(NYSE MKT: CVM)
announced today that a second interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine* (Leukocyte Interleukin, Injection) investigational new drug immunotherapy was conducted by an Independent Data Monitoring Committee (IDMC). 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.
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. 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.
Following the First Safety review by the IDMC for this study, which stated that there were no safety concerns, CEL-SCI has doubled its efforts to expand the study to many more clinical sites in the US and Europe in order to increase the accrual rate to the study. CEL-SCI terminated Inventiv Clinical and in its place engaged Aptiv Solutions, a US-based clinical research organization (CRO) and Ergomed, a European-based CRO, to help in securing clinical sites and increasing the number of subjects accrued to the study. CEL-SCI recently filed an arbitration claim against Inventiv alleging (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud, seeking at least $50 million in damages.