To: Biomaven who wrote (4545 ) 8/27/2001 4:50:26 PM From: RCMac Respond to of 52153 >> What conceivably might have happened is that there were indeed adverse effects with the BPUR product that were picked up by the TSC "contributors," but there were a similar number in the group receiving blood. << Peter, That's exactly what BPUR CEO Rausch told Reuters: "Monday August 27 4:29 PM ET Biopure Shares Soar on Hemopure Results By Toni Clarke NEW YORK (Reuters) - Shares of Biopure Corp.,(Nasdaq:BPUR - news) jumped 23 percent on Monday after the biotechnology company said a late-stage clinical trial showed its experimental substitute blood product is comparatively safe. The Cambridge, Massachusetts-based company's shares soared $4.65, or 23 percent, to $24.55 on Nasdaq. Biopure said results of its Phase III trial, the last needed before it applies for new drug status later this year, showed Biopure's Hemopure product met its primary goal, or ''endpoint.'' That goal was to show that patients receiving Hemopure were as safe as those receiving donated red blood cells. Hemopure is an oxygen-carrying chemically modified form of hemoglobin derived from cows. It contains no cells, platelets or plasma, and at this stage is suitable for elective, but not emergency, surgery. ``This clinical milestone is an important step toward addressing the critical issue of blood availability on a worldwide basis,'' said Carl Rausch, the company's chief executive officer, in a statement. The results come two weeks after an online news site, TheStreet.com, accused Biopure of hiding the fact that some patients given Hemopure suffered temporary kidney failure and heightened blood pressure. The report pushed the stock down 11 percent in one day.In an interview, Rausch did not deny that there were some negative ``events'' among patients taking Hemopure. But he said they were no more numerous than in the control group receiving regular blood. ``What we can say is that the incidence of these events was low in both groups,'' Rausch said. ``There is no statistical significance to these events that we know of.'' Rausch declined to say exactly how many negative events took place in either group, or what caused each event. He said further details will be released at medical meetings once final analysis of the data has been completed. ``The actual patient-by-patient analysis will be more difficult,'' he said. ``We are not ready to put the number of events on the label.'' Biopure aims to capture a slice of the blood transfusion market in elective surgery, which analysts estimate could be worth as much as $6 billion in the U.S. alone. It is already approved for use in South Africa. Later the company will try to develop a product for emergency use. ``The growth in the demand for blood is exceeding supply,'' said Lawrence Neibor, an analyst at Robert Baird & Co., who has a 'strong buy' recommendation on the stock. ``There is demand for a product with longer life than blood, that doesn't have to be refrigerated and has a more reliable source.'' Biopure is competing with Northfield Laboratories Inc. (NFLD.0), which plans to file for regulatory approval of its PolyHeme blood substitute within days. PolyHeme is derived from human blood. Hemosol Inc. (HML.TO) of Canada also is making a human-derived blood substitute. It faces a delay in a clinical trial. Alliance Pharmaceutical (AALP.0), another competitor, recently said it needs to conduct another Phase III trial to test its product in general surgery patients."dailynews.yahoo.com