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Biotech / Medical : Immunex -- Ignore unavailable to you. Want to Upgrade?

To: mike head who wrote (193)	3/10/1998 1:21:00 PM
From: mike head	Read Replies (2) \| Respond to of 656

Nice press release! ÿ Immunex Announces First Trial Results With Enbrel(TM) in Combination With Methotrexate for Rheumatoid Arthritis March 10, 1998 9:00 AM EST Positive Results in New Patient Population Reported SEATTLE, March 10 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX) announced today that rheumatoid arthritis (RA) patients treated in a clinical trial with Enbrel(TM) (TNFR:Fc) in combination with methotrexate experienced a statistically significant decrease in disease activity and an increase in their functional ability when compared to methotrexate alone. Enbrel is Immunex's investigational new drug that has previously reported positive clinical results in Phase II and Phase III trials involving advanced stage RA patients who have failed methotrexate and other similar drugs. In addition, the new results indicate that the combination therapy of Enbrel and methotrexate was well tolerated. There was no significant difference in the rate of occurrence of side effects between the treatment groups. "This study provides new information about Enbrel in a population of patients who are responsive to methotrexate," said Ann Hayes, MD, Immunex Senior Vice President, Medical Development. "In this patient population, the addition of Enbrel to methotrexate significantly improved patient outcomes without increased side effects. These results are important because methotrexate is today thought to be a standard of care for RA." A formal presentation of the data from this Enbrel combination study will occur at a forthcoming scientific meeting. This combination study was conducted in 89 patients at seven sites throughout the US. To qualify for this randomized, double-blind, placebo-controlled trial, patients were required to have RA, and to have been treated with methotrexate for at least six months immediately prior to the trial. In the trial, all patients were treated with a stable dose of 12.5 - 25 mg per week of methotrexate, and were required to have been on the stable dose for one month prior to the initiation of the trial. For the 6 month trial, the patients were randomized to receive either a 25 mg dose of Enbrel twice a week in combination with their stable dose of methotrexate, or to receive placebo twice a week, with their stable dose of methotrexate. Patients on this trial were not allowed to be on any other "disease modifying" drug. Safety was the primary endpoint for this study, with secondary efficacy endpoints of ACR 20 and ACR 50 at 6 months. Enbrel is a protein-based drug comprising only human amino acid sequences, scientifically referred to as a recombinant version of the soluble p75 TNF receptor linked to the Fc portion of human IgG1. It competitively inhibits the binding of TNF to its cell surface receptors, and thereby inhibits TNF biological activity. Enbrel is thought to interfere specifically with the inflammatory process in RA, which may be driven by TNF. In RA, excess TNF combines with cell surface TNF receptors and produces a cascade of damaging and inflammatory effects on joints. The clinical studies mentioned in this release are part of a global co-development program involving Immunex and American Home Products Corp. (AHP), which are working together to study the potential clinical applications of Enbrel. Pending FDA review and licensing, Immunex and Wyeth-Ayerst, a division of AHP, will co-promote ENBREL in North America. Wyeth-Ayerst will market ENBREL outside of North America. Immunex Corporation is a biopharmaceutical company dedicated to developing immune system science to protect human health. The company's products offer hope to patients with cancer, inflammatory and infectious diseases. American Home Products owns a majority interest in Immunex. AHP is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, agricultural products, and animal health care. This news release contains forward-looking statements that involve risks and uncertainties, including risks associated with clinical development, regulatory approvals, patent litigation, product commercialization, and other risk described from time to time in the SEC reports filed by Immunex, including the most recently filed Form 10-K and 10-Q. SOURCE Immunex Corp. c PR Newswire. All rights reserved.