Scottsdale site to serve Arizona patients seeking to enroll in world's largest Phase III head and neck cancer trial
Vienna, VA, April 2, 2014 -- CEL-SCI Corporation (NYSE MKT: CVM)) today announced it has expanded its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in the U.S. with the addition of a new site in Scottsdale, Arizona. The 21st Century Oncology clinic in Scottsdale, along with the Arizona Cancer Research Alliance, has just joined the study and is actively screening patients for enrollment into the trial. The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer.
"Our clinical trial is now active in over 40 medical centers internationally and we are pleased to expand the number of sites in the U.S. More American patients now have the option of enrolling in this trial for Multikine, which aims to use the body's own natural immune system to fight cancer. We look forward to working with 21st Century Oncology, and the Arizona Cancer Research Center to bring the potential of this innovative new method of treating cancer patients to Arizona," stated CEL-SCI Chief Executive Officer Geert Kersten.
The Arizona Cancer Research Alliance (ACRA) is a community-based network for testing and validating medical interventions with the potential to diagnose, treat, ameliorate or cure cancer. The alliance is focused on creating infrastructure to support physicians who are believed to be responsible for over 80% of the care provided to patients with cancer.
21st Century Oncology is the largest global, physician-led provider of integrated cancer care services, operating 166 treatment centers, with 133 centers in 16 states in the U.S. and 33 centers in six Latin American countries.
The Principal Investigator for the Scottsdale site is Dr. Steven Finkelstein, whose clinical expertise includes radiation oncology, surgical oncology and clinical immunotherapy in the treatment of head and neck malignancies, prostate, breast, lung, and colorectal cancers. Dr. Finkelstein is a Scottsdale Board Certified Radiation Oncologist, National Director of the Translational Research Consortium, Adjunct Associate Professor at Translational Genomic Research Institute, and Executive Director of the Arizona Cancer Research Alliance.
21st Century Oncology's Scottsdale clinic is the organization's second clinic to join CEL-SCI's trial as part of the CEL-SCI trial expansion. CEL-SCI recently announced 21st Century Oncology's Greenville, North Carolina site had also joined the study.
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.