Data Monitoring Committee Recommends Continuation of Phase III Study of StemEx(R), a Cord Blood Stem Cell Product, for Leukemia and Lymphoma
(JV) announced today 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.
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.,
http://www.clinicaltrials.gov )
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.,
and in
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.
For more information, please visit: http://www.gamida-cell.com. For
information regarding the ExCell study: http://www.stemexstudy.com.
Press contact:
Marjie Hadad
Media Liaison/IR
Gamida Cell
marjie@gamida-cell.com
+972-54-536-5220
SOURCE Gamida Cell Ltd.