ENGLEWOOD, Colo., March 26, 2019 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that on
March 11, 2019, the Company
resubmitted a Special Protocol Assessment (SPA) with the Food and
Drug Administration (FDA) for a confirmatory Phase III clinical
trial of its biological drug, Ampion™, for the
treatment of patients afflicted with Osteoarthritis of the Knee
(OAK).
Mr. Macaluso, Ampio's CEO added, "After a series of interactions
with the FDA, we believe we have addressed and answered all
questions regarding trial design. The FDA confirmed they would
respond to our SPA submission no later than April 25, 2019. The FDA guidance regarding our
trial design was in agreement with the advice we received from
multiple independent statisticians who analyzed our clinical
results of nearly 1,000 KL4 patients. These patients, taken as a
group, provided statistically significant results compared to
patients receiving the saline control.
"As site recruitment and patient identification for the trial
are currently underway, we will provide an update and commence the
trial as soon as practicable after the SPA is awarded. The Company
believes the anticipated cost of the trial is manageable and within
the range of our other OAK trials and we are reviewing all possible
financing alternatives including encouraging investors to exercise
the outstanding warrants.
"As recently stated in our 10-K, Ampio will focus all our
clinical and financial resources on the approval of Ampion.
However, we plan to continue seeking a partnership for
Optina™."
Receipt of Audit Opinion with Going Concern
Qualification
The Company is required under the NYSE MKT
Company Guide Sections 401(h) and 610(b) to publish certain
disclosures. As previously disclosed in its Annual Report on Form
10-K for the fiscal year ended December 31,
2018, which was filed with the Securities and Exchange
Commission on March 18, 2019, the
Company's audited financial statements contained a going concern
explanatory paragraph in the audit opinion from its independent
registered public accounting firm. This announcement does not
represent any change or amendment to the Company's financial
statements or to its Annual Report on Form 10-K for the fiscal year
ended December 31, 2018.
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
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SOURCE Ampio Pharmaceuticals, Inc.