CEL-SCI Corporation (NYSE AMEX: CVM) announced that its Taiwanese partner Orient Europharma Co. Ltd. (“Orient Europharma”) today is presenting its development strategies for CEL-SCI's investigational cancer therapy Multikine ® (Leukocyte Interleukin, Injection)* in Taiwan, at the World Orphan Drug Congress in Seoul, Korea. Orient Europharma is a development partner of CEL-SCI participating in the investigational cancer therapy Multikine (Leukocyte Interleukin, Injection) Phase III Pivotal global study for head and neck cancer. The presentation, titled: “Developing orphan drugs in Asia: Successful collaborative effort between biotechs & policy makers” will be delivered by Yao Ting Lin, Head, Orient Europharma’s Head of Business Development Division and will include a case study of its strategy for developing Multikine (Leukocyte Interleukin, Injection) in Taiwan. Taiwan has a high concentration of reported head and neck cancer cases and is expected to provide a significant number of patients for the CEL-SCI’s Phase III trial. Orient Europharma has completed the Site Initiation Visit at all seven clinical centers in Taiwan and expects to enroll patients in the Taiwanese clinical centers this month. Overall the Phase III clinical study is expected to enroll about 880 head and neck cancer patients in about 48 hospitals in 9 countries on 3 continents. CEL-SCI's partner Teva Pharmaceuticals is conducting part of the Phase III study in Israel. Multikine (Leukocyte Interleukin, Injection) Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent consisting of a mixture of naturally occurring cytokines, including interleukins, interferons, chemokines and colony-stimulating factors, currently being developed for treatment of head and neck cancer. Multikine (Leukocyte Interleukin, Injection) has been cleared by the regulators in 9 countries around the world, including the U.S., for a global Phase III clinical trial in advanced primary (not yet treated) head and neck cancer patients. This trial is believed to be the largest head and neck cancer clinical study ever conducted. A detailed description of the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01265849?term=multikine&rank=1. It is also thought to be the first Phase III study in the world in which immunotherapy is given to cancer patients first, i.e., prior to their receiving the current conventional treatment for cancer, including surgery, radiation and/or chemotherapy. This is important because conventional therapy may weaken the immune system, and may compromise the benefits of immunotherapy. Because Multikine (Leukocyte Interleukin, Injection) is given before conventional cancer therapy when the immune system is likely to be more intact CEL-SCI believes the potential exists for it to be more successful in activating an anti-tumor immune response under these conditions.
However, no definitive conclusions can be drawn from the Company’s early data about the potential efficacy profile of this investigational therapy. Further research is required, and these results must be confirmed in a well-controlled Phase III clinical trial of this investigational therapy that is currently in progress. Subject to completion of that Phase III trial and FDA’s review of our entire data set on this investigational therapy, CEL-SCI believes that these early-stage clinical trial results indicate the potential for this investigational therapy to be a benefit in the treatment of advanced primary head and neck cancer. The U.S. Food and Drug Administration also granted orphan drug status to Multikine (Leukocyte Interleukin, Injection) in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.About CEL-SCI Corporation CEL-SCI Corporation is developing investigational products that empower immune defenses. Its lead investigational product 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. 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.