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Investigational New Drug Application filed to test safety of anticancer compound IT-101

Published in Medical Letter on the CDC and FDA, March 5th, 2006

Insert Therapeutics, Inc., a majority-owned subsidiary of Arrowhead Research Corporation (ARWR), announced that it has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) to initiate a phase 1 clinical trial using its lead anticancer compound, IT-101.

IT-101 is a combination of the company's patented polymer technology, Cyclosert, and the anticancer compound camptothecin, used to treat patients with unresectable or metastatic solid tumors. The objectives of the phase 1 clinical protocol submitted with the IND are to evaluate the safety, pharmacokinetics and tolerability of IT-101 in humans.

The...

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