Ampio Receives FDA Clearance to Initiate Clinical Trial of Ampion™ for the
Treatment of Osteoarthritis of the Knee: Patient Treatments have begun.
GREENWOOD VILLAGE, Colo., April 2, 2013
GREENWOOD VILLAGE, Colo., April 2, 2013 /PRNewswire/ — Ampio Pharmaceuticals,
Inc. (NASDAQ: AMPE) today announced FDA acceptance of its IND and the
treatment of the first fifteen (15) patients in its clinical trial using
Ampion™ to treat osteoarthritis (OA) of the knee.
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer noted, "We are grateful to
the FDA for suggesting our trial design include a run-in portion to assure an
optimized dose. This randomized, placebo-controlled, double-blind trial
proceeds in two parts. This study design will allow us to present two
well-conducted clinical trials for a biologic license application (BLA). The
first run-in portion of the trial, designated as the "Spring Study" will
evaluate two doses of Ampion™ in 320 adult patients suffering from moderate to
severe OA of the knee. This run-in portion will determine the optimal dosage
of Ampion™ that will be used in the second portion of the pivotal trial. The
number of patients required in the second part of the study will be determined
based on an analysis of the first part."
Michael Macaluso, Chairman and CEO of Ampio, commented "We are excited to
begin executing this two-part, run-in trial design because it may allow us to
determine indications of efficacy with fewer patients. Our principal
investigators inform us that the high prevalence of OA of the knee may allow
for the completion of both portions of the pivotal trial in an abbreviated
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. One of the active ingredients of Ampion™ is aspartyl-alanyl
diketopiperazine, referred to as DA-DKP, which is derived from the two amino
acids from the terminal end of human albumin and appears to have a significant
role in the homeostasis of inflammation. Ampion™ ^ is protected by composition
of matter and multiple 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 (ii) activation of a specific
phosphatase or depletion of the available phosphate needed for the
inflammation process and (iii) decreasing vascular permeability – an upstream
event in the inflammation cascade.
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;
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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