Monday, July 7, 2008

Biopure seeks FDA trials of blood-replacement therapy

By Mass High Tech Staff

Biopure Corp., a Cambridge biotech firm, says it has had talks with the U.S. Food and Drug Administration about a potential clinical trial to test its blood-replacement therapy Hemopure in certain patients with acute myelogenous leukemia (AML).

The trial would be key to establishing a market for the product in the U.S., Biopure officials said.

The company (Nasdaq: BPUR) reported it would like to study the use of Hemopure in AML patients who decline actual blood transfusions. Such patients forgo potentially life-saving chemotherapy, which can cause anemia. Company officials said the firm plans to submit a protocol for the study to the FDA.

In the proposed study, Biopure would investigate the effectiveness of Hemopure to carry oxygen in the blood-cancer patients who do not receive transfusions. Hemopure would be given to the patients as an adjunct to other procedures after they begin chemotherapy, according to the company.

Hemopure, derived from the blood cells of cows, is approved for use in South Africa for anemic patients undergoing surgery. The firm is seeking approvals of the product in Europe and the U.S.

With 86 workers, Biopure reported a 2007 net loss of $36.3 million on revenue of $2.6 million.