Re: Farmas USA
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Re: Farmas USA
Re: Farmas USA
Re: Farmas USA
Re: Farmas USA
Re: Farmas USA
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Cyclacel's sapacitabine unlikely to achieve efficacy endpoint in Phase 3 AML trial
Dec 16 2014, 08:11 ET | About: Cyclacel Pharmaceutica... (CYCC) | By: Douglas W. House, SA News Editor Contact this editor with comments or a news tip
An interim analysis for futility performed by the independent Data and Safety Monitoring Board (DSMB) found that Cyclacel's (NASDAQ:CYCC) lead product candidate, sapacitabine, will be unlikely to demonstrate a statistically significant improvement in survival in a Phase 3 trial in acute myeloid leukemia. The DSMB recommended that patients remain on treatment, though, since it saw no safety issues.University of Texas MD Anderson Cancer Center Chairman and Professor, Department of Leukemia Hagop Kantarjian, M.D., says, "At this stage all patients should stay on study. It is essential that we have complete follow-up of all patients to ensure that the mature survival data do not miss any potential survival benefit in the overall patient population or subgroup of patients."Cyclacel CEO Spiro Rombotis echos the hope that something positive will emerge from the work by saying, "Absence of early benefit in the Phase 3 study does not preclude emergence of a late benefit with longer follow up. ...we are encouraged that patients on the sapacitabine regimen are not disadvantaged to those on the control arm. We have sufficient capital resources to follow up patients, reach the final analysis of [the trial] and continue existing programs through 2016."CYCC shares are down 47% premarket.