ENGLEWOOD, Colo., March 29, 2016 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced today that
enrollment is now complete in the PIVOT trial of
Ampion™ for the treatment of pain due to
osteoarthritis-of-the-knee (OAK).
Michael Macaluso, Ampio's CEO
explained: "The PIVOT trial is a randomized, placebo-controlled,
double-blind study to evaluate the efficacy and safety of an
intra-articular injection of AMPION™ in adults
with pain due to osteoarthritis of the knee that was conducted in
accordance with a Special Protocol Assessment (SPA) issued by the
FDA. A Special Protocol Assessment (SPA) is a written agreement
between the FDA and the sponsor company (Ampio Pharmaceuticals),
which defines the clinical trial end-points required for approval
and significantly reduces the risk of bringing a drug to
market. This second pivotal trial is clinically identical to
the previously successful Spring
Study, which was confirmed by the agency as one of the two
pivotal trials required for approval. Our goal is to meet the
clinical obligations for a novel biologic, a special designation
that comes with 12 years of market exclusivity.
"When we commenced the PIVOT Phase III Study in September 2015, we estimated the trial to require
484 patients. However the written guidance from the FDA required
464 patients, powered at 88%. The trial closed at 480 patients with
approximately 60% of the patients already completing the 12-week
period following dosing. Accordingly, we expect final results to be
available mid-year 2016. A full description of the trial is
outlined at:
https://clinicaltrials.gov/ct2/show/NCT02556710?term=ampion&rank=2%20%E2%80%9C."
About Osteoarthritis
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 statements
regarding Ampio's expectations with respect to the Ampion™
PIVOT trial, as well as risks associated with clinical trials,
expected results, regulatory approvals, and changes in business
conditions and similar events. These forward-looking statements
also include statements regarding the Special Protocol Assessment
(SPA) as well as the classification of Ampion™ as a novel biologic
with 12 years exclusivity. 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.
Company Contact
Gregory A.
Gould
Chief Financial Officer
Phone: (720) 437-6500
ggould@ampiopharma.com
Logo -
http://photos.prnewswire.com/prnh/20120516/MM09116LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/ampio-completes-enrollment-in-pivotal-clinical-trial-of-ampion-300242250.html
SOURCE Ampio Pharmaceuticals, Inc.