Wednesday, December 17, 2008

Biopure seeks FDA approval for Hemopure leukemia trial

By Mass High Tech staff

Biopure Corp. is seeking federal approval to conduct a pilot Phase 2 clinical trial of its Hemopure blood treatment in cases where leukemia patients refuse red blood cell transfusions and suffer from life-threatening anemia related to chemotherapy.

The Cambridge-based company (Nasdaq: BPUR) met with Food and Drug Administration (FDA) officials in July to discuss the trial and identified patients with acute myeloid leukemia (AML) who might benefit from Hemopure’s to deliver oxygen without red blood cell transfusion, the company said.

Biopure develops, manufactures and markets so-called oxygen therapeutics that are intravenously administered to deliver oxygen to the body’s tissues. Hemopure is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. On Nov. 21, the company laid off most of its work force for financial reasons, but is continuing to develop Hemopure through the U.S. Navy’s government-funded efforts to develop a potential use for the product in trauma cases outside of a hospital environment. Biopure’s veterinary product, Oxyglobin, which is used to treat anemia in dogs, is the only oxygen therapeutic approved for marketing by both the FDA and the European Commission. Biopure has sold more than 200,000 units of Oxyglobin since its launch.

Biopure has undergone several months of lawsuits and tribulations involving its stock listing. Most recently, Biopure announced an extension from the Nasdaq Stock Market until March 16, 2009, to regain compliance with minimum bid rules. The company’s original extension deadline of Dec. 8, 2008, was pushed back because of “turmoil in the marketplace,” Biopure officials reported.