U.S. Navy Seeks FDA Okay to Start Trauma Trial of Hemopure(R)
13 June 2005 - 9:55PM
PR Newswire (US)
U.S. Navy Seeks FDA Okay to Start Trauma Trial of Hemopure(R) Naval
Medical Research Center Submits IND Application for Proposed
"RESUS" Clinical Trial in Trauma Patients in the Out-of-Hospital
Setting CAMBRIDGE, Mass., June 13 /PRNewswire-FirstCall/ -- Biopure
Corporation (Nasdaq: BPURD; BPUR) announced today that the U.S.
Naval Medical Research Center (NMRC) has submitted to the Food and
Drug Administration (FDA) an investigational new drug (IND)
application to conduct a two-stage clinical trial of the company's
oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)]
for the out-of-hospital treatment of trauma patients. Under a
research agreement with Biopure, the NMRC has primary
responsibility for designing, seeking FDA acceptance of and
directing the trial, entitled "Restore Effective Survival in Shock
(RESUS)". RESUS is designed as a single-blinded, multicenter,
randomized, controlled, Phase IIb/III study. The objective is to
assess the safety and efficacy of Hemopure, as compared to 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. Patients would be randomized to receive either
Hemopure or standard therapy at the scene of the injury and during
transport to the hospital. The trial would require an exception
from informed consent and would include a community consultation
and disclosure program, as defined in federal regulations 21 CFR
50.24-25. Before the trial can proceed, the FDA and the
participating hospitals' internal review boards must review and
accept the study protocol. RESUS represents a unique collaboration
between scientists and clinicians from the military, academic
hospitals, a nonprofit organization and Biopure under the direction
and main funding of the NMRC. To date, Congress has appropriated a
total of $18.5 million to the Navy and Army* for the development of
Hemopure for potential use in military and civilian trauma
indications and to cover military administrative costs. This
funding is being used for RESUS and for preclinical studies of
Hemopure in animal models of hemorrhagic shock, including those
that mimic military trauma scenarios. Out-of-Hospital Trauma
Traumatic injuries may cause massive bleeding resulting in rapid
loss of oxygen-carrying capacity. Due to logistical issues, red
blood cells are not typically administered in emergency situations
outside of the hospital; emergency caregivers administer
intravenous fluids (Ringer's lactate, saline) that restore blood
volume but do not carry oxygen. If safety and effectiveness can be
demonstrated and regulatory approval obtained, the company believes
that the room- and elevated-temperature stability (3 years at 2 to
30 degrees Celsius, 18 months at 40 C), universal compatibility and
other properties of Hemopure could allow it to be stockpiled,
positioned abroad, and carried or stored in remote locations. These
attributes may make it well suited for use on the battlefield, in
ambulances, and in the Strategic National Stockpile. Biopure
Corporation Biopure Corporation develops and manufactures
intravenously administered pharmaceuticals, called oxygen
therapeutics, that deliver oxygen to the body's tissues. The
company is developing Hemopure(R) [hemoglobin glutamer - 250
(bovine)], or HBOC-201, for a potential indication in
cardiovascular ischemia and, in collaboration with the U.S. Naval
Medical Research Center, for an out- of-hospital trauma indication.
The product is approved in South Africa for treating surgery
patients who are acutely anemic and for eliminating, delaying or
reducing allogeneic red blood cell transfusions in these patients.
Hemopure has not been approved for sale in any other jurisdictions,
including the United States or the European Union. Biopure'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
press release that are not strictly historical, including those
about the FDA and the hospital internal review boards allowing the
RESUS trial to proceed, are forward-looking statements. Actual
results may differ materially from those projected in these
forward-looking statements due to risks and uncertainties regarding
the company's operations and business environment. These risks
include, without limitation, uncertainties regarding the company's
ability to generate revenues, cash requirements, unexpected costs
and expenses, insurance coverage, and possible delays and
unforeseen costs related to clinical trials, regulatory approvals
and marketing and distribution of the company's products. 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, and specific
factors that could cause the company's actual performance to differ
from current expectations, can be found in the company's filings
with the U.S. Securities and Exchange Commission, including the
Form 10-Q filed on June 9, 2005, which can be accessed in the EDGAR
database at the SEC Web site, http://www.sec.gov/, or through the
Investor Relations section of Biopure's website,
http://www.biopure.com/. 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. Completion of the proposed RESUS
clinical trial of Hemopure in trauma may be contingent upon further
funding. * $5,102,306 of the $6,500,000 appropriated to the Army is
from Grant DAMD17-02-1-0697. The U.S. Army Medical Research
Acquisition Activity, 820 Chandler Street, Fort Detrick MD
21702-5014, is the awarding and administering acquisition office.
Contact: Douglas Sayles Biopure Corporation (617) 234-6826
DATASOURCE: Biopure Corporation CONTACT: Douglas Sayles of Biopure
Corporation, +1-617-234-6826, Web site: http://www.biopure.com/
Company News On-Call: http://www.prnewswire.com/comp/131224.html
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