25 June 2015
HEPATITIS C CLINICAL TRIAL UPDATE
Sydney, Australia: Benitec Biopharma is pleased to advise that following review by the Data Safety Monitoring Board (DSMB) of safety data from the three patients dosed in Cohort 2 of the company’s Phase I/IIa dose escalation clinical trial of TT-034 for hepatitis C virus (HCV) infection, the first patient in Cohort 3 has been dosed. This indicates that there have been no serious drug related adverse events in the Cohort 2 patients, in line with pre-clinical expectations.
This patient is the sixth patient to be dosed in the trial, and received a dose of TT-034 representing a concentration 3.125 times higher than the dose administered to patients in Cohort 2.
As with previous patient cohorts, the patient will now be monitored for six weeks, and the data will then be reviewed by the DSMB before progressing to dosing the next patient(s) in Cohort 3. The three clinical trial sites enrolled for the study are currently screening additional patients for inclusion in Cohort 3 in anticipation of the DSMB’s review.
Benitec advises that it expects to report data from Cohort 3 patients in Q4 CY15 following completion of all patient dosing and monitoring for the cohort, in line with timelines previously advised to the market.
More detail on the TT-034 trial
TT-034 is a ddRNAi-based therapeutic, designed to treat and potentially cure hepatitis C (HCV) with a single administration. TT-034 targets the hepatitis C viral RNA at three separate, highly conserved sites. As such it acts as a “triple therapy” even though it is a monotherapy, and minimises the ability of the virus to mutate and escape the therapy. Once it reaches the liver cells it enters the nucleus and produces three separate short hairpin RNAs continuously for the life time of the cell. Thus it has the potential to not only treat the existing HCV infection but to guard against reinfection for months to years without the need to re-treat. It has been extensively tested in pre-clinical in vivo studies and no adverse effects were seen at any therapeutic dose. However, as it is regulated as a gene therapy, the trial design is to primarily ensure that treatment with TT-034 is safe, hence the gradual dose escalation.
Good luck and GOD bless,
George
