CAMBRIDGE, Mass., Sept. 6 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) today announced that it had recently met with the FDA to discuss the compassionate use protocol submitted by the company in July. At the FDA's suggestion, the company intends to submit a protocol for a Phase 2 randomized trial for the treatment of autoimmune hemolytic anemia and other forms of hemolytic anemia, including alloantibody anemia but excluding sickle cell anemia. Hemopure has been used previously, on a compassionate use basis, to treat patients with these conditions.
The proposed patient group was included in the compassionate use protocol previously proposed to the FDA. A study protocol for the treatment of autoimmune hemolytic anemia and other forms of hemolytic anemia would be in place of that compassionate use protocol. Biopure may continue to work with the FDA on compassionate use cases through single patient INDs that are requested from treating physicians.
Autoimmune hemolytic anemia is a group of disorders characterized by a malfunction of the immune system that produces antibodies to the patient's red blood cells attacking them as if they were substances foreign to the body. This group of disorders is uncommon, can occur at any age and affects women more often than men.
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. Biopure has applied in the United Kingdom for regulatory approval of a proposed orthopedic surgical anemia indication. The company is developing Hemopure for a potential indication in cardiovascular ischemia, in addition to supporting the U.S. Navy's government- funded efforts to develop a potential out-of-hospital trauma indication. Biopure's veterinary product Oxyglobin(R) [hemoglobin glutamer - 200 bovine)], or HBOC-301, the only oxygen therapeutic approved by the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Biopure has sold approximately 186,000 units of Oxyglobin, which have been used to treat an estimated 100,000 animals.
Statements in this release that are not strictly historical are forward- looking statements, including those statements implying that the FDA will approve any study protocol for the use of Hemopure in the U.S., the patients eligible for such a study, and any statements that might imply that Hemopure may receive marketing approval in additional jurisdictions or for additional indications. Actual results and their timing may differ materially from those projected in these forward-looking statements due to risks and uncertainties. These risks include, without limitation, uncertainties regarding the company's financial position, unexpected costs and expenses, delays and adverse determinations by regulatory authorities, unanticipated problems with the product's commercial use, whether or not product related, and with product distributors, sales agents or other third parties, and delays in or unpredictable outcomes of clinical trials, and the factors identified under the heading "Risk Factors" in the company's quarterly report on Form 10-Q filed on June 14, 2007, which can be accessed in the EDGAR database at the U.S. Securities and Exchange Commission's (SEC) website, http://www.sec.gov. The company undertakes no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof. A full discussion of the company's operations and financial condition can be found in the company's filings with the SEC.
The content of this release does not necessarily reflect the position or the policy of the U.S. Government or the Department of Defense, and no official endorsement should be inferred.
Contact: Todd Wood
Herb Lanzet (Investors)
H.L. Lanzet Inc.
|SOURCE Biopure Corporation|
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