JERUSALEM--(BUSINESS WIRE)--Gamida Cell announced today that the Gamida Cell-Teva Joint Venture has received an FDA Fast Track Designation for StemEx, in development as an alternative to a bone marrow transplant for patients with blood cancers such as leukemia and lymphoma.
The fast track programs of the Food and Drug Administration (FDA) are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs (fast track products).
The letter sent by the Department of Health and Human Services to the Gamida Cell-Teva Joint Venture stated: your request meets the criteria for the Fast Track designation. Therefore, we are designating as a Fast Track development program the investigation of StemEx (ex vivo expanded cord blood) as a supportive treatment to enhance hematopoietic re-constitution of umbilical cord blood cell transplant to improve 100-day post-transplant mortality in adults and adolescents who receive myeloablative therapy for high risk hematological malignancies.
StemEx is a graft of stem/progenitor cells isolated and expanded from a portion of a single unit of umbilical cord blood and transplanted in combination with non-expanded cells from the same unit. StemEx is now being studied in an international, phase III, clinical trial at leading transplant centers in the U.S., Europe and Israel. StemEx has orphan drug designation in the U.S. and in Europe, in addition to long term patent protection. For more information about StemEx or about the StemEx study, please visit www.stemexstudy.com.
About Gamida Cell
Gamida Cell is a world leader in stem cell population expansion technologies and therapeutic products for bone marrow transplantation and regenerative medicine for illnesses such as leukemia and lymphoma as well as autoimmune, hematological, and metabolic diseases. Gamida Cell’s therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, which are expanded in culture. Gamida Cell was successful in translating these proprietary expansion technologies into robust and validated manufacturing processes under GMP. Gamida Cell’s current shareholders include: Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceuticals, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: www.gamida-cell.com.