CEL-SCI Corporation announced that it has commenced its global Phase III clinical trial for Multikine®, the Company's flagship immunotherapy, at the Meenakshi Mission Hospital and Research Centre in Madurai, Tamil Nadu, India, the first clinical site in India. Enrollment is expected to commence in the first half of May. Currently, the study has a US center at Hematology and Oncology Associates in Tupelo, Mississippi, actively recruiting patients. The Company expects enrollment in India to be substantially faster than in North America since head and neck cancer is India's leading cancer. The total study is expected to enroll a total of about 880 head and neck cancer patients in about 48 hospitals in 9 countries on three continents. CEL-SCI's partners Teva Pharmaceuticals and Orient Europharma will conduct parts of the Phase III study in Israel and Taiwan respectively.
The goal of this study is to establish Multikine as a first-line standard of care therapy in treating newly diagnosed, not yet treated head and neck cancer patients. The trial is believed to be the largest head and neck cancer study ever conducted and is called "IT-MATTERS", an acronym for: Immunotherapy Multikine Anti Tumor Treatments.
"We are very excited to begin this pivotal study in the first center outside of the US," said Geert Kersten, Chief Executive Officer of CEL-SCI. "We expect foreign centers to attract a significant number of patients, which will compress the time period necessary to complete the study."
CEL-SCI's Phase III clinical trial is an open-label, randomized, controlled, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Radiochemotherapy) used for treatment naive subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus subjects treated with standard of care only. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. A detailed description of the study can be found at:http://www.clinicaltrials.gov/ct2/show/NCT01265849?term=multikine&rank=1.
Phase II clinical trials of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of subjects, which are the patient population now being selected for the Phase III Study. This was achieved following 3 weeks of treatment, the same treatment regimen that is now used in the Phase III study. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumors before the start of standard therapy. Follow-up studies of subjects enrolled in the "proof of concept" 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 U.S. Food and Drug Administration granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
