Ampio Pharmaceuticals Modifies Ampion™ IND for Osteoarthritis of the Knee to
Include A Dose Escalation Run-In Study and Prepares to Launch Pivotal Clinical
GREENWOOD VILLAGE, Colo., Feb. 25, 2013
GREENWOOD VILLAGE, Colo., Feb. 25, 2013 /PRNewswire/ -- Ampio Pharmaceuticals,
Inc. (NASDAQ: AMPE) announced today that it's Phase III clinical study of
Ampion™ for the treatment for osteoarthritis of the knee will include a
dose-escalation run-in ^ study as recommended by the FDA.
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, explained "In the
Australian trial, a single 4 ml dose provided promising results from the
Ampion™ treated patients suffering from osteoarthritis. This run-in portion of
the Phase III trial that will be launched in the US is designed primarily to
determine if the 4 mL treatment could be improved by administering a 10 ml
volume of Ampion™, the volume commonly injected into the knee with other
Dr. Clift further noted "Accordingly, the Company has modified the original
study design to accommodate the FDA recommendations and submitted this
upgraded IND study protocol for clearance to begin treating patients. A
Clinical Research Organization (CRO) has been engaged and multiple clinical
sites have been selected that are ready to enroll patients in the study. The
dose ranging run-in study will commence shortly and will include 320 patients
in total comparing 4 ml to 10 ml injection using the WOMAC pain scale."
Michael Macaluso, Chairman and CEO of Ampio, commented "The FDA has been very
helpful by recommending a single run-In study to begin our Phase III pivotal
trial that will provide us deeper understanding of the treatment effect and an
optimized dose that may well reduce the patient requirement, and the
associated time and costs as the number of combined patients in the
run-in/phase III study may be significantly less than the 1600 patients
planned for the two, phase III studies in the original IND application."
About the Australian Ampion™-In-Knee (AIK) trial
In May 2012, Ampio announced the full results of the Ampion™-In-Knee (AIK)
trial which demonstrated prolonged and sustained pain relief in osteoarthritis
following Ampion™ treatment. There was a statistically significant
improvement in pain relief at 84 days following a single injection of Ampion™
compared to placebo and overtime. The treatment was well tolerated with no
significant adverse events and no minor adverse events in the Ampion™ group
compared to the placebo group.
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
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
Forward Looking Statement
This Annual Report on Form 10-K, or Annual Report, includes forward-looking
statements within the meaning of Section27A of the Securities Act of 1933, as
amended, and Section21E of the Securities Exchange Act of 1934, or the
Exchange Act. All statements other than statements of historical facts
contained in this Annual Report, including statements regarding our
anticipated future clinical and regulatory events, future financial position,
business strategy and plans and objectives of management for future
operations, are forward-looking statements. Forward looking statements are
generally written in the future tense and/or are preceded by words such as
"may," "will," "should," "forecast," "could," "expect," "suggest," "believe,"
"estimate," "continue," "anticipate," "intend," "plan," or similar words, or
the negatives of such terms or other variations on such terms or comparable
terminology. Such forward-looking statements include, without limitation,
statements regarding the potential future commercialization of our product
candidates, the anticipated start dates, durations and completion dates, as
well as the potential future results, of our ongoing and future clinical
trials, the anticipated designs of our future clinical trials, anticipated
future regulatory submissions and events, our anticipated future cash position
and future events under our current and potential future collaborations. These
forward-looking statements are subject to a number of risks, uncertainties and
assumptions, including without limitation the risks described in "Risk
Factors" in PartI, Item1A of this Annual Report. These risks are not
exhaustive. Other sections of this Annual Report include additional factors
that could adversely impact our business and financial performance. Moreover,
we operate in a very competitive and rapidly changing environment. New risk
factors emerge from time to time and it is not possible for our management to
predict all risk factors, nor can we assess the impact of all factors on our
business or the extent to which any factor, or combination of factors, may
cause actual results to differ materially from those contained in any
forward-looking statements. You should not rely upon forward-looking
statements as predictions of future events. We cannot assure you that the
events and circumstances reflected in the forward-looking statements will be
achieved or occur and actual results could differ materially from those
projected in the forward-looking statements. We assume no obligation to update
or supplement forward-looking statements.
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;
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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