To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: PRIMATIZED Monoclonal Antibody Appears Safe and Effective URL: http://www.pslgroup.com/dg/D0FE.htm Doctor's Guide October 21, 1996
ORLANDO, Fla., Oct. 21, 1996 -- IDEC Pharmaceuticals (Nasdaq: IDPH) and SmithKline Beecham Pharmaceuticals (Nasdaq: SBH) have announced the results of a Phase II placebo-controlled, multicenter trial using a PRIMATIZED, non-depleting, anti-CD4 monoclonal antibody in the treatment of rheumatoid arthritis. The PRIMATIZED antibody, IDEC-CE9.1/SB 210396, is being jointly developed by the two companies. In the randomized, double-blinded, multiple-dose study, patients with active rheumatoid arthritis experienced a clinically significant improvement in symptoms when treated intravenously with IDEC-CE9.1/SB 210396. Treatment with the PRIMATIZED monoclonal antibody was also found to be well tolerated. Patients experienced minimal side effects, no infusion-related adverse events were reported, and prolonged depletion of CD4+ T cells did not occur: Results of the Phase II trial were presented on October 19 by investigator Craig Wiesenhutter, MD, at the annual meeting of the American College of Rheumatology held in Orlando, Florida. Phase II Trial Results A total of 122 evaluable patients received either 40 mg, 80 mg or 140 mg intravenous doses of IDEC-CE9.1/SB 210396 or intravenous placebo in the Phase II trial. Patients were randomized to treatment after withdrawal from DMARD therapy and a four-week period of disease stabilization. The respective doses were administered twice weekly over a four-week period. A clinically significant treatment response, as measured in accordance with the American College of Rheumatology guidelines (ACR 20 criteria), was experienced by 77% of the patients in the highest dosage group (140 mg). Likewise, 47% of patients responded to treatment in the 80 mg group, and 42% responded in the 40 mg group, compared to 17% of patients in the placebo group. The ACR 20 guidelines require an improvement in tender and swollen joint counts that is at least 20%, along with improvements in 3 of 5 other disease-related categories. In the 140 mg, 80 mg and 40 mg groups, the median time to clinical response was 1 week, 2 weeks and 2.5 weeks, respectively. Treatment of the 140 mg group was discontinued due to the development of rashes; however, this adverse event was not observed in the other dose groups. PRIMATIZED Antibodies PRIMATIZED antibodies are a new class of monoclonal antibodies that have been genetically engineered by IDEC Pharmaceuticals utilizing macaque monkey and human components. Due to their structural similarity to human antibodies, PRIMATIZED antibodies are less likely to cause adverse reactions in humans than monoclonals that have been derived from mice. PRIMATIZED antibodies, therefore, show potential in the treatment of chronic diseases. Anti-CD4 Antibodies PRIMATIZED anti-CD4 antibodies represent a unique approach to the treatment of rheumatoid arthritis. The antibodies work by binding to the CD4 protein on helper T cells. This action disables and reduces the T-cell activity and autoimmune processes involved in inflammation and tissue damage, potentially slowing disease progression. Traditional treatments for rheumatoid arthritis such as aspirin and non-steroidal anti-inflammatories (NSAIDS) temporarily relieve disease symptoms. Corticosteroids and so-called disease-modifying antirheumatic drugs (DMARDs) such as gold, antimalarial drugs, d-penicillamine, and methotrexate are more powerful than aspirin and NSAIDS, but are slow-acting and have serious side-effects, and contrary to their coined name, DMARDs rarely modify the natural course of the disease. By having the potential to actually interrupt the inflammatory process, PRIMATIZED anti-CD4 monoclonal antibodies show great promise in the treatment of chronic inflammatory diseases such as rheumatoid arthritis. IDEC Pharmaceuticals is a leader in the development of targeted immunotherapies for cancer and autoimmune diseases. IDEC's products are primarily designed to act through immune mechanisms and potentially offer greater specificity of action, longer therapeutic effect and lower toxicity than is typical of existing therapies. Designed for administration in outpatient settings, IDEC's products also offer the potential for reduced treatment costs. SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures, and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products, and provides healthcare services including clinical laboratory testing, disease management, and pharmaceutical benefit management. 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 Report on Form 10-K for the year ended December 31, 1995, and Form S-3 filed May 3, 1996, may affect the actual results achieved by the company. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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