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Biopure Corporation Release: U.K. Regulatory Body Authorizes Proposed Clinical Trial Of Hemopure(R) In Cardiac Surgery

Published: Oct 27, 2005

CAMBRIDGE, Mass., Oct. 27 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that it has received regulatory authorization in the United Kingdom to initiate a Phase 2 clinical trial of its investigational oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)] as a potential cardio-protective agent in patients undergoing coronary artery bypass graft (CABG) surgery. This trial is in addition to two other recently announced non-U.S. trials of the product, in ischemia applications, that have received regulatory clearance to proceed.

The U.K. Medicines and Healthcare products Regulatory Authority (MHRA) approved the protocol for a non-randomized, multi-center, prospective registry of patients undergoing multi-vessel CABG surgery. This trial is designed to assess the product's safety and feasibility in reducing heart damage, as measured by cardiac enzyme (CK-MB) elevation, and enhancing tissue preservation during cardiopulmonary bypass. Secondary endpoints include measurements of major adverse cardiac events (MACE), kidney function, transfusion requirements, cognitive impairment and length of hospital stay.

In the trial, a total of 60 patients will be consecutively enrolled in two groups to receive either standard-of-care treatment or intravenous administration of approximately 60 grams of hemoglobin in the form of Hemopure prior to cardiopulmonary bypass. Patients will be monitored until hospital discharge or six days, whichever occurs first, with a follow-up assessment at 30 days post-surgery. An independent data safety monitoring committee will monitor safety throughout the study period.

Ischemia Development Plan

Biopure's clinical development strategy for ischemia is to conduct parallel pilot trials of Hemopure to assess the potential of several ischemia indications before committing funding for advanced trials. Patient enrollment in the CABG surgery trial and the cardiac and limb ischemia trials described below is expected to begin in late 2005 and early 2006.

In Belgium, the Directorate-General for Medicinal Products has approved the protocol for a Phase 2 trial in 20 patients undergoing intra-coronary (IC) balloon angioplasty. This study is designed to support subsequent trials of Hemopure in patients experiencing a heart attack.

In South Africa, the Medicines Control Council has approved the protocol for a 100-patient, Phase 2 trial 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.

Hemopure is an oxygen therapeutic, or oxygen-carrying biologic drug, consisting of stabilized bovine hemoglobin formulated in a balanced salt solution. These polymerized (chemically cross-linked) hemoglobin molecules circulate in the plasma (the fluid part of blood) when infused and are smaller, less viscous and more readily release oxygen to tissues than red blood cells. Consistent with these properties, this stabilized hemoglobin has been shown in preclinical studies to carry oxygen through constricted or partially blocked blood vessels. The product is ultrapurified, compatible with all blood types, and stable for three years without refrigeration.

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, 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. Clinical trials may only occur in the U.S. if the Food and Drug Administration provides the necessary regulatory approvals to proceed. 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 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

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