Biopure seeks new regulatory approval

Biopure Corp. of Cambridge said today that is seeking US regulatory approval that would allow Hemopure, its controversial blood substitute product candidate, to be used in "compassionate use" situations in the treatment of acute anemia.

Biopure dislikes the description of Hemopure as a blood substitute and says Hemopure is an oxygen therapeutic made from cow hemoglobin.

Biopure said the product has been available for compassionate use in the United States since December on a case-by-case basis; under the existing program, Biopure evaluates individual requests from treating physicians for specific patients. If the patient is deemed an appropriate candidate for treatment, the Food and Drug Administration is contacted and single patient approval is requested, the company said.

Today Biopure said it has submitted a draft clinical study protocol to the FDA; 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 company said.

If the FDA approves the protocol, patients who meet the compassionate-use criteria could then receive treatment with Hemopure without Biopure having to seek FDA approval on a case-by-case basis, the company said.

In February, a Globe story noted that a former Biopure chief executive agreed to pay $120,000 to settle federal claims that he defrauded investors by concealing problems with Hemopure in 2003; the executive did not admit or deny guilt in the settlement.
(By Chris Reidy, Globe staff)