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Biotech / Medical : Celgene-CELG -- Ignore unavailable to you. Want to Upgrade?

To: mike head who wrote (178)	11/24/1998 10:03:00 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 804

One step forward! Celgene Corporation Files SelCID(TM) Compound IND as Possible Treatment for Crohn's Disease Phase II Clinical Trials to be Launched at Cedars-Sinai Medical Center in Los Angeles WARREN, N.J., Nov. 24 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG - news) announced today that the Company, has filed an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) for its lead Selective Cytokine Inhibitory Drug (SelCID™) CDC 801, for the treatment of Crohn's Disease. Celgene anticipates that it will soon initiate Phase II clinical trials of CDC 801 at the Cedars-Sinai Medical Center in Los Angeles. ''Results of earlier Crohn's Disease trials inhibiting TNF yielded highly promising results, even in patients with severe disease. This experience afforded an excellent foundation for pursuing drugs such as CDC 801,'' said Stephan Targan, M.D., Director of the Division of Gastroenterology and the Inflammatory Bowel Disease Center at Cedars-Sinai, and lead investigator on the planned Phase II trial. Extensive preclinical studies determined that SelCIDs are selective, potent inhibitors of the overproduction of tumor necrosis factor (TNF). TNF is a cytokine that causes a destructive immune response implicated in the pathology of several prevalent inflammatory diseases, including Crohn's Disease. A multiple oral dose Phase I study of CDC 801 found that the agent was well tolerated. ''In the laboratory, the SelCIDs have an apparent dramatic and sustained effect on TNF overproduction. Many patients with Crohn's Disease have TNF overproduction in the gut lining,'' said Dr. Targan. The Crohn's and Colitis Foundation of America (CCFA) estimates that between one and two million Americans suffer from Crohn's and related inflammatory bowel disease. Incidence rates for Crohn's Disease have significantly increased in the 60 years since it was first described, according to the CCFA. Economic costs for Crohn's Disease and ulcerative colitis are estimated at between $1.8 and $2.6 billion per year. ''Filing of the IND and the pending Phase II evaluation of CDC 801 are major milestones for our SelCIDs program, and in our Company's development,'' said Sol J. Barer, Ph.D., President and COO of Celgene. ''We are excited that our novel SelCID product portfolio has made such rapid and continual progress. The SelCID family is poised to offer substantial commercial and medical opportunities as it moves through development and clinical evaluation.'' Celgene has already filed more than 20 patents worldwide related to SelCIDs; eight have issued in the U.S., all covering novel structural families of compounds. Celgene Corporation, headquartered in Warren, NJ, is engaged in the development of pharmaceuticals and agrochemicals. This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as 10K, 10Q, and 8K reports. SOURCE: Celgene Corporation --------------------------------------------------------------------------------