BioTransplant Receives European Marketing Approval for the Eligix CD8-SC Cell Separation System
BusinessWire, Friday, July 26, 2002 at 08:31
CHARLESTOWN, Mass.--(BUSINESS WIRE)--July 26, 2002--BioTransplant Incorporated (NASDAQ:BTRN)
-- Product is the Third HDM Cell Separation System to be Marketed
in Europe and the Only Product Available in Europe for the
Removal of CD8+ T Cells From Donor Stem Cell Transplants --
BioTransplant Incorporated (NASDAQ:BTRN) announced today that it has received European Union authorization to affix the CE Mark to its third HDM Cell Separation product, signifying regulatory approval to market the device in Europe.
This product, the Eligix(TM) CD8-SC Cell Separation System, is intended for ex-vivo use for patients receiving allogeneic bone marrow and peripheral stem cell transplantation for hematological disorders. Two other HDM Cell Separation products have previously received CE Mark approval; these are the CD8-DLI and BCell-SC systems.
Roughly 17,000 patients per year undergo allogeneic stem cell transplantation worldwide, with 40% of the patient population based in Europe.
"The Eligix(TM) CD8-SC Cell Separation System has the potential to bring significant benefits to the European cancer patient population. With the help of Gambro, our sales and marketing partner, we intend to make this product widely available in Europe," commented Donald Hawthorne, CEO of BioTransplant.
The CD8-SC Cell Separation System is an ex-vivo system for the removal of CD8+ T cells from donor stem cell transplants, and is the only commercially available product in Europe for this important indication.
Allogeneic transplantation is a valuable therapeutic strategy for a wide range of hematological disorders. However, due to immunological incompatibilities between the donor and the recipient, Graft-versus-Host Disease (GVHD) can occur, which is a potentially devastating complication that has been linked to the infusion of donor CD8+ T cells. The rate of treatment related mortality 100 days post transplant remains a significant problem in this transplant population, ranging as high as 40% in advanced leukemias.
Preclinical studies using the Eligix(TM) Cell Separation System were presented at the European Bone Marrow Transplant Annual Meeting in April 2002. The majority of CD8+ T cells were selectively removed from the allograft, while the immune cells and stem cells that are necessary to repopulate the bone marrow and develop into the different blood cells were preserved. In addition, Dr. Robert Soiffer, Clinical Director of the Hematologic Oncology Center and the Co-Director of the Adult Hematopoietic Stem Cell Transplantation Program at the Dana Farber Cancer Institute, recently presented results suggesting that CD8 depletion of allogeneic stem cells may be performed simply and effectively without impairing engraftment using the Eligix Cell Separation System. The treatment related mortality 100 days post transplant has been approximately 8% in the first cohort of 25 HLA matched patients.
About BioTransplant
BioTransplant Incorporated, headquartered in Charlestown, Massachusetts, is developing a portfolio of products for application in a range of medical conditions, including treatment of cancer and autoimmune diseases, organ and tissue transplantation, for which current therapies are inadequate. Siplizumab (MEDI-507), a lead product the Company exclusively licensed to MedImmune, is in Phase II clinical trials for the treatment of psoriasis. In addition, the Company is developing the AlloMune System, which is designed to treat a variety of hematologic malignancies, and its distribution partner Gambro BCT markets the Eligix family of cell separation products in Europe for use in bone marrow, stem cell and donor leukocyte transplants. |
