SYDNEY, March 8, 2016 /PRNewswire/ -- Benitec Biopharma
Limited (ASX: BLT; NASDAQ: BNTC; NASDAQ: BNTCW) is pleased to
announce that BB-HB-331, a DNA-directed RNA interference (ddRNAi)
therapy targeting the hepatitis B virus (HBV), demonstrates robust
and durable suppression of HBV in vivo following a single
administration.
Benitec's ddRNAi technology is a unique combination of gene
silencing using RNA interference coupled with the long term
therapeutic potential of gene therapy. BB-HB-331 is comprised
of an AAV8 capsid and recombinant DNA engineered to express three
short hairpin RNA (shRNA) that target and inhibit viral RNA
expressed from three well conserved regions across multiple HBV
genotypes.
The current in vivo study assessed the activity of
BB-HB-331 in the PhoenixBio (PXB) mouse model, in which mouse liver
cells have been replaced with human hepatocytes making the animals
susceptible to HBV infection. Once infected with HBV, mice
were treated with a one-time systemic injection of BB-HB-331.
Weekly assessment of serum antigen levels, HBV viral proteins and
extracellular HBV DNA were conducted for the duration of the 56-day
study.
The key findings in this study were that a single BB-HB-331
treatment:
- Reduced serum HBV DNA by 1.83 logs, equivalent to 98.5%
elimination of circulating HBV
- Reduced intracellular liver HBV DNA by 94.9%
- Suppressed serum antigens, HBsAg and HBeAg, by 97.6% and 92.6%,
respectively
- Decreased levels of HBV viral RNA and cccDNA
This in vivo experiment validates the BB-HB-331 in
vitro findings previously observed in human hepatocytes
isolated from the PXB mouse model. This in vitro data,
announced to the market on 7 December 2015, was presented by
Dr. David Suhy at the Hep Dart
Conference in December 2015.
Benitec's Chief Scientific Officer, Dr. David Suhy said, "These results demonstrate the
utility of an approach that combines RNAi with gene therapy to
treat HBV. In addition to these encouraging results, we note that
the HBV serum DNA and antigen levels continued to drop through the
pre-determined conclusion of the study, and may not have reached
their lowest levels. As previously communicated, Hep B represents a
significant commercial opportunity and we will continue to apply
key learnings from our clinical stage hepatitis C program to
advance the Hep B program towards the clinic."
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
|
United
States
|
Carl
Stubbings Chief Business
Officer Tel: +61 (2) 9555
6986
Email: cstubbings@benitec.com
|
Annabel
Murphy Head of Investor
Relations & Corporate Communications
Tel: +61 (2) 9555 6986
Email:
amurphy@benitec.com
|
PCG Advisory
Group Adam
Holdsworth Managing Director
of Investor Relations Tel: + 1 646-862-4607 Email: adamh@pcgadvisory.com
Sean Leous
Managing Director of Public
Relations Tel: +1
646-863-8998 Email:
sleous@pcgadvisory.com
|
About Benitec Biopharma Limited:
Benitec Biopharma Limited (ASX: BLT; NASDAQ: BNTC; NASDAQ:
BNTCW) is a clinical-stage biotechnology company developing
innovative therapeutics based on its patented gene-silencing
technology called ddRNAi or 'expressed RNAi'. Based in Sydney, Australia with labs in Hayward, CA (USA) and collaborators and
licensees around the world, the company is developing ddRNAi-based
therapeutics for chronic and life-threatening human conditions
including hepatitis B, wet age-related macular degeneration and
OPMD. Benitec has also licensed ddRNAi to other biopharmaceutical
companies for applications including HIV/AIDS, Huntington's
Disease, chronic neuropathic pain and retinitis pigmentosa.
Safe Harbor Statement:
This press release contains "forward-looking statements" within
the meaning of section 27A of the US Securities Act of 1933 and
section 21E of the US Securities Exchange Act of 1934. Benitec has
tried to identify such forward-looking statements by use of such
words as "expects," "intends," "hopes," "anticipates," "believes,"
"could," "may," "evidences" and "estimates," and other similar
expressions, but these words are not the exclusive means of
identifying such statements. Such statements include, but are not
limited to, any statements relating to Benitec's pipeline of
ddRNAi-based therapeutics, including the initiation, progress and
outcomes of clinical trials and any other statements that are not
historical facts. Such forward-looking statements involve risks and
uncertainties, including, but not limited to, risks and
uncertainties relating to the difficulties or delays in our plans
to develop and potentially commercialize our product candidates,
the timing of the initiation and completion of preclinical and
clinical trials, the timing of patient enrolment and dosing in
clinical trials, the timing of expected regulatory filings, the
clinical utility and potential attributes and benefits of ddRNAi
and our product candidates, potential future out-licenses and
collaborations, our intellectual property position and duration of
our patent portfolio, the ability to procure additional sources of
financing and other risks detailed from time to time in filings
that Benitec makes with US Securities and Exchange Commission,
including our most recent annual report on Form 20-F and our
reports on Form 6-K. Such statements are based on management's
current expectations, but actual results may differ materially due
to various factors, including those risks and uncertainties
mentioned or referred to in this press release. Accordingly, you
should not rely on those forward-looking statements as a prediction
of actual future results.
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SOURCE Benitec Biopharma