Athersys (NASDAQ: ATHX) announced in their press release positive results from its Phase I clinical trial of MultiStem, its cell therapy product. The trial was administered to individuals undergoing allogeneic hematopoietic stem cell transplants (HSCT) for the treatment of leukemia and related conditions.
Data highlights from the study include:
- The majority of patients participating in the study received transplants from unrelated donors (19 of 36), and nearly all of the patients received peripheral blood stem cell (PBSC) transplants (34 of 36), both of which are associated with a higher risk of GvHD;
- All patients experienced successful neutrophil engraftment (median time of engraftment 15 days), and 86% of patients experienced successful platelet engraftment (median time of engraftment 16 days) which compares favorably to historical clinical experience for this patient population demonstrating a positive impact on blood and immune system recovery;
- Substantial reduction in acute GvHD incidence, relative to historical experience, at the highest single dose (11% grade II-IV GvHD, and 0% grade III-IV GvHD).
These clinical results provide the foundation for further accelerated development of MultiStem for the prevention and reduction of GvHD. Following final review of the data, and subject to input from its key scientific and clinical advisers, Athersys plans to meet with the FDA to discuss plans for the next phase of clinical development. This could include a blinded, controlled phase II/III study of MultiStem for GvHD prophylaxis and HSCT support.
Daily Dose Conclusion: Athersys is building a solid foundation to expand the pipeline in a product with Multistem.
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