Ergomed to assume up to $3 million in clinical and regulatory costs for indication that may represent faster way to submission of marketing application
Vienna, VA -- (SBWIRE) -- 10/31/2013 -- CEL-SCI Corporation announced that it has signed a co-development and profit sharing agreement with Ergomed Clinical Research Ltd. for CEL-SCI’s investigational immunotherapy drug Multikine (“Leucocyte Interleukin Inj.”) in HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI has also recently entered a Cooperative Research and Development Agreement (CRADA) for this disease indication with the US Naval Medical Center, San Diego.
Anal and genital warts are commonly associated with the Human Papilloma Virus, the most common sexually transmitted disease. Men and women with a history of anogenital warts have a 30-fold increased risk of anal cancer. Persistent HPV infection in the anal region is thought to be responsible for up to 80% of anal cancers. HPV is a significant health problem in the HIV infected population because, although they live longer as a result of greatly improved HIV treatments, their immune systems remain compromised.
Geert Kersten, Chief Executive Officer of CEL-SCI said, “We believe that if the data from the studies in HIV/HPV co-infected men and women with anal warts meet our expectations, this may represent a shorter clinical development route for Multikine which could possibly enable the submission of a marketing application before completion of our ongoing Phase III clinical trial for head and neck cancer. The addition of Ergomed as a committed co-development partner to the combined efforts of CEL-SCI and the US Navy will be extremely helpful and will potentially save us a lot of time during the clinical development process.”
Miroslav Reljanovic, Chief Executive of Ergomed added, “We took over patient recruitment of CEL-SCI’s Multikine Phase III head and neck cancer study in April of this year and are now in the process of rapidly expanding the study to meet its recruitment goals. At a recent investigator meeting we met with many enthusiastic investigators who are planning to join this trial and we are on track to meet the study’s enrollment goals. In the process of working on this Phase III study we have gained a level of comfort with Multikine that leads us to broaden our co-development collaboration, for the second time in two weeks, with CEL-SCI into this new unmet medical need indication.”
Under the terms of this new agreement, Ergomed will assume 50% (up to $3 million) of the clinical and regulatory costs for the development of Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. The full co-development program for Multikine must be jointly agreed to prior to implementation. Ergomed already has two similar co-development agreements for up to $13 million with CEL-SCI for the ongoing head and neck cancer Phase III clinical trial and HIV/HPV co-infected women with cervical dysplasia. Ergomed will receive its return on investment based on an agreed single digit percentage of any net income received by CEL-SCI for Multikine from product sales and/or certain partner milestone payments.
Multikine will be given to HIV/HPV co-infected men and women with peri-anal warts because promising early results were seen in another Institutional Review Board approved Multikine Phase I study conducted at the University of Maryland. In this study, Multikine was given to HIV/HPV co-infected women with cervical dysplasia resulting in visual and histological evidence of clearance of lesions. Furthermore, elimination of a number of HPV strains was determined by in situ polymerase chain reaction (PCR) performed on tissue biopsy collected before and after Multikine treatment. As reported by the study investigators, the study volunteers all appeared to tolerate the treatment with no reported serious adverse events.
Multikine, is an immunotherapeutic agent that is in a global Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors. The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer on 3 continents around the world. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients. HPV has been shown to be related to some head and neck cancers as well.
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 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.
Ergomed offers clinical development services for the biotechnology and pharmaceutical industry specializing in therapeutics for oncology, neurology and immunology. Ergomed also engages in shared risk ventures through co-development agreements. With its global infrastructure in Western and Eastern Europe, the Middle East, Asia and North America, Ergomed offers cost effective and efficient drug development. For further information, visit www.ergomed-cro.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.
For more information, please visit www.cel-sci.com.
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.