INSERT THERAPEUTICS GETS OK FOR CANCER TRIAL
Insert Therapeutics has announced that the FDA has approved the investigational new drug (IND) for IT-101, the company's first anticancer therapeutic. The company plans to conduct a Phase I trial of IT-101.
IT-101 is a nanotechnology-based therapeutic that combines the company's Cyclosert technology and the anti-cancer compound camptothecin. Cyclosert is a linear cyclodextrin polymer.
The Phase I trial will be an open-label, dose-escalation clinical trial of IT-101 in patients with all types of cancer. The trial is expected to enroll between 24 and 48 patients and has been designed to determine safety and tolerability of IT-101.