SYDNEY, Oct. 22, 2015 /PRNewswire/ -- Benitec Biopharma
Limited (NASDAQ: BNTC; NASDAQ: BNTCW; ASX: BLT) is pleased to
announce that clinical data on its Phase I/IIa study of TT-034 for
hepatitis C will be presented in the 'late-breaking poster' session
at The Liver Meeting® 2015, the 66th Annual Meeting of the American
Association for the Study of Liver Disease (AASLD) being held in
San Francisco on November 13-17, 2015.
The abstract, which has been published on the conference
website, details interim results from patients in the first three
cohorts in Benitec's Phase I/IIa study of TT-034, a DNA-directed
RNA interference agent (ddRNAi). The primary endpoint that this
study is monitoring is safety of this first-in-man gene
therapy-based gene silencing drug. Key findings include:
- The three doses of TT-034 administered to date have been well
tolerated in human subjects infected with the hepatitis C virus
(HCV) and there have been no reported serious adverse events
related to administration of the study drug;
- The initial dose (4E10 vg/kg) resulted in very low levels of
transduction as expected.
- The second dose (1.25E11 vg/kg) resulted in the detection of
substantially higher levels of TT-034 in the hepatocytes, the
predominant cell type in the liver, yielding 0.48, 3.65 and 10.44
copies of TT-034 DNA per cell in the three patients
respectively;
- The first subject administered with the third dose (4.00E11
vg/kg) had 17.74 copies of TT-034 per cell, indicating that a
significant portion of their hepatocytes may have been transduced,
and expression of anti-HCV shRNAs was clearly detected in the
transduced hepatocytes.
Benitec's Chief Scientific Officer, Dr David Suhy said, "We are pleased to be given the
opportunity to present this interim data at the AASLD Liver Meeting
next month. The results show that a single infusion of TT-034 is
reaching the liver and that it has a very favourable safety profile
at the doses tested to date. In the patient that has received the
highest dose to date, we are able to detect that anti-HCV shRNAs
have been expressed in the liver without any drug-related serious
adverse effects, indicating that so far the trial is achieving its
primary outcome. We are pleased with the progress of the trial to
date."
To read the full abstract, please visit:
http://www.aasld.org/sites/default/files/TLM-2015-LakeBreakingAbstracts.pdf
This announcement has been prepared for publication in
Australia and may not be released
in the United States. This
announcement does not constitute an offer to sell, or a
solicitation of an offer to buy, securities in the United States or any other
jurisdiction.
For further information regarding Benitec and its activities,
please contact the persons below, or visit the Benitec website at
www.benitec.com.
Company
|
Investor
relations
|
Carl Stubbings
Chief Business Officer
Tel: +61 (2) 9555 6986
Email: cstubbings@benitec.com
|
Kyahn Williamson
Buchan Consulting
Tel: +61 (3) 8866 1200
Email: kwilliamson@buchanwe.com.au
|
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.
About Benitec Biopharma Limited:
Benitec
Biopharma Limited is a biotechnology company (ASX: BLT; OTC:
BTEBY), which has developed a patented gene silencing technology
delivered by gene therapy, called DNA directed RNA interference
(ddRNAi) that has the potential to produce 'one-shot' cures for a
range of diseases. The company is developing ddRNAi-based
therapeutics for chronic and life-threatening human conditions
including hepatitis C and B, drug resistant lung cancer and wet
age-related macular degeneration. Benitec has also licensed ddRNAi
to other biopharmaceutical companies for applications including
HIV/AIDS, Huntington's disease, chronic neuropathic pain and
retinitis pigmentosa. For more information visit
www.benitec.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/benitec-biopharmas-abstract-accepted-for-presentation-at-the-aasld-liver-meeting-2015-300164542.html
SOURCE Benitec Biopharma Limited