Biopure Seeks Compassionate Use Protocol for Treatment of Ac...( CAMBRIDGE Mass. Aug. 23 /- Biopur...),Health

CAMBRIDGE, Mass., Aug. 23 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) today announced that the company submitted a draft clinical study protocol to the FDA for compassionate use of the investigational product Hemopure (HBOC-201) in the United States. The proposed open label study would make Hemopure available to patients for the treatment of life threatening or potentially life threatening anemia on a compassionate use basis where blood transfusion is not an option.

The product has been available for compassionate use since December 2006. Under the existing program the company evaluates individual requests from treating physicians for specific patients. If the patient is deemed an appropriate candidate for treatment, the FDA is contacted and a single patient IND is requested. To date the FDA has authorized shipment of Hemopure for 20 patients. Of the treated patients, four were experiencing severe anemia secondary to the management and treatment of leukemia and lymphoma. The balance of the compassionate use cases were for the treatment of blood loss resulting from surgical complications or trauma. The remaining patients who were not treated stabilized at the site by the time the drug was received.

The draft protocol outlines general eligibility criteria that include the following:

-- Severe, life threatening, or potentially life threatening anemia

-- Blood transfusion is not feasible

-- All alternative treatment options have been exhausted

-- Adult male or female - 18 years of age, or child with anemia secondary

to severe burns

The safety, efficacy and pharmacology of Hemopure have been studied in 22 completed clinical trials. An additional four trial
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