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Resverlogix Announces Sixth Positive Recommendation From Data Safety Monitoring Board For Phase 3 Study of Apabetalone

A data review by the independent Data Safety Monitoring Board resulted in a recommendation for the BETonMACE trial to continue as planned without any modification

 

CALGARY, Alberta, Feb. 26, 2018 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) today announced that the independent Data and Safety Monitoring Board (DSMB) for the Company's Phase 3 BETonMACE trial in high-risk cardiovascular disease (CVD) patients has completed a sixth safety review and recommended that the study should continue as planned without any modifications. The DSMB reviewed available study data and noted that no safety or efficacy concerns were identified, and will conduct additional periodic reviews. Resverlogix, the clinical steering committee, and all investigators remain blinded to the trial data.

"The BETonMACE phase 3 trial now has over 2,300 patients enrolled, representing over 95 percent of the approximately 2,400 patients outlined in the study protocol. We are currently considering the extent to which we enroll beyond 2,400 patients to ensure BETonMACE yields 250 MACE events optimally and to include US patients. We now have patients that have been on treatment with apabetalone for nearly 120 weeks, which is nearly five times longer than any treatment duration in any of the Company’s previous Phase 2 trials. Full enrollment continues to be anticipated in the first half of 2018," stated Dr. Michael Sweeney, M.D., Senior Vice President of Clinical Development.

 

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