Biopure Announces Publication Of Phase II Proof-of-Concept Coronary Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 15 May 2008 - 4:00 PDT

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Biopure Corporation (Nasdaq: BPUR) 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.

Biopure Corporation
http://www.biopure.com

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