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!

Rexahn: Holes Galore in Serdaxin Data

Will the Serdaxin data improved as we move to the next paragraph in Rexahn's press release?

"In addition, 64.3% of patients with severe MDD treated with the 5 mg of Serdaxin were considered Responders compared to 28.6% in the placebo group (p less than 0.0581). A Responder is a patient with a change from baseline in MADRS score of greater than or equal to 50% after treatment. Additionally, 42.9% of patients in the treatment group were in remission with a MADRS score of less than or equal to 12 after treatment, at 8 weeks versus 14.3% in the placebo arm (p less than 0.209)."

Rexahn is providing us with additional efficacy analyses, presumably secondary endpoints, to bolster the case for Serdaxin. That's fine, except again, the only data we're given is from patients with severe depression treated with 5 mg of Serdaxin. It's that darn subgroup of a subgroup again.

And those p values tied to the secondary endpoints aren't pretty, neither reaches the level of statistical significance. In fact, the latter, measuring remission rates for patients in the study, doesn't even come close.

Rexahn doesn't say so explicitly, but I'll assume the argument it's making is that the efficacy trends in both secondary endpoints strongly favor Serdaxin and that the study enrolled too few patients to be powered for statistical significance.

Fine, but it's just as legitimate to look at these data and conclude Serdaxin failed on two of three different measures of efficacy in the company's chosen subgroup of patients with severe depression.

More troubling signs from the Serdaxin data can be found if we revisit the details of the Serdaxin study outlined at The first bullet point under "Secondary Outcomes Measures" is "Changes from baseline on the Ham-D."

The Ham-D is another widely used measure of efficacy in depression trials. Rexahn lists analysis by Ham-D as the first of the secondary endpoints in the study, yet that analysis is missing entirely from the company's press release. Likewise, Rexanh tells us nothing about some of the other secondary efficacy endpoints that were supposed to be analyzed in the Serdaxin study, according to the details of the study listed on

If depression patients were truly responding to Serdaxin, wouldn't that response be picked up by more than one efficacy scale? Why did Rexahn selectively disclose a tiny amount of the data from this study? It's not like Rexahn didn't have time to conduct a full analysis, the company first announced top-line results from the Serdaxin study in depression back in October 2009.

Six months later, Rexahn has still not published data from the study, nor has it been presented at a medical meeting. And the data Rexahn did choose to disclose, via press release, is filled with holes and raises more questions than it answers.

3 of 4

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 18,053.71 +23.50 0.13%
S&P 500 2,088.77 +6.89 0.33%
NASDAQ 4,806.8590 +33.3870 0.70%

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