INTELGENX, CARY START TRIAL OF NEW QUITPAK FORMULATION

IntelGenx Technologies and Cary Pharmaceuticals have begun enrolling subjects in the first Phase I pilot study for Cary's extended-release QuitPak formulation. QuitPak is Cary's proprietary combination product containing bupropion and mecamylamine and is intended as an alternative therapy in smoking cessation.

The purpose of the study is to determine the suitability of IntelGenx's newly developed extended-release formulation for the once-daily administration of bupropion and mecamylamine. In the course of the study, rate and extent of the absorption of the two active ingredients will be monitored. The data obtained from this trial will be used to determine if the formulation is suitable for once-daily co-administration of the two actives.

"The data gathered during this trial will provide important information regarding the suitability of our new extended-release formulation for further Phase I and IIb studies that will be conducted later this year," Horst Zerbe, CEO of IntelGenx, said.

A previous Phase I safety and tolerability study of QuitPak demonstrated that the product was well tolerated and showed encouraging clinical activity. Cary was recently awarded a grant from the National Institute on Drug Abuse in the amount of $337,000 to fund the pharmacokinetic evaluation of the new formulation.

Upon the completion of this milestone, Cary will license QuitPak to a strategic partner to complete its clinical development through Phase III clinical trials, obtain FDA approval and commercialize the product.