VIENNA, Va.--(EON: Enhanced Online News)--CEL-SCI Corporation (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.
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 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.
About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system. The lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating a different peptide-based immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu (See Journal of Clinical Investigation – J Clin Invest. 2013; 123(7):2850-2861. doi: 10.1172/JCI67550) Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
When used in this press release, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 2012. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.