Press Release Source: Biopure Corporation
Biopure Initiates European Phase II Clinical Trial of Hemopure in Coronary Angioplasty Patients
Monday December 22, 12:43 pm ET
CAMBRIDGE, Mass., Dec. 22 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR - News) today announced the initiation of a multi-center European Phase II clinical trial as a pilot safety study of its investigational oxygen therapeutic HBOC-201, or Hemopure® [hemoglobin glutamer - 250 (bovine)], in the setting of elective angioplasty and stent procedures, or percutaneous coronary intervention (PCI).
This randomized, three-arm, double-blind, placebo-controlled, dose-finding pilot trial will assess the safety of the product in adult patients with coronary artery disease. Approximately 45 patients will be evenly randomized to intravenously receive placebo or 15 or 30 grams of hemoglobin in the form of HBOC-201 before PCI. Patients will be monitored until discharged from the hospital and at 30 days post-infusion.
The trial will be conducted in the cardiac catheterization labs at academic hospitals in The Netherlands, Belgium and Germany. Patient enrollment is underway at the lead center, Erasmus University Medical Center Rotterdam, under the direction of the principal investigator, Dr. Patrick W. Serruys, Professor and Head of Interventional Cardiology. Cardialysis B.V., a Rotterdam-based clinical research organization specializing in cardiology, is responsible for data management, site monitoring and reporting of safety data to an independent Data Safety Monitoring Board.
"This pilot study is our first clinical investigation of Hemopure specifically for the management of ischemia, rather than anemia. The product is being used at low doses strictly as an oxygen therapeutic, or oxygen- carrying drug, rather than as a replacement for red blood cells," said Biopure President and CEO Thomas A. Moore. "If successful, this safety trial may lead to additional studies assessing the product's ability to preserve cardiac tissue in the presence of arterial blockages, such as occur during heart attacks and bouts of unstable angina, or to improve the safety of angioplasty and cardiac bypass surgical procedures."
According to the Cardiovascular Research Foundation in New York City, it is projected that there will be over two million angioplasty procedures performed worldwide in 2003, the majority of which occur in the United States and Europe.
HBOC-201 is an investigational oxygen therapeutic consisting of chemically stabilized bovine hemoglobin formulated in a balanced salt solution. These linked hemoglobin molecules circulate in the plasma and are smaller, have lower viscosity and more readily release oxygen to tissues than red blood cells. Preclinical animal studies have demonstrated that HBOC-201 can carry oxygen through constricted or partially blocked blood vessels.
Biopure Corporation, headquartered in Cambridge, Mass., is a leading developer, manufacturer and marketer of a new class of pharmaceuticals, called oxygen therapeutics, which are intravenously administered to deliver oxygen to the body's tissues. Hemopure® [hemoglobin glutamer - 250 (bovine)], or HBOC-201, is an investigational product in North America and Europe and is approved in South Africa for the treatment of acutely anemic surgical patients and for the elimination, delay or reduction of red blood cell transfusions in these patients. In July 2003, the U.S. Food and Drug Administration (FDA) sent Biopure a complete response letter regarding the company's biologic license application to market Hemopure in the United States for a similar indication in orthopedic surgery patients. Biopure is currently preparing a comprehensive written response to the FDA's questions. Oxyglobin® [hemoglobin glutamer - 200 (bovine)], or HBOC-301, is the only product of its kind approved by the FDA and the European Commission for the treatment of anemia in dogs.
Statements in this press release that are not strictly historical may be forward-looking statements. There can be no assurance that Biopure Corporation will be able to commercially develop its oxygen therapeutic products, that necessary regulatory approvals will be obtained, that anticipated milestones will be met in the expected timetable, that any clinical trials will be successful, or that any approved product will find market acceptance and be sold in the quantities anticipated. Actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in the company's operations and business environment. These risks include, without limitation, the company's stage of product development, history of operating losses and accumulated deficits, and uncertainties and possible delays related to clinical trials, regulatory approvals, possible healthcare reform, manufacturing capacity, marketing, market acceptance, competition and the availability of sufficient financing to support operations. 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 Biopure's operations and financial condition, and specific factors that could cause the company's actual performance to differ from current expectations, can be found on the company's Web site at www.biopure.com/corporate/legal/home_legal.htm and in the company's filings with the U.S. Securities and Exchange Commission, which can be accessed in the EDGAR database at the SEC Web site, www.sec.gov, or through the Investor section of Biopure's Web site, www.biopure.com.
Contact: Douglas Sayles