Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, announced today topline results from APPRAISE, the company’s Phase 2b, randomized discontinuation, double-blinded, placebo-controlled, study of oral seliciclib capsules as a third or more line treatment in patients with non-small cell lung cancer (NSCLC). Topline results, after unblinding the treatment assignment among randomized patients, showed that there was no difference between the seliciclib and placebo arms in terms of median progression free survival, or PFS, (48 versus 53 days respectively) but an increase in median overall survival was observed favoring the seliciclib arm over the placebo arm (388 versus 218 days respectively).
“We were encouraged to discover an increase in overall survival favoring the seliciclib arm despite observing no difference in PFS and allowing patients whose cancer had progressed on placebo to cross-over to the seliciclib arm,” said Dr. Judy Chiao, Vice President of Clinical Development and Regulatory Affairs of Cyclacel. “We plan to collect and analyze available biopsy samples from APPRAISE patients to assess whether there is a biological basis for these results.”
Date: December 21, 2010
Source: Cyclacel Pharmaceuticals, Inc.
Filed Under: Drug Discovery
