Biopure seeks wider use for Hemopure
Boston Business Journal - September 6, 2007
Biopure Corp. said Thursday it plans to submit a protocol for a Phase 2 randomized trial for the treatment of autoimmune hemolytic anemia with its Hemopure product.
Cambridge, Mass.-based Biopure (Nasdaq: BPUR), which develops and manufactures oxygen therapeutics, said the move is in response to suggestions from U.S. Food and Drug Administration officials after a recent meeting with Biopure to discuss the compassionate use protocol for Hemopure submitted by the company in July.
Hemopure has been used previously, on a compassionate use basis, to treat patients with autoimmune hemolytic anemia and related disorders.
Hemopure is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. Biopure is also seeking regulatory approval for Hemopure in the United Kingdom.