NASDAQ: BNTCW; ASX: BLT) a clinical-stage biotechnology company
developing innovative therapeutics based on its gene-silencing
technology, DNA-directed RNA interference (ddRNAi), is pleased to
announce it has initiated a new site for its ongoing Phase 1/2a TT-034
trial at the Methodist Health System Clinical Research Institute in Dallas, Texas. The site has commenced pre-screening hepatitis C patients and is led by principal investigator Dr. Parvez Mantry, a gastroenterologist and hepatologist.
brings the total number of trial sites to four, with Benitec already
having established sites at the Duke Clinical Research Institute, the University of California San Diego and the Texas Liver Institute.
said, “We are pleased to welcome a fourth site to join our first-in-man
trial of TT-034, an innovative therapeutic based on Benitec’s gene
silencing technology, ddRNAi. The addition of this site reflects the
growing interest from the medical community in Benitec’s potentially
transformational approach to treating and curing hepatitis C.
Recruitment and dosing for the trial is proceeding well.”
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 trial design is to primarily ensure that
treatment with TT-034 is safe, hence the gradual dose escalation.