The Philippines is the 19th Country to Clear CEL-SCI for Patient Enrollment in Its Phase III Head and Neck Cancer Trial Print E-mail
Wednesday, 11 February 2015 20:14

VIENNA, Va.--CEL-SCI Corporation (NYSE MKT: CVM) today announced that the Philippines Regulatory Agency (PFDA) has cleared the Company to commence patient enrollment of the Phase III head and neck cancer trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in the Philippines.

Three hospitals in the Philippines are expected to join the study.

This marks the 19th country to approve CEL-SCI’s Phase III trial, which is expected to expand into a total of approximately 100 clinical centers in about 20 countries in addition to the U.S. The trial has over 350 patients enrolled.

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.

About Multikine

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.

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. The Phase I trial started enrolling patients in September 2014. 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 HIV/HPV co-infected women and for peri-anal warts in HIV/HPV co-infected men and women.

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 immunotherapy Multikine (Leukocyte Interleukin, Injection) is currently being studied in a pivotal Phase III clinical trial against advanced primary (not yet treated) 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. CEL-SCI received a Phase I SBIR Grant from the National Institutes of Health to develop LEAPS as a potential treatment for rheumatoid arthritis 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




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