ENGLEWOOD, Colo., April 29, 2019 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that it has
received comments from the U.S. Food and Drug Administration (FDA)
regarding their Special Protocol Assessment (SPA). The FDA
recommended the Company not start their confirmatory trial without
obtaining FDA concurrence on the trial design. The Company agreed
with the comments they received from the FDA and immediately sent a
revised SPA to the FDA for review.
"While we will not officially start the trial until the SPA is
approved," said CEO Michael
Macaluso. "Extensive preparatory work is already underway.
We hope to start the trial in May."
About Osteoarthritis
Osteoarthritis (OA) is an
incurable and progressive disorder of the joints involving
degradation of the intra-articular cartilage, joint lining,
ligaments, and bone. 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 focused on
the development of Ampion™ to treat prevalent inflammatory
conditions for which there are limited treatment options.
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 the 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 Ampion and its
classification, as well as those associated with regulatory
approvals and other FDA decisions such as the SPA, whether the FDA
will approve the same and the timing thereof, the Biological
License Application (BLA), the ability of Ampio to enter into
partnering arrangements for any of its products, including Ampion
and Optina, clinical trials and decisions and changes in business
conditions and similar events, all of which are inherently subject
to various risks and uncertainties. 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
other documents filed with the Securities and Exchange Commission.
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
Phone: (720) 437-6500
info@ampiopharma.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-provides-regulatory-update-300839360.html
SOURCE Ampio Pharmaceuticals, Inc.