To: Ian@SI who wrote (1293 ) 10/31/2000 8:21:14 AM From: Ian@SI Read Replies (1) | Respond to of 1477 SUNNYVALE, Calif., Oct 31, 2000 /PRNewswire via COMTEX/ -- Scios Inc. (Nasdaq: SCIO) today announced the initiation of a human Phase I, double-blind, placebo-controlled, dose-ranging clinical study evaluating the safety and tolerability of SCIO-469, the company's investigational compound for the treatment of rheumatoid arthritis (RA). The Company also announced that researchers presented preclinical data today involving Scios' p38 kinase inhibitors at the 64th Annual Scientific Meeting of the American College of Rheumatology (ACR) in Philadelphia. Preclinical data show SCIO-469 inhibits p38 kinase, a modulator of pro-inflammatory factors including tumor necrosis factor-alpha (TNF alpha), IL-1, and cyclooxygenase-2 (COX-2), which are known to contribute to both symptoms and disease progression in patients with RA. Proteins that antagonize TNF alpha have been shown to markedly relieve the symptoms and retard the progression of RA. "Our expertise in molecular biology and combinatorial chemistry have come together to quickly develop a new molecule that inhibits p38 kinase, a central link to numerous inflammatory diseases," said George Schreiner, M.D., Ph.D., Scios' chief scientific officer. "Through integration of the most recent advances in drug discovery technology, we have developed a uniquely efficient and rapid process by which we can develop novel therapeutics for unmet medical needs. Unlike currently available treatments that completely inhibit TNF alpha and may have unwanted side effects associated with over-suppression of the immune system, SCIO-469 is an oral formulation that can be titrated to modulate, rather than totally inhibit, TNF alpha production. We believe clinical studies with SCIO-469 could lead to the next major treatment advance for RA." The Phase I trial will enroll approximately 30 healthy volunteers, evaluate a total of six different oral doses of SCIO-469 for safety and tolerability, and evaluate pharmacokinetic differences in female and elderly populations. The trial is being conducted in England, and results should be available during the first quarter of 2001. RA is a progressively worsening autoimmune disease of unknown origin in which the body's natural immune system attacks healthy joint tissue causing inflammation and joint damage. Over 2.1 million Americans -- nearly two thirds of which are women -- suffer from RA. "Our success in advancing SCIO-469 into clinical development is testimony to our ability to generate drug targets quickly, assess their market potential, and make focused development decisions," said Richard B. Brewer, Scios' President and Chief Executive Officer. "Development of SCIO-469 from preclinical research to initiation of the Phase I study progressed with tremendous speed." Scios also announced that an abstract entitled "Inhibition of Collagen-Induced Arthritis with a p38-kinase Inhibitor" was presented today at the ACR meeting. The study demonstrated that Scios' p38 kinase inhibitors had statistically significant anti-inflammatory effects in both acute and chronic animal models of inflammation. A copy of this abstract is available on-line at rheumatology.org , or from Scios' website at sciosinc.com . Scios Inc. Scios is a biopharmaceutical company developing novel treatments for heart failure and rheumatoid arthritis. The company's disease-based technology platform integrates expertise in protein biology with combinatorial and medicinal chemistry to identify novel targets and rationally design large- and small-molecule compounds to treat cardiovascular and inflammatory diseases, two of the world's leading unmet medical needs. Additional information on Scios is available at its web site located at sciosinc.com and in the company's various filings with the Securities and Exchange Commission.