CEL-SCI Corporation

Southern Illinois University School of Medicine Becomes Clinical Site for CVM Phase III Trial

Estimated 52,000 new cases of head and neck cancer are diagnosed each year in the U.S.


Vienna, VA -- (SBWIRE) -- 05/01/2014 -- CEL-SCI Corporation today announced its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection) has activated another U.S. clinical site at Southern Illinois University School of Medicine's Simmons Cancer Institute in Springfield, Illinois. The Illinois site, which has become part of the world's largest Phase III trial for head and neck cancer with dozens of hospitals and clinical centers in 12 countries, has now officially joined the study. According to the National Cancer Institute, researchers estimated that about 52,000 men and women in the U.S. will be diagnosed with head and neck cancers annually.

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only. CEL-SCI's Multikine investigational immunotherapy is intended to create an anti-tumor immune response to reduce local/regional tumor recurrence and thereby increase the survival rate of these patients.

Southern Illinois University School of Medicine's SIU HealthCare is the University's health care practice which served over 477,000 patients in 2013. SIU HealthCare has nearly 240 teaching physicians providing new treatments and technologies that have transformed the practice of medicine. SIU HealthCare's clinical outreach extends to approximately 100 sites in 46 Illinois communities.

Dr. Krishna A. Rao, M.D., Ph.D., will serve as the Principal Investigator for the CEL-SCI's Phase III head and neck cancer trial at Southern Illinois University School of Medicine. Dr. Rao is an Associate Professor of hematology and medical oncologist specializing in head and neck cancer. Previously, he was at Fred Hutchinson Cancer Research Center in Seattle, Washington, where he completed a four-year fellowship in hematology and medical oncology. Dr. Rao completed his internal medicine residency at Mayo Graduate School of Medicine in Rochester, Minnesota.

"We are pleased to have the opportunity to enroll patients from Illinois into our Phase III trial which offers a potential new way to treat cancer by using the body's own natural immune system as a first-line treatment. The clinical investigators at Southern Illinois University School of Medicine will be a key part of our global trial which is designed to include over 100 centers across the world, with ten to twelve of them being in the U.S. Our intention is to rapidly add numerous additional clinical sites in the U.S. and accelerate patient enrollment in this country," stated CEL-SCI Chief Executive Officer Geert Kersten.

About Multikine
Multikine (Leukocyte Interleukin, Injection) is an immunotherapeutic agent that is being tested in a randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100-110 clinical centers in about 20 countries.

In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also announced that it entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

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 our 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.