New Human Trial for Blood Substitute?

Biopure Corporation in Cambridge Massachusetts announced that it has had discussions with the Food and Drug Administration about starting a new human trial for it’s Hemopure product, a product already approved to treat anemia in dogs. The product is already approved for human testing in Europe and South Africa and has been for sale commercially in South Africa since 2001.

Hemopure is an oxygen therapeutic which was developed from chemically stabilized bovine hemoglobin and designed to be used as a blood substitute either because of short blood supply or for patients who for some reason refuse transfusions with human blood components.

Hemopure has been tested on humans in the United States but there were some safety concerns so further human testing was not allowed. The FDA and Biopure reached an agreement to do further animal testing to study those concerns and determine if another human trial could be started. Biopure wants to do a study of the product with patients who have Acute Myelogenous Leukemia (AML).

“Currently, AML patients who do not accept blood transfusions are unable to undergo potentially life-saving induction chemotherapy because of the profound anemia the chemotherapy causes,” the company said in a press release.

Zafiris G. Zafirelis, Biopure chief executive and president, added in a statement, “By serving as an oxygen delivery bridge following chemotherapy-induced suppression of red blood cell count, use of Hemopure, as part of a bloodless treatment regimen, may potentially reduce mortality in these patients, who currently have no hope.”

The U.S. Naval Medical Research Center has received congressional funding – four million dollars, FY 2006, 22.5 million dollars so far – to continue research and development of Hemopure. Under its research agreement with Biopure, the Naval Medical Research Center (NMRC) has primary responsibility for designing, seeking Food and Drug Administration (FDA) acceptance of and conducting a proposed Phase 2/3 clinical trial of Hemopure in trauma patients with severe hemorrhagic shock in the out-of-hospital setting. Hemopure attributes would seem to make it an ideal medical component fot the military branches.

• It is stable for 36 months (three years) at room temperature.
• It does not require refrigeration, warming or reconstitution.
• It is compatible with all blood types.
• It does not require blood typing, testing or cross-matching.
• It is ultra-purified through a patented pharmaceutical manufacturing process that has been demonstrated to remove or inactivate potential contaminants, including infectious agents.