Vienna, VA -- (ReleaseWire) -- 04/10/2014 -- CEL-SCI Corporation today announced that the Henry Ford Health System in Detroit, Michigan is the latest U.S. clinical center to join the Company's Phase III head and neck cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection). CEL-SCI is currently expanding and accelerating patient enrollment in its trial. The Company expects to rapidly expand the number of clinical sites active in the U.S. As the world's largest Phase III trial for head and neck cancer, CEL-SCI's study is already active in dozens of clinical centers in 12 countries and is expected to expand to a total of 20 countries by the end of 2015.
CEL-SCI's Multikine investigational cancer immunotherapy is intended to create an anti-tumor immune response to reduce local/regional tumor recurrence and thereby increase the survival rate of patients. 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.
According to a report published by the Metropolitan Detroit Cancer Surveillance System in 2010, there were 24,651 new invasive and in situ cancers diagnosed in residents of the metropolitan Detroit area of Wayne, Oakland, and Macomb Counties. In a national study researchers estimated that more than 52,000 men and women would be diagnosed in the U.S. with head and neck cancers in 2012, according to the National Cancer Institute.
Founded in 1915 by auto pioneer Henry Ford and now one of the nation's leading health care providers, Detroit's Henry Ford Health System is comprised of hospitals, medical centers and one of the nation's largest group practices, which includes more than 1,200 physicians practicing in over 40 specialties.
The Josephine Ford Cancer Institute at Henry Ford is a leader in groundbreaking techniques, offering the most advanced diagnostic testing, and multiple treatment approaches including surgery and radiation therapy. Dr. Haythem Ali, a medical oncologist, is the Principal Investigator for CEL-SCI's study at Henry Ford. His specialties include head and neck cancer and he has published several articles in peer reviewed journals.
"This is our first U.S. clinical center to open in the Midwest. Our intention is to rapidly add more clinical research centers located across North America so that patients seeking to enroll in our immunotherapy trial may have the opportunity to access a site. We are pleased that Dr. Haythem and one of the leading healthcare providers in country, Henry Ford Health System, have chosen to participate in our groundbreaking study," stated CEL-SCI Chief Executive Officer Geert Kersten.
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 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 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.
- 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.