VIENNA, Va.–(BUSINESS WIRE)–
CEL-SCI Corporation (NYSE MKT: CVM) today announced that during the month of May 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 49 patients were enrolled over the past three months, with 14 patients enrolled in March, 21 in April, and 14 in May of 2014. This marks a continued increase over the prior three month period when a total of 18 patients had been enrolled, with 4 enrolled in December 2013, 8 in January, and 6 in February 2014.
“While there may be monthly variations, we are seeing a general trend of rapidly increasing enrollment through the support of our new CROs, Ergomed and Aptiv Solutions, the addition of new centers, and a definite increase in interest by investigators in enrolling patients in our study. As we continue to expand the study to more centers in more countries, we expect to see continued increase in the rate of enrollment in this Phase III trial,” stated CEL-SCI Chief Executive Officer Geert Kersten.
So far, a total of 197 patients have been enrolled in the study. The study is expected to complete enrollment of 880 patients by the end of 2015.
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-lable, 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.
