CEL-SCI Corporation

U.S. Navy Approves Start of CEL-SCI'S Phase I Trial for Treatment of Anal Warts in HIV/HPV Co-Infected Patients

Marks 3rd indication for Multikine in clinical trials


Vienna, VA -- (SBWIRE) -- 02/05/2014 -- CEL-SCI Corporation 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.

About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

For more information, please visit http://www.cel-sci.com.

* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with its future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.

When used in this release, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 2013. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.