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IDEC Pharmaceuticals' PRIMATIZED Anti-CD4 Antibody Demonstrates Clinical Activity in Severe Asthma
SAN DIEGO, May 19 /PRNewswire/ -- IDEC Pharmaceuticals Corporation and SmithKline Beecham today announced positive results of a pilot Phase I/II single dose, dose-ranging study of a PRIMATIZED(R) anti-CD4 monoclonal antibody, in patients with chronic, severe asthma. IDEC and its partner, SmithKline Beecham Pharmaceuticals, are co-developing IDEC-CE9.1/SB210396, which is also currently undergoing Phase III clinical testing for the treatment of rheumatoid arthritis.
SmithKline Beecham sponsored the randomized, double-blinded, placebo- controlled study to assess the activity of three dose levels (0.5, 1.5 and 3.0 mg/kg) of a single intravenous infusion of IDEC-CE9.1/SB210396 in 22 severe asthmatics requiring chronic corticosteroid therapy to control their disease. The clinical investigators saw a significant dose-dependent improvement in lung function (increased morning and evening peak expiratory flow rate) and symptom scores in the 3.0 mg/kg group. The patients tolerated treatment with the antibody well, and the investigators reported no serious adverse events. Treatment with IDEC-CE9.1/SB210396 produced only a transient decrease in circulating CD4+ lymphocytes.
"These results provide further supportive evidence that CD4+ lymphocytes play an important role in chronic severe asthma and suggest that IDEC- CE9.1/SB210396 may provide a useful adjunct to corticosteroids in the treatment of severely affected patients," said Alan Solinger, M.D., IDEC's director, clinical therapeutics.
Results of the asthma study were reported by clinical investigators from the London Chest Hospital, SmithKline Beecham Pharmaceuticals and the Imperial College School of Medicine at the National Heart and Lung Institute (United Kingdom) at the American Thoracic Society conference in San Francisco.
Genetically engineered from cynomolgus macaque monkey and human components, PRIMATIZED antibodies are structurally indistinguishable from human antibodies. Therefore, PRIMATIZED antibodies are less likely to cause adverse reactions in humans, making them potentially suited for long-term, chronic treatments. To date, IDEC Pharmaceuticals Corporation has received four Notices of Allowance from the United States Patent and Trade Office for patents covering the company's PRIMATIZED antibody technology.
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The statements made in this press release contain certain forward looking statements that involve a number of risks and uncertainties. Actual events or results may differ from the company's expectations. In addition to the matters described in this press release, timelines for clinical ongoing activity are subject to change, results of pending or future clinical trials cannot be accurately predicted and decisions by the FDA and other regulatory agencies, as well as the risk factors listed from time to time in the company's SEC filings, including but not limited to its Annual Reports on Form 10-K for the year ended December 31, 1996, and Form S-3 filed May 3, 1996, may affect the actual results achieved by the company.
IDEC Pharmaceuticals and PRIMATIZED are registered U.S. trademarks of the company. The company headquarters is located at 11011 Torreyana Road, San Diego, CA 92121. |