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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Protalix BioTherapeutics' Taliglucerase Alfa Phase III Results Published In Blood, The Journal Of The American Society Of Hematology

Stocks in this article: PLX

CARMIEL, Israel, Sept. 8, 2011 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE: PLX), today announced that an article entitled "Pivotal Trial with Plant-Cell–Expressed Recombinant Glucocerebrosidase, taliglucerase alfa, a Novel Enzyme Replacement Therapy for Gaucher Disease" has been published in Blood, the Journal of the American Society of Hematology.  The full article can be found on the American Society of Hematology's website at http://bloodjournal.hematologylibrary.org. (First Edition Paper, pre-published online September 6, 2011; DOI 10.1182/blood-2011-07-366955)

The reported study is based on the Company's phase III clinical trial of taliglucerase alfa for the treatment of Gaucher disease.  The authors, who include among others specialists in the treatment of Gaucher disease that served as investigators in our phase III clinical trial, concluded that treatment of 31 naive Gaucher disease patients with taliglucerase alfa at doses of 60 U/kg or 30 U/kg administered intravenously every two weeks for nine months reduced mean spleen volume by 38.0 percent and 26.9 percent, respectively.  Additionally, patients treated with taliglucerase alfa in the phase III clinical trial demonstrated an increase in hemoglobin, decrease in liver volume and increase in platelet count.

"The sustained efficacy and safety that we observed among Gaucher patients receiving taliglucerase alfa in this study suggests that it is a valuable long-term treatment option for patients with Gaucher disease pending regulatory approval," stated Professor Ari Zimran, M.D., Director of the Gaucher Clinic in Shaare Zedek Medical Center, Jerusalem, Israel and lead clinical investigator.  

Phase III Trial Design

The pivotal Phase III clinical trial was a world-wide, multi-center, randomized, double-blind, parallel group, dose-ranging study to assess the safety and efficacy of taliglucerase alfa in 31 treatment-naive patients suffering from Gaucher disease.  In the trial, patients were selected randomly for one of two dosing arms (60 U/kg or 30 U/kg) and received intravenous infusions of taliglucerase alfa once every two weeks for a nine month period.  The primary endpoint of the study was a mean reduction from baseline in spleen volume after nine months, as measured by MRI. Major secondary endpoints were an increase in hemoglobin, decrease in liver volume and increase in platelet count.  The trial was performed in 11 centers throughout Europe, Israel, North America, South America and South Africa.

Phase III Trial Results

Taliglucerase alfa significantly reduced mean spleen volume after nine months compared with baseline in both treatment groups.  The 60 U/kg group demonstrated a statistically significant mean reduction in spleen volume of 38.0 percent (p<0.0001) and the 30 U/kg group demonstrated a statistically significant mean reduction in spleen volume of 26.9 percent (p<0.0001).  In addition, the primary endpoint was achieved in both treatment groups after only six months of therapy.

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

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