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|  |  Celgene Corporation (CELG) Release: Clinical Data On Thalidomide Reported In Recurrent Epithelial Ovarian CancerPress Release November 3, 2005 SUMMIT, N.J., Nov. 3 /PRNewswire-FirstCall/ -- Celgene Corporation announced today that preliminary clinical data was reported at the XXIII Chemotherapy Foundation Symposium in New York City, New York on T hursday, November 3, 2005 comparing the efficacy and safety of the combination of thalidomide and topotecan vs. topotecan being studied in a Phase II Clinical study for the treatment of recurrent epithelial ovarian cancer in patients who had received prior treatments. Ovarian cancer is the fifth most common cancer among women, and the American Cancer Society estimates that about 25,580 new cases of ovarian cancer will be diagnosed in the United States in 2005. Ovarian cancer accounts for 4% of all cancers in women and close to 16,000 women are expected to die of ovarian cancer in the U.S. in 2005. "Our clinical findings have shown that thalidomide may slow down the growth of ovarian cancer, which could mean more options for physicians treating ovarian cancer, though further clinical studies are warranted," says Levi Downs, M.D., assistant professor of gynecologic oncology and researcher at the University of Minnesota's Medical School and Cancer Center who led this study. At the Chemotherapy Foundation Symposium oral presentation, Levi S. Downs Jr., M.D., Assistant Professor of the University of Minnesota Medical School, Division of Gynecologic Oncology, Minneapolis, Minnesota highlighted a multicenter, randomized Phase II trial comparing the clinical response in women with recurrent ovarian cancer treated with topotecan with or without thalidomide. Dr. Downs reported that patients in the topotecan plus thalidomide arm reported an overall response rate of 50% compared to 22% of patients in the topotecan only arm. Preliminary analysis of the topotecan plus thalidomide arm, 32% of the patients achieved a complete response (CR) as compared to 16% of patients achieving a CR in the topotecan only arm (p=0.03). Furthermore, the preliminary clinical data suggests that patients in the topotecan plus thalidomide arm achieved a median progression free survival (PFS) of 6 months compared to 4 months in the topotecan only arm (p=0.02). The median overall survival (OS) was 19 months for patients in the topotecan plus thalidomide arm and 15 months in the topotecan only arm (p=0.95). Further clinical studies are being planned to confirm these preliminary results. About the Phase II Study This multicenter prospective randomized trial enrolled 75 women between April 2001 and July 2005. Based on an intent-to-treat analysis, the study evaluated 69 women (thalidomide n=28; control n=37). Six patients were excluded for never receiving treatment (thalidomide n=4; control n=2), and patients who were not assessable for response were considered non-responders. Eligible patients had recurrent or persistent epithelial ovarian carcinoma as documented by exam, imaging study or elevated CA-125. Patients had received 1 or 2 prior platinum based chemotherapy regimens. Treatment arms were topotecan 1.25 mg/m2 days 1-5 of a 21-day cycle with or without thalidomide starting at 200 mg/day and increased as tolerated to 800 mg/day. Patients were registered in the "System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)) program to assure proper consent and safe use of thalidomide. Toxicity was graded according to NCI-CTC. The Chi Square test was used to assess differences in response and toxicity. Log rank test was used to compare Kaplan-Meyer survival curves. Well-characterized prognostic factors, including platinum sensitivity (70% of patients) were equally represented in both arms of the study. The median thalidomide dose was 200mg/day, and toxicities were similar between both groups. Adverse events observed were fatigue, constipation, peripheral neuropathy and deep vein thrombosis.
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