The Institutional Review Board (IRB) of the U.S. Navy’s Naval Medical Center San Diego (NMCSD), has approved the start of a Phase I dose escalation study of CEL-SCI Corporation's investigational immunotherapy Multikine (Leukocyte Interleukin, Injection) in HIV/HPV co-infected men and women with peri-anal warts. This approval marks the third indication for which Multikine is being investigated in clinical trials. Multikine is currently being investigated in the largest Phase III trial in the world for the treatment of head and neck cancer. It has previously been evaluated as a potential treatment for cervical dysplasia in HIV/HPV co-infected women and a Phase II study to further investigate this indication is currently in the planning stages.
The Phase I dose escalation study is being funded and conducted through a Cooperative Research and Development Agreement (CRADA) between the U.S. Navy and CEL-SCI. CEL-SCI will contribute the investigational immunotherapy drug Multikine, will retain all rights to any currently owned technology and will have the right to exclusively license any new technology developed from the collaboration. By entering into this CRADA, NMCSD does not directly or indirectly endorse any product or service provided, or to be provided, by CEL-SCI, its successors, assignees, or licensees.
Anal and genital warts are commonly associated with the Human Papilloma Virus (HPV), the most common sexually transmitted disease. The U.S. Center for Disease Control and Prevention (CDC) has named HPV the 4th largest health threat the U.S. will face in 2014. According to the CDC, 360,000 people in the U.S. get genital warts each year. Persistent HPV infection in the anal region is thought to be responsible for up to 80% of anal cancers. HPV is an even more significant health problem in the HIV infected population as individuals are living longer as a result of greatly improved HIV medications, but are mostly unable to clear HPV due to their weakened immune system.
"Anal warts have become an increasing problem in the general population. Patients with anal warts who are co-infected with HIV/HPV have a 30-fold increased risk of developing anal cancer because their immune system is compromised,” stated CEL-SCI Chief Executive Officer Geert Kersten.
"Though this disease appears to be completely unrelated to head and neck cancer, our current Phase III lead indication, HPV has been implicated as a potential causative agent in both diseases. The virus is now thought to be a cause of many head and neck cancers, particularly in younger people in the U.S. In the anal warts study being conducted we hope to repeat the promising results seen in the study with HIV infected women with cervical dysplasia where we saw the elimination of many HPV strains following Multikine treatment,” Geert Kersten added.