University of Cincinnati Cancer Institute's Head & Neck Cancer Center Joins CVM Phase III Trial
University of Cincinnati Cancer Institute’s Comprehensive Head and Neck Cancer Center Joins CEL-SCI’S Phase III Trial
Vienna, VA -- (SBWire) -- 05/30/2014 --CEL-SCI Corporation today announced that the University of Cincinnati Cancer Institute is the latest medical center in the U.S. to join its Phase III head and neck cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection). 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 with an estimated 880 patients to be enrolled by the end of 2015. According to the American Society of Clinical Oncology, head and neck cancers account for about 3% to 5% of all cancers in the United States.
The University of Cincinnati’s Comprehensive Head and Neck Cancer Center offers patient-centered care from a multidisciplinary team that focuses exclusively on treating cancers of the head and neck. This includes cancers of the oral cavity (tongue, jaw, lip, cheek, and hard palate), throat (tonsil, and base of tongue), larynx (voice box), nose and sinus cavity, skull base, salivary glands, thyroid gland and parathyroid gland. The clinical team includes head and neck cancer surgeons, radiation oncologists, medical oncologists, head and neck radiologists, pathologists, speech therapists and experienced head and neck cancer nurses.
Dr. Keith Casper, Co-Director of the Comprehensive Head and Neck Cancer Center, is the Principal Investigator of CEL-SCI’s Phase III trial at the University of Cincinnati. Dr. Casper has been a Head and Neck Surgical Oncologist at UC Health since 2009. He is also an Assistant Professor of Otolaryngology- Head and Neck Surgery at the University of Cincinnati College of Medicine.
“The University of Cincinnati Cancer Institute’s Comprehensive Head and Neck Cancer Center is one of the largest centers in its region specialized in head and neck cancer. Dr. Casper is a renowned expert and thought leader in head and neck cancer and we are very pleased to have his participation in our global 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.
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.
When used in this press release, 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.
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