VIENNA, Va.–(BUSINESS WIRE)–
CEL-SCI Corporation (NYSE MKT: CVM) today announced the first volunteer patient has been enrolled and administered Multikine* (Leukocyte Interleukin, Injection) in a Institutional Review Board approved Phase I Clinical Trial evaluating peri-anal wart immunotherapy in HIV/HPV co-infected men and women at the Naval Medical Center San Diego (NMCSD). The purpose of this dose escalation study is to evaluate the safety and impact of Multikine as a treatment of Human Papilloma Virus associated peri-anal warts and assess the effect on anal intraepithelial dysplasia (AIN) in HIV/HPV co-infected men and women.
The study is being conducted through a Cooperative Research and Development Agreement (CRADA) between CEL-SCI Corporation and Naval Medical Center San Diego. 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. CEL-SCI is contributing doses of the investigational drug Multikine and will have the right to exclusively license a new technology developed from the collaboration.
“This is an important milestone in our Phase I trial, which is the third indication for which Multikine is being evaluated as a potential immunotherapy. We are pleased to have this working relationship with the Naval Medical Center San Diego and look forward to completing enrollment and Multikine administration for the 15 patients planned for this trial,” stated CEL-SCI Chief Executive Officer Geert Kersten.
Multikine has the potential to improve the clinical treatment of HPV lesions that are associated with cancer. The NMCSD Clinical Investigation Department has a robust spectrum of ongoing research with over 300 Institutional Review Board approved research studies and clinical trials to advance medical treatment and improving quality of life for patients.
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 have difficulty clearing HPV due to their compromised immune system.
