CEL-SCI initiated an arbitration claim against inVentiv in October 2013. CEL-SCI initially retained inVentiv 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 inVentiv with new CROs.
CEL-SCI's arbitration claim is initiated under the Commercial Rules of the American Arbitration Association alleging breach of contract, fraud in the inducement and common law fraud, and seeks at least $50 million in damages.
Multikine is an investigational immunotherapeutic agent being tested in a pivotal phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved, CEL-SCI said 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 to approximately 100 clinical centers in 20 countries.
In October 2013, CEL-SCI 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 entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women co-infected with HIV and HPV and for peri-anal warts in men and women co-infected with HIV and HPV.