today announced that it has signed a Cooperative Research and Development Agreement (CRADA) with the Naval Medical Center, San Diego. Pursuant to this agreement, the US Naval Medical Center, San Diego will conduct a Human Subjects Institutional Review Board approved Phase I dose escalation study of CEL-SCI’s investigational immunotherapy Multikine (Leukocyte Interleukin, Injection) in HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI will contribute the investigational study drug Multikine and will retain all rights to any currently owned technology and will have the right to exclusively license any new technology developed from the collaboration. CEL-SCI is supporting the project by providing Multikine and funding for laboratory studies.
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 as individuals are living longer as a result of greatly improved HIV medications.
The purpose of this dose escalation study is to evaluate the safety and clinical impact of Multikine as a treatment of peri-anal warts and assess the effect on anal intraepithelial dysplasia (AIN) in HIV/HPV co-infected men and women. Five participants will be treated with Multikine injections around the peri-anal warts at the lower dose for 5 days/week for 2 weeks, off 2 weeks, then 5 days per week for two more 2 weeks. If no serious adverse events are noted, 10 more patients will receive the higher dose of Multikine in the same manner. The study is open to adult HIV positive men and women that are eligible for medical care from the Naval Medical Center San Diego.