Biopure announces meeting with FDA

July 7, 2008 08:19 AM E-mail| |Comments ()| Text size +

BPUR707.jpg Biopure Corp., a struggling Cambridge biotechnology company, said today that it has had discussions with the Food and Drug Administration about identifying an acceptable patient population for a new clinical trial of its Hemopure product.

Biopure makes products from cattle blood that is refined to replenish oxygen-starved tissue. Biopure has won regulatory approvals for a product to treat anemia in dogs.

Now the company seeks to convince the FDA that it should approve a study in humans that would investigate the use of Hemopure in patients with Acute Myelogenous Leukemia, or AML, who refuse transfusion with blood components.

"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."

Last month, Biopure said it laid off 50 employees, about 60 percent of its staff.

For more stories on Biopure, please click here.
(By Chris Reidy, Globe staff)

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