ENGLEWOOD, Colo., March 26, 2018 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced partial
results of a follow-up (3.4-3.7 years), double-blind, randomized,
controlled trial evaluating Ampion™ for pain due to
osteoarthritis-of-the-knee after the last Ampion™ or saline
injections in the STRUT study, exploring the effect of repeat
Ampion™ injections on delaying Total Knee Replacement (TKR).
The STRUT study (AP-007, ClinicalTrials.gov NCT02184156)
was a randomized, saline vehicle-controlled study to evaluate the
safety and efficacy of Ampion™ when administered as three 4mL IA
injections delivered every two weeks (at Baseline, Week 2, and Week
4). The trial was conducted in two phases at a US clinic: 1)
a 7-patient single-blind phase where all patients received Ampion™;
2) a 40-patient double-blind phase where patients were
randomized 1:1 to Ampion™ or saline. The primary endpoint was
change in WOMAC A pain between baseline and week 20.
Dr. David Bar-Or, MD, Ampio's CSO, explained, "An IRB approved protocol was followed to
survey the TKR status of the STRUT study patients approximately 3.5
years after treatment with Ampion™ or saline vehicle control. All
subjects were contacted by the clinical site which recruited and
enrolled these subjects. In total, 39 of 45 patients (87%)
responded to the telephone questionnaire interview. An initial
analysis of the results revealed:
- The severe KL4 patients most likely to require a TKR (n=16),
treated with Ampion obtained a lower rate of TKR compared to
patients treated with saline (40.0% or 4/10 vs. 83.3% or
5/6).
- The KL4 subset of patients that were responders (n=10)
treated with Ampion also obtained a lower rate of TKR compared to
patients treated with saline (14.3% or 1/7 vs. 100% or 3/3),
a result which did reach significance (p=0.033).
A more detailed analysis of this follow up study will be
presented in a peer-reviewed publication."
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™,
as well as those associated with clinical trials, regulatory
approvals, the ability of Ampio to enter into partnering
arrangements, the Biological License Application (BLA) 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
Tom
Chilcott
Chief Financial Officer
Phone: (720) 437-6500
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SOURCE Ampio Pharmaceuticals, Inc.