BENITEC BIOPHARMA LIMITED (NASDAQ: BNTC; NASDAQ: BNTCW; ASX: BLT)
17 September 2015
CLARIFICATION: HEPATITIS C CLINICAL TRIAL ANNOUNCEMENT
Sydney, Australia: In yesterday’s ASX announcement regarding the initiation of a fourth US site for its hepatitis C clinical trial, Benitec Biopharma Limited (NASDAQ: BNTC; NASDAQ: BNTCW; ASX: BLT) referred to the trial as being a Phase I trial. It should have been referred to as a Phase I/IIa trial as it is being conducted in hepatitis C virus-infected patients.
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 lifetime 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 Phase I/IIa trial design is to primarily ensure that treatment with TT-034 is safe, hence the gradual dose escalation. In addition, the ability of TT-034 to reduce HCV viral load is assessed at each dose level.
Good luck and GOD bless,
George
