CHOC Children's Joins ExCell Pivotal Study For Leukemia And Lymphoma Patients As Only Pediatric Site On West Coast

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Pediatrics / Children's Health
Article Date: 13 Feb 2009 - 2:00 PST

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CHOC Children's and the Gamida Cell-Teva Joint Venture (JV) announced that the CHOC Children's Cancer Institute has joined a select group of cancer centers in Europe, the United States and Israel, actively enrolling patients for the ExCell study. CHOC Children's is the only pediatric site for the study on the West Coast.

The pivotal registration study is testing the safety and efficacy of StemEx, a potential alternative transplantation option for adolescents and adults with leukemia, lymphoma and other high-risk hematological malignancies, who are unable to find an adequately matched, bone marrow donor. StemEx is being developed by a Joint Venture equally owned and managed by Jerusalem-based biomedical company Gamida Cell and Teva Pharmaceutical Industries (NASDAQ:TEVA).

For many patients suffering from blood-based cancers such as leukemia and lymphoma, the odds of survival have been historically poor because they cannot find a suitable match bone marrow donor. According to the National Marrow Donor Program, each year in the United States more than 70 percent of the 35,000 patients with life-threatening diseases who could benefit from a bone marrow transplant cannot be matched with a donor.

"We are hopeful that this cellular technology will benefit our transplant patients. We also believe that this new methodology may expand the role for stem cell transplantation in treating life-threatening diseases, especially in patients without matched donors," said lead investigator Steven Neudorf, MD, clinical director of the Blood and Marrow Transplant Program at CHOC Children's.

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. While UCB has been used mainly for the treatment of small children, the increase in stem/progenitor cells through StemEx, boosts the therapeutic potential of this treatment for adolescents and adults. The preliminary results of the Phase I/II study of StemEx presented at the 2004 Annual Meeting of the American Society of Hematology (ASH) in San Diego California, encouraged the further investigation of the safety and efficacy of StemEx in the ExCell study.

"We are proud to work together with Dr. Neudorf in an effort to improve care for the patients being treated at CHOC Children's," said Dr. David Snyder, vice president of clinical development at Gamida Cell.

The ExCell study is recruiting patients ages 12 to 55, with leukemia or lymphoma, who meet all of the eligibility criteria of the study. All of the enrolled patients will receive StemEx. Visit http://www.stemexstudy.com for a full list of study sites and investigators.

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading global generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe. http://www.tevapharm.com

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 cell therapeutics to effectively treat debilitating and often fatal illnesses such as cancer, cardiac disease and peripheral vascular disease. Gamida Cell's therapeutic candidates contain adult stem cells, selected from non-controversial sources such as umbilical cord blood and bone marrow, and which are enriched in culture using the company's proprietary technologies. The company is dedicated to making a significant difference in the clinical practice of modern medicine by first creating, then tapping the regeneration power of an ample body of therapeutic stem cells. Current shareholders include: Elbit Imaging, Biomedical Investment, Israel Healthcare Venture, Teva Pharmaceuticals, Amgen, Denali Ventures and Auriga Ventures. http://www.gamida-cell.com

About CHOC Children's

CHOC Children's is exclusively committed to the health and well being of children through clinical expertise, advocacy, outreach and research that brings advanced treatment to our patients. CHOC Children's regional healthcare network includes two state-of-the-art hospitals in Orange and Mission Viejo, several community clinics, a residency program that trains tomorrow's pediatricians, and four centers of excellence - The CHOC Children's Heart, Cancer, Neuroscience, and Orthopaedic Institutes.

CHOC earned the Silver Level CAPE Award from the California Council of Excellence - the only children's hospital in California to ever earn this distinction, and was one of only eight children's hospitals in the nation to be named to the Leapfrog "Top Hospitals 2007" list for hospital safety and quality. CHOC was also awarded Magnet designation - the highest honor bestowed to hospitals for nursing excellence. CHOC is the only children's hospital to earn the Beacon Award for Critical Care Excellence, an award given by the American Association of Critical-Care Nurses for extraordinary commitment to high-quality critical care standards and dedication to the exceptional care of patients and their families.

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