CEL-SCI RECEIVES GOVERNMENT APPROVAL IN SERBIA TO COMMENCE PHASE III CLINICAL TRIAL OF MULTIKINE IN HEAD AND NECK CANCER
World's largest Phase III trial for head and neck cancer being conducted as cancer immunotherapy is named Breakthrough of the Year by Science Magazine
Vienna, VA, January 23, 2014 -- CEL-SCI Corporation (NYSE MKT: CVM) announced today that it has received approval from the Medicines and Medical Device Agency of Serbia to begin enrollment of subjects in its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). Serbia is the 11th country from which approval to participate in the world's largest Phase III trial for the treatment of head and neck cancer has been obtained. The clinical sites in Serbia are expected to become active in the next few weeks. Approximately 72 of the worldwide total of 880 patients for the study are expected to be enrolled in Serbia.
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 by regulatory agencies (e.g. FDA) for use following completion of CEL-SCI's clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that aims to employ our body's natural ability to fight tumors.
"Immunotherapy has come to be recognized as the next great breakthrough in cancer therapeutics. Science Magazine named cancer immunotherapy the Breakthrough of the Year for 2013. The magazine suggests that clinical trials have cemented immunotherapy's potential in patients and swayed even the skeptics. Science Magazine also reports that oncologists say a corner has been turned and we won't be going back. CEL-SCI has been an early participant in the study of cancer immunotherapeutics and it's very exciting to see this class of cancer therapies acknowledged for its potential to transform the treatment of cancer," stated CEL-SCI CEO Geert Kersten. "We are pleased to advance our Phase III trial, as Serbia becomes the latest country to participate in this important immunotherapy trial."
To read the Science Magazine article in full, please visit: http://www.sciencemagazinedigital.org/sciencemagazine/20_december_2013?pg=28#pg28.
The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant, 10% improvement in overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only. CEL-SCI's Multikine investigational immunotherapy is intended to create an anti-tumor immune response to reduce local/regional tumor recurrence and thereby increase the survival rate of these patients.
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. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as 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, 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.
* 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 its 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 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, 2013. 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.