GREENWOOD VILLAGE, Colo., April 9, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that the results of the 20 weeks extension of the Ampion™ SPRING study will be presented by Dr. Nathan Wei, MD of the Arthritis Treatment Center Frederick, MD at the Western Orthopedic Association Conference in July 2014. http://www.woa-assn.org/.
This 20-week extension of a multicenter, randomized, vehicle-controlled, double-blind study (NCT01839331) evaluated the safety and efficacy of a single intra-articular injection of Ampion™ treatment of inflammation-associated pain in symptomatic OA of the knee (OAK). A summary of the results follows:
- Ninety-seven patients who received a 4-mL intra-articular injection of Ampion™ or vehicle control were followed for an additional 8 weeks beyond the initial 12-week endpoint of the SPRING study. Efficacy measures included changes from baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain and function subscores. Patients were considered "responders" if they achieved ≥40% improvement in WOMAC pain and function.
- In a subgroup of patients with moderate-to-severe OAK (Kellgren-Lawrence grades 3-4; n=64), there were statistically significant improvements in WOMAC pain (mean change from baseline -0.99 vs -0.65) (p=0.005) and function scores (-0.85 vs -0.58) (p=0.04) over 20 weeks for patients who received Ampion™ compared with vehicle control, respectively.
- At 20 weeks, the percentage of patients in the moderate-to-severe subgroup who reported a reduction in pain was significantly higher for patients who received Ampion™ (50%) compared to those who received vehicle control (25%) (p=0.04).
- Similar rates and severity of adverse events were observed in the Ampion™ and vehicle control groups.
- A single injection of Ampion™ was associated with sustained improvements in knee pain over 20 weeks. (p=0.005)
Vaughan Clift, Ampio's Chief Regulatory Officer, stated:" Ampion™ provided a therapeutic option for patients with moderate-to-severe OAK. We are delighted at the acceptance of the presentation of results of this study in the prestigious Western Orthopedic Association Conference forum."
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.
Forward Looking Statements
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, 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 without limitation, under Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
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