Ampio Pharmaceuticals, Inc. Announces Additional Positive Results for
Ampion(TM) in Osteoarthritis of the Knee Clinical Trial
GREENWOOD VILLAGE, Colo., Sept. 30, 2013
GREENWOOD VILLAGE, Colo., Sept. 30, 2013 /PRNewswire/ --Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced additional positive
results from the SPRING study (clinicaltrials.gov NCT01839331) of Ampion^™ for
the treatment of osteoarthritis of the knee (OAK). In this study of 329
patients, patients treated with a single intra-articular injection of Ampion^™
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:
oThe 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).
oThis study demonstrated that a single intra-articular (IA) injection of
Ampion^™ 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 Ampion^™.
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
oThe Ampion^™ 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). Ampion^™
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.
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: email@example.com
SOURCE Ampio Pharmaceuticals, Inc.
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