Wednesday, August 13, 2008

Stromedix kidney transplant therapy gets FDA orphan drug status

By Mass High Tech Staff

The U.S. Food and Drug Administration has granted orphan drug status to Cambridge biotech Stromedix Inc.’s STX-100, a treatment for chronic allograft nephropathy, a cause of transplant failure in patients with kidney transplants.

The condition currently has no treatment approved by the FDA, though it affects about 20 percent of patients waiting for a kidney retransplant, according to Stromedix officials.

Stromedix licensed STX-100, a humanized monoclonal antibody, from Biogen Idec Inc. last year and began Phase 1 clinical trials on it this year. The company announced in April that it had raised $25 million in a Series B round of venture capital to fund development of STX-100. New Leaf Venture Partners, of New York City and Menlo Park, Calif., led the round, which included investments from Boston area firms Bessemer Venture Partners and Atlas Venture. Other investors were Frazier Healthcare Ventures of Seattle and Red Abbey Venture Partners of Baltimore, Stromedix officials said.