- Arrangements have been completed with leading clinical investigators and institutions from 8 countries on 3 continents to conduct the study. So far thirty five (35) clinical centers have met all legal, regulatory, and protocol requirements to screen and enroll patients. Ten of these centers in the study are controlled by CEL-SCI's partners Teva Pharmaceuticals Industries Ltd. (Israel) and Orient Europharma (Taiwan). Both companies manage their parts of this Phase III trial under procedures provided by CEL-SCI’s global Clinical Research Organization (CRO). CEL-SCI is currently arranging to bring on line an additional 10 centers to ensure rapid enrollment of the study.
- MD Anderson Radiological Physics Center, the contractor that CEL-SCI hired to assess that each clinical center is adequately equipped to accurately and precisely deliver the radiotherapy dosage regimen prescribed by CEL-SCI’s protocol to the study subjects as part of their standard care and assess that each center has an established a satisfactory Radiotherapy Quality Assurance (RTQA) program so as to assure that the radiotherapy delivered to the subjects which meets the requirements of our Phase III protocol and is consistent and comparable between patients and centers worldwide, has concluded its assessment of all 35 clinical centers. Each center has demonstrated these capabilities to the satisfaction of MD Anderson Radiological Physics Center.
- CEL-SCI has produced multiple lots of its investigational therapy Multikine (Leukocyte Interleukin, Injection) for the Phase III trial in its manufacturing facility and has supplied the product to the clinical sites in the U.S. and Canada, and six other countries around the world. CEL-SCI has sufficient manufacturing capacity in its manufacturing facility to produce the entire drug supply that will be needed for all the subjects in the trial who will receive Multikine.
- The cold chain distribution and storage methods used during shipping and storing Multikine at the clinical centers have been established and validated, and also tested in numerous shipments of Multikine around the world.
- Multiple subjects have been enrolled in the Phase III trial and have received either Multikine followed by standard therapy (surgery followed by radiation or surgery followed by radiation plus chemotherapy), or only standard therapy, the control group for the Phase III trial.
- The Company also extended the existing licensing agreements with Teva Pharmaceuticals to include the countries of Croatia and Serbia.
- CEL-SCI also entered into a licensing agreement with IDC-GP Pharm for Argentina and Venezuela.
CEL-SCI’s Phase III study is designed to determine if Multikine (Leukocyte Interleukin, Injection) investigational therapy administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Radiochemotherapy) used for the treatment naive (yet untreated) subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus the subjects treated with standard of care only.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 developing (and 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, 2010. 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.