood Cancers, Nashville, Tenn. Date & Time: Oral #927, Monday, December 9, 2019, 6:45 p.m. ET

SCD Presentations at ASH

The Relationships Between Target Gene Transduction, Engraftment of HSCs and RBC Physiology in Sickle Cell Disease Gene Therapy Presenting Author: Melissa Bonner, Ph.D., bluebird bio, Cambridge, Mass. Date & Time: Oral #206, Saturday, December 7, 2019, 2:15 p.m.

Exploring the Drivers of Clinical Benefit in Initial Patients Treated in the HGB-206 Study of LentiGlobin for Sickle Cell Disease (SCD) Gene Therapy Presenting Author: Mark Walters, M.D., Benioff Childrens Hospital, Oakland, Calif. Date & Time: Poster #2061, Saturday, December 7, 2019, 5:30 7:30 p.m.

Resolution of Sickle Cell Disease Manifestations in Patients Treated with LentiGlobin Gene Therapy: Updated Results from the Phase 1/2 HGB-206 Group C Study Presenting Author: Julie Kanter, M.D., University of Alabama at Birmingham, Birmingham, Ala. Date & Time: Poster #990, Saturday, December 7, 2019, 5:30 7:30 p.m.

TDT Presentations at ASH

Clinical Outcomes after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Transfusion-Dependent -Thalassemia Treated at the Bambino Ges Childrens Hospital, Rome, Italy Presenting Author: Pietro Merli, M.D., IRCCS Ospedale Pediatrico Bambino Ges, Rome, Italy Date & Time: Poster #969, Saturday, December 7, 2019, 5:30 7:30 p.m.

Northstar-3: Interim Results from a Phase 3 Study Evaluating LentiGlobin Gene Therapy in Patients with Transfusion-Dependent -Thalassemia and Either a 0 or IVS-I-110 Mutation at Both Alleles of the HBB Gene Presenting Author: Ashutosh Lal, M.D., UCSF Benioff Childrens Hospital, Oakland, Calif. Date & Time: Oral #815, Monday, December 9, 2019, 5:30 p.m.

Northstar-2: Updated Safety and Efficacy Analysis of LentiGlobin Gene Therapy in Patients with Transfusion-Dependent -Thalassemia and Non-0/0Genotypes Presenting Author: Alexis Thompson, M.D., MPH, Ann & Robert H. Lurie Childrens Hospital of Chicago, Chicago, Ill. Date & Time: Poster #3543, Monday, December 9, 2019, 6:00 8:00 p.m.

Long-Term Clinical Outcomes of LentiGlobin Gene Therapy for Transfusion-Dependent -Thalassemia in the Northstar (HGB-204) Study Presenting Author: Janet Kwiatkowski, M.D., MSCE, Childrens Hospital of Philadelphia, Philadelphia, Pa. Date & Time: Poster #4628, Monday, December 9, 2019, 6:00 8:00 p.m.

Routine Management, Healthcare Resource Use and Patient/Caregiver-Reported Outcomes of Patients with Transfusion-Dependent -Thalassaemia in the United Kingdom: A Mixed Methods Observational Study Presenting Author: Farrukh Shah, MBBS, FRCP, FRCPath, M.D., Whittington Hospital, London, U.K. Date & Time: Poster #3550, Monday, December 9, 2019, 6:00 8:00 p.m.

SCD and TDT Presentation at ASH

Results from the Completed HGB-205 Trial of LentiGlobin for -Thalassemia and LentiGlobin for Sickle Cell Disease Gene Therapy Presenting Author: Elisa Magrin, Ph.D., Necker Childrens Hospital, Assistance Publique-Hpitaux de Paris, Paris, France Date & Time: Poster #3358, Sunday, December 8, 2019, 6:00 8:00 p.m.

Abstracts outlining bluebird bios accepted data at ASH will be available on the ASH conference website at 9 a.m. EST today.

About ide-cel and bb21217 for Multiple Myeloma

bluebird bios lead oncology programs, idecabtagene vicleucel (ide-cel, formerly referred to as bb2121) and bb21217, are investigational BCMA-targeted chimeric antigen receptor (CAR) T cell therapies being studied in a broad clinical development program for patients with multiple myeloma. ide-cel and bb21217 are being developed in partnership with Celgene.

KarMMa is a registration-enabling, open-label, single-arm, multi-center Phase 2 study evaluating the efficacy and safety of ide-cel in patients with relapsed/refractory multiple myeloma. In November 2018, bluebird bio announced completion of enrollment in the trial. ide-cel was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration and Priority Medicines (PRIME) eligibility by the European Medicines Agency in November 2017 based on preliminary clinical data from the Phase 1 CRB-401 study.

bluebird bios clinical development program for bb21217 includes the ongoing Phase 1 CRB-402 study. CRB-402 is the first-in-human study of bb21217 in patients with RRMM, designed to assess safety, pharmacokinetics, efficacy and duration of effect. CRB-402 is a two-part (dose escalation and dose expansion), open-label, multi-site Phase 1 study of bb21217 in adults with RRMM with a projected final enrollment of 74 patients. For more information visit: clinicaltrials.gov using identifier NCT03274219.

ide-cel and bb21217 are not approved for any indication in any geography.

