CEL-SCI says IDMC recommends continuation of Phase 3 head and neck cancer study
CEL-SCI announced that the Independent Data Monitoring Committee, or IDMC, for the company's pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine has completed its recent review of the Phase 3 study data. The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization responsible for data management of this Phase 3 study. The IDMC made the following recommendation: The IDMC recommendation is to continue the trial until the appropriate number of events have occurred. IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials, especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time.