March 21, 2013, 7:00 p.m. EDT
Benitec Selects the Duke Clinical Research Unit as a Site for Hepatitis C Phase I/II Clinical Trial
SYDNEY and DURHAM, N.C., March 21, 2013 /PRNewswire via COMTEX/ -- RNAi-based
therapeutics company Benitec Biopharma Limited (asx code:BLT) today announced
the selection of the Duke Clinical Research Unit, the early phase unit of the
Duke Clinical Research Institute (DCRI), Durham, North Carolina, USA as a site
for its upcoming phase I/II first-in-man trial for TT-034 in Hepatitis C. TT-034
is being developed as a potential "one-shot-cure" for Hepatitis C (HCV).
"We are very excited to be working with Duke, a world renowned research
institution with significant experience in this area," said Peter French, Ph.D.,
Chief Executive Officer of Benitec. "The TT-034 trial marks the transition of
Benitec to a clinical stage company. We expect that positive results from the
trial will provide a value inflection point for the company, and also be a
validation for our ddRNAi technology as an effective platform for therapeutics."
The phase I/II clinical trial is an open-label dose escalation study to
evaluate the safety and activity of single doses of TT-034 in patients with
chronic HCV genotype 1 infection who have failed previous treatments. The trial
is expected to involve 14 patients in 5 sequential dose cohorts. Additional
consolidation cohorts may be added during the study to confirm the results of
the trial. The primary safety endpoints are dose limiting adverse events. The
primary activity end points are serum viral load reduction and degree of
hepatocyte transduction (measured through liver biopsies). There is a
pre-specified interim read on safety and activity within months of trial
commencement. The clinical trial is expected to begin enrolling patients during
the second half of 2013.
Duke's principal investigator for the study will be Keyur Patel, M.D. Dr
Patel has previous experience with oligonucleotide therapeutics in HCV, is a
recipient of the prestigious American Association for the Study of Liver
Diseases (AASLD) Shelia Sherlock Clinical and Translational Research award and
has over 100 citations in peer-reviewed publications.
"TT-034 is a potentially transformative new treatment," Dr. Patel commented.
"A therapeutic that could cure an HCV patient with a single injection would
obviously be a big step forward compared to even the best treatments that are
currently on the horizon, as they all involve comparatively lengthy regimens
with a combination of several drugs."
About TT-034
TT-034 is a potentially transformative therapeutic that is intended to
provide a "one-shot-cure" for Hepatitis C with a single injection. TT-034 works
through RNA interference (RNAi), which is a naturally occurring regulatory
process in cells that acts to "silence" genes after they have been transcribed
from DNA into messenger RNA. Benitec's proprietary ddRNAi approach involves the
introduction of a DNA vector that produces short hairpin RNAs (shRNAs) that are
processed by the cell into siRNAs. This approach emulates the cell's own gene
silencing mechanism and provides long term activity (months). Moreover, the
virus vector used to deliver the TT-034 construct, an engineered non-replicating
adeno-associated virus (AAV8), targets almost exclusively liver cells (where HCV
replicates). TT-034 is further designed to prevent viral escape through
mutations (a major problem for most HCV drugs) by using three different shRNAs
to simultaneously target three separate highly conserved regions in the HCV
genome. In mice and monkeys, TT0-034 has been shown to transduce 100% of
hepatocytes in the liver and provide high shRNA activity for 180 days (the
duration of the studies), without adverse effects.
About the Duke Clinical Research Unit:
The Duke Clinical Research Unit (DCRU) is a state-of-the-art research
facility located within the Duke Medicine campus that provides infrastructure
support to sponsors and investigators who are testing new drug candidates and
other cutting-edge therapies, or seeking to identify and validate novel
biomarkers. The DCRU has more than 20 years of early-phase clinical trial
experience and has successfully conducted more than 150 early-phase studies,
including 80 phase 1 studies. The experience, support systems and infrastructure
of the DCRU enable provision of the highest level of program management and
services for early-phase clinical trials, including quality processes, accurate
reporting, and regulatory expertise. The DCRU combines the clinical expertise
and scientific leadership of one of the most prestigious academic medical
centres in the world with the operational capabilities of a full-service
contract research organization. The DCRU is part of the Duke Clinical Research
Institute. The DCRI is a comprehensive academic research organization and the
only one of its kind that can offer all the services of a commercial contract
research organization with the academic credibility and expertise of an academic
medical center.
About Benitec Biopharma Limited:
Benitec Biopharma Limited (asx code:BLT), based in Sydney, Australia, has a
pipeline of in-house and partnered therapeutic programs based on its patented
gene-silencing technology, ddRNAi. Benitec is developing treatments for chronic
and life-threatening human conditions. Its most advanced program is TT-034 for
the treatment of chronic HCV infection. Benitec has licensed ddRNAi technology
to other biopharmaceutical companies who are advancing their programs toward the
clinic for applications including HIV/AIDS, retinitis pigmentosa and
Huntington's disease. For more information on Benitec refer to the Company's
website at www.benitec.com.
For more information please contact:
For Duke Clinical Research Unit:Barry Mangum, PharmD | Director Clinical
Pharmacology Phone: 919 210 8099 | Barry.Mangum@duke.edu | www.dcru.org
For Benitec:Dr Peter French | Chief Executive Officer Phone: +61 (02) 9555
6986 | pfrench@benitec.com | www.benitec.com
SOURCE Benitec Biopharma Limited
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