Staff and Wire Reports
Tuesday, 31 January 2012 09:18
Heavily shorted Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) 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.
Mr. Michael Macaluso, Chairman and CEO, stated, "our pre IND meeting request with the FDA was already submitted and given these positive results, we hope to rapidly gain clarity and initiate the definitive trial(s) in the second half of this year."
Ampion™ is a non-steroidal anti-inflammatory drug that appears to have a significant role in the homeostasis of inflammation, so that it has the potential to be used in a broad array of inflammatory conditions which impact millions of patients. Ampion™ is a molecule produced by humans in response to injury and is protected globally by composition of matter and use patents including means of synthetically manufacturing the molecule and method of extraction from commercial albumin preparations.
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