(NYSE AMEX: CVM)
is in the process of expanding its Phase III clinical trial of
the investigational therapy
Multikine (Leukocyte Interleukin, Injection)* to 4 additional European countries - Spain, Czech Republic, Slovakia and Croatia. These four countries were selected because they have not only the required facilities and well trained scientific and technical personnel with the experience necessary for running this Phase III study, but also because they have a high incidence of head and neck cancer. CEL-SCI’s partner, Teva Pharmaceuticals Industries, who has the marketing rights to Croatia has selected 2-3 clinical centers in Croatia that have the capability and interest in conducting this study. The Multikine Phase III study is currently being run in 8 countries, including the US, on 3 continents.
"We are encouraged by recent observations from the study and therefore feel that all resources should be put into getting this study completed as quickly as possible to definitively establish Multikine’s effectiveness. That is why we are adding as many as 15 clinical centers in these 4 countries,” said Geert Kersten, CEL-SCI's Chief Executive Officer.
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.
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 developing (and 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.