Ampio Pharmaceuticals announces extended analysis of Ampion(TM) In the Knee (AIK) Study shows pain relief of osteoarthritis, 84 days after a single injection into the knee, is statistically significant
GREENWOOD VILLAGE, Colo., April 30, 2012 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company conducting clinical trials on its three lead drugs (Ampion(TM), Optina(TM) and Zertane(TM)), licensing distribution of those drugs and engaged in further drug development, announced the completion of the planned analysis of the day 84 data of the Ampion(TM) in the Knee (AIK) 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.
Dr. Vaughan Clift, Ampio’s Chief Regulatory Officer, explained:
- “There are a number of ways to analyze the pain score data to determine efficacy. One method 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 (p < 0.05 for day 30 and day 84) and the change from baseline for the placebo treated patients was not statistically significant (p =0.08 day 30, p= 0.34 at day 84).
- “The difference in pain relief between Ampion(TM) and placebo at day 84 after a single injection into the knee was statistically significant (p=0.04, n=32) despite the small number of patients included in each group (saline and Ampion(TM) groups).
- “Another relevant way to assess pain relief is the “responders vs. 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(TM) was more than twice the percentage of those who received saline (53% vs. 24%) and this approached statistical significance (p=0.06).”
“This study in Australia was designed to explore safety and efficacy in a proof of principle study,” commented Dr. David Bar-Or, Chief Scientific Officer. “Despite the small number of patients included, we observed prolonged and sustained pain relief in the Ampion(TM) treated group even after 84 days from a single injection into the knee and the safety profile was good. These are very gratifying results as our in-vitro studies indicate that Ampion(TM) has multiple mechanisms of action many of which would be consistent with long term efficacy from a single injection. There were no significant adverse events and no minor adverse events that were more common in the Ampion(TM) group compared to the placebo group indicating the treatment is well tolerated. These results will inform our discussions with the FDA at our scheduled meeting in May 2012 and our design of a pivotal trial in the United States.”
Ampion(TM) 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. Because 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(TM) 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.
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS disease, and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities (“NMEs”). By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio’s product development programs. For more information about Ampio, please visit our website, www.ampiopharma.com.
Ampio’s statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions These forward-looking statements include risks associated with clinical trials, expected results, regulatory approvals, successful commercialization and marketing of Zertane(TM) and the combination drug in Korea, and changes in business conditions and similar events. The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
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SOURCE Ampio Pharmaceuticals, Inc.