The Gamida Cell-Teva Joint Venture (JV) announced that the Data Monitoring Committee (DMC) has independently reviewed preliminary data from the pivotal registration, Phase III clinical trial of StemEx (called ExCell) and has recommended that the JV continue to enroll patients in this study. The next data analysis is anticipated to take place during Q2 2010. StemEx is being evaluated as a therapeutic treatment for adolescents and adults with blood cancers such as leukemia and lymphoma, who cannot find a family related matched bone marrow donor.
The DMC's primary charge is to ensure that the study is conducted in an ethical manner that does not expose participants to undue risk. In addition, the Committee monitors the quality and overall conduct of the study and assesses whether to recommend that the sponsor modify or terminate an ongoing study, or whether to request further information for review. The DMC for the Phase III StemEx study, comprised of an independent group of medical and scientific experts, reviewed safety and efficacy data from participating sites to assess treatment benefit (or harm) to study participants. The DMC had no safety concerns and recommended that accrual on the study continue.
Dr. Yael Margolin, president and chief executive officer of Gamida Cell said, "This is another important milestone, that the DMC has reviewed the data and recommended continuing the phase III study of StemEx. With this green light, we shall continue enrolling patients in the trial with plans to bring StemEx to the market in 2011. We also hope that today's news will help to increase awareness of StemEx as an investigational treatment amongst patients with leukemia and lymphoma to consider in consultation with their physician."
StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining unit of non-manipulated cells. The ExCell study is currently enrolling adolescents and adults with high-risk hematologic malignancies, at clinical sites in the U.S., Italy, Spain, Hungary and Israel.
About Gamida Cell
Gamida Cell Ltd. is a world leader in stem cell expansion technologies and therapeutic products. The company is developing a pipeline of products in stem cell transplantation and in tissue regeneration to effectively treat debilitating and often fatal illnesses such as cancer, hematological, autoimmune and ischemic 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 flagship product, StemEx, is now being studied as a therapy, for patients with blood cancers who cannot find a family related matched bone marrow donor, in an international phase III trial at leading transplant centers in the U.S., Europe and Israel. StemEx has orphan drug designation in the U.S. and in Europe with 7-10 years market exclusivity, in addition to long term patent protection. It is also expected to be among the first allogeneic cell products to reach the market in 2011. Gamida Cell's current shareholders include: Elbit Imaging, Biomedical Investment, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures.
Source: Gamida Cell Ltd