VIENNA, Va.–(BUSINESS WIRE)–
CEL-SCI Corporation (NYSE MKT: CVM) (“CEL SCI” or the “Company”) today announced it has added a second clinical site for its Phase I clinical trial evaluating peri-anal wart immunotherapy in HIV/HPV co-infected men and women with its investigational cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection). Dr. Joel Palefsky, world renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, has joined the study as a Principal Investigator at the University of California San Francisco (UCSF). UCSF becomes the second clinical site for the study. The first site, the U.S. Naval Medical Center San Diego, continues to enroll patients under a Cooperative Research and Development Agreement (CRADA).
Dr. Joel Palefsky is the Chair of the HPV Working Group of the AIDS Malignancy Consortium (AMC) and is the head of the AMC HPV Virology Core Lab at UCSF. The AMC is a U.S. National Cancer Institute-supported clinical trials group founded in 1995 to support innovative trials for AIDS-related cancers. The AMC is composed of over 37 clinical trials sites worldwide, five Working Groups, an Administrative Office, a Statistical Office, and an Operations and Data Management Office. Collectively, these components develop and oversee the scientific agenda, manage the groups’ portfolio of clinical trials and other scientific-based studies, and help to develop new protocols. Dr. Palefsky has extensive experience in the biology of HPV infection, HPV infection in HIV-positive men and women, HPV vaccines and in the design and implementation of multiple clinical research trials of HPV-related disease.
Having published over 280 papers, Dr. Palefsky is Principal Investigator of the ANCHOR study, an $89 million NIH-funded study of the efficacy of secondary prevention of anal cancer. He is also the Principal Investigator on several laboratory-based and clinical research studies of HPV-associated neoplasia, particularly in the setting of HIV infection. He also specializes in the molecular biology and development of new treatments for HPV. Dr. Palefsky is the founder and immediate past president of the International Anal Neoplasia Society and is currently president of the International Human Papillomavirus Society. He is actively involved in training students in clinical and translational research. Dr. Palefsky has led the Doris Duke Charitable Foundation (DDCF) program at UCSF since its inception in 2001 and has been the leader of the Clinical Translational Science Awards (CTSA) TL1 program at UCSF since its inception in 2006.
“We are very pleased to welcome Dr. Palefsky as a Principal Investigator for our Phase I study and we believe his interest in Multikine is a very important testament of our immunotherapy’s potential in the treatment of HPV related diseases in HIV infected patients,” stated CEL-SCI Chief Executive Officer Geert Kersten. “Dr. Palefsky is widely recognized as one of the world’s top researchers in the field HPV infection in HIV co-infected patients. With his participation through UCSF we anticipate rapid patient enrollment in our Phase I study.”
Anal and genital warts are commonly associated with 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.
