CEL-SCI Corporation (NYSE MKT: CVM) 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.
”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," stated Geert Kersten, Chief Executive Officer of CEL-SCI. "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.”
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.