CEL-SCI Corporation (NYSE AMEX: CVM) provided an update today of the progress of its Phase III clinical trial of its investigational therapy Multikine (Leukocyte Interleukin, Injection)*, which is currently being investigated in an open-label, randomized, controlled, multi-center study.
Notable highlights include:
- Patients have been enrolled into the Study in all three continents (North America, Europe and Asia).
- To date, thirty six (36) clinical centers have met all legal, regulatory, and protocol requirements to screen and enroll patients. Ten of these centers in the study are controlled by CEL-SCI's partners Teva Pharmaceuticals Industries Ltd. (Israel) and Orient Europharma (Taiwan). CEL-SCI anticipates that approximately 15 additional centers will be added for this study.
- CEL-SCI is looking to expand the Phase III study to several additional European countries to further accelerate patient enrollment. One of those countries is Croatia, a country in which Teva Pharmaceutical Industries has exclusive marketing rights to sell Multikine.
- Dr. Eyal Talor, Chief Scientific Officer of CEL-SCI, has already visited 21 clinical centers around the world and is planning to visit all of the remaining clinical centers in 2012 to help ensure the study quality.
"We are pleased that enrollment in this clinical study has been accelerating,” said Geert Kersten, CEL-SCI's Chief Executive Officer. “This study is designed to prove that Multikine added to the standard of care can increase overall survival of head and neck cancer patients in a statistically significant manner. Everything is being done to complete the study in an efficient and timely manner.”
CEL-SCI’s Phase III study is designed to determine if Multikine (Leukocyte Interleukin, Injection) investigational therapy administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Radiochemotherapy) used for the treatment naive (yet untreated) subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus the subjects treated with standard of care only.