Cel-Sci Receives Orphan Drug Designation for Its Cancer Drug Multikine

Cel-Sci announced that its cancer drug Multikine has been granted orphan-drug designation as neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck by the FDA.

Multikine is currently cleared for a Phase III clinical trial in the U.S. and Canada in advanced primary head and neck cancer patients. These are recently diagnosed, not yet treated patients.

The Phase III study is expected to enroll approximately 800 advanced primary head and neck cancer patients worldwide, the company said.

In its last Phase II clinical trial Multikine increased overall survival by 33 percent, according to the company. This Phase III study will need to show a 10 percent increase in overall survival to be successful, the company said.