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Ampio Pharmaceuticals Completes Enrollment in Run-In SPRING study of Ampion in Osteoarthritis of the Knee

Ampio Pharmaceuticals Completes Enrollment in Run-In SPRING study of Ampion in
                          Osteoarthritis of the Knee

PR Newswire

GREENWOOD VILLAGE, Colo., April 25, 2013

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.

(Logo: http://photos.prnewswire.com/prnh/20120516/MM09116LOGO)

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."

About Ampion^™
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.

About Osteoarthritis
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.

References:
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

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

SOURCE Ampio Pharmaceuticals, Inc.

Website: http://www.ampiopharma.com
 
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