About LentiGlobin for Sickle Cell Disease

LentiGlobin for sickle cell disease is an investigational gene therapy being studied as a potential treatment for SCD. bluebird bios clinical development program for LentiGlobin for SCD includes the ongoing Phase 1/2 HGB-206 study.

SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the -globin gene that leads to the production of abnormal sickle hemoglobin (HbS), causing red blood cells (RBCs) to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and painful vaso-occlusive events (VOEs). For adults and children living with SCD, this means unpredictable episodes of excruciating pain due to vaso-occlusion as well as other acute complicationssuch as acute chest syndrome (ACS), stroke, and infections, which can contribute to early mortality in these patients.

LentiGlobin for SCD received Orphan Medicinal Product designation from the European Commission for the treatment of SCD.

The U.S. Food and Drug Administration granted Orphan Drug status and Regenerative Medicine Advanced Therapy designation for LentiGlobin for the treatment of SCD.

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 LentiGlobin for SCD. For more information visit: https://www.bluebirdbio.com/medical-professionals/our-clinical-trials/ or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.

About LentiGlobin for -Thalassemia

The European Commission granted conditional marketing authorization for LentiGlobin for TDT, to be marketed as ZYNTEGLO (autologous CD34+ cells encoding A-T87Q-globin gene) gene therapy, for patients 12 years and older with 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.

TDT is a severe genetic disease caused by mutations in the -globin gene that result in reduced or absent 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.

LentiGlobin 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 LentiGlobin for TDT were hot flush, dyspnoea, abdominal pain, pain in extremities and non-cardiac chest pain. One serious adverse event (SAE) of thrombocytopenia was considered possibly related to LentiGlobin for TDT.

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 conditional marketing authorization for ZYNTEGLO is only valid in the 28 member states of the EU as well as Iceland, Liechtenstein and Norway. For details, please see the Summary of Product Characteristics (SmPC).

The U.S. Food and Drug Administration granted LentiGlobin for -thalassemia Orphan Drug status and Breakthrough Therapy designation for the treatment of TDT.

LentiGlobin for -thalassemia 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), 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 LentiGlobin for TDT. For more information visit: https://www.bluebirdbio.com/medical-professionals/our-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.

The full common name for ZYNTEGLO: A genetically modified autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiviral vector encoding the A-T87Q-globin gene.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Companys views with respect to the potential for LentiGlobin to treat transfusion-dependent -thalassemia and sickle cell disease, the potential for the bb21217 product candidate to treat relapsed/ refractory multiple myeloma. 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 risks that the preliminary positive efficacy and safety results from our prior and ongoing clinical trials of our product candidates will not continue or be repeated in our ongoing or planned clinical trials or in the commercial context, risks that the current or planned clinical trials of our product candidates will be insufficient to support future regulatory submissions or to support marketing approval in the US and EU, and the risk that any one or more of our product candidates, will not be successfully developed, approved or commercialized. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191106005511/en/

Contacts

Investors: Elizabeth Pingpank, 617-914-8736 epingpank@bluebirdbio.com or Media: Catherine Falcetti, 339-499-9436 cfalcetti@bluebirdbio.com

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bluebird bio to Present New Data from Gene and Cell Therapy Programs at 61st American Society of Hematology Annual Meeting and Exposition - Financial...

Cardiac Stem Cells Comments Off on bluebird bio to Present New Data from Gene and Cell Therapy Programs at 61st American Society of Hematology Annual Meeting and Exposition – Financial… | November 6th, 2019

This is therefore a comparing of the institutional ownership, earnings and valuation, profitability, risk, dividends, analyst recommendations in Capricor Therapeutics Inc. (NASDAQ:CAPR) and Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI). The two are both Biotechnology companies that compete with one another.

Earnings and Valuation

Demonstrates Capricor Therapeutics Inc. and Brainstorm Cell Therapeutics Inc. earnings per share, top-line revenue and valuation.

Profitability

Table 2 represents Capricor Therapeutics Inc. (NASDAQ:CAPR) and Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI)s return on assets, return on equity and net margins.

Volatility and Risk

A beta of 1.8 shows that Capricor Therapeutics Inc. is 80.00% more volatile than Standard & Poors 500. Brainstorm Cell Therapeutics Inc. has a 1.19 beta and it is 19.00% more volatile than Standard & Poors 500.

Liquidity

Capricor Therapeutics Inc.s Current Ratio and Quick Ratio are 5.3 and 5.3 respectively. The Current Ratio and Quick Ratio of its competitor Brainstorm Cell Therapeutics Inc. are 1 and 1 respectively. Capricor Therapeutics Inc. therefore has a better chance of paying off short and long-term obligations compared to Brainstorm Cell Therapeutics Inc.

