Benitec Biopharma expands hepatitis C trial
The “first in man” clinical trial has been conducted at the Duke Clinical Research Unit. This fifth patient is the third, final subject in Cohort 2 to be dosed. Patients who received the new doses will be observed by researchers for six weeks, and then the Data Safety Monitoring Board (DSMB) will review the data.
Benitec has already started to screen potential patient subjects for Cohort 3, as the researchers anticipate positive feedback from the review.
All three of the Cohort 2 patients were administered with doses of TT-034 of 1.25 x 10^11 vg/kg, which is a concentration made a half log higher than the Cohort 1 doses. In order to determine the safety of the treatment, the level of the dose is less than the concentration that researchers estimate will inhibit viral replication of HCV. Data from Cohort 2 is being gathered as an additional assessment of the therapy’s safety.
In addition, Benitec has decided to open a third site for the study. This third site is the Texas Liver Institute in San Antonio, where researchers from Benitec have started the screening process for patient subjects to be involved in the TT-034 trial.