CEL-SCI Corporation announced today that an interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine (Leukocyte Interleukin, Injection) investigational immunotherapy by an Independent Data Monitoring Committee (IDMC) raised no safety concerns. The IDMC also indicated that no safety signals were found that would call into question the benefit/risk of continuing the study. 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 and the IDMC’s safety findings from this interim review were similar to those reported by investigators during CEL-SCI’s Phase I-II trials. 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.
IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients 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 (3-5 years). The committee’s membership should include physicians and clinical trial scientists knowledgeable in the appropriate disciplines, including statistics. The CEL-SCI IDMC includes prominent physicians and scientists from major institutions in the USA and abroad who are key opinion leaders in head and neck cancer and who are knowledgeable in all of the disciplines related to CEL-SCI’s study, including statistics.
The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer on 3 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 treated patients receive 15 local injections of Multikine over a 3 week period prior to standard of care treatment. Multikine injections are administered in the area around the tumor and in the area of the adjacent lymphnodes since those two areas are where the tumor is most likely to recur. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients.
Multikine is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved for use following completion of our clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that employs our body’s natural ability to fight tumors.
Source: CEL-SCI Corporation