Athersys (ATHX) Reports Positve Data from MultiStem Phase I in HSCT Patients
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Athersys, Inc. (Nasdaq: ATHX) today announced positive results from its Phase I clinical trial of MultiStem, its cell therapy product, administered to individuals undergoing allogeneic hematopoietic stem cell transplants (HSCT) for the treatment of leukemia and related conditions. According to the Center for International Blood and Marrow Transplant Research, there are approximately 25,000 allogeneic HSCT performed annually, globally. The study demonstrated that MultiStem therapy was well tolerated in both the single infusion and repeat infusion arms and also suggested that the therapy may provide benefit to recipients of allogeneic HSCT, such as reducing the incidence and severity of Graft-versus-Host Disease (GvHD) as compared to historical clinical experience. The results are consistent with previous preclinical studies that show that MultiStem provides multiple benefits in HSCT and other transplant models, such as reducing inflammatory damage and promoting graft acceptance.
These clinical results could provide the foundation for further, accelerated development of MultiStem to prevent or reduce the severity of GvHD, a potentially life-threatening complication of such transplants. Athersys received orphan drug designation from the U. S. Food and Drug Administration for prevention of GvHD in September 2010. Orphan drug designation, which is intended to facilitate drug development, provides substantial potential benefits to the sponsor, including funding for certain clinical studies, study-design assistance, tax incentives and seven years of market exclusivity for the product upon regulatory approval.
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These clinical results could provide the foundation for further, accelerated development of MultiStem to prevent or reduce the severity of GvHD, a potentially life-threatening complication of such transplants. Athersys received orphan drug designation from the U. S. Food and Drug Administration for prevention of GvHD in September 2010. Orphan drug designation, which is intended to facilitate drug development, provides substantial potential benefits to the sponsor, including funding for certain clinical studies, study-design assistance, tax incentives and seven years of market exclusivity for the product upon regulatory approval.
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