- SEAMLESS DSMB recommended that the study should continue as planned - - Company to Present at the Biotech Showcase™ 2013 Conference on Monday January 7, 2013 at 3:15 pm PT -
BERKELEY HEIGHTS, N.J., Jan. 7, 2013 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company) today reviewed 2012 achievements and provided an outline of the Company's key clinical development objectives for 2013, which will be highlighted at the Company's presentation during the Biotech Showcase™ 2013 Conference at 3:15 pm Pacific Time on Monday, January 7, 2013, at the Parc 55 Wyndham Hotel in San Francisco, CA.
"During 2012, we advanced the clinical development of sapacitabine in multiple indications. For example, in our SEAMLESS, Phase 3, registration-directed study, of sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (AML), our lead indication, we exceeded 100 patients enrolled with 37 trial sites open," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "In addition, the independent committee overseeing SEAMLESS recently recommended that the study should continue as planned and identified no safety or efficacy concerns. We are encouraged by the continued investigator interest in SEAMLESS and plan to open additional sites during 2013. Updated survival data in AML with sequential administration of sapacitabine and decitabine is promising and provided further support for the SEAMLESS Phase 3 study. With regard to other disease indications, recent Phase 2 data demonstrated that sapacitabine nearly doubled expected survival of elderly patients with myelodysplastic syndromes (MDS) after treatment failure of hypomethylating agents. For 2013, we are focused on executing our product development plan for sapacitabine in AML, MDS and other cancers using, among other funds, the proceeds of the recent funding agreement with Aspire Capital. We are also advancing CYC065, our second-generation cyclin dependent kinase (CDK) inhibitor, enabled by a $1.9 million grant from the UK Government."