Analyst Ratings

The following table given below contains the ratings and recommendations for Capricor Therapeutics Inc. and Brainstorm Cell Therapeutics Inc.

$11.5 is Capricor Therapeutics Inc.s average target price while its potential upside is 342.31%. Competitively Brainstorm Cell Therapeutics Inc. has a consensus target price of $9, with potential upside of 134.99%. The data from earlier shows that analysts belief suggest that Capricor Therapeutics Inc. seems more appealing than Brainstorm Cell Therapeutics Inc.

Institutional and Insider Ownership

Capricor Therapeutics Inc. and Brainstorm Cell Therapeutics Inc. has shares owned by institutional investors as follows: 5.1% and 11.4%. Insiders owned 32.93% of Capricor Therapeutics Inc. shares. On the other hand, insiders owned about 0.6% of Brainstorm Cell Therapeutics Inc.s shares.

Performance

Here are the Weekly, Monthly, Quarterly, Half Yearly, Yearly and YTD Performance of both pretenders.

For the past year Capricor Therapeutics Inc. has weaker performance than Brainstorm Cell Therapeutics Inc.

Summary

Brainstorm Cell Therapeutics Inc. beats on 7 of the 10 factors Capricor Therapeutics Inc.

Capricor Therapeutics, Inc., a biotechnology company, focuses on the discovery, development, and commercialization of novel therapeutics primarily for the treatment of cardiovascular diseases. The companys development stage drug candidates for cardiovascular diseases include CAP-1002 that is in Phase II clinical trials; and CAP-2003, which is in pre-clinical development for the treatment of certain cardiac and inflammatory conditions. The company was founded in 2005 and is headquartered in Beverly Hills, California.

Brainstorm Cell Therapeutics Inc., a biotechnology company, develops adult stem cell therapies for neurodegenerative disorders that include amyotrophic lateral sclerosis, multiple sclerosis, Parkinsons disease, and others. The company holds rights to develop and commercialize its NurOwn technology through a licensing agreement with Ramot of Tel Aviv University Ltd. Its NurOwn technology is based on a novel differentiation protocol, which induces differentiation of the bone marrow-derived mesenchymal stem cells into neuron-supporting cells and secreting cells that release various neurotrophic factors, including glial-derived neurotrophic factor, brain-derived neurotrophic factor, vascular endothelial growth factor, and hepatocyte growth factor for the growth, survival, and differentiation of developing neurons. The company was formerly known as Golden Hand Resources Inc. and changed its name to Brainstorm Cell Therapeutics Inc. in November 2004 to reflect its new line of business in the development of novel cell therapies for neurodegenerative diseases. Brainstorm Cell Therapeutics Inc. was founded in 2000 and is headquartered in Hackensack, New Jersey.

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Reviewing Capricor Therapeutics Inc. (CAPR)'s and Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI)'s results - FinanceMercury

Cardiac Stem Cells Comments Off on Reviewing Capricor Therapeutics Inc. (CAPR)’s and Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI)’s results – FinanceMercury | November 6th, 2019

CHICAGO, Nov.5, 2019 /PRNewswire/ -- Scientists from Dystrogen Therapeutics Corp. published data supporting cardioprotective effects of the Company's therapy for muscular dystrophy disorders. Cardiomyopathy is the most devastating cause of morbidity and mortality in Duchenne Muscular Dystrophy (DMD) patients and affects 30% of patients by 14years of age and 50% of patients by 18years of age. Heart failure in these patients is the result of cardiac myocyte death and fibrosis, leading to both diastolic and systolic dysfunction. Dystrogen Therapeutics Corp has developed an engineered chimeric cell therapy which has been previously shown to restore muscle function in pre-clinical studies. For Duchenne's muscular dystrophy, the company has developed dystrophin expressing chimeras "DECs." Using the company's proprietary technology, DECs are created by an ex vivo fusion of allogeneic human myoblast from a healthy donor with autologous human myoblast received from DMD patient. DECs have been shown to maintain the ability to express normal dystrophin protein in previously published pre-clinical studies. The new study published in the October 15th, 2019 online edition of the journal Stem Cell Reports and Reviewsconfirmed the protective effect of DEC on cardiac function after intraosseous delivery shown by increased values of both ejection fraction and fractional shortening, which at 90days revealed a rebound effect when compared to the vehicle injected controls and mice receiving not-chimeric cell therapy. Moreover, these functional improvements correlated with restoration of dystrophin expression in cardiac muscle at 90days post-DEC treatment.

"These findings are potentially significant for the treatment of DMD," said Dr. Maria Siemionow, MD, PhD Dystrogen Therapeutics Corp chief scientific officer and the therapy's inventor. "This study establishes DEC as a promising new option for cardiac protection and potential amelioration of DMD related cardiac pathology."

