Biopure Completes Patient Enrollment in European Phase 2 Clinical Trial of Hemopure(R

Nika · #1 (**permalink**) 04-06-2005, 11:42 PM

Source:
PR Newswire
www.prnewswire.com

Apr 6, 2005 04:30 America/Los_Angeles http://media.prnewswire.com/en/images/spacer.gifBiopure Completes Patient Enrollment in European Phase 2 Clinical Trial of Hemopure(R) in Coronary Angioplasty Patients

CAMBRIDGE, Mass., April 6 /PRNewswire-FirstCall/ -- Biopure Corporation (NASDAQ:BPUR) announced today that it has completed enrolling patients in the Phase 2 human clinical trial in Europe evaluating the safety and feasibility of the company's investigational oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)] in patients undergoing elective coronary angioplasty. The generation of trial data will conclude at the end of April after all enrolled patients complete the 30-day follow-up period. Biopure is hopeful that the clinical trial investigators will be able to present their preliminary study results in May at the late-breaking session of the EuroPCR conference in Paris.

The clinical trial was designed as a randomized, double-blind, dose- finding, multi-center study to assess the safety and feasibility of Hemopure in patients with coronary artery disease. The trial enrolled a total of 46 patients at five hospitals in Germany, Belgium and The Netherlands. Patients were evenly randomized to intravenously receive placebo or either 15 or 30 grams of hemoglobin in the form of Hemopure before undergoing elective coronary angioplasty. The company is discussing with the European investigators how best to continue this work to capture preliminary efficacy data and additional safety information to support subsequent Phase 2/3 trials in heart attack patients undergoing emergency angioplasty.

In related preclinical research published in the April 2005 issue of the American Journal of Physiology - Heart and Circulatory Physiology, researchers at Louisiana State University reported the results of an animal study of Hemopure in an article entitled "A novel hemoglobin-based blood substitute protects against myocardial reperfusion injury."

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. The product is ultrapurified, compatible with all blood types, and stable for three years without refrigeration.

About 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 potential indications 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 adult surgical patients who are acutely anemic and for eliminating, delaying or reducing the need for allogeneic red blood cell transfusions in these patients. Hemopure has not been approved for sale in any 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 may be forward-looking statements. Actual results may differ materially from those projected in these forward- looking statements due to risks and uncertainties regarding the company's operations and business environment. These risks include, without limitation, uncertainties regarding the company's ability to generate revenues, cash requirements, unexpected costs and expenses, insurance coverage, and possible delays and unforeseen costs related to clinical trials, regulatory approvals and marketing and distribution of the company's products. 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 March 14, 2005, which can be accessed in the EDGAR database at the SEC Web site, http://www.sec.gov/, or through the Investor Relations section of Biopure's website, http://www.biopure.com/.

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.comSource: Biopure Corporation

CONTACT: Douglas Sayles of Biopure Corporation, +1-617-234-6826 or
IR@biopure.com

Web site: http://www.biopure.com/

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Biopure Completes Patient Enrollment in European Phase 2 Clinical Trial of Hemopure(R

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