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!

Ampio Pharmaceuticals Reports Pre-IND Meeting With The FDA To Obtain Clinical Path Guidance For Ampion™ For The Treatment Of Chronic Pain Of Osteoarthritis Of The Knee And Schedules May 16th Webcast To Update Shareholders

Stocks in this article: AMPE

GREENWOOD VILLAGE, Colo., May 11, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company conducting clinical trials on its three lead drugs (Ampion , Optina and Zertane ) announced completion of a pre-IND meeting with the Center for Biological Evaluation and Research (CBER) division of the FDA that took place on May 10th regarding Ampio's lead biologic, Ampion for the chronic treatment (repeat injections) of pain in osteoarthritis (OA) of the knee.  

The purpose of the meeting with CBER was to obtain guidance for the clinical path to a Biologics License Application (BLA) for Ampion for OA of the knee in the US and clarity as to the steps necessary for Investigational New Drug (IND) submission. The discussions included manufacturing criteria and the scope and design of the phase III trial(s).

Michael Macaluso, Ampio's CEO, noted, "The Company agreed with all the guidance for Ampion provided by CBER and believes the regulatory path described is both reasonable and manageable by the Company.  The results of these trials (two phase III, well conducted, placebo controlled trials, run concurrently) will form the basis for a BLA submission.  The scope and design of these studies will be available in our IND submission."

The Company will hold a webcast on Wednesday, May 16, 2012 at 4:15 EDT to present a 30-minute overview of the Company's progress and future plans and then open the call to a Q & A session.  A press release on May 14th will describe how the shareholders and the general public can join and listen to the call.


About Ampion

Ampion , a molecule protected by a composition of matter and use patents, is naturally produced by humans in response to injury and is present in commercial human serum albumin (HSA) preparations.

Ampion is a non-steroidal anti-inflammatory drug that appears to have a significant role in the homeostasis of inflammation, so may have potential to treat a broad array of inflammatory conditions, which impact millions of patients.


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 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

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