Medimmune Submits MEDI-507 IND

MedImmune and BioTransplant Incorporated have submitted anInvestigational New Drug Application to the US Food and Drug Administration to begin a Phase I open-label, dose-escalating, renal transplantation induction trial with MEDI-507, a "humanized" monoclonal antibody.

"Promising" Results In Ph I/II BioTransplant's BTI-322 is the rat form of MEDI-507, both of which are thought to work by inhibiting the response of T cells to transplant antigens, while retaining a normal immune response to other antigens. BTI-322 has shown promising results in Phase I/II trials in the treatment and prevention of acute renal transplant rejection, says the company, and is currently being investigated in a Phase II trial for the treatment of acute graft-versus-host disease.

Additionally, MEDI-507 may have potential in autoimmune disorders such as psoriasis, inflammatory bowel disease and rheumatoid arthritis, says the company.