Accelerating pace of patient enrollment driven by commitment and capabilities of new CROs and increasing number of clinical centers participating in the trial
Vienna, VA, April 1, 2014 -- CEL-SCI Corporation (NYSE MKT: CVM) today announced that during the month of March the Company enrolled 14 patients with advanced primary, not yet treated, head and neck cancer into its global Phase III head and neck cancer trial. This marks the largest number of patients enrolled in the Company's trial with its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in any month to date.
CEL-SCI's trial, the largest Phase III head and neck cancer trial in the world, is now active in 12 countries through about 40 clinical sites. During the month of March five clinical centers were added to the study. By the end of 2015 the study is expected to complete enrollment of 880 patients through over 100 clinical centers. As the number of clinical centers increases, patient enrollment is scheduled to accelerate each month.
"In the balance of 2014 and 2015 we plan to add about 60 additional clinical centers to our study. With our new clinical research organizations, Ergomed and Aptiv Solutions, on board we are confident that we will meet our objective of completing patient enrollment by the end of 2015. We anticipate consistent month-over-month increases in the number of new patients enrolled," commented CEL-SCI Chief Executive Officer Geert Kersten.
Multikine was well tolerated and used safely in CEL-SCI's Phase II studies in head and neck cancer, as reported by the Phase II study investigators. In the trial, which formed the basis for the Phase III study, Multikine administration appeared to have caused, on average, the disappearance of about 50% of the cancer cells of treated patients. Based on pathology reports, 12% of patients had no remaining cancer cells after treatment with Multikine. These results were published 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 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.