ExCell Study Assessing The Safety And Efficacy Of StemEx(R) As An Alternative To Bone Marrow Transplants

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Stem Cell Research;  Blood / Hematology;  Clinical Trials / Drug Trials
Article Date: 20 Mar 2009 - 0:00 PDT


The Western Pennsylvania Hospital (WPH) and the Gamida Cell - Teva Joint Venture (JV) announced today that the hospital is now enrolling patients to participate in the ExCell study. The trial is assessing the safety and efficacy of StemEx as a treatment for hematological malignancies, including leukemia and lymphoma, in a single arm, global, pivotal registration study. StemEx is a graft of expanded stem/progenitor cells, derived from a single unit of umbilical cord blood and transplanted in combination with non expanded cells from the same unit.

StemEx® is being developed by a Joint Venture equally owned and managed by Gamida Cell and Teva Pharmaceutical Industries (NASDAQ: TEVA).

"Stem cell transplantation can be a life-saving procedure, but the need for matching donors limits its use," said Entezam Sahovic, MD, Director of the Cell Transplantation Program at the Western Pennsylvania Cancer Institute at West Penn Hospital in Pittsburgh. "Umbilical cord blood is a promising alternative but does not always provide enough stem cells for a successful transplant. We are hopeful that this new technology will enable us to help more patients in need of transplants."

Cord blood has less matching requirements than bone marrow or peripheral blood transplants, providing the potential to increase the number of suitable transplant matches and to shorten the time it can take to find a match. However, there are a limited number of stem/progenitor cells in cord blood, enabling a quantity sufficient generally only for pediatric treatment. StemEx® employs a technology that expands this small number of cord blood stem/progenitor cells, increasing their therapeutic capacity for transplantation in adolescents and adults.

Since its inception in 1990, West Penn Hospital's Cell Transplantation Program has been nationally recognized as a leader in the treatment of patients with leukemias, myelodysplastic syndromes, Hodgkin's disease, lymphoma, myeloma and related disorders. In 2000, West Penn Hospital physicians combined blood from multiple umbilical cords to perform the region's first umbilical cord blood transplant in an adult leukemia patient. The hospital is one of just 41 nationwide institutions recognized as a Center of Excellence by the Myelodysplastic Syndromes Foundation.

"We are delighted to be working with the esteemed clinical team at West Penn Hospital led by Dr. Entezam Sahovic. The commencement of enrollment at WPH further advances this very important research in cell therapy and brings us one step closer to learning the effects of using StemEx as a therapeutic treatment for certain blood cancers," said Dr. David Snyder, V.P. of Clinical Development at Gamida Cell.

The ExCell trial will enroll 100 patients, ages 12 to 55, with high-risk hematological malignancies, who do not have a matched, family-related bone marrow donor, and who meet all of the eligibility criteria of the study. For a list of other leading research centers now enrolling in the ExCell trial and more information regarding the study, please visit http://www.stemexstudy.com.

The Western Pennsylvania Hospital

The Western Pennsylvania Hospital is an academic medical center with two hospital campuses that serve Pittsburgh and the surrounding five-state area: The Western Pennsylvania Hospital in Pittsburgh and The Western Pennsylvania Hospital - Forbes Regional Campus in Monroeville.

The Western Pennsylvania Hospital in Pittsburgh is the first hospital in Pittsburgh and western Pennsylvania to be awarded Magnet recognition status by the American Nurses Credentialing Center in 2006. This prestigious 4-year designation recognizes excellence in nursing. Part of West Penn Allegheny Health System, West Penn Hospital is a leader in patient care, education, and research, and serves as the clinical campus for Temple University School of Medicine.

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 first product, StemEx for blood cancers, is anticipated to reach the market in 2011. Gamida Cell's current shareholders include: Elbit Imaging, Biomedical Investment, Israel Healthcare Venture, Teva Pharmaceuticals, Amgen, Denali Ventures and Auriga Ventures.

Source
Gamida Cell

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