CAMBRIDGE, Mass., March 13 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that the Food and Drug Administration (FDA) has notified the Navy of its intention to consult an FDA Advisory Committee within six months to discuss the Navy's proposed "RESUS" clinical trial of Biopure's oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)] for out-of-hospital treatment of hemorrhagic shock resulting from traumatic injury. The investigational new drug application (IND) for RESUS that the Naval Medical Research Center (NMRC) submitted to FDA in June 2005 remains on clinical hold because of issues related to the predicted risk-benefit profile of the product under the proposed protocol. FDA has requested additional information, clarification and comment on completed animal studies, the RESUS protocol and other aspects of the IND. FDA also requested changes to the protocol and investigators brochure.
"We continue to believe that the product's risk-benefit profile, as an emergency pre-hospital treatment until patients can receive blood or other standard treatment at a hospital, supports allowing RESUS to proceed," said Biopure Chairman and CEO Zafiris G. Zafirelis. "We are working with NMRC and its RESUS Advisory Board to further address FDA's concerns so this important study can ultimately move forward."
Under a research agreement with Biopure, NMRC has primary responsibility for developing, obtaining FDA acceptance of and conducting the RESUS trial. As part of this process, NMRC conducted preclinical studies of Hemopure in animal models of hemorrhagic shock, including an FDA-requested study in uncontrolled hemorrhage with traumatic brain injury.
NMRC also established a RESUS Advisory Board of military and academic experts in trauma, emergency medicine, emergency medical services, surgery, critical care, anesthesiology, hematology, internal medicine, infectious diseases, bioethics and biostatics. This board has evaluated clinical and preclinical data on Hemopure, designed the proposed RESUS trial and provided ongoing program review and consultation.
RESUS (Restore Effective Survival in Shock) is a government-funded study designed as a single-blinded, multi-center, randomized, controlled, Phase 2b/3 clinical trial. The objective is to assess the safety and efficacy of Hemopure, as compared with standard treatment, in reducing morbidity and mortality in severely injured patients experiencing hemorrhagic shock (acute blood loss) in the out-of-hospital setting, where blood is not available for transfusion.
In the proposed study, patients would be randomized to receive either Hemopure or standard therapy (crystalloid solution) at the scene of the injury and during transport to the hospital. All patients would receive standard therapy (blood transfusion if indicated) upon arrival at the hospital. Because patients would be unconscious or traumatized, the trial design provides an exception from informed consent and a community consultation and disclosure process, as defined in FDA regulation 21 CFR 50.24.
In order for RESUS to proceed, FDA must lift the clinical hold and the Department of Defense and the internal review boards of participating hospitals in the communities where the study would take place must provide final authorization.
Traumatic injuries may cause massive bleeding resulting in rapid loss of oxygen-carrying capacity. The current standard of care for acute hemorrhage outside of the hospital is fluid resuscitation with crystalloids or colloids, which replace lost blood volume but do not carry oxygen. These resuscitative floods may not sufficiently extend survival in trauma casualties, particularly when evacuation to a hospital is delayed or prolonged. Blood transfusion provides both volume and oxygen-carrying support, but is rarely practical in the field because stored blood requires refrigeration, is type specific and has a limited shelf life.
If safety and effectiveness can be demonstrated and regulatory approval obtained, Biopure believes that the compatibility with all blood types, long-term stability without refrigeration (3 years at 35.6 to 86 degrees Fahrenheit, 18 months at 104 degrees Fahrenheit) and other properties of Hemopure could allow it to be stockpiled, positioned abroad, and carried or stored in remote locations for use as an oxygen-carrying resuscitative fluid when blood is not available. These attributes may make it well suited for use on the battlefield, in ambulances, and in the Strategic National Stockpile.
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 product has not been approved for sale in other countries. Biopure plans to apply in Europe, in mid 2006, for approval of an acute anemia indication in orthopedic surgery patients. The company is developing Hemopure for a potential indication in cardiovascular ischemia, in addition to supporting the U.S. Naval Medical Research Center's government-funded development of a potential out-of-hospital trauma indication. To date, Hemopure has been administered to over 350 patients post approval in South Africa and to over 800 human subjects in clinical trials, including two ongoing trials in Europe and South Africa. 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. To date, Biopure has sold approximately 173,000 units of Oxyglobin, which have been used to treat an estimated 90,000 animals.
Statements in this press release that are not strictly historical are forward-looking statements, including any that might imply that the proposed RESUS trauma trial will receive authorization to proceed. 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, 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-K filed on January 17, 2006, 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 Herb Lanzet (Investors)
Biopure Corporation H.L. Lanzet Inc.
(617) 234-6826 (212) 888-4570