Benitec selects new site for phase I/II hepatitis C trial of TT-034

The Duke clinical research unit is the early phase unit of the Duke Clinical Research Institute.

Benitec chief executive officer Peter French said, "The TT-034 trial marks the transition of Benitec to a clinical stage company. We expect that positive results from the trial will provide a value inflection point for the company, and also be a validation for our ddRNAi technology as an effective platform for therapeutics."

The safety and activity of single doses of TT-034 will be assessed in patients with chronic HCV genotype 1 infection who showed inadequate response to earlier treatments in the open-label dose escalation study.

A total of 14 patients will participate in five sequential dose cohorts in the study, in which additional consolidation cohorts will be added to confirm study results.

Dose limiting adverse events are primary safety endpoints while the primary activity end points include serum viral load reduction and degree of hepatocyte transduction.