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Circulation publishes phase I study of ENBREL in patients with chronic heart failure

SEATTLE - A Phase I study published today in CIRCULATION: Journal of the American Heart Association, demonstrates ENBREL® (etanercept, a soluble TNF p75 receptor) was well tolerated in patients with advanced heart failure. The study also suggests that ENBREL may lead to improvement in the functional status of patients with chronic heart failure. This is the first published paper of an ENBREL study in chronic heart failure.

The study was conducted by Dr. Douglas Mann of the Veterans Administration Medical Center and Baylor College of Medicine in Houston Texas and Immunex Corporation, Seattle WA. The randomized, double-blind dose escalation study consisted of 18 patients with New York Heart Association class III heart failure and elevated TNF levels. Patients were randomized to receive a single intravenous infusion of one of three doses of ENBREL or placebo. Patients receiving ENBREL had increased quality of life scores, with a 6-minute walk distance and ejection fraction from baseline while those on placebo had no significant increases in these measurements from baseline. ENBREL was well tolerated without any significant adverse effects.

RENAISSANCE Trial

Immunex Corporation (NASDAQ:IMNX) and Wyeth-Ayerst Laboratories began a Phase II/III clinical trial (called the RENAISSANCE Trial - Randomized ENBREL North American Strategy to study Antagonism of Cytokines) with ENBREL® (etanercept) in chronic heart failure patients, one of the first large-scale studies undertaken to evaluate cytokine inhibition, a new approach to studying chronic heart failure.

The Role of TNF in Chronic Heart Failure

Research has shown that tumor necrosis factor TNF is present in increased amounts in damaged heart tissue. TNF exerts its effects by interacting with specific TNF receptors that are on the surface of cells. When TNF binds with TNF receptors, it sets off a chain of events within the cell that may lead to further damage to the heart.

ENBREL® - a
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Contact: Pam Rabe
prabe@immunex.com
206-470-4131
Immunex Corporation
1-Jun-1999


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