ENGLEWOOD, Colo., May 22, 2019 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced updates
on subjects of interest to shareholders.
Clinical: The results of the AP-003-C open label
extension study outlining the safety and efficacy of repeat
injections of Ampion™ in patients with severe
osteoarthritis-of-the-knee (OAK) have been accepted as a podium
presentation at the 83rd Annual Meeting of the Western Orthopedic
Association (WOA) in Monterey,
CA., held from July
31st to August
3rd, 2019. The WOA meeting was developed
primarily for orthopedic and trauma surgeons and allied health
professionals. The WOA Committee selected multiple research papers
and invited nationally respected speakers to present
practice-related techniques and findings in orthopedic surgery that
cover a variety of specialty orthopedic disciplines and advances in
treatment.
The Ampion study is entitled "Investigating Repeated
Intra-Articular Injections of The Anti-Inflammatory Compound
LMWF-5A (Ampion) In Adults with Severe Osteoarthritis: An
Open-Label Extension Study" and will be presented by orthopedic
surgeon, John Schwappach, MD. on
August 3, 2019.
Dr. Schwappach summarized the findings: "The purpose of the
open label extension study was to evaluate repeat dosing of Ampion
every 12 weeks for 52 weeks for safety, efficacy, and structural
changes to the joint. The study reported that repeated injections
of Ampion are safe and well tolerated, and patients can expect a
consistent, beneficial effect with repeat injections. Importantly,
there was an improvement in joint space thickness of 12% in the
medial compartment for subjects with medial disease, and an
improvement of 6% in the lateral compartment for subjects with
lateral disease. These in vivo measurements of space, occupied by
cartilage in a healthy knee, along with available in vitro
data are highly suggestive of Ampion being a safe and effective
disease-modifying drug for OAK (DMOAD)."
Regulatory: Ampio Pharmaceuticals has been in
contact with the U.S. Food and Drug Administration (FDA) regarding
the Special Protocol Assessment (SPA) following its re-submission
of a revised protocol for AP-013, which the Company believes
implements all of the Agency's recommendations provided since the
beginning of the SPA review cycle. The Agency confirmed that it
would make every effort to expedite this review, however due
to a heavy workload, they were not able to commit to providing a
response to the Company's SPA re-submission earlier than the 45-day
window outlined in the Guidance for Industry Special
Protocol Assessment, leading the Company to expect the response
will be in mid-June rather than late May
2019, as previously predicted.
Corporate: Ampio Pharmaceuticals has
engaged Squire Patton Boggs (US) LLP (SPB) as legal counsel
for the Company. SPB is a full-service global law firm featuring a
multidisciplinary team of over 1,500 lawyers in 47 offices across
20 countries. https://www.squirepattonboggs.com
Ampio Pharmaceuticals has also commenced a process to review its
appointment of its independent audit firm and has commenced a
search to evaluate its options. If the Company were to
appoint a new independent audit firm, it would expect to
onboard that firm by the end of the second quarter. Plante Moran has agreed to assist with the
search process and with any resulting transition.
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. 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. Other symptoms include
narrowing of the joint space, synovial membrane thickening,
osteophyte formation, and increased density of subchondral
bone.
About Ampio Pharmaceuticals, Inc.
Ampio Pharmaceuticals, Inc. is a development stage
biopharmaceutical company primarily focused on the development of
Ampion, our product candidate, to treat prevalent inflammatory
conditions for which there are limited treatment options.
Forward-Looking Statements
Ampio Pharmaceutical'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," "predict," "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 responses and decisions including the
timing thereof, the Special Protocol Assessment (SPA), the
Biological License Application (BLA), the ability of Ampio to enter
into partnering arrangements, to initiate, conduct and report the
results of 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,
quarterly reports of Form 10-Q, periodic reports on Form 8-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.