CEL-SCI Receives Positive Safety Review

CEL-SCI Corp. has received the second interim review of the safety data from its open-label, randomized, controlled, pivotal Phase III study of Multikine (Leukocyte Interleukin, Injection). The review, conducted by an Independent Data Monitoring Committee (IDMC), reported that the data raised no safety concerns, and recommended that the Phase III study continue unmodified.

CEL-SCI management considers the results of the review to be important since studies have shown that as much as 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.

Following the first safety review by the IDMC for this study, which stated that there were no safety concerns, CEL-SCI expanded the study to more clinical sites in the U.S. and Europe in order to increase the accrual rate to the study.

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer on three continents around the world. The objective of the study is to demonstrate a statistically significant 10% improvement in overall survival of enrolled patients who are treated with Multikine plus Standard of Care (SOC) vs. subjects who are treated with SOC only. The universally accepted current standard of care for the patient population being enrolled in the CEL-SCI study is surgery plus radiation or surgery plus concurrent radiation and chemotherapy, dependent on the risk factors for recurrence found after surgery.

Multikine is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer.