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
$1 buys you full access to ALL of TheStreet's Subscription Services! Learn More

Ampio Pharmaceuticals Modifies Ampion™ IND For Osteoarthritis Of The Knee To Include A Dose Escalation Run-In Study And Prepares To Launch Pivotal Clinical Trial

Stocks in this article: AMPE





GREENWOOD VILLAGE, Colo., Feb. 25, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) announced today that it's Phase III clinical study of Ampion™ for the treatment for osteoarthritis of the knee will include a dose-escalation run-in study as recommended by the FDA. 

(Logo:  http://photos.prnewswire.com/prnh/20120516/MM09116LOGO)

Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, explained "In the Australian trial, a single 4 ml dose provided promising results from the Ampion™ treated patients suffering from osteoarthritis. This run-in portion of the Phase III trial that will be launched in the US is designed primarily to determine if the 4 mL treatment could be improved by administering a 10 ml volume of Ampion™, the volume commonly injected into the knee with other therapeutic agents."

Dr. Clift further noted "Accordingly, the Company has modified the original study design to accommodate the FDA recommendations and submitted this upgraded IND study protocol for clearance to begin treating patients. A Clinical Research Organization (CRO) has been engaged and multiple clinical sites have been selected that are ready to enroll patients in the study. The dose ranging run-in study will commence shortly and will include 320 patients in total comparing 4 ml to 10 ml injection using the WOMAC pain scale."

Michael Macaluso, Chairman and CEO of Ampio, commented "The FDA has been very helpful by recommending a single run-In study to begin our Phase III pivotal trial that will provide us deeper understanding of the treatment effect and an optimized dose that may well reduce the patient requirement, and the associated time and costs as the number of combined patients in the run-in/phase III study may be significantly less than the 1600 patients planned for the two, phase III studies in the original IND application."



1 of 4

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!

Markets

DOW 17,827.75 +12.81 0.07%
S&P 500 2,072.83 +5.80 0.28%
NASDAQ 4,787.3170 +29.0650 0.61%

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