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January 7, 2013
07:20 EDTCYCCCyclacel says SEAMLESS committee recommends study should continue as planned
Cyclacel Pharmaceuticals 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. The company said, "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, our lead indication, we exceeded 100 patients enrolled with 37 trial sites open. 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 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 inhibitor, enabled by a $1.9 million grant from the UK Government."
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September 18, 2014
07:06 EDTCYCCCyclacel Pharmaceuticals CYC065 data shows selectivity, activity
Cyclacel Pharmaceuticals announced the presentation of preclinical data demonstrating the therapeutic potential of CYC065, Cyclacel's second-generation cyclin dependent kinase, or CDK, inhibitor, to treat acute leukemias, and in particular those with rearrangements in the mixed lineage leukemia, or MLL, gene. The data showed that in vitro all human acute myelogenous leukemia, or AML, and acute lymphocytic leukemia, or ALL, cell lines with MLL rearrangements, or MLLr, tested were sensitive to CYC065 and that the drug inhibited MLL-driven gene expression. Potent anticancer activity of CYC065 was demonstrated in vivo in AML xenograft models resulting in over 90% inhibition of tumor growth. The data were presented at the 2014 Society of Hematologic Oncology meeting taking place September 17-20, 2014 in Houston, Texas.

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