Astellas Pharma Inc. today announced that Astellas has decided to initiate Phase II clinical trials for ASP0485  for prophylaxis of renal transplant rejection in North America and Europe

TOKYO, Japan | September 12, 2007 | Astellas Pharma Inc. (headquarters: Tokyo, president and CEO: Masafumi Nogimori, “Astellas”) today announced that Astellas has decided to initiate Phase II clinical trials for ASP0485 (generic name: alefacept) for prophylaxis of renal transplant rejection in North America and Europe.

ASP0485 is a compound with a novel mechanism which inhibits T-cell co-stimulation by blocking the interaction between antigen presenting cell and T-cell which plays a major role in immunity, and also potentiates natural killer cell-mediated apoptosis of T-cell. ASP0485 has a different mechanism from immunosuppressant, Prograf®, discovered and marketed by Astellas. Astellas expects ASP0485 to be used concomitantly with Prograf. Astellas has decided to initiate Phase II clinical trials for prophylaxis of renal transplant rejection in North America and Europe and is planning to develop the product globally including Japan.

ASP0485 is already commercially available under the brand name of AMEVIVE® for the treatment of psoriasis in 12 countries worldwide including the US. AMEVIVE has an established safety and tolerability profile in this population with once weekly intramuscular injection.
Astellas is committed to contributing the progress of organ transplantation by providing products in this therapeutic area.

SOURCE: ASTELLAS