"These data add to the growing body of literature supporting the potential of our chimeric cell platform to restore systemic muscle function, with less potential side effects then gene therapy-based approaches," said Dr. Kris Siemionow, MD, PhD Dystrogen Therapeutics Corp CEO. "We are very pleased to have these data published in a highly relevant journal for the field and look forward to further exploring this opportunity."

About Dystrogen Therapeutics

Dystrogen Therapeutics is a clinical-stage life sciences company committed to developing personalized therapies for rare diseases. The company has developed a chimeric cell therapy platform. Dystrophin expressing chimeras "DEC" are based on ex vivo fusion of allogeneic human myoblast derived from donors with autologous human myoblast received from the DMD patient, where chimeric cells maintain the ability to express normal dystrophin protein. DEC cells increase the number/pool of normal myoblasts and reduce inflammation. DEC cells induce replacement of fibrotic tissue, thus significantly improving muscle strength and function in DMD pre-clinical studies. The therapy minimizes immune response effects and the need for immunosuppression. This new approach will be based on delivery and restoration of dystrophin in affected muscles preventing the premature loss of mobility and early mortality of DMD patients. The company is planning on enrolling patients for its DEC chimeric cell therapy Duchenne muscular dystrophy trial. This therapy offers a unique advantage and allows the patient's body and immune system to accept the chimeric cells without rejection. Pre-clinical results have demonstrated that increased dystrophin levels correlate with improved functional outcomes. First clinical results from DEC therapy are expected in late 2020.

Contact: info@dystrogen.com

View original content:http://www.prnewswire.com/news-releases/dystrogen-therapeutics-announces-that-treatment-with-dystrophin-expressing-chimeric-dec-cells-improves-cardiac-function-in-preclinical-duchennes-study-300951205.html

SOURCE Dystrogen Therapeutics Corp

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Dystrogen Therapeutics Announces That Treatment With Dystrophin Expressing Chimeric (DEC) Cells Improves Cardiac Function in Preclinical Duchenne's...

Cardiac Stem Cells Comments Off on Dystrogen Therapeutics Announces That Treatment With Dystrophin Expressing Chimeric (DEC) Cells Improves Cardiac Function in Preclinical Duchenne’s… | November 5th, 2019

A Qualitative Research Study done by Crystal Market Research on Global Autologous Stem Cell Based Therapies Market report provides current and future trends are outlined to determine the overall attractiveness and to single out profitable Autologous Stem Cell Based Therapies trends to gain a stronger position in Industry anticipated to reflect a positive growth trend in Upcoming years as well. Global Autologous Stem Cell Based Therapies market provide in depth coverage from various aspects and scenario to future trends and opportunities. This Autologous Stem Cell Based Therapies report provide latest customized and syndicated research along with consulting services.

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The detailed study of global Autologous Stem Cell Based Therapies market report portraying the current landscape and important projections for market forecast, growth trend. This report is an whole guide for new aspirant to understand the trending values and Autologous Stem Cell Based Therapies future trend. The report arranged dependent on a top to bottom market examination with contributions from industry expert.

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Future Outlook: Autologous Stem Cell Based Therapies Market Prediction and Analysis Offered By New Study 2019 2025: Leading Key Players: JCR...

Cardiac Stem Cells Comments Off on Future Outlook: Autologous Stem Cell Based Therapies Market Prediction and Analysis Offered By New Study 2019 2025: Leading Key Players: JCR… | November 5th, 2019

BioRestorative Therapies (OTCMKTS:BRTX) and Livongo Health (NASDAQ:LVGO) are both medical companies, but which is the better investment? We will contrast the two companies based on the strength of their dividends, risk, analyst recommendations, valuation, institutional ownership, profitability and earnings.

Profitability

This table compares BioRestorative Therapies and Livongo Healths net margins, return on equity and return on assets.

Analyst Recommendations

This is a breakdown of recent ratings for BioRestorative Therapies and Livongo Health, as provided by MarketBeat.

Livongo Health has a consensus price target of $44.20, suggesting a potential upside of 87.93%. Given Livongo Healths higher probable upside, analysts clearly believe Livongo Health is more favorable than BioRestorative Therapies.

Institutional & Insider Ownership

0.1% of Livongo Health shares are owned by institutional investors. 17.9% of BioRestorative Therapies shares are owned by insiders. Strong institutional ownership is an indication that large money managers, endowments and hedge funds believe a stock will outperform the market over the long term.

Valuation and Earnings

This table compares BioRestorative Therapies and Livongo Healths top-line revenue, earnings per share (EPS) and valuation.

BioRestorative Therapies has higher earnings, but lower revenue than Livongo Health.

Summary

Livongo Health beats BioRestorative Therapies on 7 of the 9 factors compared between the two stocks.

