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 Receives FDA Confirmation That The Spring Study Is Pivotal And Will Initiate The Final Pivotal Trial For Ampion™ Biological License Application (BLA)

Stocks in this article: AMPE

GREENWOOD VILLAGE, Colo., Dec. 2, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced receipt of FDA correspondence confirming the acceptance of The Spring Study as pivotal and providing guidance for the design of the second and final pivotal trial of Ampion™ for the treatment of osteoarthritis of the knee (OAK).


Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted the letter summarized the FDA's conclusions after reviewing the complete clinical data set provided by Ampio following their October 29 th pre-BLA meeting.  The FDA letter includes the following statements:

  • " Upon review of the dataset received on November 5, 2013, FDA concludes that study AP-003-A can be considered as one of two "pivotal trials" required in support of a BLA."
  • "This recommendation is based on the fact that study AP-003-A was adequate (n=329) and well controlled (normal saline), the trial conduct was acceptable and the study met its primary endpoint (change in WOMAC score at 12 weeks)."
  • "The strength of the evidence is robust"
  • "FDA recommends that Ampio conduct an adequately powered study to confirm the effect size of AP-003-A and design the study to obtain information on the duration of action and repeat dosing."
  • "The study to evaluate safety and efficacy of repeat dosing may be conducted post market approval."

Dr. Clift continued, "Our interactions with the FDA have been helpful at every step of this process and we are very grateful for their guidance.  The final pivotal trial will confirm the efficacy and safety of the 4 ml injection in approximately five hundred (500) patients with a follow-up of no less than twenty (20) weeks in order to better understand the duration of action. This trial is planned to begin in early January 2014 with an additional six (6) clinical sites added to the nine (9) sites utilized in the SPRING study.  Submission of the BLA, the documents used for approval, could then occur in the 3 rd quarter of 2014."

Michael Macaluso, Chairman and CEO of Ampio commented "We are all very proud of the excellent work of our clinical team, led by Dr. David Bar-Or, our Chief Science Officer, and the inventor of Ampion , and Dr. Clift, that culminated in this encouraging FDA guidance."

"Most important, greater improvement in pain relief was reported in patients with the most severe disease (Grades III and IV), which means we are now closer to the day when we may be able to significantly reduce the suffering and improve the quality of life for the millions of patients so greatly afflicted."

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