Vienna, VA -- (ReleaseWire) -- 05/05/2014 -- CEL-SCI Corporation today announced that during the month of April 2014 the Company enrolled 21 patients with advanced primary, not yet treated, head and neck cancer into its global Phase III head and neck cancer trial for its investigational immunotherapy Multikine (Leukocyte Interleukin, Injection). This marks a substantial increase over the previous monthly record of 14 patients in March 2014.
CEL-SCI’s trial is now active in 46 clinical centers in 12 countries. Further expansion is underway to a total of about 20 countries and about 100 clinical centers. So far, 183 patients have been enrolled in the study.
“During the past months we have seen very rapid increases in rate of enrollment in this study. We think that increases in the enrollment rate in our trial in recent months are, in part, due to the addition of new centers and the intense site support by our clinical research organization Ergomed. In addition, we have observed a definite increase in interest by investigators in enrolling subjects in our study once they have gained some experience with Multikine in their own patients and once they become more familiar with it. As we continue to add new centers in our study and as the investigators become more experienced with using Multikine, we can expect that the rate of enrollment in our study will continue to increase and make it possible to reach our goal of full enrolment by the end of 2015,” commented Geert Kersten, CEL-SCI’s Chief Executive Officer.
Multikine was reported to be well tolerated and was used safely in CEL-SCI’s Phase II studies in head and neck cancer, as reported by the Phase II study investigators. In the Phase II trial, which formed the basis for the Phase III study, Multikine administration appeared to have caused, on average, the reduction/elimination of about 50% of the cancer cells of treated patients, as determined by pathology. Also, based on pathology reports, about 12% of patients had no remaining cancer cells after their treatment with Multikine Phase II results published (by Timar et al) in the Journal of Clinical Oncology.
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 an open-label, 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 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 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.