This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

HCV Clinical Trial Application Submitted To Recombinant DNA Advisory Committee (RAC)

Stocks in this article: BLT

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).

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,433.04 +45.83 0.26%
S&P 500 2,032.36 +2.81 0.14%
NASDAQ 4,707.3480 +25.8510 0.55%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs