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Ampio Pharmaceuticals, Inc. Announces Additional Positive Results for Ampion in Osteoarthritis of the Knee Clinical Trial


09/30/2013 | Press Release

GREENWOOD VILLAGE, CO., September 30, 2013 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced additional positive results from the SPRING study (clinicaltrials.gov NCT01839331) of AmpionTM for the treatment of osteoarthritis of the knee (OAK). In this study of 329 patients, patients treated with a single intra-articular injection of AmpionTM achieved a clinically meaningful reduction in pain. Ampio announced on August 14, 2013 that the SPRING study met its primary and key secondary endpoints.

Dr. Vaughan Clift, Ampio’s Chief Regulatory Officer, explained “The previously reported achievement of primary end point efficacy for pain (WOMAC A, p=0.0038), function (WOMAC C, p=0.04) and Patient Global Assessment (PGA, p=0.01) at 12 weeks following a single intra-articular injection is now augmented by significant results from secondary end points. The newly announced positive results include:

• The reduction in pain compared to the vehicle control (saline) was also significant across/over the whole twelve-week period and not just at the 12 weeks end point (p=0.01).

• This study demonstrated that a single intra-articular (IA) injection of AmpionTM resulted in a clinically and statistically significant reduction in pain, with an estimated difference from control at the study endpoint of -0.25 on the WOMAC A scale (95% CI: -0.41 to -0.08, p=0.004), corresponding to a 42.3% improvement in pain at 12 weeks in patients treated with AmpionTM.
Note: In contrast, despite recommendations against their use, Hylan G-F 20 is the current treatment of choice in patients who cannot be managed with analgesics. In the pivotal trial of a single IA injection of 6 ml Hylan G-F 20, a borderline statistically significant reduction in pain was demonstrated, with an estimated difference from control of -0.15 (95% CI: -0.30 to -0.002, p = 0.047), corresponding to a 31.3% improvement in pain over 26 weeks in patients treated with Hylan G-F20.
Note: The accepted threshold for a Minimum Clinically Important Improvement (MCII), defined as the smallest change in a measurement that signifies important improvement in a patient’s symptom, is -40.8% [ Ann Rheum Dis. 2005;64:29-33 Tubach F, Ravaud P, Baron G, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement] in WOMAC A pain change from baseline with knee OA, which only Ampion exceeded as an intra-articular injection.

• The AmpionTM SPRING study included “all comers”, including Kellgren-Lawrence IV patients that make up a significant portion of the “real world” osteoarthritis patients (19% in the SPRING study). AmpionTM was not only effective overall (p=0.004) as previously reported, but was specifically effective in the subset of patients with severe osteoarthritis (Kellgren-Lawrence IV, p=0.017) who currently face a severe unmet medical need.
Note: In contrast pivotal trials for the approved hyaluronic acid and derivatives, which commonly exclude patients with severe osteoarthritis (Kellgren-Lawrence IV stage of disease), these patients are sometimes considered “intractable” due to lack of efficacy of any approved therapy (NSAIDS, hyaluronic acid and steroids). The only accepted therapy is joint replacement, which is not only a significant patient burden but also has significant morbidity associated with it and is contraindicated in many patients with comorbidities.

About Osteoarthritis
Osteoarthritis is the most common form of arthritis, affecting over 27 million people in the United States. It is a progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. The incidence of developing osteoarthritis of the knee or hip over a lifetime is approximately 46% and 25%, respectively. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.

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.

Investor Contact:Rick Giles, Director of Investor Relations, Ampio Pharmaceuticals, Inc. Direct: (720) 437-6530, Email: rgiles@ampiopharma.com



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