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pharmaphorumuk · 5 years

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Mesoblast poised to file cell therapy for GVHD in US

Australian biotech Mesoblast can go ahead with a US filing for its off-the-shelf stem cell therapy for acute graft-versus-host disease (GVHD), after negotiations with the FDA.

The ‘rolling’ biologics license application (BLA) for remestemcel-L in children with steroid-refractory acute GVHD – a life-threatening complication that can arise in blood cancer patients who’ve had bone marrow transplants – comes a few months after the company revealed positive trial data with the therapy.

In the 55-patient open-label trial study reported last year, 69% of treated children had a complete or partial response, which compares to a historical control response rate of around 45%.

GVHD is one of the leading causes of death in patients receiving donor stem cell transplants, and occurs when the donated bone marrow cells mount an immune response against the recipient’s healthy tissues.

Steroids are the first-line therapy, but in around 15% of cases can’t resolve the acute inflammatory response. In those cases, the death rate can be as high as 70% after 100 days, but in Mesoblast’s trial 78% of patients treated with remestemcel-L were still alive at that timepoint.

Mesoblast said it will submit each module of the BLA to the FDA on a rolling basis as it is completed. That approach will provide “opportunity for ongoing and frequent communication, and during this process the company expects it will be able to adequately address any substantial matters raised by the FDA”, said the company in a statement.

Remestemcel-L has already been granted a fast track designation from the FDA and will be eligible for priority review once the filing is accepted by the FDA.

The therapy has already been approved for GVHD in Japan, where it is sold by licensee JCR Pharmaceuticals as Temcell HS Inj, and was filed last month for the additional indication of epidermolysis bullosa, a serious rare genetic disease in which minor friction causes blisters or erosion of the skin.

News of a filing is a boost to Mesoblast, after its Revascor (MPC-150-IM) therapy failed to hit the mark in a phase 2 trial in heart failure patients reported last November.

Injections of MPC-150-IM (mesenchymal precursor cells) directly into the myocardium during the implantation of a left ventricular assist device (LVAD) did not improved the chances of them being able to do without the device, although the therapy did work in some subgroups.

The biotech is planning a second trial that will try to show that the therapy can reduce complications including gastrointestinal bleeding in end-stage heart failure patients implanted with an LVAD.

The therapy is still in a larger phase 3 trial pf Revascor in chronic heart failure that completed patient recruitment earlier this year. Former partner Teva returned the rights to the therapy in 2016.

The post Mesoblast poised to file cell therapy for GVHD in US appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/mesoblast-cell-therapy-gvhd-fda/

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saojip13 · 5 years

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Stem Cell Therapy Market Players: Cytori Therapeutics Inc., Fibrocell Science, Cellartis AB, BioTime, GE Healthcare, etc

Stem cell therapy involves use of stem cells to treat various diseases or disorders. Stem cells are fundamental for every tissue and organ in the body. Stem cells are indistinguishable biological cells that are able to differentiate into specialised cells (liver cells, cardiac cells etc.) and can renew itself (through mitosis) to produce more stem cells. Stem cells have the ability to replicate, repair, and replace other damaged tissues in the human body. In addition, stem cell based therapies are also used to treat several chronic diseases such as blood disorders, cancer and others.

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Growing awareness about the potency of stem cells in disease management, development of advanced gene based analysis techniques and increase in public, private investments in stem cell research are acting as growth drivers for stem cell therapy market. In addition, identification of new stem cell lines and development of infrastructure for stem cell banking & processing are propelling the growth of the global stem cell therapy market. However, ethical issues involved in stem cells research such as destruction of human embryos, religious beliefs are considered as road blocks for adaptation of stem cell therapy by patients. However, stringent regulations to conduct trials on humans, high-cost of research and storage of stem cells are some restraining factors for stem cell therapy market.

Stem cell therapy market has been segmented on the basis of treatment mode, cell types, application, technology, and end-user

Based on treatment, stem cell therapy market is segmented into

Allogeneic Autologous

Based on cell type, stem cell therapy market is segmented into

Adult Stem cells Induced Pluripotent Stem cells Human Embryonic Stem Cells Others

Based on technology, stem cell therapy market is segmented into

Cell Production Cell Acquisition Cryopreservation

Based on end-user, stem cell therapy market segmented into

Hospitals Ambulatory Centers Research Centers

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Stakeholders in stem cell therapy such as academic institutions and research firms are collaborating in development of stem cell therapy and industry collaborations also projecting enormous growth of stem cell therapy market. For instance, in November 2015, Cellular Dynamics International, Inc. (FUJIFILM) collaborated with Roche to supply iCell (CDI’s induced pluripotent stem cell derived) products that enables in identification of novel drug candidates at the early stages of drug discovery. Similarly, in May 2018, Magenta Therapeutics, entered into strategic partnership with Be The Match BioTherapies, to improve and expand the use of curative stem cell transplantation.

Geographically stem cell therapy market has been segmented into following regions viz. North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa. Among the regions, North America dominates global stem cell therapy market due to factors such as increasing prevalence of chronic diseases, growing awareness, and rising investment in research and development activities. In Asia Pacific region, due to the favourable government policies, development healthcare infrastructure, industry collaborations in research and developments expected to boost stem cell therapy market. For instance, in April 2018, Plasticell, a developer of stem cell technologies and cell-based therapies, has announced that it has signed agreements with the Agency for Science, Technology and Research (A*STAR), Singapore, and the Nanyang Technological University (NTU), Singapore, to progress its therapeutic stem cell pipeline.

Some of the players in stem cell therapy market are Cytori Therapeutics Inc. (U.S.), Fibrocell Science (U.S.), Cellartis AB (Cellectis) (France), BioTime, Inc. (U.S.), GE Healthcare (U.S.), Thermo Fisher Scientific (U.S.), STEMCELL Technologies Inc. (Canada), Fujifilm Holdings Corporation (Japan), Vericel Corporation (Aastrom Bioscience) (U.S.), Brainstorm cell therapeutics (U.S.), Becton, Dickinson and Company (U.S.), Stryker Corporation (U.S.), Celgene Corporation (U.S.), and Osiris Therapeutics, Inc. (U.S.) to name a few.

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In February 2016, Mesoblast Limited’s licensee in Japan, JCR Pharmaceuticals Co. Ltd., launched “TEMCELL HS Inj”, the first allogeneic cell therapy to be fully approved in Japan, for the treatment of acute graft versus host disease in children and adults

Details of the market study:

Historical Data: 2014 & 2017

Base Year: 2018

Forecasts: 2019-2025

CAGR: 2019-2025

Market trend analysis in terms of drivers, restraints and opportunities

Industry analysis using Porter’s, PESTEL and SWOT

Market players analysis in terms of company’s overview, financial performance, product/service benchmarking and strategic initiatives taken up by them

#Stem Cell Therapy Market

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