CEL-SCI has signed a co-development and profit sharing agreement with Ergomed Clinical Research for CEL-SCI’s investigational immunotherapy drug Multikine (Leucocyte Interleukin Inj.) in HIV/ HPV co-infected women with cervical dysplasia. Ergomed will assume 50% (up to $3 million) of the clinical and regulatory costs for the development of Multikine as a potential treatment for women co-infected with HIV/HPV suffering from this condition.
Ergomed already has a similar co-development agreement made in April for up to $10 million with CEL-SCI for an 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.
The co-development program aims to follow up on the results seen in a Phase I study conducted at the University of Maryland, where Multikine was given to HIV/HPV co-infected women with cervical dysplasia. This reportedly resulted in visual and histological evidence of clearance of lesions. In addition, in situ PCR performed on tissue biopsy collected before and after Multikine treatment determined that a number of HPV strains had been eliminated.
"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," Geert Kersten, chief executive of CEL-SCI, said in a statement. "HPV infection in immune-compromised HIV infected patients is clearly one of those areas in need of new treatments.