PITTSBURGH, Pennsylvania, and JERUSALEM, Israel — The University of Pittsburgh Cancer Institute (UPCI) and the Gamida Cell – Teva Joint Venture announced today that the Institute has joined an elite group of cancer centers in Europe, the United States and Israel that are now enrolling patients to participate in the ExCell research study.
The phase III study is assessing the safety and efficacy of StemEx(R), an investigational product derived from stem cells, as an alternative treatment to bone marrow transplants for hematological malignancies, including leukemia and lymphoma. StemEx is a graft of expanded stem/progenitor cells taken from a single unit of umbilical cord blood and then transplanted in combination with non-expanded cells from the same unit.
“I am extremely pleased UPCI has the opportunity to be a part of this study,” said Mounzer Agha, M.D., clinical director of UPCI’s Hematopoietic Stem Cell Transplant Program. “Using umbilical cord blood stem cells instead of a traditional bone marrow transplant opens tremendous treatment possibilities for patients with diseases like leukemia and lymphoma.”
Bone marrow transplantation is a life-saving treatment for many types of leukemia and lymphoma. However, more than half the number of patients in need of a transplant can’t find matching bone marrow donors. Cord blood could be an alternative of choice.
Previous research has shown that umbilical cord blood stem cells offer a viable therapeutic option for leukemia and lymphoma patients without the necessity of a matched donor. Umbilical cord blood has two important advantages – it is a readily available source for stem cells and it has a lower matching requirement for patients. With StemEx(R), the cord blood unit is enriched with stem cells, which are critical for a successful transplantation.
“We are pleased to work with the able and highly experienced team at UPCI led by Dr. Agha. They join an extraordinary group of cord blood cancer centers currently recruiting patients for the ExCell trial. Everyone on the international ExCell clinical team shares the same goal – to validate the therapeutic potential of StemEx as a treatment for blood cancers,” said David Snyder, M.D., vice president of clinical development at Gamida Cell.
Founded in 1984, the University of Pittsburgh Cancer Institute became a National Cancer Institute (NCI)-designated Comprehensive Cancer Center in 1990. UPCI, the only cancer center in western Pennsylvania with this elite designation, serves the region’s population of more than 6 million. Presently, UPCI receives a total of $154 million in research grants and is ranked 10th in funding from the NCI.
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 Pharmaceuticals, Amgen, Denali Ventures and Auriga Ventures.
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