CEL-SCI Corporation (NYSE MKT: CVM) today announced that the Japanese patent office has issued a key patent covering CEL-SCI’s investigational cancer drug, Multikine (Leukocyte Interleukin, Injection)*. The patent, Japanese patent number 5,122,279, is titled, “A Method of Pre-Sensitizing Cancer Prior to Treatment with Radiation and/or Chemotherapy and a Novel Cytokine Mixture”. Key patents on Multikine have now been issued in the largest pharmaceutical markets in the world: the United States, European Union, China and Japan. This invention relates to a novel effect of Multikine observed during clinical trials that CEL-SCI believes indicates it has the potential to pre-sensitize cancer cells to a therapeutic treatment such as chemotherapy, radiation therapy or immunotherapy. Phase I and II clinical studies with Multikine demonstrated that Multikine induced cancerous cells to enter into the cell cycle phase, and thereby possibly increased their vulnerability to chemotherapy and radiation therapy. Further research is required and currently underway in CEL-SCI’s Phase III clinical trial in an effort to confirm the observed potential synergies of Multikine. In CEL-SCI’s ongoing Phase III global trial, advanced primary (not yet treated) head and neck cancer subjects randomized to Multikine treatment are administered Multikine ahead of surgery, radiation and chemotherapy, in the same way as it was given during CEL-SCI’s Phase I and II trials. A recent interim review of the safety data from the Phase III trial 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 important since the findings from this interim review were similar to those reported by investigators during CEL-SCI’s Phase I-II trials in which the potential synergistic effects of Multikine on radiotherapy and chemotherapy were observed.
Head and neck cancer accounts for about 6% of the world’s cancer cases, for a total of about 650,000 new cases every year and is associated mainly with excessive alcohol and tobacco use. Many head and neck cancers are also associated with and are thought to be caused by the Human Pappiloma Virus (HPV), the same virus that causes cervical cancer.Multikine, an investigational immunotherapeutic agent consisting of a mixture of naturally occurring cytokines, including interleukins, interferons, chemokines and colony-stimulating factors, is currently being developed for treatment of head and neck cancer. 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 the Company’s clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that employs the 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. 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. 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 report, 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, 2011. 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.