Biopure Pressured by FDA Panel Vote

Biopure Shares Fall After FDA Panel Recommends Against Proposed Clinical Trial

CAMBRIDGE, Mass.-- Shares of Biopure Corp. fell sharply Friday after a Food and Drug Administration advisory panel said the Navy's proposed clinical trial of the company's blood substitute would be too risky, and recommended the study not take place.

Biopure shares fell 26 cents, or 44 percent, to 33 cents in morning trading on the Nasdaq. Shares have traded under $1 since late July, causing the company to become non-compliant with Nasdaq listing requirements.

The FDA panel voted 11 to 8 with one abstention to not recommend the Navy's proposed mid- to late-stage clinical trial for Biopure's Hemopure, an emergency treatment made from cow's blood that delivers oxygen to the body when it has lost too much blood.

The panel questioned whether current data on Hemopure allows a Phase III clinical trial under a federal regulation that waives a patient's consent to participate. The product is meant to be used in emergency situations when fresh blood is not readily available, and often, those who would benefit from such a product are not conscious.

I have been following the research and the companies that are working on blood substitues for some time now and even applied for a job at one such company in CO in the early 90's. There are always issues with immune reactions or the product being unstable. I really dont see a profitable market here anytime soon in my scientific opinion.