CAMBRIDGE, Mass., May 14 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) today announced that the results from its Phase II coronary
revascularization trial have been published in the peer-reviewed
EuroIntervention Journal. The paper is entitled "Proof-of-concept trial to
evaluate haemoglobin based oxygen therapeutics in elective percutaneous
coronary revascularization. Rationale, protocol design, and haemodynamic
results." The manuscript was authored by principal investigator Patrick W.
Serruys, MD, PhD and colleagues of the Department of Interventional
Cardiology, Thoraxcenter, Erasmus MC, University Medical Centre Rotterdam,
The Netherlands.
"Biopure's COR-0002 study in the EuroIntervention Journal demonstrates
the potential use of Hemopure (HBOC-201) in patients with coronary artery
disease," said Biopure Chairman and CEO Zafiris G. Zafirelis. "Based on the
efficacy and safety of the drug in this trial, we believe that Hemopure
could be an oxygen bridge to prevent permanent myocardial damage in
patients sustaining a heart attack."
The COR-0002 trial is a single-blind, open-label, single-center, cross-
over pilot study where subjects underwent coronary balloon occlusion, with
and without oxygenated HBOC-201. The primary objective of the study was to
test the hypothesis that intracoronary infusion of HBOC-201 during brief,
total coronary artery occlusion would preserve left ventricular function.
The primary endpoints in COR-0002 were left ventricular diastolic
relaxation indices as assessed by left ventricular pressure-volume loops
and ST segment changes as assessed via electrocardiograms.
The study concluded that HBOC-201 was indeed capable of preserving left
ventricular function, likely through maintenance of myocardial oxygenation.
According to the findings, the absence of coronary vasoconstriction,
despite exposure to undiluted HBOC-201, further supports the potential
utility of HBOC-201 in complicated patient subsets such as those with
coronary artery disease. In addition, changes in electrocardiograms,
indicating severe ischaemia during control coronary artery occlusions, were
not present during or following HBOC-201 infusion. The report states that
HBOC-201 did not cause any serious adverse event or significantly alter
blood chemistry parameters through the 4-day follow-up period.
Based on the results, the authors hypothesized that, in an acute
setting, HBOC-201 could serve as an oxygen bridge to reperfusion by
percutaneous coronary intervention, extending the "golden" time period
during which permanent myocardial damage is unlikely. The report noted that
further studies will be required to determine whether HBOC-201 can enhance
treatment efficacy in more complicated patient populations. The report
concluded that this trial represents an important next step in the clinical
development program for this product as a treatment for acute myocardial
ischaemia.
Biopure Corporation
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 company is
developing Hemopure for other indications and is supporting the U.S. Navy's
government- funded efforts to develop a potential out-of-hospital trauma
indication. Biopure's veterinary product Oxyglobin(R) [hemoglobin glutamer
- 200 (bovine)], or HBOC-301, the only oxygen therapeutic approved for
marketing by both the U.S. Food and Drug Administration and the European
Commission, is indicated for the treatment of anemia in dogs. Biopure has
sold approximately 200,000 units of Oxyglobin since its launch in 1998.
Contact: Tiana Gorham
Biopure Corporation
(617) 234-6826
IR@biopure.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
http://www.prnewswire.com/comp/131224.html /
CONTACT:
Tiana Gorham of Biopure Corporation,
+1-617-234-6826, IR@biopure.com
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