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Biotech / Medical : SANGUINE CORP. (SGNC) -- Ignore unavailable to you. Want to Upgrade?

To: chirodoc who wrote (1470)	6/20/1998 1:39:00 AM
From: Prospector	Read Replies (2) \| Respond to of 5402

W.S.J. 6/3/98 Baxter Suspends Trial of Blood Substitute By Thomas M. Burton staff reporter Baxter International Inc. Suspended a European Trial of Its Blood Substitute after Finding the Product Wasn't Producing Expected Advantages, Leaving the Company with $110 Million Production Plant in Switzerland, but no viable product to make there, at least for now. European regulatory authorities, particularly those in France, decided along with outside medical experts that the product, called HemAssist, showed no advantages over donated blood and avoiding organ failure in critically injured patients. Two months ago, the Deerfield, Illinois Company prematurely ended a U.S. as clinical trial on a similar trauma patients-victims of accidents,gun shots and knifings - after findings that more people died in the HemAssist group then in a group receiving standard treatment. The preponderance of the evidence is that the product should be buried, asserted Robert M Winslow, a professor of medicine at the University of California at San Diego and an authority on blood substitutes. Baxter was saying in that last release about the U.S. trials that things were going swimmingly in Europe. Baxter has long pointed to HemAssist as a potential Blockbuster product. Including the $110 million in the Neuchatel, Switzerland, Plant, one Baxter official estimated that the company has spent about $500 million in the effort to make a blood substitute. The company declined to provide a precise figure. Baxter said it's still plans to go ahead with the U.S. trial of the product in the elective surgery patients, and that it is studying what went wrong in Europe. In a spokeswoman said the company still believes the product is a efficacious, The company said there might have been something wrong with that design of the European trauma-patient trial, and that it still might restart the study. In New York stock exchange composite trading yesterday, Baxter shares fell $1.8752 to $54.875. Baxter had enrolled 117 patients in Germany, France and Belgium to take either HemAssist or blood and other standard emergency-care fluids. The studying ultimately was supposed to include 900 patients. But after analyzing data from 79 of the patients, regulators and outside medical experts concluded that HemAssist wasn't preventing organ failure, as had been hoped. Baxter had previously conducted safety experiments and found that the product was safe. It was the first company to enter advanced, Phase III clinical trials of blood substitute. And some early, smaller Baxter studies found that the product was able to supplant some use of donated blood in certain patients-and advantage considering the time-consuming cross matching required with human blood. Also, donated blood carries a risk of AIDS and hepatitis, through the current testing methods, that risk is getting smaller. Baxter had theorized HemAssist's tendency to raise blood pressure was a beneficial phenomenon in patients who were bleeding profusely. The company believed a large clinical trial would show fewer deaths in HemAssist patients and less more morbidity in such internal organs as the liver, brain and kidneys. Neither premise has checked out so far in the U.S. or European trials. But some doctors contend that the experience may simply highlight how difficult it is to conduct clinical trial of trauma patients, whose entries are very severe in difficult to compare with those of other critically injured people. Baxter declined to make executives available to discuss the clinical trial or to provide any specific results of the study. Dr. Winslow, who formally headed U.S. Army research in blood substitutes, said the Army almost decided to use HemAssist on injured U.S. soldiers during the Persian Gulf war in 1992, but backed away because of the blood pressure increase called vasoconstriction-associated with the product. I am sure that vasoconstriction is at the root of the problem, he said yesterday. If HemAssist fades from the scene, Baxter has some alternatives, but none that would offer speedy solutions. The company recently bought, for stock valued at $190 million, the Colorado based blood substitute Company Somatogen Inc., that has alternate products. However, doctors and industry executives said that somewhat opens most promising Next-Generation products wouldn't be ready to be marketed for a few years. Some industry executives also noted that those products couldn't be manufactured at Baxter's Switzerland Plant without major changes to the facility. That's because HemAssist is made from outdated, donated human blood. By contrast Somatogen products are recombinant, in which the gene to make an oxygen-Carrying blood substitute is inserted into a bacteria, which then mass-produce it. Prospector ( from W.S.J. )