CEL-SCI says committee affirms continuation of Phase III head, neck cancer trial
CEL-SCI Corporation announced that a second interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine investigational new drug immunotherapy was conducted by an Independent Data Monitoring Committee. The IDMC said that the data raised no safety concerns, and recommended that the Phase III study continue unmodified. CEL-SCI considers the results of the IDMC review to be important since studies have shown that up to 30% of Phase III trials fail due to safety considerations. The IDMC’s safety findings from this interim review were similar to those reported by investigators during CEL-SCI’s Phase I-II trials. IDMC interim reviews are a standard part of clinical trial protocol. Ultimately, the decision as to whether a drug is safe is made by the FDA based on an assessment of all of the data from a trial.