Pharmaceutical company CEL-SCI has begun phase III clinical trials for its immunotherapy drug Multikine in Hungary.
Studies are already ongoing at 12 clinical sites in the U.S., Canada, Poland, and India. The total study is expected to enroll about 880 head and neck cancer patients in more than 40 hospitals in nine countries.
The goal is to establish Multikine as a first-line standard of care therapy in treating newly diagnosed patients with head and neck cancer. The trial is believed to be the largest study ever conducted for head and neck cancer, according to the company.
The clinical trial is an open-label, randomized, controlled, multicenter study designed to determine if Multikine administered prior to current standard of care (surgery plus radiotherapy or surgery plus concurrent radiochemotherapy) used for treatment of subjects with advanced primary squamous cell carcinoma of the oral cavity/soft palate will result in an increased overall rate of survival. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted.
Phase II clinical trials of Multikine demonstrated that the product was safe and well-tolerated, and that it eliminated tumors in 12% of the subjects less than a month into treatment, the company said. The Multikine treatment regimen also killed approximately half the cancer cells in the subjects' tumors before the start of standard therapy. Follow-up studies of subjects enrolled in the phase II trial showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery.
The FDA has granted orphan drug status to Multikine for neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck. The Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases and disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
