SYDNEY, April 16, 2013 /PRNewswire/ -- RNAi-based
therapeutics company Benitec Biopharma Limited (ASX Code: BLT)
today announced that the company's wholly owned US subsidiary,
Tacere Therapeutics Inc., has submitted an application to the US
National Institutes of Health's Recombinant DNA Advisory Committee
(RAC) .
The RAC submission document comprises the full clinical trial
protocol for its first-in-man ddRNAi-based therapeutic (TT-034) for
hepatitis C virus (HCV) infection, as well as the safety and
toxicology data and responses to questions concerning the objective
and rationale for the proposed trial. Most of this material will be
utilised in the subsequent US Food and Drug Administration (FDA)
Investigational New Drug (IND) application for TT-034.
The RAC review is a required step for a product that involves
gene therapy vectors before a clinical trial can be initiated. The
RAC process results in recommendations that are disseminated to
various bodies, including the Company and the FDA. The review
can be administrative or include a public hearing. If the
application is subject to a hearing, this is expected to be part of
the next RAC meeting in June
2013.
David Suhy, Ph.D., Tacere's
US-based, Senior Vice President of Research and Development
commented, "Completing this submission is an important step in
moving TT-034 into the clinic. We look forward to receiving the
Committee's recommendations and then moving ahead with an IND and
initiating the clinical trial for TT-034 this year. It has been
very gratifying to oversee the development of a first-in-class
therapeutic from concept to the clinic."
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. Preclinical studies have shown that the vector used to
deliver TT-034 specifically targets liver cells where it transfects
almost every cell without causing toxic effects. TT-034 is designed
to prevent development of viral resistance (a major problem for
most hepatitis C drugs) by simultaneously silencing three separate
highly conserved regions on the virus genome. Studies have
demonstrated that a single treatment of TT-034 is active out to 180
days (the duration of the studies).
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 a range of chronic and life-threatening human conditions.
Benitec has licensed its 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:
Dr Peter French |
Chief Executive Officer
Phone: +61 (02) 9555 6986 |
pfrench@benitec.com | www.benitec.com
SOURCE Benitec Biopharma Limited
