Trial Drug Aims to Fight HPV Symptoms

CEL-SCI Corporation and the Naval Medical Center, San Diego, will be working together to conduct research on Multikine, an investigational immunotherapeutic treatment against primary head and neck cancer. The patients involved in the study will be male and female volunteers who are co-infected with HIV and Human Papilloma Virus, ad eligible for medical care from the Naval Medical Center, San Diego.

HPV is the most common sexually transmitted disease, and also poses a significant health problem within the HIV-positive population. Anal and genital warts, a frequent symptom of HPV, have been linked to increased chances of various cancers. Multikine is designed to initiate an anti-tumor immune response to reduce tumor recurrence.

"As a special group, persons at risk for or infected with HIV have an increased incidence of other sexually associated infections," explains Edmund C. Tramont, M.D., associate director for special projects at the National Institute of Allergy and Infectious Diseases. "One of the most prevalent is Human Papilloma Virus, or HPV, which carries with it the potential to cause an associated cancer. As with many cancers caused by micro-organisms or germs, HPV can be controlled by an optimally functioning immune system. Since a dysfunctional immune system is the primary defect in HIV-infected persons, HIV-infected persons are at a higher risk of developing HPV induced cancers.

"Multikine is mixture of proteins known as cytokines and chemokines, which are required to stimulate and direct an effective immune response," continues Tramont. "By injecting Multikine locally into the precancerous or cancerous lesions, the augmented local immune response may eliminate or control the HPV and hence, any associated cancer."

An approved Multikine Phase I study at the University of Maryland gave promising results when used on HIV and HPV co-infected women with cervical dysplasia. The dose escalation study, to be held at the Naval Medical Center, aims to evaluate the safety and efficiency of Multikine as a treatment of peri-anal warts and anal intraepithelial dysplasia in HIV and HPV co-infected men and women.