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!

German Regulator Authorizes NW Bio's Phase III GBM Trial To Open





BETHESDA, Md., Sept. 17, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing non-toxic DCVax ® personalized immune therapies for solid tumor cancers, announced today that the German regulatory authority (the Paul Ehrlich Institute, or PEI) has approved the Company's implementation of the three minor amendments required by the PEI's initial decision announced in August, and has authorized the Company's Phase III GBM clinical trial to open in Germany. 

(Logo: http://photos.prnewswire.com/prnh/20110329/SF73084LOGO)

NW Bio made its submission of the clinical trial documents with the three amendments included on September 5, 2013, and received the PEI's approval on September 16, 2013.  The PEI approval letter stated that:

"The documents submitted have been assessed and deemed sufficient to fulfill the additional conditions imposed. As all legal requirements of Sections 40, 42 of the German Medicinal Products Act (AMG) are now complied with, the clinical trial can be started immediately." (English translation of German text).

This rapid regulatory response represents the last step in a long approval process before one of the most rigorous regulators in the world.  It enables NW Bio to proceed with its Phase III trial in Germany, where the Company plans to include more than 20 top German hospital centers.  These German centers will be joining more than 55 clinical trial sites currently operating in the US, as well as sites in the UK, as part of NW Bio's international 312-patient, double blind, randomized, placebo-controlled Phase III clinical trial of DCVax®-L for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. Based upon the PEI's approval, NW Bio will now proceed with the final administrative steps with the individual German hospital centers, in order for enrollment to begin.

"We are excited to receive this rapid final approval of our Phase III GBM trial from the German regulator," commented Linda Powers, CEO of NW Bio.  "DCVax®-L is now one of the first active immune therapies to reach approval for Phase III trials by multiple major regulatory authorities.  DCVax®-L is also now one of the first Advanced Therapy Medicinal Products (the legal classification covering all types of cell therapies in Europe) to reach Phase III clinical trials.  We are now beginning the final phase of this important international Phase III trial, with enrollment in both Europe and the US occurring in parallel, potentially finishing enrollment by the late summer of next year, and potentially reaching top line results by the end of next year."

About Northwest Biotherapeutics



1 of 2

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!
DOW 16,960.57 -123.23 -0.72%
S&P 500 1,978.34 -9.64 -0.48%
NASDAQ 4,449.5640 -22.5440 -0.50%

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