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ExCell Study Joined By Children's Memorial Hospital, Chicago

August 23, 2017

Children's Memorial Hospital and the Gamida Cell - Teva Joint Venture (JV) have announced that Children's Memorial has joined a select group of cancer centers in Europe, the United States and Israel, actively enrolling patients for the ExCell study. 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 unique cellular technology will benefit our transplant patients at Children's Memorial. 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 Sonali Chaudhury, MD, attending physician in the Division of Hematology, Oncology and Stem Cell Transplantation at Children's Memorial and assistant professor of pediatrics at Northwestern University's Feinberg School of Medicine.

Research shows that cells derived from umbilical cord blood (UCB) can effectively be used for bone marrow transplantation. In addition, cord blood transplants have been associated with a reduced risk for Graft versus Host Disease (GvHD). 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. Chaudhury in an effort to improve care for adolescents being treated at Children's Memorial," said Dr. David Snyder, vice president of clinical development at Gamida Cell.

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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.

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. tevapharm

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.

About Children's Memorial Hospital

Children's Memorial Hospital, Chicago, is recognized as one of the top pediatric hospitals in the country and is rated number one in Illinois in rankings published in U.S. News & World Report. Its physicians are faculty members at the Feinberg School of Medicine, Northwestern University. To learn more about StemEx, visit stemexstudy and gamida-cell.

Source: Julie Pesch
Children's Memorial Hospital