Biopure Seeks Compassionate Use Protocol For Treatment Of Acute Anemia
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 trials are ongoing. The clinical program was initially designed to evaluate Hemopure as a replacement for red blood cell transfusions, by providing an Oxygen Bridge(TM) in the setting of acute surgical anemia. More than 800 subjects have received HBOC- 201 and dosing ranged from 25g to 1230g of HBOC-201 administered over a period of up to eighteen days.
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 the draft study protocol for the use of Hemopure in the U.S. in certain life-threatening situations, the patients eligible for any such 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.
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