Sites in Europe and Asia add to patient enrollment and position Company to apply for global regulatory approvals
December 8, 2014
CEL-SCI Corporation today announced that during November it has added seven new clinical sites to its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). Patient screening has begun at new clinical centers in France, Turkey, Poland, Sri Lanka, Russia and Taiwan.
“The addition of these seven centers is one of the ways in which we intend to increase patient enrollment beyond the 800% year-over-year increase we have already achieved between 2013 and 2014. By conducting a study on this global scale, in the U.S. and about 20 other countries, we are not only increasing the speed of enrollment, but are also positioning CEL-SCI, pending favorable clinical results, to apply for marketing approval in the U.S. and the majority of regulatory agencies around the world,” stated CEL-SCI Chief Executive Officer Geert Kersten.
A total of 880 patients are expected to be enrolled through over 100 clinical sites in about 20 countries by the end of 2015 in the world’s largest Phase III trial for head and neck cancer.
About Multikine Phase III Study
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 improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care (SOC) vs. subjects who are treated with SOC only.
Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal 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. 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 into a total of approximately 120 clinical centers in over 20 countries.
In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the U.S. 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 announced that it entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women who are HIV/HPV co-infected and for peri-anal warts in men and women who are HIV/HPV co-infected.
About CEL-SCI Corporation
CEL-SCI’s work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational therapy Multikine (Leukocyte Interleukin, Injection) is currently being studied in a pivotal Phase III clinical trial against head and neck cancer. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied, the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Navy under a CRADA.
CEL-SCI is also developing its LEAPS technology for the treatment of pandemic influenza and as a potential therapeutic vaccine against rheumatoid arthritis. The Company has recently received a Phase I SBIR Grant from the National Institutes of Health to develop LEAPS as a potential treatment for RA with researchers from Rush University Medical Center in Chicago, Illinois. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.