Panel on Hemoglobin-Based Oxygen Carriers Indicates Support for Continued
Investigational Use Where Blood Is Not an Option
CAMBRIDGE, Mass., May 7 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that the Company's strategy to pursue indications for its product Hemopure(R) [hemoglobin glutamer-250 (bovine)] , or HBOC-201, when blood is not an option was reinforced by the National Institutes of Health/Food and Drug Administration (NIH/FDA) recent workshop. The workshop, entitled "The Safety of Hemoglobin-based Oxygen Carriers," took place on April 29 and 30, 2008 in Bethesda, Maryland. The purpose of a public workshop is to discuss issues in featured presentations and roundtable discussions led by experts from academic institutions, government, and industry. No actions are typically taken at workshops. The transcript is expected to be available on the FDA website by late May 2008.
"A number of participants in this important workshop recognize the therapeutic potential that Hemoglobin-based Oxygen Carriers (HBOCs) offer to patients who may not have the option of receiving packed red blood cells," said Biopure Chairman and CEO Zafiris G. Zafirelis. "The company's initial strategy with Hemopure was to develop indications in the treatment of adult surgical patients who are acutely anemic, as in South Africa, where Hemopure has market authorization and is being used clinically. We also believe there are excellent applications for its use where blood is not indicated, and in out-of-hospital treatment of trauma patients in hemorrhagic shock, where red blood cells are not available."
Biopure Vice President of Medical Affairs Dr. A. Gerson Greenburg delivered the company's presentation, including a platform for moving forward with its Hemopure product. Dr Greenburg noted first, that future trials should exclude competition with packed red blood cells. and target use where blood is not an option or not available. Furthermore, the safety profile of each member of the class of HBOCs should be evaluated individually. He also presented results of analysis of the company's surgical orthopedic trial, HEM- 0115, which will be published in the Journal of Trauma. Dr. Greenburg's presentation is available on Biopure's website.
The day before the workshop, the Journal of the American Medical Association (JAMA) published a meta-analysis of HBOCs as a class. At the workshop, one of the article's authors presented the findings, which raised questions about safety signals in the absence of clinical benefit shown in some of the trials in the meta-analysis. Dr. Greenberg stated that the different compositions of the HBOCs considered, including some no longer in development, invoke a principle of heterogeneity that would argue against any comparisons made from combining data.
Experts presenting at the workshop repeatedly opined that FDA should permit carefully designed randomized controlled clinical trials of the current generation of HBOCs in patients with life-threatening anemia who do not have the option of a blood transfusion. Dr. Colin MacKenzie of the University of Maryland chaired a symposium prior to the workshop during which clinicians discussed their experience with the clinical use of Hemopure in South Africa and in compassionate use patients, approved on an individual basis by the FDA. This symposium is available at the University of Maryland website at http://hfrp.umm.edu/cucases .
Dr. Demetrios Demetriades, Professor of Surgery and Director of Trauma and Surgical Intensive Care Unit, University of Southern California School of Medicine, suggested that the products might be made available for compassionate use in patients such as Jehovah's Witnesses, for whom blood transfusions are unacceptable. He conceded that there was a major unmet need for these products and that he felt "we are not there yet." Dr. Gus Vlahakes, Professor of Surgery, Harvard Medical School, and Chief of Cardiac Surgery , Massachusetts General Hospital and Co-Director of the Massachusetts General Hospital Heart Center, stated that, theoretically, HBOCs may have significant benefit in clinical settings where blood is not available, specifically in trauma and cardiac surgery.
Daniel Freilich, MD, CDR, MC, USN, and head of the hematomimetics program at the Naval Medical Research Center, presented his opinion that an optimization of study design and practice guidelines would enable clinical evaluation of the current generation of HBOCs with reasonable risk. To maximize the potential for benefit and minimize potential for harm, he suggested targeting a population younger than 70 who were seriously wounded and would most likely die in situations where blood is not available, such as on the battlefield. The Naval Medical Research Center has been attempting to conduct a clinical trial using Hemopure in out-of-hospital trauma patients.
Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics, that are intravenously administered to deliver oxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. The company is developing Hemopure for other indications and is supporting the U.S. Navy's government- funded efforts to develop a potential out-of-hospital trauma indication. Biopure's veterinary product Oxyglobin(R) [hemoglobin glutamer - 200 (bovine)], or HBOC-301, the only oxygen therapeutic approved for marketing by both the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Biopure has sold approximately 200,000 units of Oxyglobin since its launch in 1998.
Statements in this press release that are not strictly historical are forward-looking statements, including any statements related to the company's platform for moving forward with Hemopure, future clinical applications of Hemopure, the company's strategy for commercialization in South Africa, and statements implying future clinical studies and the availability of HBOC products. 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, determinations by the FDA, and unpredictable outcomes of preclinical and 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 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 March 17, 2008, 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.
|SOURCE Biopure Corporation|
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