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 TNF Inhibitor
Recent studies have used ENBREL, a genetically engineered soluble receptor, that works by binding to TNF and preventing it from interacting with cell surface receptors that are on the cells in the heart and circulatory system.
Human Trials
At the American College of Cardiology annual conference in early March, results of a double-blind, randomized, placebo-controlled multi-dose Phase I safety study in 47 heart failure patients demonstrated that ENBREL was well tolerated and incidence of adverse events was similar in all treatment groups. The study was conducted by Dr. Douglas Mann and Dr. Guillermo Torre-Amione at Baylor College of Medicine, and Dr. Arthur M. Feldman at University of Pittsburgh Medical Center.
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.
NOTE: 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 risks described from time to time in the SEC reports filed by Immunex, including the most recently filed form 10-K and form 10-Q. For more information, please refer to www.immunex.com.
An electronic version of this news release - as well as additional information about Immunex of interest to investors, customers, future employees and patients - is available on the Immunex home page at www.immunex.com.
Tuesday, June 1, 1999
Mark Leahy 206-389-4363 (investors)