BioRestorative Therapies Company Profile

BioRestorative Therapies, Inc. develops therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells for the treatment of disc/spine disease and metabolic disorders. The company's lead cell therapy candidate is the BRTX-100, which focuses on providing non-surgical treatment for protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. It also develops the ThermoStem program, a pre-clinical program for the treatment of metabolic diseases, such as type 2 diabetes, obesity, hypertension, and other metabolic disorders, as well as cardiac deficiencies. In addition, the company provides curved needle device, a needle system with a curved inner cannula that allows access to difficult-to-locate regions for the delivery or removal of fluids and other substances. Further, it offers skin care products under the Stem Pearls brand name. BioRestorative Therapies, Inc. has a research and development agreement with Rohto Pharmaceutical Co., Ltd.; and a research agreement with Pfizer, Inc. and the University of Pennsylvania. The company was formerly known as Stem Cell Assurance, Inc. and changed its name to BioRestorative Therapies, Inc. in August 2011. BioRestorative Therapies, Inc. was incorporated in 1997 and is headquartered in Melville, New York.

Livongo Health Company Profile

Livongo Health, Inc. provides an integrated suite of solutions for the healthcare industry in North America. It solutions promote health behavior change based on real-time data capture supported by intuitive devices and insights driven by data science. The company offers a platform that provides cellular-connected devices, supplies, informed coaching, data science-enabled insights, and facilitates access to medications. Its products include Livongo for Diabetes, Livongo for Hypertension, Livongo for Prediabetes and Weight Management, and Livongo for Behavioral Health by myStrength. The company was formerly known as EosHealth, Inc. and changed its name to Livongo Health, Inc. in 2014. Livongo Health, Inc. was incorporated in 2008 and is headquartered in Mountain View, California.

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Head-To-Head Analysis: BioRestorative Therapies (OTCMKTS:BRTX) versus Livongo Health (OTCMKTS:LVGO) - Casper Courier

Cardiac Stem Cells Comments Off on Head-To-Head Analysis: BioRestorative Therapies (OTCMKTS:BRTX) versus Livongo Health (OTCMKTS:LVGO) – Casper Courier | November 5th, 2019

Crystal Market Research has recently updated its massive report catalog by adding a fresh study titled Global Autologous Stem Cell Based Therapies Market Report 2019. The Autologous Stem Cell Based Therapies market report presents an analytical study that is defined based on the various parameters and trends followed by the global Autologous Stem Cell Based Therapies market. The report contains the assessment of futuristic growth based on past growth models and currently accompanied by the market. Extensive information on factors entered and market growth forecasts are also included in the market.

Global Autologous Stem Cell Based Therapies Market report provides an in-depth study of industry size, share, trend, opportunities within the latest research report added by CMR. The report consists of market sizes and forecast for the period from 2019 to 2025, and compounded annual growth rate (CAGR%) measured for individual segments and regional markets, competitive landscape of main market players, vital analysis of market dynamics and profiling of key providers collaborating in the Autologous Stem Cell Based Therapies market.

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Latest Released Report on Autologous Stem Cell Based Therapies Market to Witness the Highest Growth Globally in Coming Years: Osiris...

Cardiac Stem Cells Comments Off on Latest Released Report on Autologous Stem Cell Based Therapies Market to Witness the Highest Growth Globally in Coming Years: Osiris… | November 3rd, 2019

HOUSTON--(BUSINESS WIRE)--InGeneron, Inc., a regenerative medicine and cell therapy company, today announced the publication of promising results in developing a novel treatment for chronic ischemic heart failure using its regenerative cell therapy platform.

A newly-released research paper published in the World Journal of Stem Cells provides missing pieces of evidence for a fundamental change in the treatment of chronic ischemic heart failure, showing efficacy and safety of a novel stem cell treatment in cardiology. Patients with heart failure as a consequence of previous myocardial infarction are a large and currently underserved patient population, due to the lack of regenerative treatment options.

The publication, performed in a pig model for the study of chronic myocardial infarction, evidences for the first time that regeneration of the damaged tissue in the heart - responsible for chronic ischemic heart failure - is possible. Specifically, the study demonstrates that InGenerons fresh, uncultured, autologous adipose derived regenerative cells (UA-ADRCs) - isolated and administered at point of care - provide a significant improvement of cardiac circulatory parameters in chronic ischemic heart failure. The results show that the mean cardiac output increased by 37%, the mean left ventricular mass increased by 29% and the mean relative amount of scar volume of the left ventricular wall decreased by 21% six weeks after treatment with the cells. All results were statistically significant compared to the control group. Notably, on average only 18 gram of adipose tissue were required to recover the averaged 18 million cells injected to achieve the reported effects.

The findings represent an important step in research, laying the foundation for new frontiers on cardiac regeneration of chronic ischemic heart failure in human patients. While previous studies indicated that stem cells (including UA-ADRCs) might be of benefit in acute myocardial infarction, this benchmark had previously not been achieved by studies of autologous stem cells for chronic heart failure following myocardial infarction.

