The accepted manuscript reports on the Company's first pilot ischemia clinical trial in patients with coronary artery disease undergoing angioplasty and stenting procedures, or percutaneous coronary intervention (PCI). This trial was carried out at five hospitals in Germany, Belgium and The Netherlands.
Dr. Patrick W. Serruys, Professor of Interventional Cardiology at Erasmus University in Rotterdam, The Netherlands, will present this study at the Plenary Session of the Europe PCR meeting being held May 13-16, 2008 in Barcelona, Spain.
Clinical Program Update
The Company's second trial in patients undergoing PCI ended in late 2007. A key objective of this study was to observe whether intracoronary delivery of Hemopure lessens ischemia as measured by standard tests. Enrollment was stopped after five patients even though the protocol had allowed for an enrollment of up to ten, because the investigator concluded that the results from five patients were sufficient to show a trend toward proving the principle being tested. A second safety trial, in patients undergoing limb amputation was also ended in late 2007, primarily because of slow enrollment caused by a protocol design that did not take into account different clinical practices across institutions and countries.
The Company's ongoing clinical trial in patients undergoing cardiopulmonary bypass surgery is nearing completion. Fifty-four of an anticipated 60 patients have been enrolled.
Biopure is continuing to work toward a clinical trial in terminally ill
patients to examine Hemopure's potential, owing to its oxygen-carrying
capacity, to increase perfusion and improve the quality of life in those
patients. A consultant for this proposed palliative care trial has been
retained by Biopure. Margaret Laccetti, PhD, RN, AOCN, Assistant Professor
of Adult Health at Boston College and an on
|SOURCE Biopure Corporation|
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