CAMBRIDGE, Mass., Nov. 2 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that it has received regulatory authorization in the United Kingdom to initiate the Phase 2 clinical trial of its investigational oxygen therapeutic Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] in patients undergoing lower limb amputation.
The U.K. Medicines and Healthcare products Regulatory Authority (MHRA) authorized the protocol for this randomized, multi-center, single-blinded, parallel-group, placebo-controlled, 100-patient clinical trial. The trial is designed to assess the product’s safety and feasibility in increasing the incidence of complete wound healing and reducing the incidence of subsequent amputations in patients with severe peripheral vascular disease who are undergoing lower limb amputation below or through the knee joint.
As previously announced, Biopure has also received regulatory authorizations in South Africa for this trial, in the U.K. for a proposed Phase 2 cardiac surgery trial and in Belgium for a proposed Phase 2 coronary angioplasty trial of the product. The company expects to initiate patient enrollment in these trials in late 2005 and early 2006.
Biopure Corporation
Biopure Corporation develops and manufactures intravenously administered pharmaceuticals, called oxygen therapeutics, that deliver oxygen to the body’s tissues. The company is developing Hemopure(R) [hemoglobin glutamer -- 250 (bovine)], or HBOC-201, for a potential indication in cardiovascular ischemia and, in collaboration with the U.S. Naval Medical Research Center, for an out-of-hospital trauma indication. The product is approved in South Africa for treating surgery patients who are acutely anemic and for eliminating, delaying or reducing allogeneic red blood cell transfusions in these patients. Hemopure has not been approved for sale in other jurisdictions, including the United States or the European Union. 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.
Statements in this press release that are not strictly historical, including those about conducting further clinical trials in Europe and South Africa and the timing for patient enrollment in these trials, are forward-looking statements. Actual results 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, possible delays related to clinical trials, and unpredictable outcomes of clinical trials. 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, and specific factors that could cause the company’s actual performance to differ from current expectations, can be found in the company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Form 10-Q filed on September 9, 2005, which can be accessed in the EDGAR database at the SEC Web site, http://www.sec.gov. The content of this press 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: Douglas Sayles Biopure Corporation (617) 234-6826 IR@biopure.com
Biopure Corporation
CONTACT: Douglas Sayles of Biopure Corporation, +1-617-234-6826,IR@biopure.com
Web site: http://www.biopure.com/
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