Haenel et al., the authors of the publication, attribute the success of the study to two important improvements over previous attempts. The primary success factor was the use of InGeneron's technology for isolating the stem cells at point of care. In this regard, a recent publication by Winnier et al. (PLoS One 2019;14:e0221457) demonstrated that the technology used (TransposeRT / Matrase; InGeneron, Inc., Houston, TX, USA), provides the highest published number of living, uncultured, autologous, adult pluripotent stem cells recovered per gram of adipose tissue.

The second differentiator to all previously published results for myocardial regeneration is the application method to the damaged heart. Haenel et al. administered the stem cells retrograde through the hearts venous system, precisely to the area in need of regeneration. This retrograde injection technique, combined with a temporary blockage of the coronary vein at the level of a previous arterial occlusion, allowed the stem cells to overcome the endothelial barrier and thereby created a homogenous distribution of injected cells throughout the damaged myocardial tissue.

Dr. Eckhard Alt, Executive Chair of InGeneron, Inc. and senior author of the study, commented "this therapy, which may be performed in an ambulatory setting without the known risks associated with major anticoagulation, delivers the stem cells in about 15 minutes and involves a total treatment time of approximately 3 hours. This gives hope that millions of patients suffering from chronic ischemic heart failure might benefit from rebuilding the heart with their own stem cells".

The study, entitled "Unmodified autologous stem cells at point of care for chronic myocardial infarction", by Haenel et al. was published in the World Journal of Stem Cells on October 26, 2019.

While the company is advancing its ongoing clinical programs for key orthopedic conditions, additional studies are designed to validate the clinical potential of stem cells in patients with coronary artery disease and chronic heart failure.

About InGeneron

InGeneron is a clinical stage cell therapy company enabling novel, safe and evidence-based regenerative medicine therapies. Our purpose is to set new therapeutic standards by developing treatments that unlock the healing potential of each patients own regenerative cells processed at the point of care for same-day application. We focus on helping patients who are impacted by musculoskeletal indications and are pursuing research to extend the application of our platform technology to additional treatment areas.

http://www.ingeneron.com

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InGeneron Announces Publication of Preclinical Results for its Cell Therapy in Chronic Ischemic Heart Failure - Business Wire

Cardiac Stem Cells Comments Off on InGeneron Announces Publication of Preclinical Results for its Cell Therapy in Chronic Ischemic Heart Failure – Business Wire | November 1st, 2019

More than 10 million people worldwideabout 1 percent of people over age 60live with Parkinsons disease. There are treatments that can help control symptoms, but there is no cure.

The hallmark of the disease is the death of certain brain cellsneurons that produce dopamine. Most Parkinsons researchers have focused on studying these cells. But what if the disease starts elsewhere? What if it involves not only neurons but other cells that interact with neurons? In particular, what role is played by astrocytes, star-shaped cells that nurture and help form the connections, or synapses, between the neurons?

(This article by Angela Spivey, with photos by Alex Boerner, originally appeared in Duke Medical Alumni News. Read that story here.)

Thats the question a team of Duke researchers led by Cagla Eroglu, PhD, associate professor of cell biology and neurobiology, is exploring, thanks to a $1 million grant from the Chan Zuckerberg Initiative.

Sitting in her office, Eroglu picks up an orange plastic object that resembles a piece of coral, its tentacles branching this way and that. This is a model of a mouse astrocyte, she says. It can interact with 100,000 synapses at the same time. Astrocytes, she explains, infiltrate the brain, touching everything within their reach. They communicate with its synapses, regulating blood flow and metabolism.

Astrocytes from the Greek astron, meaning "star"have traditionally been thought of as support cells. But that thinking is changing. Since astrocytes are in such close contact and continuously communicating with synapses, we are beginning to appreciate that they are also fundamentally involved in regulating brain function, Eroglu says.

Collaborating with Albert La Spada, MD, PhD, Eroglu found that a certain gene known to be important in Parkinsons is more highly expressed in astrocytes than in neurons. And when the researchers mutated that gene in astrocytes, they saw some intriguing changes. This still-unpublished work laid the foundation for their proposal to the Chan Zuckerberg Initiative, which is bringing together experimental scientists from divergent fields to take a fresh look at the causes of neurodegenerative disorders.

There are vanishingly few papers that have delved into how astrocytes are contributing to the Parkinsons disease process, says La Spada, professor of neurology and vice chair of research for the Department of Neurology. This is an area that's been under-studied, and I think that the results that we're generating are suggesting that it deserves more attention.In addition to his long experience studying neurodegenerative diseases, La Spada brings expertise in growing astrocytes from induced pluripotent stem cells (IPSCs). That process starts by growing skin cells from a skin biopsy from a Parkinsons patient. Then we use what's called a reprogramming protocol to basically revert them to stem cells that are pluripotent. Once you create the IPSCs, you could use them to make any cell you wanta muscle cell or a cardiac cell or a neuron or an astrocyte, La Spada says. The beauty of this is, it comes from the patient who has the disease of interest."

