North American meeting of 14 clinical centers follows recent meeting of 56 centers in Europe
Vienna, VA -- (SBWIRE) -- 11/22/2013 -- CEL-SCI Corporation announced that it has held the Investigator Meeting for the North American clinical investigators participating in the ongoing international Phase III clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Inj.).
Investigators from 14 clinical centers in Canada and the U.S who are participating in the Phase III clinical trial for head and neck cancer were in attendance. The Investigator Meeting for the 56 clinical centers in Europe that are participating in the study was held in October 2013. A total of approximately 880 patients are expected to be enrolled in the Phase III study. Patients are also being enrolled in the Phase III study in Israel and Taiwan where CEL-SCI's partners Teva Pharmaceuticals and Orient Europharma are based.
“The number of investigators involved in CEL-SCI’s Phase III trial has increased substantially since we started working with our new clinical research organizations, Ergomed and Aptiv Solutions. At both recent Investigator Meetings critical discussions surrounding the protocol, regulatory issues, enrollment criteria, study procedures and safety issues, among other topics, were discussed,” stated CEL-SCI CEO Geert Kersten. ”These meetings are very important to the successful completion of our trial.”
The 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 the current SOC prove successful in demonstrating a statistically significant overall survival advantage in the Phase III study, CEL-SCI will apply to the FDA for a marketing permit to allow the use of Multikine plus the current SOC to treat treatment of naïve patients with advanced primary head and neck cancer. Should this permit be granted by FDA following their review of the totality of the data from the Multikine development program, Multikine would become part of a new standard of care treatment for this indication. The use of Multikine as a part of SOC 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.
CEL-SCI, through the newly hired Clinical Research Organization (CROs) Aptiv Solutions and its co-development partner Ergomed, 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 two co-development agreements with Ergomed to further develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and 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 http://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.