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January 13, 2014
07:28 EDTCYCCCyclacel outlines the company's key clinical development objectives
Cyclacel Pharmaceuticals provided an outline of the company's key clinical development objectives for 2014. For Sapacitabine in SEAMLESS, the company plans to continue enrollment and expand study into Europe to at least double enrolling sites, report next interim periodic DSMB review at approximately 300 patients enrolled, report DSMB interim analysis for futility after 212 events, and complete enrollment. For Sapacitabine in MDS, the company plans to announce registration-directed, clinical development plan in 2nd line MDS following treatment failure after hypomethylating agents. For Sapacitabine in solid tumors, the company plans to report updated Phase 1 sapacitabine and seliciclib combination data in patients with solid tumors including those carrying the gBRCA mutation. The company also plans to advance early pipeline.
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October 9, 2014
07:10 EDTCYCCCyclacel announces DSMB recommendation to continue Sapacitabine Phase 3 trial
Cyclacel Pharmaceuticals announced that the independent Data and Safety Monitoring Board, or DSMB, for the company's Phase 3 SEAMLESS study in acute myeloid leukemia, or AML, has completed its fourth planned safety review and recommended that the study should continue as planned without any modifications. The DSMB reviewed available data from 317 randomized patients with at least 60 days of follow-up and noted that no safety or efficacy concerns were identified.

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