His labs expertise will only grow because of the Chan Zuckerberg Initiative, which has formed focus groups for grantees around various areas, such as stem cell modeling, CRISPR gene-editing technology, bioinformatic analysis of data sets, and more. We're meeting other researchers from around the world who are doing really unique things. It's a chance for us all to compare notes, and I think this will accelerate all of our endeavors, La Spada says.

Rounding out the team is Nicole Calakos, MD, PhD, a scientist and clinician who treats patients with movement disorders, including Parkinsons. Calakos says that when she first met Eroglu, she was intrigued by her idea that since astrocytes are involved in sculpting the language of neurons, perhaps they play a role in the events that can lead to disease.

Everybody has been fixated like a magnet on the idea that the problem is the neuron that's dying, Calakos says. Cagla said, Hey, let's think outside of the box of that dead cell. Lets consider whether astrocytes are like the soil around a plant, providing the nutrition, and allowing it to form roots, and maybe that is whats broken. Why aren't we even thinking about this critical piece of the brain?

Eroglu puts it this way: Maybe the problem is loss of connections between neurons, even before they die.

Calakos says that part of the reason she came to Duke was the close intermingling of physicians and bench scientists. Because of how the community is at Duke, Cagla and I had been exchanging ideas and collaborating over the years, she says. The Chan Zuckerberg grant is an opportunity to get together as a formal team. I think it's really forward-thinking of them to have teams of basic scientists and practicing physicians all talking to each other.

The Chan Zuckerberg Initiative was launched in December 2015 by Mark Zuckerberg, founder and CEO of Facebook, and Priscilla Chan, a pediatrician and founder and CEO of The Primary School in East Palo Alto. In addition to her clinical insight, Calakos brings expertise in electrophysiologyreal-time recording and observation of electrical signals coming from brain cells. We can listen to the language of synapses, she says. They speak in electrical currents,which we can measure. Eroglu believes that by learning all they can about how astrocytes support synaptic development and health in the normal brain, they may find ways to stop neurodegenerative diseases like Parkinsons.

We are seeing aging as a part of development, Eroglu says. If your house is built on a strong base, then it might last longer. Whereas, if you build it in another way, it may be there for a while, but gradually start to break down.

This doesn't mean that we are destined to have neurodegeneration and we can't do anything. We may be more predisposed to get the disease, but we may not get it if we have done something else in our lives that helps strengthen our brain. I strongly believe that there will be ways to stop neurodegeneration.We will find a way to strengthen the brain connections. If we can figure out the weakest link, then we could concentrate on solving that.

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The Stars in Our Brains - Duke Department of Neurology

Cardiac Stem Cells Comments Off on The Stars in Our Brains – Duke Department of Neurology | October 30th, 2019

DUBLIN--(BUSINESS WIRE)--The "Cell Based Assay & High Content Screening Markets Market Forecasts by Application, With Executive and Consultant Guides and including Customized Forecasting and Analysis 2020 to 2024" report has been added to ResearchAndMarkets.com's offering.

Cell Based Assays are a mainstay of drug development and scientific research, but growth is now accelerating as new immuno-oncology markets create unprecedented investment in the race to cure cancer. On top of this new technology is allowing Cell Based Assays to be used to measure any aspect of cell function. This market just keeps on growing with no end in sight. The workhorse of the pharmaceutical industry is becoming a central player in biotechnology.

This is a complex area but this readable report will bring the entire management team up to speed, on both the technology and the opportunity.

The technology is moving faster than the market. Genomics and Immunology are playing a role too. Find opportunities and pitfalls. Understand growth expectations and the ultimate potential market size.

