GREENWOOD VILLAGE, Colo., Oct. 7, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced interim results from the ongoing 450 patient, dose finding, 505 (b) 2 study of Optina TM as a treatment for Diabetic Macular Edema (DME). This interim analysis was conducted by an Independent Data Review Committee (IDRC) comprised of a statistician and an ophthalmologist/retinologist, who were permitted to view the unmasked data from the trial. At least thirty percent (30%) of patients had reached the first 4 week time point and their clinical results were considered representative data for the trial.
Vaughan Clift, Ampio's Chief Regulatory Officer explained: "As is common with interim analyses of this sort, the analysis parameters were defined a priori and could have resulted in three possible scenarios as follows: 1) Termination of the study due to lack of efficacy or safety concerns, 2) delayed analysis if no conclusion could be drawn or 3) indication of an optimum dose if sufficient differentiation from placebo was present to indicate clinical benefit and no serious adverse events. The IDRC elected the third option and stated:
"After a thorough review of the interim data from the ongoing study, it was determined that there was a treatment dosage that was demonstrating a potentially beneficial anatomic effect. Given that there were no significant safety concerns identified in the study to date, a recommendation to continue the trial was made".
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- 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 + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV