CEL-SCI Corporation (NYSE AMEX: CVM) announced today that it has begun its global Phase III clinical trials for the flagship Multikino, immunotherapy company, Canada, to St. Joseph – Hamilton (Division of St. Joseph Health System) , Hamilton, Ontario. The study is already underway in several clinical centers in the United States, Poland and India. The total consideration is expected to enroll approximately 880 patients with head and neck in about 48 hospitals in nine countries on three continentsThe objective of this study is to establish a standard Multikino as first-line treatment in the treatment of patients with newly diagnosed and not yet treated with head and neck cancer. The process is considered the greatest of the head and neck cancer trial ever conducted and is called IT-PROBLEMS , an acronym for: anti-tumor immunotherapy treatments Multikino.
A Phase II clinical Multikino demonstrated the product was safe and well tolerated and eliminated tumors in 12percent of subjects, which are the patient population being selected for the Phase III study. The Multikino treatment regimen has also been shown to kill, on average, about half of cancer cells in tumors of subjects before the start of standard therapy. The follow-up studies of subjects included in the proof of concept Phase II showed a 33percent improvement in survival of patients treated with Multikino to a median of three and a half years after surgery. The Food and Drug Administration granted orphan drug status for Multikino neoadjuvant treatment of patients with squamous cell carcinoma of the head and neck.
CEL-SCI clinical Phase III trial is an open-label, randomized, controlled, multicenter Multikino to determine if administered before the current standard of care (surgery and radiotherapy or surgery plus concurrent chemotherapy) used for processing naive subjects, advanced squamous cell carcinoma of the oral cavity / soft palate (head and neck) will result in an increase in overall survival compared to patients treated with standard therapy alone. It will also be the first test in which immunotherapy be administered before other traditional treatments are attempted.