On April 1, 2015 CEL-SCI Corporation (NYSE MKT: CVM) reported that in March it has enrolled 29 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) (Press release, Cel-Sci, APR 1, 2015, View Source [SID:1234506998]). March marks the third consecutive month of record enrollment for CEL-SCI this year following January and February, 2015. 406 patients have been enrolled in the Phase III study as of March 31, 2015.
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"The accelerating pace of enrollment in our trial is very good. We expect to see continued increases in monthly patient enrollment throughout the year as new clinical centers are added and as existing centers gain more experience with Multikine," 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 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’s Clinical Research Organization, who runs the study for CEL-SCI, is aiming to complete enrollment of about 880 patients 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 over 25 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.