Gamida Cell

Gamida Cell

October 19, 2009 02:00 ET

Article Published in Expert Opinion on Biological Therapy Evaluates StemEx® (carlecortemcel-l) for Leukemia and Lymphoma

The article, entitled Carlecortemcel-l, an ex vivo expanded umbilical cord blood cell graft for allogeneic transplantation, is now available online.

StemEx is being studied in a pivotal, FDA-registration trial called ExCell, currently enrolling patients at clinical sites worldwide.

JERUSALEM, ISRAEL--(Marketwire - Oct. 19, 2009) - Gamida Cell announced today the publication of an article evaluating carlecortemcel-l, the generic name of what is widely known as "StemEx", as a therapy for blood cancers such as leukemia and lymphoma. The article, Carlecortemcel-l, an ex vivo expanded umbilical cord blood cell graft for allogeneic transplantation, written by Dr. Ka Wah Chan and Dr. Demetrios Petropoulos, will be published in the November 2009 issue of Expert Opinion on Biological Therapy. It is now available for online review at (http://informahealthcare.com/doi/abs/10.1517/14712590903321447).

Dr. Chan is the director of the Hematology/Oncology and Blood and Marrow Stem Cell Transplant Programs at the Texas Transplant Institute on the campus of Methodist Children's Hospital in San Antonio, Texas. He is also a principal investigator of the ExCell study currently evaluating StemEx. Dr. Petropoulos is a pediatric hematologist-oncologist at the Children's Cancer Hospital at The University of Texas M. D. Anderson Cancer Center in Houston, Texas, where the Phase I study of StemEx was conducted.

In the article Dr. Chan and Dr. Petropoulos note, "Early results suggested that carlecortemcel-l infusion ... may be associated with favorable non-relapse mortality rates…. Ex vivo expansion of umbilical cord blood (UCB) cells appears to be a logical approach to increase the availability of this source for hematopoietic stem cell (HSC) transplantation. Laboratory research showed that the critical element of success is to improve HSC proliferation without promoting differentiation. The manufacturing of carlecortemcel-l represents a novel methodology that fulfills this criterion. It is the only product that has reached the confirmatory stage of clinical development. A single institution study (Phase I study at M. D. Anderson Cancer Center) suggested that the infusion of these expanded cells … may improve transplant outcome in large-sized patients."

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 along with the remaining unit of non-manipulated cells. It is currently being evaluated in an international, Phase II/III, FDA, pivotal registration study called ExCell, now enrolling adolescents and adults with high-risk hematologic malignancies, at clinical sites in the U.S., Italy, Spain, Hungary and Israel. (www.stemexstudy.com ).

The study is being conducted to verify the safety and efficacy of this product by comparing the overall 100-day mortality with that of a historical cohort from international umbilical cord blood transplant registries. It is also evaluating the feasibility of centralized manufacturing and shipping of expanded cord blood cells to transplant centers for infusion. The speed and completeness of engraftment and the long-term hematologic and immunologic reconstitution of the recipients will shed light on the role of expanded UCB cells in transplantation.

StemEx is being developed by the joint venture of Gamida Cell and Teva Pharmaceutical Industries (NASDAQ: Teva). Market launch is anticipated for 2011.

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 and bone marrow, 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 in an international pivotal trial at leading transplant centers in the U.S., Europe and Israel. StemEx has orphan drug designation in the U.S. and in Europe. 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: www.gamida-cell.com. For information regarding the ExCell study: www.stemexstudy.com.

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