Benitec Proceeds With ‘First In Man’ Trial for TT - 034: A Single Injection To Treat Hepatitis C

Hepatitis C Trial To Proceed
1/14/2014 9:04:01 AM

Sydney Australia, 14th January 2014: RNAi - based therapeutics company Benitec Biopharma Limited (ASX: BLT) today announced that the US Food and Drug Administration (FDA) has advised the Company that it may proceed with it s ‘first in man’ clinical trial for TT - 034, a ddRNAi - based therapeutic, designed to treat Hepatitis C with a single injection .

This follows the FDA’s review of Benitec’s Investigational New Drug (IND) application, which was filed on 6 December 2013.

Benitec Biopharma’s CEO and Managing Director, Peter French said, “We are very pleased with this outcome which establishes Benitec as a clinical stage company .” 

 Excerpt From:March 2013/ Benitec Selects the Duke Clinical Research Unit as a Site for Hepatitis C Phase I/II Clinical Trial

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. 

For further information, please contact the persons outlined below, or visit the Benitec website at www.benitec.com 

Company
Carl Stubbings
Chief Business Officer
Tel: +61 (2) 9555 6986
Email:
cstubbings@benitec.com

Investor relations
Jane Lowe
Buchan Consulting
Te
l: +61 (2) 9237 2807
Email:
jlowe@buchanwe.com.au

About Benitec Biopharma Limited:
Benitec Biopharma Limited is an ASX - listed biotechnology company (ASX Code: BLT) based in Sydney, Australia. The company has a pipeline of in - house and partnered therapeutic programs based on its patented ge ne - silencing technology, ddRNAi . Benitec is developing treatments for chronic and life - threatening human conditions such as Hepatitis C , Hepatitis B, wet age - related macular degeneration, cancer - associated pain, drug resistant lung cancer and oculopharyngeal muscular dystrophy based on this technology. In addition, Benitec has licensed ddRNAi technology to other biopharmaceutical companies who are progressing their programs t owards 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 .