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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: Tharos who wrote (5126)	12/16/1997 5:21:00 AM
From: Walter R. Roche	Respond to of 17367

Unfortunately maybe not, Genetically Engineered Transplant Drug Approved By Maggie Fox, Health and Science Correspondent WASHINGTON (Reuters) - A new drug that works with the immune system to prevent it from rejecting organ transplants was approved by the U.S. Food and Drug Administration Thursday. The drug, to be sold by Hoffman-La Roche under the name Zenapax, is the first human monoclonal antibody to get approval from the FDA for organ transplants. It uses the body's own immune system to prevent the acute rejection that can make kidney transplants fail. It works alongside other drugs that tone down the immune system so that it does not attack the transplanted organ. Monoclonal antibodies are genetically engineered molecules that have been altered so they home in in specified cells. In the case of Zenapax, these are the T-cells that are meant to protect the body from attack by invaders such as parasites or bacteria. The T-cells fire up and attack what they see as a giant alien invader -- a transplanted kidney. Zenapax, known generically as daclizumab, stops the T-cells from attacking by blocking the compound, interleukin-2, that activates the T-cells in the first place. ''It basically targets specific cells in the immune system that are activated by a transplant,'' an FDA spokeswoman said. ''The ability of Zenapax to selectively block certain T-cells from attacking the new kidney -- without shutting down the entire immune system -- is a significant step in reducing the risk of organ rejection and improving survival rates,'' Dr John Neylan, a transplant expert at Emory University in Atlanta, said in a statement. The trouble with immunosuppressive drugs is that they do shut down the immune system, leaving the transplant patient open to infection or cancer. Zenapax was discovered by Mountain View, Calif.-based Protein Design Labs Inc and is licensed to Roche for development and marketing. The FDA said its approval was based on two clinical trials that showed the drug significantly reduced acute rejections in patients who got the drug along with the standard three-drug cocktail of immunosuppressant drugs. Patients on Zenapax had 37 to 40 percent fewer rejection episodes than those given a placebo. They also lived longer. ''Zenapax is a breakthrough drug because for the first time we have a drug that can significantly improve the efficacy of organ transplantation without an increase in drug toxicity,'' Dr Flavio Vincenti, a professor of clinical medicine at the University of California, San Francisco, said in a statement'' But the FDA spokeswoman said, ''The long-term effects on the immune system are not clear.'' Roche has has filed for approval to market Zenapax in Europe, Canada and other countries. Although Zenapax is approved specifically for kidney transplants, the company hopes there will be ''off-label'' use for other kinds of transplants. ''There's reason to think that it will,'' Fred Kurland, chief financial officer of Protein Design Labs said. He hoped for a large market, and noted there are about 12,000 kidney transplants a year in the United States. ''I would assume that everyone who is going through a kidney transplant is an eligible candidate,'' he said. Monoclonal antibodies are starting to succeed in the drug market. Reopro, a joint project by Centocor and Eli Lilly, has been used by more than 260,000 heart patients since its launch in 1995. Known generically as abciximab, it stops blood platelets from clotting up. Last month the FDA approved Genentech's drug Rituxan, a monoclonal antibody genetically engineered to target cancer cells in non-Hodgkin's lymphoma. It flags B cells, the type of immune cells that multiply out of control in the cancer. Reut18:16 12-11-97 (11 Dec 1997 18:14 EST)