Biopure Submits IND Application for Proposed Clinical Trial in Patients with Acute Myeloi...( CAMBRIDGE Mass. Dec. 17 /- Biopure Co...),Health

CAMBRIDGE, Mass., Dec. 17 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that it has submitted to the Food and Drug Administration (FDA) an investigational new drug (IND) application to conduct a pilot phase 2 clinical trial of the company's oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)]. In the proposed trial Hemopure would be studied for use in the treatment of life-threatening anemia secondary to induction chemotherapy in patients with acute myeloid leukemia (AML) who refuse red blood cell transfusion.

As previously reported, the company met with the FDA in July 2008 to discuss an acceptable patient population for a new clinical trial. At that time the company proposed a trial in AML patients who will not accept blood transfusions and consequently are unable to undergo potentially life-saving induction chemotherapy because of the profound anemia the chemotherapy causes. The purpose of the proposed study would be to study the efficacy of Hemopure in delivering oxygen in the absence of red blood cell transfusion. An effective treatment for this patient population represents an unmet medical need because of an expected 100% mortality within several months without induction chemotherapy.

Biopure Corporation

Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics that are intravenously administered to deliver oxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. On November 21, 2008, the Company announced that it had terminated most of its work force for financial reasons. Using its limited resources, the Company is developing Hemopure and is supporting the U.S. Navy's governm
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