(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.”