Gamida Cell announced today that its joint venture with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has received an US Food and Drug Administration (FDA) fast track designation for its stem cell therapy for blood cancers.
The product, called StemEx, is being developed as an alternative to a bone marrow transplant for patients with blood cancers such as leukemia and lymphoma.
The FDA fast track programs 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. A letter from the US department of health and human services said, "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 uses cells from umbilical cord blood. It is in a Phase III trial in Israel, the US, and Europe. StemEx has orphan drug designation in the US and in Europe.
Gamida Cell’s current shareholders include Elbit Imaging Ltd. (Nasdaq: EMITF; TASE: EMIT), Clal Biotechnology Industries Ltd. (TASE: CBI), Israel Healthcare Venture, Teva, Amgen, Denali Ventures and Auriga Ventures.
Published by Globes [online], Israel business news - www.globes-online.com - on June 21, 2010
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