15th nation to join world’s largest Head and Neck cancer Phase III trial
July 17, 2014
CEL-SCI Corporation today announced that Sri Lanka’s Ministry of Health has cleared the Company to commence patient enrollment for its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in Sri Lanka. This follows similar clearance to conduct the Phase III study in the UK and Austria during the past weeks. Further expansion of the trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centers in 20 countries by the end of 2015.
CEL-SCI’s global pivotal Phase III clinical trial is the largest trial for head and neck cancer in the world. The trial, which already has over 220 patients enrolled, is assessing the Company’s investigational immunotherapeutic agent Multikine 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.
“If Multikine can be proven to harness the immune system against cancer, we believe this could offer a new modality for the treatment of head and neck cancer that could work in concert with the other methods – surgery, chemotherapy, and radiation therapy, used today for the treatment of this debilitating disease.” stated CEL-SCI Chief Executive Officer Geert Kersten.
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 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 a 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 100 clinical centers in about 20 countries.
In October 2013, CEL-SCI announced that it had 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 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 co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.
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 (Cooperative Research and Development Agreement).
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 NIH to develop LEAPS as a potential treatment for RA with Rush University researchers. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.