Cel-Sci Expands Study for Treatment of Anal Warts in HIV/HPV Patients

CEL-SCI Corporation 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).�

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. 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.

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.

Having published over 280 papers, 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.�

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. 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," said 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.

Multikine is being given to 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 immunotherapy Multikine was given to HIV/HPV co-infected women with cervical dysplasia. In these patients, 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 utilized in the Multikine cervical study in HIV/HPV co-infected patient volunteers is identical to the regimen being administered in the current Phase I study of HIV/HPV co-infected patient volunteers with peri-anal warts that is in progress at the U.S. Naval Medical Center San Diego and the University of California San Francisco.

CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational therapy, Multikine (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck.�If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care (SOC) as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. �

Additional clinical indications for Multikine that are being investigated include the treatment of cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase 1 trial of the former indication has been completed at the University of Maryland CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis.
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