2013-10-21 19:34:37 - Centers are Participating In Ongoing Phase III Cancer Trial with Multikine
CEL-SCI Corporation announced today it has held the Investigator Meeting for the European clinical investigators participating in the ongoing Phase III clinical trial of CEL-SCI’s investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Inj.). The meeting had 108 participants from 56 clinical centers that are or will be participating in the Multikine Phase III clinical trial for head and neck cancer. These clinical centers come from 13 European countries. The Investigator Meeting for the clinical centers in the United States and Canada is scheduled for November 2013. A total of approximately 880 patients are expected to be enrolled in this international Phase III study.
The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck
cancer. About 6% of all cancers are head and neck cancer with an estimated 650,000 new cases globally and about 150,000 in the U.S. and Europe. The objective of the study is to demonstrate a statistically significant 10% improvement in overall survival of enrolled patients who are treated with the investigational therapy Multikine plus Standard of Care (SOC) vs. subjects who are treated with SOC only. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients.
Should Multikine treatment plus SOC prove to be successful in demonstrating a statistically significant overall survival advantage in the Phase III study, and following the FDA review of the totality of the Multikine development program, Multikine plus the current standard of care treatment, following an anticipated marketing approval from the FDA, could then become part of the new standard of care treatment in this indication. That would represent a multi-billion dollar market. The U.S. Food and Drug Administration (FDA) has already granted orphan drug designation to Multikine in the treatment of advanced primary head and neck cancer.
These Investigator Meetings are required since the number of clinical investigators involved in this Phase III trial under the new management of Ergomed and Aptiv Solutions has increased substantially. At these meetings critical discussions surrounding protocol, regulatory issues, enrollment criteria, procedures and safety issues, among other topics, are discussed, which are all very important to the success of the trial.
CEL-SCI, through the newly hired Clinical Research Organizations (CROs) Ergomed and Aptiv Solutions, is currently in the process of adding a large number of clinical centers in countries where regulatory approval has already been received to start the Multikine Phase III clinical trial as well as in new countries around the world, with an emphasis on the United States and Europe. The centers are being added to accelerate the enrollment in the clinical trial. These new centers are in addition to the existing study centers and the clinical centers being run in Israel and Taiwan where Teva Pharmaceuticals and Orient Europharma are partners in the Phase III clinical trial.
CEL-SCI recently announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center, San Diego to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. It has also announced that it entered into a co-development agreement with Ergomed to further develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV.
CEL-SCI's lead investigational therapy Multikine, is 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 our 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 immune system 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 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 (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 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, 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.