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Biopure Announces 2007 Fourth Quarter and Year-End Financial Results
Date:1/28/2008

ls. Our first pilot ischemia trial was designed to assess the product's safety in patients with single-vessel coronary artery disease who were undergoing angioplasty and stenting procedures, or percutaneous coronary intervention (PCI). This Phase 2 trial, completed in 2005, enrolled a total of 45 evaluable patients at five hospitals in Germany, Belgium and The Netherlands.

A second PCI trial, a study in patients with multi-vessel coronary artery disease who are undergoing PCI, was designed to capture additional safety and preliminary efficacy data to support subsequent trials in patients experiencing a heart attack. The hypothesis the trial was intended to test is that Hemopure may improve oxygenation and heart function during times of coronary artery blockage. This proof of concept trial enrolled five patients, all at the Erasmus Medical Center in Rotterdam, The Netherlands. The protocol had allowed for an enrollment of up to ten subjects. However, the investigator stopped enrollment at the end of 2007, after concluding that the results from five patients were sufficient to show a trend towards proving the principle being tested.

Wound Healing. In 2006, patient enrollment also began in a Phase 2 clinical trial to assess the safety and feasibility of Hemopure in increasing the incidence of complete wound healing and reducing the need for subsequent amputations in patients with severe vascular disease who are undergoing limb amputation. The rationale for this pilot trial was that the product might promote wound healing by transporting oxygen through partially blocked arteries to oxygen-deprived tissues. Because of slow enrollment, the trial was stopped at the end of 2007 after enrolling 16 of the proposed 100 patients. The slow enrollment in the trial was largely due to a trial design that did not adequately take into account the different clinical practices across both institutions and countries.

Trauma Trial. At the Johannesburg Hospital Trauma
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