Gamida-Cell Pre-Clinical Study Shows that Expanded Population of Cord Blood Stem Cells May Successfully Treat Heart Disease; Company Primes for Phase I/II Cardiac Trial in 2004.Business Editors/Health/Medical Writers BIOWIRE2K American Society of Hematology 45th Annual Meeting/Exposition JERUSALEM--(BUSINESS WIRE)--Oct. 15, 2003 Gamida-Cell Ltd. (www.gamida-cell.com) a leader in hematopoietic hematopoietic /he·ma·to·poi·et·ic/ (-poi-et´ik) 1. pertaining to hematopoiesis. 2. an agent that promotes hematopoiesis. hematopoietic 1. pertaining to or affecting the formation of blood cells. (blood) stem cell therapeutics in clinical development for cancer and autoimmune diseases, as well as future regenerative cell-based medicines, announced today that the company is planning to commence in 2004 a Phase I/II trial of its product for the treatment of cardiac disease based on the success of a recently completed pre-clinical study. The study, entitled Expansion of Human Umbilical Cord Blood-Derived CD34+ Stem/Progenitor Cells to treat Myocardial Infarction, will be presented on December 7, 2003 at the annual conference of the American Society for Hematology (ASH) in California by Professor Arnon Nagler, Head of Hematology Division Stem Cell Transplantation Stem Cell Transplantation Definition Stem cells are basic human cells that reproduce (replicate) easily, providing a continuous source of new, sometimes different types of cells. and Cord Blood Bank A cord blood bank is a facility which stores umbilical cord blood for future use. Cord blood, a precious resource physiologically tranfused from the placenta through the umbilical cord to the neonate for stabilization upon birth, is not recommended to be harvested for the vast , Chaim Sheba Medical Center, Tel Hashomer and Clinical Advisor to Gamida-Cell. The investigation was conducted in tandem by Prof. Nagler and Prof. Jonathan Leor, Neufeld Cardiac Research Institute, Tel-Aviv University, Tel-Hashomer, Israel. "The results of this study indicate that a cord blood stem cell population expanded by Gamida-Cell technology shows promise in treating heart disease. Specifically, ex vivo expanded CD34+ S/P cells derived from human umbilical cord blood umbilical cord blood Transplantation A source of primitive and stem cells that can be used to reconstitute BM destroyed by aplastic anemia or by RT or chemotherapy for CA, lymphoproliferative malignancies. See Bone marrow transplantation, Stem cell therapy. engrafted and colonized Colonized This occurs when a microorganism is found on or in a person without causing a disease. Mentioned in: Isolation the infracted myocardium myocardium /myo·car·di·um/ (-kahr´de-um) the middle and thickest layer of the heart wall, composed of cardiac muscle. hibernating myocardium see myocardial hibernation, under . In addition, cell therapy with ex-vivo expanded cord blood derived cells resulted in new vessel formation and may thus be used for prevention of heart dilatation, dysfunction and future heart attacks," explained Professor Leor. In addition, the results of an ongoing expansion study show that Gamida-Cell's proprietary copper chelator chelator A chemical–eg, EDTA that binds metal ions from solutions. See Chelation therapy. enables the preferential expansion of early progenitor cells; it also appears to be the driving force behind the longer duration of in vitro cord blood and BM stem cell expansion and the increased engraftment engraftment /en·graft·ment/ (en-graft´ment) incorporation of grafted tissue into the body of the host. Engraftment The process of transplanted stem cells reproducing new cells. potential demonstrated in vivo. These results were recently successfully applied to large-scale experiments in a cGMP environment and are currently being assessed in the Company's Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of its lead product StemEx(R) (expanded population of cord blood cells) at M. D. Anderson in Texas. The pre-clinical data, also to be presented at ASH, combined with the StemEx(R) IND, serve to support the safety of the upcoming cardiac Phase I/II trial. "It is both an honor and a privilege to be accepted to deliver two presentations at ASH 2003. We see this as the latest in a series of great milestones achieved this year. Our intentions are to continue cultivating existing programs and fostering fresh opportunities with new global business and pharmaceutical partners that share a common interest in developing viable stem cell therapeutic treatments," said Gamida-Cell CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Mr. Ehud Marom. About Gamida-Cell Gamida-Cell Ltd., headquartered in Jerusalem, Israel, was founded in 1998, based on technology for stem cell expansion licensed from and jointly developed with Hadassah University Medical Center, Jerusalem, Israel. The company is currently engaged in a Phase I study of its lead product, StemEx(R) (expanded population of cord blood stem cells cord blood stem cells Umbilical cord blood Hematology A therapeutic 'agent' containing concentrated hematopoietic stem cells for Pts with BM depleted–'wiped out' by disease; they are transfused into HLA-identical siblings and used to reconstitute the BM of ) at M. D. Anderson in Texas, which, pending regulatory approval, will be followed by a pivotal multi-center study in the US and Europe. The combined market potential of Gamida-Cell products and indications is estimated at $30 billion worldwide. The Company's first commercial product is expected in 2006. Gamida-Cell recently commenced several new pre-clinical studies of stem cell expansion under the umbrella of the newly established Israel Stem Cell Consortium, of which it is a founder and a leader. Gamida-Cell's scientific and clinical collaborators include The University of Texas M. D. Anderson Cancer Center, Dana Farber Institute, Duke University, and Stanford University Medical School. |
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