Drug wins fast-track status

Edmonton Journal

August 8, 2007

EDMONTON / Isotechnika's lead drug has been given a fast-track designation by the U.S. Food and Drug Administration for the treatment of uveitis, an inflammation of the middle layer of the eye.

The designation, granted to U.S. partner Lux Biosciences, will help expedite the development of ISA247 and provide the ability to submit portions of the New Drug Application early for review as part of a "rolling" submission, CEO Randall Yatscoff said.

Isotechnika is continually encouraged by the broad potential use of ISA247 in transplantation, psoriasis and uveitis, he said.

Lux began enrolling patients in pivotal clinical trials for uveitis earlier this year. ISA247 is also in late-stage trials as an anti-rejection drug in kidney transplants.