CEL-SCI announces results from Multikine Phase II trial on head and neck cancer

April 29, 2017

The Company expects its ongoing Phase III trial, which is the largest study ever conducted in head and neck cancer, to generate additional data on the effect that Multikine has on lowering cholesterol. The study is run in 9 countries and partnered with Teva Pharmaceuticals and Orient Europharma. This 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 the 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. 

The goal of this study is to establish Multikine as a first-line standard of care therapy in treating newly diagnosed head and neck cancer patients. The trial is called "IT-MATTERS," an acronym for: Immunotherapy Multikine Anti Tumor Treatments.

The "proof of concept" Phase II clinical trial of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment. 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.

Source: CEL-SCI Corporation