Insert asks FDA to permit clinical trials of cancer drug

The compound, IT-101, is a combination of Insert’s patented polymer technology, Cyclosert, and the anticancer compound camptothecin. The application seeks to assess the formula in patients with unresectable or metastatic solid tumors.

The objectives of the phase I clinical protocol submitted with the investigational new drug application (IND) are to evaluate the safety, pharmacokinetics and tolerability of IT-101 in humans. If the IND becomes effective without delay Insert expects to begin treating patients in the second quarter of 2006.

“While advancing the clinical development of IT-101 is Insert’s highest priority, IT-101 is only the first in a series of therapeutics under development at Insert that will seek to take advantage of Cyclosert’s unique properties,” said Thomas Schluep, Insert’s chief scientific officer.

Insert’s proprietary Cyclosert delivery system is based on small cyclic repeating molecules of glucose called cyclodextrins. Using modified cyclodextrins as building blocks, Insert has developed an entirely new proprietary class of materials called linear cyclodextrin-containing polymers.

To the company’s knowledge, Cyclosert is the first nanoparticle drug delivery platform to be designed de novo and synthesized specifically to overcome limitations in existing delivery technologies used for the systemic delivery of therapeutics.