CAMBRIDGE, Mass., Nov. 2 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) 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
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
Company News On-Call:
http://www.prnewswire.com/comp/131224.html
CONTACT:
Douglas Sayles of Biopure Corporation,
+1-617-234-6826, IR@biopure.com
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