SYDNEY, April 7, 2015 /PRNewswire/ -- Benitec Biopharma
(ASX:BLT; OTCPK:BTEBY), a biopharmaceutical company focused on
providing potentially curative therapies with its proprietary
gene-silencing technology called ddRNAi or "expressed RNAi," is
pleased to advise that laboratory results from liver biopsies in
the company's 'first in man', Phase I/IIa clinical trial of TT-034
for hepatitis C confirmed that the trial is proceeding according to
expectations.
TT-034 works by producing (in the liver) three silencing short
hairpin RNAs (shRNAs), each responsible for targeting a different
part of the hepatitis C virus' genome. The expression of the three
shRNAs in patients' liver cells is thus an essential requirement
for TT-034 to exert a clinical reduction of hepatitis C viral load.
The most recent assay of the biopsies confirmed this expression
occurred in all three patients dosed to date. These results were
obtained from the biopsies of the first two patients in cohort 1
and the first patient in cohort 2. The second patient in cohort 2
has not yet been biopsied, and the third patient in cohort 2 is yet
to be dosed due to a personal issue.
In cohorts 1 and 2, the dose of TT-034 is sub-therapeutic and,
therefore, the amount of shRNA produced will not result in
reduction of hepatitis C viral load.
Furthermore, to date there have been no treatment-related
serious adverse effects (SAEs) in any of the four patients
dosed.
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 an ASX-listed biotechnology company
(ASX:BLT; OTC:BTEBY) which has developed a 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 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 further information regarding Benitec and its activities,
please contact the persons below, or visit the Benitec website at
www.benitec.com.
Company
|
Investor
relations (Australia)
|
United
States
|
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
|
Tiberend Strategic
Advisors, Inc.
Joshua Drumm
(Investors)
Tel: +1
212-375-2664
Email: jdrumm@tiberend.com
Andrew Mielach
(Media)
Tel: +1
212-375-2694
Email: amielach@tiberend.com
|
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SOURCE Benitec Biopharma Limited