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

Northwest Bio Fuzzier on Cancer Vaccine Study Patient Enrollment

By: Adam Feuerstein | 06/05/14 - 08:30 AM EDT

Stocks in this article: NWBO

I don't want to write about Northwest Biotherapeutics (NWBO) all the time. Honestly, there are better ways for me to spend my time, but every time CEO Linda Powers speaks, another truth bomb explodes and I'm forced to clean up the mess.

On Wednesday afternoon during a presentation at an investor conference, Powers once again offered conflicting language on the timeline for enrollment of 312 glioblastoma patients in the phase III study of the experimental cancer vaccine DC-Vax.

Enrollment is expected to complete "this year," said Powers.

Uh oh...

Last September, Northwest Bio's guidance for the DC-Vax phase III study was, " potentially finishing enrollment by the late summer of next year." That implied this upcoming August, maybe into September if generous about summer's end.

"This year" implies ... this year! September? October? December? Powers will keep us guessing, just as she's done with the actual number of patients enrolled in the study to date, which is never disclosed. Results of the interim efficacy analysis announced last December are still MIA. And Powers disappeared any mention of the next interim analysis, which was supposed to take place after 88 patient deaths. 

As she so often likes to do these days, Powers on Wednesday talked up the global reach of the DC-Vax phase III study, which is allegedly recruiting patients in the U.S., the United Kingdom and Germany.

Except it's not. A perusal of ClinicalTrials.gov shows the number of hospitals enrolling patients stuck at 55, where it's been for a really long time. The company's most recent 10-Q filed with the SEC says there are 51 clinical trial sites open. Back in September, Northwest Bio claimed German regulators had given the clearance for the DC-Vax study to recruit patients there

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.

Nine months have passed and none of those 20 promised German hospitals are listed on ClinicalTrials.gov. Northwest Bio has had a problem in the past translating English into German and vice versa, so perhaps that's the holdup. Let's not forget the other red flags waving above the DC-Vax phase III study: A questionable choice of primary endpoint and dodgy statistical analysis plan.

And let's not even get started on how many more delays will occur if/when Northwest Bio decides to add patients to the GBM DC-Vax study. That's the next truth bomb waiting to drop.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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.

Markets

DOW 17,959.44 +154.64 0.87%
S&P 500 2,078.54 +7.89 0.38%
NASDAQ 4,781.4240 +16.0440 0.34%

Adam's Tweets

Brokerage Partners

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS

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
Real Money Pro

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
Trifecta Stocks

Trifecta Stocks analyzes over 4,000 equities weekly to find the elite 1% of stocks that pass rigorous quantitative, fundamental and technical tests.

Product Features:
  • Model portfolio
  • Trade alerts
  • Recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
Stocks Under $10

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
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
  • Upgrade/downgrade alerts
Dividend Stock Advisor

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
Breakout Stocks

Bryan Ashenberg, using sophisticated stock screening and fundamental research, identifies potentially explosive small and mid-cap stocks.

Product Features:
  • Model portfolio
  • Small-cap and mid-cap focus
  • Intraday trade alerts
  • Weekly roundups
Options Profits

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
Top Rated Stocks Top Rated Funds Top Rated ETFs