CEL-SCI Corporation, a biotechnology company involved in the research and development of investigational immunotherapy products for the treatment of cancer and infectious diseases, has signed a co-development and profit sharing agreement with Ergomed Clinical Research Ltd. for its investigational immunotherapy drug Multikine (Leukocyte Interleukin Injection) 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 Centre, 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 per cent 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 per cent (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.

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.

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.