This Day On The Street
Continue to site
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

Protalix BioTherapeutics Receives FDA IND Clearance To Initiate A Phase I/II Study Of Fabry Disease Patients With PRX-102, A Modified Enzyme Replacement Therapy

CARMIEL, Israel, Aug. 13, 2012 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX) (TASE:PLX), announced today that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate clinical trials of PRX-102. The Company plans to commence enrollment of Fabry disease patients for a phase I/II trial in the fourth quarter of 2012.

PRX-102 is a proprietary plant cell-expressed, chemically modified, recombinant alpha-galactosidase-A in development as a long-term enzyme replacement therapy (ERT) for the treatment of Fabry disease. The phase I/II clinical trial is designed as a multi-center, open label, dose ranging study to evaluate the safety, tolerability, pharmacokinetics and efficacy of PRX-102 in adult Fabry patients.

"We are very excited to begin the clinical development of PRX-102, which we believe may prove to present an important improvement to the well being of patients with Fabry disease, a rare, genetic lysosomal storage disorder affecting approximately 8,000 people globally," said Dr. David Aviezer, Protalix's President and Chief Executive Officer. "We have designed PRX-102 as a potentially improved version of the currently marketed enzyme replacement therapies for Fabry disease given its potential to be a more stable, potent and specific enzyme. This enzyme is expressed through ProCellEx ®, our proprietary, plant cell-based protein expression system. We are also excited that another biotherapeutic protein evolving from our ProcellEx platform technology is anticipated to enter clinical development shortly."

Eighteen adult Fabry patients will be enrolled in one of three dosing groups. Each patient will receive intravenous infusions of PRX-102 every two weeks for 12 weeks, and will be infused sequentially and stepwise in order to evaluate safety. Exploratory efficacy parameters will be evaluated as a preliminary assessment. Following the end of the trial, the Company intends to offer patients the option to continue to receive PRX-102 in an open-label extension study.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr 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

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 17,131.86 +47.37 0.28%
S&P 500 2,014.89 +15.91 0.80%
NASDAQ 4,838.6430 +8.1730 0.17%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs