Ampio Pharmaceuticals, Inc. Announces Statistically Significant Improvement In Pain Relief For Its Lead Product, Ampion In The Osteoarthritis Of The Knee Trial.
GREENWOOD VILLAGE, Colo., Jan. 31, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced preliminary results of the pain score portion of the expansion phase of Ampion™ in Knee (AIK) trial which was recently completed in Australia.
Preliminary analysis of the pain scores portion of the trial demonstrated positive results, suggesting that Ampion™ may be a therapeutic alternative to steroids for osteoarthritis with a very favorable safety profile.
One simple way to analyze the data is to determine the overall change in pain scores at different time points after the knee injections with Ampion™ or vehicle control. Pain trials are notorious for involving a significant placebo effect which usually tends to fade with passage of time. The overall difference in pain score was 41% for Ampion™ at 30 days post injection compared to baseline (predose baseline 4.45/0.96 mean/SD, versus 2.47/1.9 mean/SD at 30 days, p=0.016). The placebo vehicle control (saline) showed a difference of 28% over the same time period and was not statistically significant (predose baseline 5.29/1.38 mean/SD compared to 3.60/2.47 at 30 days post injection p=0.081).
With Ampion™, 64% of patients had a clinically meaningful improvement (2 or more on the 1-10 pain scale) and 18% did not benefit. With the vehicle control/placebo, no clear difference was seen as 40% showed improvement and 40% did not benefit (Chi square=0.125).
"To achieve any statistically significant effect on a pain score scale with less than 40 patients is fantastic," stated Dr. Vaughan Clift, Chief Regulatory Officer. "Some of these changes are greater than published in the medical literature for some approved drugs for this condition," added Dr. Clift.Select the service that is right for you!
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