Radiopharmaceutical company, Cyclopharm Limited (ASX: CYC) is pleased to confirm that an independent Data Monitoring Efficacy Committee (DEMC), requested by the USFDA as part of its assessment process, has reviewed the efficacy data of the current Technegas Phase 3 clinical trial (CYC-009) and has provided the following recommendation:
“The three member DEMC is unanimous in recommending that the CYC-009 trial should be terminated because of success. On the basis of the DEMC’s review of the Interim Efficacy Analysis Report, the DEMC deems that the trial has met the Primary Efficacy Endpoint.”
As a consequence of the DEMC announcement, Cyclopharm is now advising the investigators of the trial sites that recruitment should be suspended and, following consultation with the USFDA, the CYC-009 study will be terminated with orderly formal site close out and notification to reviewing Investigational Review Boards.
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