U.S. Navy IND for Proposed 'RESUS' Trauma Trial Remains on Hold; Navy to Seek
FDA Meeting to Present Experts' Medical and Scientific Basis for Trial
Belgium and South Africa Regulatory Authorities Approve Proposed Ischemia
Trials
CAMBRIDGE, Mass., Oct. 19 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today that, following the submission of additional
information by the Naval Medical Research Center (NMRC), the U.S. Food and
Drug Administration (FDA) has maintained its clinical hold on the NMRC's
investigational new drug application (IND) for the proposed "RESUS" Phase 2/3
clinical trial of Hemopure(R) [hemoglobin glutamer - 250 (bovine)] for out-of-
hospital treatment of trauma patients. The company also announced that it has
received regulatory approvals in Belgium to initiate a Phase 2 trial of
Hemopure in coronary angioplasty patients and in South Africa to initiate a
Phase 2 trial in patients undergoing lower limb amputation.
Out-of-Hospital Trauma
As previously announced, the NMRC submitted its IND to the FDA Center for
Biologics Evaluation and Research (CBER) for review in June 2005 and the IND
was placed on hold in July 2005. The NMRC, in consultation with its RESUS
advisory board of trauma, emergency medicine and critical care experts and
Biopure scientists, subsequently modified the proposed protocol and submitted
a response to CBER's clinical hold letter in September 2005.
After reviewing the response, CBER maintained the hold. There continues
to be disagreement regarding the risk-benefit profile and the clinical
significance of potential vasoactivity associated with Hemopure in the target
patient population. The agency noted that "the only practicable path forward"
for this trial is to develop a new, less vasoactive product formulation, the
first time it has stated this opinion.
"We believe the product has a potentially favorable risk-benefit profile,
and we're working with the NMRC to explore all options for addressing the
agency's comments on the RESUS trial," said Biopure President and CEO Zafiris
G. Zafirelis. The NMRC has requested an FDA meeting where military and
academic trauma experts from the RESUS advisory board will present the medical
and scientific basis for proceeding with the proposed trial. These experts
designed the trial and have independently evaluated clinical and preclinical
data on the product.
RESUS (Restore Effective Survival in Shock) is 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. 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. 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.
Cardiovascular Ischemia
Biopure's clinical development strategy for ischemia is to conduct
parallel pilot trials of Hemopure to assess the potential of several ischemia
indications before committing funding for advanced trials. Biopure expects to
initiate patient enrollment in the trials described below in late 2005 and
early 2006.
Peripheral Limb Ischemia
In South Africa, the Medicines Control Council has approved the protocol
for a randomized, multi-center, single-blinded, parallel-group, placebo-
controlled Phase 2 trial of Hemopure in limb ischemia patients. The trial is
designed to assess the product's safety and feasibility in increasing the
incidence of complete wound healing and reducing the incidence of subsequent
amputations in patients with severe peripheral vascular disease who are
undergoing lower limb amputation below or through the knee joint. The
hypothesis is that the product will pass through partially occluded arteries
and promote wound healing by delivering oxygen to oxygen-deprived tissues.
In this study, 100 patients will be randomized to intravenously receive
either a control colloidal solution (6% hetastarch) or 32.5 grams of
hemoglobin in the form of Hemopure before surgery followed by the same dose
daily for three days. Patients will be monitored until discharged from the
hospital and at 15, 30 and 60 days post surgery, with survival and quality of
life information collected at three and six months post surgery. The primary
safety endpoint is mortality at 60 days. Secondary endpoints include
additional safety, quality of life and pharmacoeconomic assessments. A data
safety monitoring board will monitor safety throughout the study period.
Percutaneous Coronary Intervention
In Belgium, the Directorate-General for Medicinal Products has approved
Biopure's clinical trial application (CTA) to initiate a 20-patient,
randomized, placebo-controlled, cross-over, open-label Phase 2 trial in
patients undergoing intra-coronary (IC) balloon angioplasty. The trial is
designed to capture preliminary efficacy and additional safety data to support
subsequent trials of Hemopure in patients experiencing a heart attack. The
hypothesis is that Hemopure may improve oxygenation and function of the
myocardium (heart wall muscle) during coronary occlusion.
In the catherization laboratory, patients will receive IC administration
of Hemopure and placebo (heparin) but will be blinded to the order of
administration. Both drugs will be infused through the central lumen of a
dilated catheter at the same flow rate. Patients will be monitored up to
hospital discharge or four days, whichever occurs sooner. The primary
endpoint is to study whether IC delivery of Hemopure mitigates ischemia as
measured by standard electrocardiographic (ECG) and cardiac function tests.
Secondary endpoints include various measures of hemodynamics and safety. A
data safety monitoring board will monitor safety throughout the study.
Cardiopulmonary Bypass Surgery
European regulatory authorities are currently reviewing a separate CTA the
company submitted for a proposed Phase 2 trial designed to assess the safety
and efficacy of Hemopure administered pre-operatively to improve outcomes in
patients undergoing cardiopulmonary bypass surgery.
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 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 working with the NMRC to respond to the FDA and
proceeding with the RESUS trial and those about conducting further clinical
trials in Europe and South Africa, are forward-looking statements. 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 NMRC and the company's ability to
provide adequate responses to the FDA in a reasonable timeframe, if at all,
the company's financial position, unexpected costs and expenses, and possible
delays and unforeseen costs related to clinical trials. The RESUS trial may
occur in the U.S. only if the FDA is provided responses that it deems
satisfactory. 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 September 9, 2005, 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. Completion of the proposed
RESUS clinical trial of Hemopure in trauma may be contingent upon further
funding.
Contact:
Douglas Sayles
Biopure Corporation
(617) 234-6826
IR@biopure.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
Company News On-Call:
http://www.prnewswire.com/comp/131224.html
CONTACT:
Douglas Sayles of Biopure Corporation,
+1-617-234-6826, IR@biopure.com
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