Benitec Biopharma, a Sydney, Australia-based biopharmaceutical company focused on providing potentially curative therapies with its proprietary gene-silencing technology called ddRNAi or "expressed RNAi,” has doesed the fifth patient in the company's first-in-man, phase I/IIa dose escalation clinical trial of TT-034 for hepatitis C virus (HCV) infection at the Duke Clinical Research Unit. The fifth patient is the third and final patient to be dosed in cohort two.
The three patients in cohort two received a dose of TT-034 of 1.25 x 10^11vg/kg, a concentration that is a half log higher than the doses administered in cohort one. In line with the trial's primary endpoint of safety, this dose level is still below the concentration expected to inhibit HCV viral replication and data from the second dosing cohort is therefore expected to serve primarily as a further safety assessment.
As with previous patients, the newly dosed patient will be monitored for six weeks and this data will then be reviewed by the Data Safety Monitoring Board (DSMB). Benitec currently is screening patients for inclusion in cohort three in anticipation of the DSMB's review.
Benitec now has initiated a third site, the Texas Liver Institute in San Antonio, Texas, and they have started to pre-screen patients for the TT-034 trial.
Following completion of the first two patient cohorts and initiation of a third trial site, Benitec now will move to conventional clinical trial reporting for cohorts three through to five of the dose escalation study. The company will provide an update to investors (via ASX announcement) should a material event occur or when the trial is completed.