BioTransplant, Inc., has received orphan drug designation from the Food and Drug Administration for its MEDI-507 antibody when the antibody is used as part of the company's AlloMune transplantation system, which is designed to allow long-term organ acceptance without the use of chronic immunosuppressive drugs.
"The FDA's grant of orphan drug status of MEDI-507 ... recognizes the need to develop new transplantation therapies for this patient population," said Elliot Lebowitz, PhD, president and chief executive officer of BioTransplant.
MEDI-507 is a humanized monoclonal antibody derived from BTI-322, a rodent antibody. It binds specifically to the CD2 antigen receptor found on T cells and natural killer cells. As part of the AlloMune System, MEDI-507 is used to deplete mature T cells and natural killer cells in transplant recipients to permit the engraftment of donor bone marrow. "The AlloMune System approach is based on transplanting hematopoietic progenitor cells from the donor to a recipient to establish mixed bone marrow chimerism and thus recognition of the donor organ as self," BioTransplant said.
The company also reported that it has received FDA clearance to begin a phase I/II clinical trial to evaluate the AlloMune system in kidney transplant patients. Enrollment is expected to begin following institutional review board approval of the protocol.
Under an alliance with MedImmune, Inc., MEDI-507 is also being developed for its potential to treat autoimmune diseases and as an antirejection pharmaceutical for organ and tissue transplantation.
For Your Information:
BioTransplant Incorporated
Bldg. 75, Third Avenue
Charlestown Navy Yard
Charlestown, MA 02129
617-241-5200 (phone); 617-241-8780 (fax)
http://www.biotransplant.com/
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