VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) today announced that the University of Minnesota’s Masonic Cancer Center has becomes the 7th clinical site 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 currently being conducted at about 60 active clinical centers on three continents and is expected to expand from 17 countries to a 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 Masonic Cancer Center creates a collaborative research environment focused on the causes, prevention, detection, and treatment of cancer; applying that knowledge to improve quality of life for patients and survivors; and sharing its discoveries with other scientists, students, professionals, and the community. It is one of only 41 institutions in the U.S. to become a National Cancer Institute-designated comprehensive cancer center. With more than 500 faculty and staff members, the Masonic Cancer Center is home to some of the world's top cancer researchers.
The Principal Investigator of CEL-SCI’s Phase III study at this site is Dr. Gautam Jha, Assistant Professor and Medical Oncologist, at the University of Minnesota’s Medical School. Dr. Jha’s interests focus on solid tumor oncology including genito-urinary malignancies and head and neck tumors. His research interests include developing immune-based therapies by disrupting Treg mediated immune suppression in patients with cancers of prostate and head and neck. He is a member of the American Society of Hematology, the American Society of Clinical Oncology, the American Association for Cancer Research, and the Society of Immunotherapy of Cancer.
"Dr. Jha’s research interests and expertise in immunotherapies for the treatment of head and neck cancer is an asset for our study, as well as for the patients to be enrolled and treated at the Masonic Cancer Center,” stated CEL-SCI Chief Executive Officer Geert Kersten. “We are pleased to see more top-notch cancer centers joining our clinical trial.”
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 investigational 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 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 U.S. 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 request 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 recently received a Phase I SBIR Grant from the NIH to develop LEAPS as a potential treatment for RA with Rush University researchers. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit 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.