To: SnowShredder who wrote (433 ) 2/29/2000 10:09:00 PM From: Miljenko Zuanic Respond to of 804
Tuesday February 29, 7:30 am Eastern Time Company Press Release SOURCE: Celgene Corporation Celgene Advances Immunomodulatory Drug (IMiD(TM)) Clinical Program Novel Drugs Well-Tolerated, Non-sedating in Initial Clinical Study; Lead candidate to Move Quickly into Phase I/II Trial for Myeloma WARREN, N.J., Feb. 29 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG - news) today announced the results of its initial Phase I clinical studies of the first two compounds from its proprietary class of Immunomodulatory Drugs (IMiDs). The IMiDs are a class of orally available small molecule compounds that are structurally and mechanistically similar to thalidomide and are designed with the objective of improving the beneficial characteristics of thalidomide and eliminating its adverse effects. Previously published reports have documented the IMiDs improved potency in animal models and in in vitro systems including enhanced anti-angiogenic and TNF-a modulating properties. In addition, preliminary evaluations in animal models have demonstrated that the lead IMiDs did not cause birth defects. The two IMiDs evaluated were found to be well-tolerated in healthy human volunteers in the double blind, placebo controlled trials. Each IMiD was administered orally in a single ascending dose in thirty subjects. No serious adverse events were reported in the trials which were conducted in the United Kingdom. Importantly, sedation which can be a significant and undesirable characteristic of thalidomide, was not detected in these trials. Celgene also announced that the clinical development of the lead IMiD CDC-501 is planned to be initiated with Phase I/II clinical studies in multiple myeloma patients at Dana-Farber Cancer Institute and other institutions nationwide. In laboratory studies, the IMiDs were potent inhibitors of myeloma cells. ``The IMiDs are among the most potent molecules tested in our early preclinical laboratory tests of human multiple myeloma. I look forward to examining the results of upcoming studies to evaluate their safety and possible efficacy in myeloma patients.' said Ken Anderson, M.D., Associate Professor of Medicine at Harvard Medical School and Dana-Farber Cancer Institute. ``Having successfully completed this trial, we intend to accelerate and broaden the development of the IMiD(tm) class for a wide range of oncologic and immunologic indications. The growing data regarding thalidomide provides us with a valuable road map for this class of compounds' said Sol Barer, Ph.D., President and COO of Celgene Corporation.