August 1st, 2014
–14 patients enrolled in July brings total enrollment to over one-quarter of the 880 patients planned for enrollment by the end of 2015
CEL-SCI Corporation (NYSE MKT: CVM) today announced that during the month of July the Company enrolled 14 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). A total of 47 patients were enrolled over the past three months, with 14 in May, 19 in June, and 14 in July. This marks a 15% increase over the prior three month period when a total of 41 patients were enrolled.
“We reached an important milestone in July with total patient enrollment reaching 232, which is over one-quarter of the total 880 patients we expect to enroll by the end of 2015. We are on track with the pace of enrollment, which should accelerate in the fall based on the increasing number of clinical centers joining our study,” stated CEL-SCI Chief Executive Officer Geert Kersten. “In the past three months alone, we have received clearances to expand the trial into the United Kingdom, Austria, Sri Lanka, Turkey and France, while we also continue to add clinical sites in North America.”
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 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 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 co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.