Insert Therapeutics seeks FDA OK to begin phase 1 trial of anticancer compound

By Angela McDaniels

Seattle, Feb. 9 - Insert Therapeutics Inc. has submitted an Investigational New Drug application to the Food and Drug Administration to begin a phase 1 clinical trial of the anticancer compound IT-101 - a combination of the company's patented polymer technology, Cyclosert, and the anticancer compound camptothecin - to treat patients with inoperable or metastatic solid tumors.

The trial's objective is to evaluate the safety, pharmacokinetics and tolerability of IT-101. If approved, the company will begin the trial at the City of Hope Cancer Center in Duarte, Calif., during the second quarter.

"We hope IT-101 will become a potent new therapy for patients suffering from various forms of cancer," president John Petrovich said in a company news release.

In addition to preclinical test data on IT-101, the application contains data that Insert said demonstrates the safety of Cyclosert in animals. This data may allow Insert to accelerate Cyclosert's use in the clinic with other existing therapeutics.

Insert's proprietary Cyclosert is a nanoparticle drug-delivery system that uses a new class of materials, also proprietary, called linear cyclodextrin-containing polymers.

The anticancer compound in IT-101, camptothecin, is a naturally occurring, water-insoluble alkaloid that has established potent activity against a broad spectrum of cancer types.

Although global sales of analogues of camptothecin (e.g., irinotecan and topotecan) reach nearly $1 billion annually, camptothecin itself has not been commercialized due to its poor solubility and unfavorable pharmacokinetics, the company said.

In numerous animal studies conducted by Insert, delivery of camptothecin with Cyclosert has resulted in protracted antitumor activities that are substantially more effective at significantly lower doses than all other treatment groups, including irinotecan, according to the release.

Insert Therapeutics, a subsidiary of Arrowhead Research Corp., is based in Pasadena, Calif., and uses Cyclosert, to design, develop and commercialize drug-delivery-enhanced small-molecule therapeutics.

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