This Day On The Street
Continue to site right-arrow
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!

Northwest Bio DC-Vax Study Changes Hint at Failure

Stocks in this article: NWBO

BETHESDA, Md. (TheStreet) -- I long believed Northwest Biotherapeutics (NWBO) buried the interim efficacy analysis of its DC-Vax brain tumor clinical study in a deep hole, never to be seen again. But these things have a way of rising to surface.

It's been nine months since Northwest Bio initiated an interim efficacy look at the DC-Vax phase III study. The company has stubbornly refused to disclose those results. Monday, I believe we found out why. It seems obvious that DC-Vax came up futile in the interim efficacy analysis of the phase III study data conducted in December 2013, leaving almost no chance the experimental cancer vaccine would delay tumor progression or prolong survival.

Absent any hope of rescuing DC-Vax from failure with the brain tumor study designed as is, Northwest Bio announced a radical -- and seemingly desperate -- re-working of the study. Monday's press release said the DC-Vax study changes were made following a "9-month process of regulatory submissions and reviews by regulators in the US, UK and Germany..." Nine months? That means Northwest Bio started the process last December, which is also when the interim efficacy analysis of the study was conducted. What a coincidence! In classic spin mode, Northwest describes the DC-Vax study changes as "enhancements" which will improve the odds of success.

Read MoreDendreon Warns Debt Bomb Might Wipe Out Shareholders

Northwest Bio is adding more patients to the DC-Vax study. The company hinted about an increase in enrollment previously, so this isn't much of a surprise. Northwest Bio said Monday it will increase enrollment for the DC-Vax study to 348 brain tumor patients from its previous target of 312 patients, even though the company has never disclosed how many patients are currently enrolled. In June, Northwest Bio CEO Linda Powers promised to complete enrollment in the study by the end of 2014. Monday, the company said enrollment in the study would now be completed in the third quarter of 2015.

Why will it take extra time to enroll 36 additional patients? Northwest Bio has claimed in the past to be expanding the number of German and United Kingdom hospitals participating in the study. As of today, none of those promised European trial sites have materialized. 

The most devastating and damning change made to the DC-Vax study is the more than doubling of the number of "events" (tumor progression or patient deaths) required to trigger a final analysis of the primary endpoint. The study had been designed with statistical power allowing for an analysis of progression-free survival (PFS) after 110 patients had progressed or died. Monday, Northwest Bio raised the number of required events to 248 -- a whopping 125% increase! In my 13 years covering biotech, I have never seen a company make such a large change to the statistical analysis of a phase III study.

If DC-Vax was demonstrating a positive effect on brain cancer patients, there would be no need to wait for 248 of 348 patients to progress or die before analyzing the study results. Again, Monday's announced changes make it clear that the interim efficacy analysis conducted nine months ago showed DC-Vax to be futile. Northwest Bio can argue all it wants to the contrary, but the need to dramatically boost the statistical power of a study years after it begins shows that there is no efficacy signal with DC-Vax at all. Northwest Bio is flailing, but then, anyone who bothered to dig deep into the prior DC-Vax studies knows the cancer vaccine is nothing more than a placebo

Read MoreRetrophin CEO Under Fire for Twitter Faux Pas

Northwest Bio says top-line results from the DC-Vax study should be announced at the end of 2015. That's an ambitious (unrealistic) timeline given the more than doubling of required events. It does give Northwest Bio ample time to come up with more study design changes (excuses). The planned, second, interim analysis expected at 88 events seems to have been disappeared.

1 of 2

Select the service that is right for you!

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 17,356.87 +288.00 1.69%
S&P 500 2,012.89 +40.15 2.04%
NASDAQ 4,644.3120 +96.4780 2.12%

Brokerage Partners

Rates from

  • 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