CEL-SCI Corp. reported that the Italian Medicines Agency (AIFA) has authorized the Company to commence patient enrollment for its ongoing Phase 3 trial of its investigational immunotherapy Multikine (Leukocyte Interleukin, Injection) in patients with advanced primary squamous cell carcinoma of the oral cavity/soft palate, a type of head and neck cancer.
The company said that Italy is the 23rd country to authorize CEL- SCI's Phase 3 trial for patient enrollment.
According to a release, having surpassed its originally planned milestone of receiving authorization to conduct the Phase 3 study from 21 countries, CEL-SCI is now aiming to expand the trial into a total of approximately 100 clinical centers in about 25 countries. As of April 30, 437 patients had been enrolled in the global Phase 3 study.
The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. 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 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to 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.
Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Center, San Diego, as a potential treatment for peri- anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited to further the development of 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.
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