(By Balaseshan) Ampio Pharmaceuticals Inc. (NASDAQ:AMPE) said the extended analysis of Ampion in the knee (AIK) study showed pain relief of osteoarthritis.
The company announced the completion of the planned analysis of the day 84 data of the Ampion in the knee study conducted in Australia. With the previously reported positive results 30 days after a single injection to the knees of patients suffering from osteoarthritis, the analysis was extended to also review pain outcomes at day 84 after the injection.
A method to analyze the pain score data is to determine if any change from baseline is significant (each patient serves as their own control). The change from baseline for the Ampion treated patients was statistically significant at both 30 and 84 days after injection and the change from baseline for the placebo treated patients was not statistically significant.
The difference in pain relief between Ampion and placebo at day 84 after a single injection into the knee was statistically significant despite the small number of patients included in each group (saline and Ampion groups).
Another relevant way to assess pain relief is the "responders versus non- responders" to treatments at day 84. A "responder" was defined as someone who experienced a two or more points shift improvement in pain relief as measured by the numerical pain scale (scale of 1-10).
Non-responders experienced an improvement of at most 1 point or an actual worsening of pain relief. Percentage of "responders" in the group who received Ampion was more than twice the percentage of those who received saline (53% versus 24%) and this approached statistical significance.
Despite the small number of patients included, the company observed prolonged and sustained pain relief in the Ampion treated group even after 84 days from a single injection into the knee and the safety profile was good.
There were no significant adverse events and no minor adverse events that were more common in the Ampion group compared to the placebo group indicating the treatment is well tolerated. These results will be informed in the company's discussions with the FDA at its scheduled meeting in May 2012 and its design of a pivotal trial in the United States.
Ampion is 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. As HSA and blood derived products are currently managed by the Center for Biologics Evaluation and Research division of the FDA, Ampio believes this product will be classified as a biologic.
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.
AMPE closed Friday's regular session down 0.65% at $3.07. The stock has been trading between $2.61 and $9.27 for the past 52 weeks.