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

To: scaram(o)uche who wrote (596)	10/22/2001 11:52:03 AM
From: scaram(o)uche	Respond to of 656

Monday October 22, 11:00 am Eastern Time Press Release SOURCE: Centocor, Inc. Centocor Places Congestive Heart Failure Clinical Program on Hold MALVERN, Pa., Oct. 22 /PRNewswire/ -- Centocor, Inc. announced today that, following evaluation of the preliminary results of an ongoing Phase II clinical trial, further development of REMICADE® (infliximab) for the treatment of patients with advanced congestive heart failure (CHF) has been placed on hold. The results demonstrated no improvement in patients' clinical status and showed higher incidence of mortality and hospitalization for worsening heart failure in REMICADE-treated patients, especially those treated at the higher dose of 10 mg/kg. This trial evaluated three infusions of REMICADE 5 mg/kg, REMICADE 10 mg/kg, or placebo over six weeks in patients with NYHA Class III-IV congestive heart failure. These patients typically experience either a marked limitation in, or a complete inability to, carry on any form of physical activity. Over the next several weeks, Centocor will continue to follow patients who participated in the trial to better characterize the risks posed to patients with advanced CHF. In the interim, Centocor, in consultation with the U.S. Food and Drug Administration (FDA), has mailed a ``Dear Doctor'' letter communicating these preliminary results to health care professionals nationwide, and providing guidance on the management of patients receiving REMICADE who have concomitant CHF. (A copy of this letter can be found at remicade.com.) Although experimental preclinical studies and previous small clinical trials suggested that therapy targeted at TNF might be of benefit in patients with CHF, this and other recent trials have failed to demonstrate that agents that bind TNF can improve the clinical course in these patients. ``Centocor is committed to ensuring that REMICADE is used safely and effectively,'' said Jerry Boscia, M.D., vice president of clinical research and development. ``With more than 170,000 patients treated worldwide since its introduction in 1998, the benefit-to-risk ratio of REMICADE is well established.'' He added that the company is fully committed to continuing its clinical development program for REMICADE in other indications. REMICADE was the first biologic approved by the FDA for short-term use in patients with Crohn's disease who have had inadequate response to conventional therapy. REMICADE is also indicated, in combination with methotrexate, for reducing the signs and symptoms and inhibiting progression of joint damage in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate alone. Centocor is a leading biopharmaceutical company that creates, acquires and markets cost-effective therapies that yield long-term benefits for patients and the healthcare community. Its products, developed primarily through monoclonal antibody technology, help physicians deliver innovative treatments to improve human health and restore patients' quality of life. Centocor is a wholly owned subsidiary of Johnson & Johnson, a worldwide leader in healthcare products. For more information and current REMICADE labeling, visit Centocor's web site at centocor.com. Media Contact: Susan Thiele 212-583-2740 SOURCE: Centocor, Inc.

To: scaram(o)uche who wrote (596)	12/9/2001 3:38:21 PM
From: teevee	Read Replies (1) \| Respond to of 656

Richard, Off topic: Isotechnika claims that its drug ISAtx247 is a potent immunosuppressant that is well tolerated, but will it have a low rate of opportunistic infections? You stated that universal immunosuppression kills people. Is that comment related to the rate of opportunisitic infections associated with suppressing the immune system? How likely is it that a well tolerated, potent immunosuppressant would have a high rate of opportunistic infections? What are the most likely "infections": bacterial?, viral?, or cell mutations unchecked by the immune system leading to cancer?Thank you for you comments. regards, teevee