GREENWOOD VILLAGE, Colo. April 30, 2012 ™ ™ ™
- was was not
- "The difference in pain relief between Ampion™ 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™ 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™ was more than twice the percentage of those who received saline (53% vs. 24%) and this approached statistical significance (p=0.06)."
Australia May 2012 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. 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™ 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’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™ 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.
SOURCE Ampio Pharmaceuticals, Inc.