VIENNA, Va.--CEL-SCI Corporation (NYSE MKT: CVM) today 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 women with cervical dysplasia. Human Papilloma Virus (HPV) is the most common sexually transmitted disease. HPV is a significant health problem in the HIV infected population as individuals are living longer as a result of greatly improved HIV medications. People living with HIV and others with compromised immunity are more at risk for HPV-related complications. Persistent HPV infection can also be a precursor to cervical cancer.
Under the terms of this 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 women with cervical dysplasia. The full co-development program for Multikine must be jointly agreed to prior to implementation. Ergomed already has a similar co-development agreement for up to $10 million with CEL-SCI for the ongoing head and neck cancer Phase III clinical trial. 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 sales in this and the head and neck cancer indications.
Miroslav Reljanovic, Chief Executive of Ergomed said, "We took over the largest part 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. 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 with CEL-SCI into this new indication."
Geert Kersten, Chief Executive of CEL-SCI said, "As the Phase III trial in head and neck cancer is now gaining momentum under the new guidance of Ergomed and another CRO, we are able to expand our Multikine development program to cover other unmet medical needs. HPV infection in immune-compromised HIV infected patients is clearly one of those areas in need of new treatments."
The co-development program aims to follow up on the early results seen in a Phase I study, conducted at the University of Maryland, where the investigational therapy Multikine was given to HIV/HPV co-infected women with cervical dysplasia. In this study, investigational therapy 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 associated with the Multikine treatment.
Cervical Intraepithelial Neoplasia (CIN) in HIV/HPV co-infected women:
Genital HPV infection is the most common sexually transmitted disease in both men and women. Usually, HPV infection does not cause overt signs or symptoms of disease, but some types of HPV cause cervical and anal intraepithelial neoplasia, or anal warts. Generally, HPV can be eliminated by an individual having a healthy immune system without treatment. However, certain HPV strains may cause persistent infection, which can lead to cancer. This is particularly evident in immune-compromised individuals, such as those who are HIV infected. Men and women who have HIV are therefore at a higher risk of developing these types of cancers, which include cancers of the cervix, vulva, vagina, penis and anus. Persistent HPV infection has been linked to development of cervical intraepithelial dysplasia/neoplasia (CIN) and high-grade CIN may become the precursor of cervical cancer.
Multikine, is an investigational immunotherapeutic agent that is currently being tested 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. The treatment with 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 also been shown to be related to some head and neck cancers.
CEL-SCI also announced recently 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.
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.
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.
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 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.
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.