Biopure Corporation has signed a Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC) that will enable the NMRC to participate in a pivotal clinical trial of the company's investigational oxygen therapeutic Hemopure [hemoglobin glutamer - 250 (bovine), or HBOC-201] in pre-hospital trauma. Participation in this collaborative effort is estimated to cost the NMRC at least $4 million. Biopure will contribute an estimated $8.7 million, of which at least $643,000 will be provided during the first year.
"When we send Sailors and Marines into harm's way, we owe them the best possible combat casualty prevention, care and management. This CRADA supports our Future Naval Capability for both oxygen-carrying blood substitutes and low volume resuscitation fluids that inhibit shock," said Captain Richard B. Oberst, U.S. Navy Medical Service Corps, Commanding Officer, Naval Medical Research Center, Silver Spring, Md.
The funding is intended to support a pivotal, randomized, standard therapy controlled trial of Hemopure in pre-hospital resuscitation of patients with severe hemorrhagic shock (acute blood loss). Entitled Restore Effective Survival in Shock (RESUS), the trial is intended to lead to U.S. Food and Drug Administration (FDA) approval of Hemopure for pre-hospital military and civilian trauma applications, including military use in Tactical Combat Casualty Care and the En Route Care System, naval vessels, and potentially in National Aeronautics and Space Administration (NASA) vehicles. Patient enrollment in the RESUS trial is expected to begin at multiple centers in the United States and possibly at sites in South Africa following Phase II trauma trials of Hemopure.
Hemopure is approved in South Africa for perioperative treatment of adult surgical patients who are acutely anemic. The U.S. Food and Drug Administration (FDA) is currently reviewing Biopure's biologic license application (BLA) to market the product in the United States for the treatment of acutely anemic adult patients undergoing orthopedic surgery. The BLA was based on two completed, Phase III red blood cell controlled surgery trials, an integrated database of more than 1400 subjects from 21 clinical trials, approximately 800 of whom received Hemopure, and more than 200 preclinical animal and laboratory studies.
"Our product introduction plan is to build awareness and understanding of this first-in-class product in surgical use and then expand into trauma following the successful completion of our DoD-supported trauma trials," said Biopure President and CEO Thomas A. Moore. "The Navy CRADA and the recent Army-administered Congressional funding together allow us to pursue this important trauma indication, which addresses an unmet medical need."
The NMRC funding for the pivotal RESUS trial is in addition to the previously announced $4.9 million in FY02/03 Congressional funding administered through the U.S. Army Medical Research and Material Command for Phase II trauma trials of Hemopure. Biopure is also pursuing other government and non-government funding for its trauma program.
The company is currently preparing to submit a Phase II study protocol to the FDA for a randomized, standard-therapy controlled trauma trial of Hemopure in hospital emergency rooms. It is also working with civilian and military trauma experts and medical ethicists to finalize the protocols for pre-hospital trials, including the pivotal RESUS trial. Trauma trials of Hemopure are expected to begin this year, initially at Parkland Hospital in Dallas, Texas, with the lead investigators Drs. Paul Pepe and Joseph Minei.
The Navy-Biopure CRADA allows for potential additional agreements with individual trauma centers and with the U.S. Air Force, which contributed to the study protocol for the pivotal trauma trial and participated in previous preclinical and clinical studies of Hemopure. Biopure and the NMRC are developing an additional CRADA for pre-clinical studies using Hemopure in the development of next-generation hemoglobin-based oxygen carriers. These studies are being directed by Commander Daniel Freilich, Head of the NMRC's Hematomimetics Program and the Navy's principal investigator for the pivotal RESUS clinical trial of Hemopure.
Hemopure is an oxygen therapeutic solution that is stable over a broad temperature range (including room temperature) for three years, is compatible with all blood types, and undergoes a pharmaceutical manufacturing process that ensures consistent purity, potency and stability. The product consists of chemically stabilized hemoglobin in a balanced salt solution. This stabilized hemoglobin is smaller than red blood cells, circulates in plasma (the fluid part of blood), and has a lower viscosity (resistance to flow) and more readily releases oxygen to tissues than blood. Consequently, it has been shown to carry oxygen at low pressure and through constricted or partially blocked blood vessels.