VIENNA, Va.–(BUSINESS WIRE)–
CEL-SCI Corporation (NYSE MKT: CVM) announced today 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 the Company’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.
The Principle Investigator for the Phase I study is John D. Malone MD, MPH, Infectious Diseases Staff Physician, NMCSD. 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.
According to Dr. Malone, the immunologic agent Multikine has potential to improve the clinical treatment of HPV lesions that are associated with cancer. The NMCSD Clinical Investigation Department has a robust spectrum of research ongoing, participating in over 400 research studies/trials annually with the hope of advancing medical treatment and improving quality of life for patients.
NMCSD, a referral center of excellence for HIV/AIDS care of active duty, family members, and retired individuals since the start of the HIV epidemic in the 1980s, has conducted over 30 HIV/AIDS human subjects approved clinical research protocols to advance clinical patient care.
Multikine is being given to the HIV/HPV co-infected patients with peri-anal warts based on the results obtained in a Multikine Phase I study conducted at the University of Maryland in which the investigational therapy Multikine was given to HIV/HPV co-infected women with cervical dysplasia. In these subjects visual and histological evidence of clearance of lesions was observed. Elimination of a number of HPV strains was also determined by in situ polymerase chain reaction (PCR) performed on tissue biopsy collected before and after Multikine treatment. The study investigators reported that the study volunteers in this study all appeared to tolerate the Multikine treatment with no reported serious adverse events. The treatment regimen for the study of up to 15 HIV/HPV co-infected patient volunteers with peri-anal warts to be conducted by NMCSD will be identical to the regimen that was used in the Multikine cervical study in HIV/HPV co-infected patient volunteers.
“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.
