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!

Galena's Breast Cancer Vaccine Doomed to Fail

When life hands you lemons, you make lemonade. In biotech, when a study fails, you go on a mining expedition into the bad data to find something positive to say. This is what Keryx did unsuccessfully with perifosine, and this this is exactly what Apthera, the original developer of NeuVax, and Galena, which later bought Apthera for just $7 million, have also done.

Pouring through the data from the failed trials, Apthera/Galena discovered that breast cancer tumors with low and intermediate levels of HER2 expression appeared to respond better to NeuVax.

At 36 months, the cancer relapse rate for a subgroup of 50 NeuVax-treated women with breast cancer that expressed low (1+) and intermediate (2+) levels of HER2 had a relapse rate of 8% compared to a 23.5% relapse rate for a subgroup of 34 women in the control arm with tumors that also expressed relatively low levels of HER2. This difference in relapse rate was statistically significant with a p value of 0.045, claims Galena.

Naturally, Galena is conducting its phase III study of NeuVax in breast cancer patients with tumors that express low and intermediate HER2.

And of course, this NeuVax study will fail because the premise upon which it is designed -- culled from a retrospective data-mining adventure through the phase II study -- is false.

How do I know it's false? For starters, it makes no sense for a HER2-targeted cancer vaccine to work better in tumors that express low levels of HER2, or no HER2 expression at all.

Breast cancers in the phase II study were analyzed for HER2 expression using a staining process called immunohistochemistry, or IHC. It's not the most accurate or reliable way of determining HER2 status -- flourescence in situ hybridization (FISH) testing is better. Moreoever, tumors that come back HER2 1+ via IHC are usually categorized as HER2 negative.

How is a HER2 cancer vaccine like NeuVax supposed to work on HER2-negative tumors? Galena doesn't explain.

Again, logic and science dictates that NeuVax should work really well in breast cancers that express high levels of HER2, the so-called HER 3+ group. But some mathematical extrapolation on the data made available by Galena from the phase II study reveals that NeuVax actually performs worse in the HER 3+ group.

The 36-month relapse rate for NeuVax-treated patients with HER 3+ tumors is 9% compared to a 7% relapse rate for the control group, also with HER 3+ tumors.

Galena cherrypicks a subgroup of patients where it claims NeuVax works but ignores another equally large subgroup of patients where NeuVax actually hurts patients, even though the vaccine should work for better these latter patients.

None of this bodes well for NeuVax. The phase III study is going to fail, all that's necessary is patience since we may not see results for three years. NeuVax isn't going to work -- the phase II data don't lie.

Before wrapping up this dissection of Galena, let's do away with a couple more canards that seem to have retail investors excited and optimistic.

First, Roche/Genentech is not interested in acquiring Galena, nor is the company a partner in a phase II study testing the combination of NeuVax and Herceptin in breast cancer.

Galena has issued many press releases claiming Roche/Genentech's involvement in this small phase II study, but that's misleading because Roche/Genentech's participation is limited to a small amount of funding and the donation of Herceptin supplies to the investigator so he can conduct the study, says company spokesman Ed Lang.

2 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!
DOW 17,098.45 +18.88 0.11%
S&P 500 2,003.37 +6.63 0.33%
NASDAQ 4,580.2710 +22.5760 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