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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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August 12, 2014
16:14 EDTCYCCCyclacel Pharmaceuticals reports Q2 EPS (22c), consensus (30c)
Reports cash and cash equivalents totaled $33.5M as of June 30. The company said, "We are pleased to report that we have enrolled over 70% of the required number of patients in our Phase 3 SEAMLESS trial in front-line AML. At present we have approximately 90 study centers open for enrollment in the US and Europe with additional sites to be added. We expect to complete SEAMLESS enrollment around the end of 2014 with data readout in the second half of 2015. Having surpassed enrollment of 300 patients, we expect the study's Data Safety Monitoring Board to perform the fourth periodic safety review once 60 days of follow-up have been observed."

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