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
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Biotech Data Mining Comes Up Empty

That's a classic data dredge. The MycoVa studies in "all comer" patients with mild to moderate toeail fungus failed as designed originally, so Apricus just ignores the data and finds a subgroup of patients (those who have toenail fungus but not athlete's foot) where MycoVa allegedly works. Victory declared.

Except, of course, that the studies do not prove at all that MycoVa works in toenail fungus, non-athlete's foot patients because the studies weren't designed with this goal in mind. What looks good in a press release will almost certainly be dismissed as pseudo-scientific nonsense by regulators, if Apricus ever follows through on a promise to seek approval for MycoVa based on this dubious "re-analysis."

Moving on to Cel-Sci, which announced last week that a "meta analysis" of four phase II clinical trials involving 120 patients with head and neck cancer found a "highly statistically significant" reduction in total cholesterol following treatment with the company's experimental drug Multikine.

I must admit to confusion reading the Cel-Sci announcement a few times because Multikine is being developed as a treatment for head and neck cancer. In fits and starts, Cel-Sci is now trying to conduct a phase III study. Who cares if Multikine lowers cholesterol, especially since Cel-Sci has never before discussed the possibility of developing Multikine as a cholesterol-lowering drug? (I'm also putting aside the nontrivial issue of explaining how Multikine might lower cholesterol, since Cel-Sci doesn't offer any.)

Cel-Sci's claim about Multikine lowering cholesterol is just more hyer-promotional data mining and doesn't pass the smell test. According to regulatory filings, Multikine was studied in previous clinical studies enrolling over 200 patients, so how does Cel-Sci explain a meta-analysis that includes four studies and 120 patients? How were those studies and patients selected and why were others left out?

A 2005 phase II study of Multikine in head and neck cancer published in the Journal of Clinical Oncology was almost certainly included in the meta-analysis, but that study makes no mention of any cholesterol-lowering effects of the drug. In fact, the study publication doesn't mention cholesterol at all.

2 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
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
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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!
SYM TRADE IT LAST %CHG
CTIC $2.72 10.57%
AGEN $5.28 3.73%
APRI $2.46 -1.60%
CVM $1.14 -4.20%
OSIR $16.94 -4.83%

Markets

DOW 18,135.72 +38.82 0.21%
S&P 500 2,101.04 +2.51 0.12%
NASDAQ 4,982.8090 +15.6680 0.32%

Partners Compare Online Brokers

Free Reports

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