Achieve Life Sciences announced that the Data Safety Monitoring Committee, or DSMC, met on March 28, 2019 to conduct its second and final safety review of the ORCA-1 Trial. The DSMC is an independent committee that advises on continuation or stopping of clinical trials based upon safety and study conduct considerations. The ORCA-1 DSMC has had the responsibility for safeguarding the interests of trial subjects by assessing the safety of the interventions and monitoring the conduct of the ORCA-1 trial. The committee has reviewed the ORCA-1 data twice during the conduct of the study, and has concluded following each review that there are no safety concerns for subjects or study conduct issues, and the trial should continue for completion as planned. ORCA-1 topline efficacy and safety data are expected to be announced by end of the second quarter of 2019. “We are very pleased with the speed of enrollment and efficient conduct of the ORCA-1 trial, which is attributed to the commitment of the trial subjects, clinical investigators and their support teams,” said Dr. Cindy Jacobs, Chief Medical Officer at Achieve. “We look forward to sharing the data results in the near future.”
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