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StemEx Noted as a Reliable Investigational Product of an Expanded Population of Stem Cells at Umbilical Cord Blood Symposium in Israel


11/2/2009 10:33:35 AM

HERZLIYA, Israel, November 2 /PRNewswire/ -- At a symposium today in Herzliya entitled Umbilical Cord Blood: An Alternative for Bone Marrow Transplantation in Adults, bone marrow transplantation experts Professor Patrick Stiff and Professor Guillermo Sanz addressed participants on the current challenges presented by bone marrow transplantation and the importance of investigating cord blood as an alternative source for treating patients with leukemia and lymphoma.

Professor Stiff is the Director of the Cardinal Bernardin Cancer Center and the Coleman Professor of Hematology/Oncology at Loyola University School of Medicine in Chicago. Professsor Sanz is the Head of the Dept. of Bone Marrow Transplantation; Dept. of Hematology, Hospital Universitario La Fe, Valencia, Spain. The symposium was sponsored by the Gamida Cell-Teva Joint Venture.

"We have performed more than 200 transplants at our center. The problem is that in the case of a bone marrow transplant, it takes too much time from transplant to engraftment. And, the longer the time to engraftment, the more risk of complications," explained Professor Sanz. "Cord blood offers a real alternative to bone marrow. And, cell dose is the most critical function of a cord blood transplant. The main advantage of StemEx, therefore, is that is offers a reliable investigational product and can provide a high rate of expansion, 200x of the amount of stem cells. We think that StemEx will likely result in a shorter time to engraftment and even potentially generate better results than bone marrow transplantation in the long run."

Professor Stiff said, "StemEx has been proven in animal models. Now we need to prove that it can have the same results in humans and this trial will do so. So far we've been impressed. While this is not our first trial using expansion technology, it is the first time at our center that we are able to transplant significantly more stem cells."

He continued, "The challenge is getting the word out to referring physicians and for physicians to refer in time. We need to see patients at first remission or upon diagnosis. It is disappointing for us and the patients when they are sent late and are not eligible for this type of innovative therapy. The more lead time we have, the better."

About StemEx

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 intravenously 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 lymphoid and hematologic malignancies, at clinical sites in the U.S., Italy, Spain, Hungary and Israel. (http://www.stemexstudy.com ). StemEx is being developed by the joint venture of Gamida Cell and Teva Pharmaceutical Industries . 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: http://www.gamida-cell.com.

CONTACT: Press contact: Marjie Hadad, Media Liaison/IR, Gamida Cell,
marjie@gamida-cell.com, +972-54-536-5220



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