Shawshank, VA 4/4/12 (StreetBeat) -- Athersys, Inc. (Nasdaq:ATHX) announced today that it has been granted U.S. patent 8,147,824 that covers the use of non-embryonic, multipotent stem cells for the reduction in severity or prevention of Graft-versus-Host Disease (GvHD), a serious condition associated with hematopoietic stem cell transplants (HSCTs) used to treat leukemia and related conditions. Athersys recently completed a successful clinical study evaluating the adjunctive administration of MultiStem(R) for prevention of GvHD, an indication for which the company has already received orphan drug designation.The issued patent covers the use of MultiStem, Athersys' proprietary cell product platform, for the suppression of GvHD when administered in conjunction with an HSCT. The patent covers the administration of non-embryonic, multipotent stem cells derived from bone marrow as well as other tissues sources and applies to single or repeat dosing over a broad dose range in the context of HSCT-based treatment.
Athersys recently announced positive results from its Phase I clinical trial of MultiStem administered to patients undergoing HSCTs. In the highest dose group, a substantial reduction from the expected GvHD incidence was observed. Additionally, there were apparent benefits in several other important clinical parameters over the observation period, including engraftment rates, mortality and incidence of infection, relative to what would typically be expected for the high risk patient population enrolled in the study. The clinical results support the further, accelerated development of MultiStem for the prevention and reduction of GvHD. The company will be interacting with the FDA to discuss plans for the next phase of clinical development, which is intended to include a blinded, controlled Phase II/III study of MultiStem for GvHD prophylaxis and HSCT support.
"GvHD prophylaxis and transplant support represent areas of substantial unmet clinical need and as such, represent an attractive market opportunity for Athersys," said William (B.J.) Lehmann, President and COO of Athersys. "The '824 patent provides the company with protection in this high value area through 2028 and lays the groundwork for additional protection in related areas of treating immune system dysfunction."
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 for disease indications affecting fewer than 200,000 individuals, 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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