The Gamida Cell-Teva Joint Venture announced today that five prestigious cord blood transplantations centers in Spain, three in Barcelona and two in Valencia, have joined the ExCell study.
Participating clinical sites include, in alphabetical order:
The trial is assessing the safety and efficacy of StemEx as a treatment for hematological malignancies, including leukemia and lymphoma, in a single arm, global, pivotal marketing authorization trial. 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. StemEx is being developed by a Joint Venture of Gamida Cell and Teva Pharmaceutical Industries (NASDAQ: TEVA).
ExCell is a study that gives clinicians the opportunity to explore a new path in the pursuit of a therapeutic treatment for patients with blood cancers. Cord blood can successfully be used to treat leukemia and lymphoma in young children. It stands to reason therefore that the same basic source could also be used to effectively treat adolescents and adults. The ExCell trial provides an opportunity to determine if StemEx can indeed make this a possibility.
Cord blood has less matching requirements than bone marrow or peripheral blood transplants, providing the potential to increase the number of suitable transplant matches and to shorten the time it can take to find a match. However, there are a limited number of stem/progenitor cells in cord blood, enabling a quantity sufficient generally only for pediatric treatment. StemEx employs a technology that expands this small number of cord blood stem/progenitor cells, increasing their therapeutic capacity for transplantation in adolescents and adults.
It is estimated that more than 11,000 patients in the European Union are in need of an allogeneic (from a source outside of the patient's body) hematopoietic (blood) stem cell transplantation. This is an unofficial figure calculated based on the method proposed by the US government's General Accounting Office (GAO) report and The EBMT Activity Survey 2006 on Hematopoietic Stem Cell Transplantation: Focus on the Use of Cord Blood Products.
"We are enthusiastic about working with these five outstanding hospitals in Spain, the esteemed principal investigators and their experienced staves. Together, we hope to demonstrate the advantage of the StemEx transplant for patients," said Dr. David Snyder, vice president of clinical development at Gamida Cell.
|Contact: Alex Argemi|
IDIBAPS - Institut d'Investigacions Biomdiques August Pi i Sunyer