Insert Therapeutics receives OK for clinical trial

Mar. 15, 2006 – Arrowhead Research Corp. (NASDAQ: ARWR) announced that the U.S. Food and Drug Administration has approved the investigational new drug (IND) application submitted by its majority-owned subsidiary Insert Therapeutics Inc. Under the IND, Insert will conduct a Phase I study for IT-101, its first anti-cancer therapeutic, at the City of Hope in Duarte, California.

IT-101 is a nanotechnology-based therapeutic that combines Insert’s Cyclosert technology and the anti-cancer compound camptothecin. Cyclosert is a linear cyclodextrin polymer that was invented at Caltech in the lab of Mark Davis, a professor in chemical engineering and founder of Insert.

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.

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