The Company postponed the meeting we had planned to request for July 2008 with the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom on the Company's pending application for marketing authorization for Hemopure. The Company decided to apply its limited resources to the submission of the AML protocol and working with the FDA. As previously noted, FDA and the MHRA have communicated about Hemopure.
On September 11, 2008, Biopure is scheduled to deliver a brief presentation on Hemopure and its safety and efficacy at the Blood Products Advisory Committee meeting at the FDA. The meeting agenda includes a review of the workshop on hemoglobin based oxygen carriers held at the National Institutes of Health in Bethesda, Maryland on April 29 and 30, 2008.
The journal Expert Opinion Biological Therapeutics has published a Drug
Evaluation focused on HBOC-201, authored by Jonathan S. Jahr, M.D., et al,
of the David Geffen School of Medicine at UCLA, Department of Anesthesia.
The article, appearing in the September 2008 issue of the journal, is
entitled, "HBOC-201, hemoglobin glutamer-250 (bovine), Hemopure (Biopure
Corporation)." Dr. Jahr was a principal investigator in Biopure's pivotal
trial in orthopedic surgery patients and co-author of a June 2008 Journal
of Trauma article that presented the data from that trial. The Expert
Opinion article concludes that; "While HBOC-201 may not replace allogenic
blood transfusions, it may serve to allow critically ill patients to be
resuscitated in the field or hospital setting until either regeneration of
red cell occurs or a transfusion is available." Addi
|SOURCE Biopure Corporation|
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