CEL-SCI Corporation (NYSE AMEX: CVM) today announced that it has entered into an exclusive Sales, Marketing and Distribution agreement with IDC-GP Pharm LLC (“IDC-GP Pharm”) under which CEL-SCI has granted IDC-GP Pharm an exclusive license to market and distribute the Company’s investigational cancer therapy, Multikine ® (Leukocyte Interleukin, Injection)* in the countries of Argentina and Venezuela (the “Territory”). IDC-GP Pharm is a Joint Venture between two groups of experienced pharmaceutical entrepreneurs with expertise in the registration and commercialization of pharmaceutical products in South America, among other regions. One of these two groups represents former employees of a large pharmaceutical company, while the other group is GP Pharm ( http://www.gp-pharm.com/), headquartered in Barcelona, Spain, with operations in each major country in Latin America either directly or through local partners. CEL-SCI already has existing licensing agreements for Multikine (Leukocyte Interleukin, Injection) with Teva Pharmaceuticals Industries Ltd., Orient Europharma Co. Ltd. and Byron Pharmaceuticals. Pursuant to the agreement, IDC-GP Pharm will be responsible for receiving regulatory approval to use Multikine (Leukocyte Interleukin, Injection) in the territory. Once Multikine (Leukocyte Interleukin, Injection) has been approved in any of the two countries, CEL-SCI will be responsible for manufacturing the product, while IDC-GP Pharm will be responsible for sales in the Territory. Revenues will be split 50/50 between CEL-SCI and IDC-GP Pharm after payment to CEL-SCI for the manufacturing costs of Multikine (Leukocyte Interleukin, Injection). “This agreement is consistent with CEL-SCI’s strategy to license Multikine (Leukocyte Interleukin, Injection) in the emerging markets,” said Geert Kersten, Chief Executive Officer of CEL-SCI. 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) is currently being investigated in an open-label, randomized, controlled, multi-center study designed to determine if Multikine (Leukocyte Interleukin, Injection) administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Radiochemotherapy) used for 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. It is the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. A detailed description of the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01265849?term=multikine&rank=1. In Phase II clinical studies, subjects with locally advanced disease who received the investigational therapy Multikine (Leukocyte Interleukin, Injection) as first-line investigational treatment were observed to have demonstrated a 33% increase in overall survival rate as compared to the overall survival rate that was determined from a review of 55 trials of the same cancer population, which were reported (in the scientific literature) between 1987 and 2007. However, no definitive conclusions can be drawn from these data about the potential efficacy profile of this investigational therapy. Moreover, 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 breakthrough 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 CorporationCEL-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.