Vienna, VA, July 8, 2014 -- CEL-SCI Corporation (NYSE MKT: CVM) today announced that it has received regulatory clearance from the Austrian Federal Office for Safety in Health Care to begin patient enrollment in the Company's Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). Austria is the 14th country to participate in CEL-SCI's trial which is already active in numerous clinics around the world.
CEL-SCI's Phase III trial is assessing the use of the Company's Multikine immunotherapy as a first line treatment for patients diagnosed with advanced primary head and neck cancer, prior to standard of care, which involves surgery, chemotherapy, and/or radiation therapy. 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.
There were more than 150,000 new patients diagnosed with head and neck cancer in Europe in 2012 according to the European Head and Neck Society's (EHNS) Makes Sense Campaign, sponsor of the 2nd Annual European Head and Neck Cancer Awareness Week September 22 - 26, 2014. The goal of the Makes Sense Campaign is to raise awareness of head and neck cancer symptoms in order to drive earlier diagnosis, which is a key factor in survival. According to the Makes Sense Campaign, if patients are diagnosed in the early stages of the disease there is an 80-90% survival rate. However 60% of people with head and neck cancer present with locally advanced disease at diagnosis, and 60% of those people diagnosed at an advanced stage die from the disease within five years. Key risk factors, as identified by the Makes Sense Campaign are smoking, alcohol, and human papillomavirus virus (HPV).
"There is growing awareness in Europe of head and neck cancer, as well as our Phase III immunotherapy study for the disease. We recently were a Gold Sponsor of the European Congress on Head and Neck Oncology 2014 conference, which was also sponsored by the European Head and Neck Society. We are encouraged to see that the increasing number of head and neck oncologists, who already have experience with Multikine, are looking to enroll more of their patients in our study," stated CEL-SCI Chief Executive Officer Geert Kersten.
Further expansion of CEL-SCI's Phase III head and neck cancer trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centers through by the end of 2015. Over 200 patients are already enrolled in, and being treated with Multikine.
About Multikine Phase III Study
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 the 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.
Multikine* (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-lable, 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 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'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 III clinical trial against head and neck cancer. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied, the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include 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 I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Navy under a CRADA (Cooperative Research and Development Agreement).
CEL-SCI is also developing its LEAPS technology for the treatment of pandemic influenza and as a potential therapeutic vaccine against rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
* 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.
When used in this report, the words "intends," "believes," "anticipated", "plans" 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.