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Cyclacel Pharmaceuticals Announces Results of Phase II Seliciclib,Combination Studies

BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Jun 28, 2007 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP) announced today the results from two Phase II non-randomized studies of seliciclib fixed dose combinations. In one study seliciclib was given in combination with gemcitabine and cisplatin and in another with docetaxel in patients with advanced non-small cell lung cancer (NSCLC).

The primary objectives of the studies were to assess the safety and efficacy of the two combinations. In the first study, 45 patients with advanced NSCLC, who were previously untreated or treated with no more than one prior chemotherapy, were enrolled and treated with the combination of seliciclib plus gemcitabine and cisplatin. Seliciclib was administered twice daily (b.i.d.) by mouth for 4 days every week. Gemcitabine was administered once a week for two weeks followed by one week of rest. Cisplatin was administered once every three weeks. Patients were entered into 3 seliciclib cohorts dosed at 400 mg b.i.d. (n=3), 800 mg b.i.d. (n=36) and 1200 mg b.i.d. (n=6). In the second study, 7 patients with advanced NSCLC who have had one prior chemotherapy were enrolled and treated with the combination of seliciclib plus docetaxel. Seliciclib was administered at 1600 mg b.i.d. for 3 days every 3 weeks. Docetaxel was administered once every three weeks. The combination study with docetaxel was discontinued early due to slow accrual.

The best response by investigator assessment consisted of 9 patients with partial response and 21 with stable disease in patients treated with the combination of seliciclib plus gemcitabine/cisplatin and 2 with partial response and 1 with stable disease in the combination of seliciclib plus docetaxel. The major dose-limiting toxicities were nausea, vomiting, fatigue, hypokalemia and elevation in liver enzymes which were primarily attributed to seliciclib. There were no unexpected toxicities.'"/>




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