(NYSE MKT: CVM)
announced today that it has initiated an arbitration claim against inVentiv Clinical, LLC (f/k/a PharmaNet, LLC and PharmaNet GmbH (f/k/a PharmaNet AG)), a clinical research organization. CEL-SCI initially retained inVentiv Clinical to conduct the Phase III Clinical Trial of CEL-SCI’s investigational drug Multikine* (Leukocyte Interleukin, Injection). CEL-SCI terminated inVentiv in or about April 2013 and replaced it with two clinical research organizations, Aptiv Solutions, Inc. and Ergomed Clinical Research Ltd. CEL-SCI’s arbitration claim is initiated under the Commercial Rules of the American Arbitration Association alleging (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud, and seeks at least $50 million in damages.
Multikine is a new investigational immunotherapeutic agent that is in a global 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. The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer on 3 continents around the world. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients. CEL-SCI has recently signed a Cooperative Research and Development Agreement with the US Navy to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with anal warts. CEL-SCI also recently signed a co-development agreement with Ergomed Clinical Research for the development of Multikine for HIV/HPV co-infected women with cervical dysplasia and another agreement to support the development with the US Navy of Multikine as a potential treatment for HIV/HPV co-infected men and women with anal warts. HPV has been shown to be related to some head and neck cancers as well.