ENGLEWOOD, Colo., Dec. 13, 2018 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today updates the regulatory
status of Ampion.
![Ampio Pharmaceuticals Logo. (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.) Ampio Pharmaceuticals Logo. (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.)](https://mma.prnewswire.com/media/479965/Ampio_Pharmaceuticals_Logo.jpg)
As announced on November 26, 2018,
statisticians representing Ampio and the U.S. Food and Drug
Administration (FDA) were to meet and discuss the clinical pathway
of Ampion™, the company's lead drug, for the treatment of severe
osteoarthritis of the knee (OAK) followed by an additional,
internal meeting that included reviewers from the FDA Office of
Tissue and Advanced Therapies (OTAT). That meeting has taken place
and OTAT has, on the afternoon of December
12th, provided final guidance that Ampio should
complete an additional trial of KL4 osteoarthritis patients with
concurrent controls that would be carried out under a Special
Protocol Assessment (SPA) to obtain FDA concurrence on the trial
design. Under the guidance of statistician Dr. Jason Connor, President of ConfluenceStat LLC, a
trial of approximately 150 KL4 patients, half in the treatment arm
and half in the control arm has been designed, and Ampio will be
filing the SPA submission in the near future. The trial is designed
to expand by 150 patients (300 total patients) if necessary.
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. The incidence of developing
osteoarthritis of the knee over a lifetime is approximately 45%. As
this disease is associated with age, obesity, and diabetes, this
number will continue to grow. 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 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 including the timing thereof, the Biological License
Application (BLA), the ability of Ampio to enter into partnering
arrangements, 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
April Ramirez
Operations Manager
Phone: (720) 437-6500
aramirez@ampiopharma.com
Ampio Pharmaceuticals, Inc.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/ampio-updates-regulatory-status-for-ampion-300764793.html
SOURCE Ampio Pharmaceuticals, Inc.