Key Topics Covered

1. Introduction and Market Definition

1.1 What are Cell Based Assays?

1.2 Clinical Trial Failures

1.2.1 Immuno-oncology Plays a Leading Role in Cell Based Assays

1.3 Market Definition

1.3.1 Market Size

1.3.2 Currency

1.3.3 Years

1.4 Methodology

1.4.1 Authors

1.4.2 Sources

1.5 U.S. Medical Market and Pharmaceutical Research Spending - Perspective

1.5.1 U.S. Expenditures for Pharmaceutical Research

2. Cell Based Assays - Guide to Technology

2.1 Cell Cultures

2.1.1 Cell Lines

2.1.2 Primary Cells

2.1.3 Stem Cells

2.1.3.1 iPSC's - The Special Case

2.2 Cell Assays

2.3 Cell Viability Assays

2.3 Cell Proliferation Assays

2.4 Cytotoxicity Assays

2.5 Cell Senescence Assays

2.6 Apoptosis

2.7 Autophagy

2.8 Necrosis

2.9 Oxidative Stress

2.10 2D vs. 3D

2.11 Signalling Pathways, GPCR

2.12 Immune Regulation & Inhibition

2.13 Reporter Gene Technology

2.14 CBA Design & Development

2.15 Cell Based Assays - The Takeaway

3. Industry Overview

3.1 Players in a Dynamic Market

3.1.1 Academic Research Lab

3.1.2 Contract Research Organization

3.1.3 Genomic Instrumentation Supplier

3.1.5 Cell Line and Reagent Supplier

3.1.6 Pharmaceutical Company

3.1.7 Audit Body

3.1.8 Certification Body

4. Market Trends

4.1 Factors Driving Growth

4.1.1 Candidate Growth

4.1.2 Immuno-oncology

4.1.3 Genomic Blizzard

4.1.4 Technology Convergence

4.1.5 The Insurance Effect

4.2 Factors Limiting Growth

4.2.1 CBA Development Challenges

4.2.2 Instrument Integration

4.2.3 Protocols

4.3 Technology Development

4.3.1 3D Assays

4.3.2 Automation

4.3.3 Software

4.3.4 Primary Cells

4.3.5 Signalling and Reporter Genes

4.3.6 The Next Five Years

5. Cell Based Assays Recent Developments

5.1 Recent Developments - Importance and How to Use This Section

5.1.1 Importance of These Developments

5.1.2 How to Use This Section

6. Profiles of Key Cell Based Assay Companies

7. Global Market Size

7.1 Cell Based Assay Global Market Size by Region with Charts

7.2 Cell Based Assays Global Market Size by Type with Charts

8. Global Market by User Type

8.1 Pharmaceutical Market

8.1.1 Pharmaceutical Market by Region with Chart

8.2 Basic Research Market

8.2.1 Basic Research Market by Region with Chart

8.3 Industrial/Cosmetic Market

8.3.1 Industrial/Cosmetic Market by Region with Chart

9. Cell Based Assay by Product Class

9.1 Instrument Market

9.1.1 Instrument Market by Region with Chart

9.2 Reagent Market

9.2.1 Reagent Market by Region with Chart

9.3 Services Market

9.3.1 Services Market by Region with Chart

9.4 Software Market

9.4.1 Software Market by Region with Chart

10. Appendices

10.1 FDA Cancer Drug Approvals by Year

10.2 Clinical Trials Started 2010 to 2016

10.3 Share of Pharma R&D by Country

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/atsea9

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Global Cell Based Assay & High Content Screening Markets, 2020-2024 | Forecast by Application with Executive & Consultant Guides -...

Cardiac Stem Cells Comments Off on Global Cell Based Assay & High Content Screening Markets, 2020-2024 | Forecast by Application with Executive & Consultant Guides -… | October 30th, 2019

Michael Schumacher was said to have been admitted to a hospital in Paris the past September. Based on the news, he was transported to the medical facility by helicopter, and he was there to receive the procedure called Stem Cell Therapy.

According to The Telegraph, Schumachers latest treatment is giving his family and friends the big hope that his condition would improve. The treatment is one of the latest procedures that was developed to help people suffering from various illnesses. It uses stem cells to treat patients and help prevent disease or certain health conditions.

Did Schumi really try the Stem Cell Therapy for his condition?

Michael Schumachers health is a closely guarded matter so no knows exactly how he is doing after coming out of his coma more than five years ago. It can be recalled that he sustained a grave head injury after hitting a rock while skiing in the Alps in 2013.

Thus, it is not surprising if details of this alleged stem cell procedure are also being kept a secret by his family. They would not even confirm if he was really hospitalized for the treatment but a nurse supposedly said that Schumi is now conscious after the procedure. La Parisien via Mirror reported that an unnamed nurse claimed that the F1 legend showed signs of recovery.

"Yes he is in my service," she said. "And I can assure you that he is conscious."

Doctor may have confirmed the therapy

It was said that Dr. Philippe Menasche, a French cardiac surgeon, performed the procedure on Michael Schumacher and when the news broke out for the first time, he slammed the people who were alleging that his treatment on Schumi was only experimental.

As per Australias 7News, the doctor hit out the media for covering the treatment on Michael Schumacher and giving out false information. When the media called his advanced procedures experimental, he refuted the claims and said that he dont perform miracles.

"My team and I are not doing an experiment, an abominable term that is not in line with a serious medical view, he told the Italian newspaper La Republica. In any case, Menasch reaction was meant to defend his stem cell therapy treatment however, he seemed to have unknowingly confirmed that he treated Michael Schumacher as well.

See more here:
Michael Schumacher: Has the racing champ recovered? Stem Cell Therapy doctor unknowingly confirmed Schumi's procedure? - EconoTimes

Cardiac Stem Cells Comments Off on Michael Schumacher: Has the racing champ recovered? Stem Cell Therapy doctor unknowingly confirmed Schumi’s procedure? – EconoTimes | October 28th, 2019

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Plant of the week: Plant thought to boost milk production now used for skin eruptions - Cyprus Mail

Cardiac Stem Cells Comments Off on Plant of the week: Plant thought to boost milk production now used for skin eruptions – Cyprus Mail | October 25th, 2019