NIH/FDA Workshop. The company's strategy to pursue indications for its product Hemopure, when blood is not an option, was reinforced by a National Institutes of Health/Food and Drug Administration (NIH/FDA) recent workshop. The workshop, entitled "The Safety of Hemoglobin-based Oxygen Carriers," took place on April 29 and 30, 2008 in Bethesda, Maryland. The company presentation included a platform for moving forward with Hemopure and is posted at http://www.biopure.com. The workshop transcript is expected to be available on the FDA website by late May 2008.
Symposium: University of Maryland. The University of Maryland hosted a symposium on April 28th on "Compassionate Use of Hemoglobin Based Oxygen Carriers (HBOCs) When Blood is Neither an Option Nor Available." Dr. Colin MacKenzie of the University of Maryland chaired the symposium prior to the NIH/FDA workshop. Clinicians discussed their experience with the clinical use of Hemopure in South Africa and in compassionate use patients, approved for treatment on a case by case basis by the FDA. The video of the symposium is available at the University of Maryland website at http://hfrp.umm.edu/cucases.
Two papers presenting data from Biopure trials were accepted for publication recently in peer-reviewed journals.
COR-0002. Preliminary findings from the company's Phase 2 coronary
revascularization trial, COR-0002, were published in the EuroIntervention
Journal's May 13, 2008 issue. 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, Erasmus Medical Centre,
|SOURCE Biopure Corporation|
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