CAMBRIDGE, Mass., Oct. 27 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today that it has received regulatory authorization
in the United Kingdom to initiate a Phase 2 clinical trial of its
investigational oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250
(bovine)] as a potential cardio-protective agent in patients undergoing
coronary artery bypass graft (CABG) surgery. This trial is in addition to two
other recently announced non-U.S. trials of the product, in ischemia
applications, that have received regulatory clearance to proceed.
The U.K. Medicines and Healthcare products Regulatory Authority (MHRA)
approved the protocol for a non-randomized, multi-center, prospective registry
of patients undergoing multi-vessel CABG surgery. This trial is designed to
assess the product's safety and feasibility in reducing heart damage, as
measured by cardiac enzyme (CK-MB) elevation, and enhancing tissue
preservation during cardiopulmonary bypass. Secondary endpoints include
measurements of major adverse cardiac events (MACE), kidney function,
transfusion requirements, cognitive impairment and length of hospital stay.
In the trial, a total of 60 patients will be consecutively enrolled in two
groups to receive either standard-of-care treatment or intravenous
administration of approximately 60 grams of hemoglobin in the form of Hemopure
prior to cardiopulmonary bypass. Patients will be monitored until hospital
discharge or six days, whichever occurs first, with a follow-up assessment at
30 days post-surgery. An independent data safety monitoring committee will
monitor safety throughout the study period.
Ischemia Development Plan
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. Patient enrollment
in the CABG surgery trial and the cardiac and limb ischemia trials described
below is expected to begin in late 2005 and early 2006.
In Belgium, the Directorate-General for Medicinal Products has approved
the protocol for a Phase 2 trial in 20 patients undergoing intra-coronary (IC)
balloon angioplasty. This study is designed to support subsequent trials of
Hemopure in patients experiencing a heart attack.
In South Africa, the Medicines Control Council has approved the protocol
for a 100-patient, Phase 2 trial 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.
Hemopure is an oxygen therapeutic, or oxygen-carrying biologic drug,
consisting of stabilized bovine hemoglobin formulated in a balanced salt
solution. These polymerized (chemically cross-linked) hemoglobin molecules
circulate in the plasma (the fluid part of blood) when infused and are
smaller, less viscous and more readily release oxygen to tissues than red
blood cells. Consistent with these properties, this stabilized hemoglobin has
been shown in preclinical studies to carry oxygen through constricted or
partially blocked blood vessels. The product is ultrapurified, compatible
with all blood types, and stable for three years without refrigeration.
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 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 company's financial position, unexpected costs and expenses,
possible delays related to clinical trials, and unpredictable outcomes of
clinical trials. Clinical trials may only occur in the U.S. if the Food and
Drug Administration provides the necessary regulatory approvals to proceed.
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.
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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