Marks 10th country where Phase III trial is approved to commence accruing patients to the Study and achieving a milestone where half of the planned country approvals for the trial are active
Vienna, VA -- (SBWIRE) -- 12/09/2013 -- Further advancing one of the largest Phase III trials for head and neck cancer in the world, CEL-SCI Corporation announced today that it has received approval from the Agency for Medicaments and Medical Devices of the government of Bosnia and Herzegovina to begin enrollment of subjects into the Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). Bosnia and Herzegovina is the 10th country into which CEL-SCI has now expanded its global Phase III trial. This also marks the Company’s milestone in receiving approval to commence accrual in one-half the number of countries in the currently planned expansion of the study. The trial is expected to expand into a total of approximately 100 clinical centers in 20 countries. CEL-SCI expects to enroll approximately 30 patients in Bosnia and Herzegovina through three clinical centers.
Multikine is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved by regulatory agencies (e.g. FDA) for use following completion of CEL-SCI’s clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that aims to employ our body's natural ability to fight tumors.
CEL-SCI is currently accelerating enrollment in its Phase III clinical trial for Multikine by adding a large number of clinical centers. In addition to these centers, the trial also benefits from clinical centers in CEL-SCI’s partners’ territories, Teva Pharmaceuticals in Israel and Orient Europharma in Taiwan.
“We are pleased with the accelerating pace at which new clinical centers and countries, which will participate in our study, are being added. From this we expect to see a fast pick-up in the number of patients enrolled in the study. We are aiming to complete enrollments of subjects in the second half of 2015. CEL-SCI offers a potential first-line approach to cancer treatment that employs the body’s own immune system, before the current standard of care, which includes surgery plus radiation therapy or surgery and combined radiochemotherapy, is used,” stated CEL-SCI CEO Geert Kersten.
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, 10% improvement in overall survival of enrolled patients who are treated with Multikine plus Standard of Care (SOC) vs. subjects who are treated with SOC only. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival rate of these patients.
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 its 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" 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, 2012. 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.