GREENWOOD VILLAGE, Colo., April 25, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) today announced the completion of patient enrollment in a dose-escalation run-in study to a Phase III pivotal trial evaluating Ampion in the treatment of moderate to severe osteoarthritis of the knee. Twelve week primary endpoint data are expected in the third quarter of 2013.
In the SPRING trial, Ampion is being evaluated for its effect on reducing pain as a single intra-articular injection into the knee in 4 milliliter (mL) and 10 milliliter (mL) volumes as compared to placebo at twelve weeks. The study has enrolled in excess of the targeted 320 patient goal. This study is part of the US development program for Ampion and was designed as a run-in to a Phase III pivotal trial which Ampio will initiate once the optimal volume is determined and the proposed pivotal trial is properly powered to achieve its scientific objectives.
"I am extremely pleased with the speed we were able to complete patient enrollment in SPRING," said Michael Macaluso , Chairman and CEO of Ampio. "While we set very stringent site criteria to optimize the rate of enrollment, I believe this could indicate the severe degree current therapeutics are not meeting the needs of osteoarthritis sufferers."
Ampion is a non-steroidal anti-inflammatory biologic that has the potential to be used in a broad array of inflammatory conditions and autoimmune diseases. The active ingredient is aspartyl-alanyl diketopiperazine, referred to as DA-DKP, which is derived from two amino acids from human albumin and appears to have a significant role in the homeostasis of inflammation. Ampion is protected by composition of matter, use, and synthetic form patents. Ampio has published a number of studies and articles on the anti-inflammatory activity of DA-DKP.
Osteoarthritis (OA) is the most common form of arthritis, affecting 27 million people in the US.1 Symptomatic OA of the knee occurs in 10-13% of individuals over the age of 60.2 OA 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, narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.3 These changes eventually result in chronic pain and disability, and deterioration of the joint despite drug therapy may require eventual surgery of total joint replacement. Current drug treatment for OA of the knee relies on pain control with analgesics, and anti-inflammatory treatment with NSAIDs and intra-articular injections of steroids or hyaluronates. The current drug treatments have been shown to have mixed results and may have significant limitations due to various adverse effects such as gastrointestinal irritation and bleeding.4
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company focused on the rapid development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibition of specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level or (ii) activation of a specific phosphatase or depletion of the available phosphate needed for the inflammation process.
Forward Looking Statement
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 Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
1. Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum.2008 Jan; 58(1):26–35.
2. Dillon CF, Rasch EK, Gu Q, Hirsch R. "Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94." Journal of Rheumatology. 2006 Nov; 33(11):2271-2279.
3. Bonnet CS, Walsh DA (2005) Osteoarthritis, angiogenesis and inflammation. Rheumatology (Oxford). 44:7–16
4. Richmond J, Hunter D, Irrgang J, et al. Treatment of osteoarthritis of the knee (nonarthroplasty). J Am Acad Orthop Surg. 2009; 17:591-6000
Director of Investor Relations
Ampio Pharmaceuticals, Inc.
Direct: (720) 437-6530
|SOURCE Ampio Pharmaceuticals, Inc.|
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