CAMBRIDGE, Mass., Nov. 7 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that the independent Data and Safety Monitoring Board (DSMB) for the company’s Phase II clinical trial of Hemopure(R) [hemoglobin glutamer - 250 (bovine)] in trauma patients has completed its first scheduled interim analysis of blinded study data and recommended that the trial continue without modification. The DSMB reviewed mortality and other safety data from the first 21 patients enrolled in this single-center trial at Johannesburg Hospital Trauma Unit in South Africa.
The 50-patient, single-blind Phase II trial is designed to assess the safety and tolerability of Hemopure, in a hospital setting, for emergency treatment of unstable patients who have significant blood loss as a result of blunt or penetrating trauma. Patients are randomly assigned to receive either standard therapy resuscitation fluids (crystalloids, colloids and/or blood) or up to 10 units of Hemopure plus standard therapy. The treatment period for administering Hemopure is up to four hours from the first infusion. Patients are monitored until discharged from the hospital and at 28 days post-infusion.
The role of the DSMB is to evaluate data from the ongoing trial to determine whether there are safety issues that would warrant modification of the protocol or early termination of the study. The DSMB is independent of Biopure and is comprised of one biostatistician and three doctors from the U.S. with relevant expertise in the care of trauma patients, experience in clinical trials involving traumatic injuries, and no intellectual or financial conflict of interest. The next DSMB meeting is scheduled to occur after patient #38 is enrolled and has completed the 28-day follow up visit. After the trial is completed, the DSMB will meet again to review the data for all 50 enrolled, evaluable patients and assess the safety of the product. The trial has enrolled 23 patients to date.
About Biopure Corporation
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. Biopure has applied in the United Kingdom for regulatory approval of a proposed orthopedic surgical anemia indication. The company is developing Hemopure for a potential indication in cardiovascular ischemia, in addition to supporting the U.S. Navy’s government-funded efforts to develop a potential out-of-hospital trauma indication. The company’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 announcement that are not strictly historical are forward-looking statements. Actual results and their timing 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, delays and determinations by regulatory authorities, unanticipated problems with the product’s commercial use, whether or not product related, and with product distributors, sales agents or other third parties, and delays in or 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 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 11, 2006, which can be accessed in the EDGAR database at the SEC Web site, http://www.sec.gov.
The content of this announcement 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 Herb Lanzet (Investors) Biopure Corporation H.L. Lanzet Inc. (617) 234-6826 (212) 888-4570 IR@biopure.comlanzet@aol.com
Biopure Corporation
CONTACT: Douglas Sayles of Biopure Corporation, +1-617-234-6826,IR@biopure.com; or Investors: Herb Lanzet of H.L. Lanzet Inc.,+1-212-888-4570, lanzet@aol.com
Web site: http://www.biopure.com//
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