NEW YORK, Oct. 25, 2016 /PRNewswire/ -- Dipexium
Pharmaceuticals, Inc. (NASDAQ: DPRX) ("Dipexium" or the "Company")
today announced that the OneStep-1 and OneStep-2 Phase 3 clinical
trials of Locilex® (pexiganan cream 0.8%) in patients with mild
infections of diabetic foot ulcers (Mild DFI) did not meet the
primary clinical endpoint of superiority versus vehicle plus
standardized wound care and also did not show any meaningful
difference in wound closure rate between the Locilex arm and the
vehicle arm in each study. Neither trial met the secondary
endpoint of demonstrating a higher rate of eradication of bacteria
for the Locilex arm. While the overall adverse event
incidence was comparable to vehicle alone, serious adverse events
with Locilex included higher than anticipated osteomyelitis and
cellulitis in the Locilex arm of each study.
David P. Luci, President &
CEO of Dipexium, stated, "Although we are disappointed with these
results, we are continuing to evaluate the data and will consider
potential regulatory pathways forward in other possible clinical
indications based on an evaluation of all data emerging from the
Phase 3 studies."
Benjamin A. Lipsky, MD, FACP,
FIDSA, FRCP, Chair of the OneStep trials and lead author of the
2012 Infectious Disease Society of America (IDSA) Clinical Practice
Guideline for the Diagnosis and Treatment of Diabetic Foot
Infections stated, "Speaking as Chairman of the OneStep trials, and
on behalf of Warren Joseph, DPM,
FIDSA, Co-Chair, we are certainly disappointed that we did not see
a clear advantage to treating these patients with Mild DFI with
Locilex cream. As diabetic foot infection is a complex problem, and
this trial generated a great deal of data, we are currently
reviewing the results to better interpret the outcome. I can,
however, say that these pioneering studies were carefully designed
and operationally well conducted. In over 30 years of
conducting DFI clinical trials, I have not seen a more diligent or
careful approach to ensuring patient safety and accurate data. The
results of this study will provide important information regardless
of the outcome. This will include a better understanding of the
natural course of diabetic foot ulcer and infection, and a
recognition that some Mild DFI patients may not need antibacterial
treatment. The exemplary conduct of the trial reflects
extremely well on the participating investigators. We look forward
to continuing analyses of the wealth of data accumulated and to
report more details of our findings."
Robert J. DeLuccia, Executive
Chairman of Dipexium, emphasized, "The OneStep trials were the
first ever 'placebo'-controlled studies conducted for mildly
infected diabetic foot ulcers. In these studies, the
'placebo' was the cream vehicle without pexiganan, the active
pharmaceutical ingredient in Locilex. These complex trials
required stringent standardized wound care, in both study arms,
including ulcer debridement, daily wound dressing changes and
pressure off-loading devices. Since antibiotics are generally
used by clinicians to treat an infected ulcer, no clinical trial in
diabetic foot infection has ever established a 'response rate' for
an ulcer infection that had standardized wound care but was
untreated with an antibiotic."
About OneStep-1 and OneStep-2 Pivotal Phase 3 Clinical
Trials
OneStep-1 and OneStep-2 were identical, double-blind,
placebo-controlled clinical trials conducted simultaneously that
enrolled a total of 389 patients at 59 separate centers in
the United States. The primary
objective was to establish the clinical superiority and safety of
topical Locilex® plus standard local wound care as compared to
placebo cream plus standard local wound care, in the treatment of
Mild DFI. Patients were randomized 1:1 to receive either topical
Locilex® plus standard local wound care or placebo cream plus
standard local wound care for 14 days, with final evaluation at day
28. The primary endpoint of the trials is clinical response, which
is defined as infection resolved per the judgment of each treating
physician using the 2012 Infectious Disease Society of America
(IDSA) Clinical Practice Guideline for the Diagnosis and Treatment
of Diabetic Foot Infections. Secondary endpoints include
microbiological success, which is defined as complete
microbiological response, as well as the incidence and severity of
adverse events. Other endpoints include several measurements with
respect to the time and extent of wound healing. The FDA has agreed
to a Special Protocol Assessment (SPA) with Dipexium for Locilex®'s
pivotal Phase 3 clinical trial program in Mild DFI.
About Dipexium Pharmaceuticals, Inc.
Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) is a late-stage
pharmaceutical company focused on the development and
commercialization of Locilex® (pexiganan cream 0.8%), a novel,
broad-spectrum, topical antimicrobial peptide. For more
information, please visit www.dipexiumpharmaceuticals.com.
Cautionary Note on Forward-Looking Statements
This press release and any statements of representatives and
partners of Dipexium Pharmaceuticals, Inc. (the "Company") related
thereto contain, or may contain, among other things, certain
"forward-looking statements" within the meaning of the U.S. federal
securities laws. Such forward-looking statements involve
significant risks and uncertainties. Such statements may
include, without limitation, statements with respect to the
Company's plans, objectives, projections, expectations and
intentions and other statements identified by words such as
"projects," "may," "will," "could," "would," "should," "believes,"
"expects," "anticipates," "estimates," "intends," "plans,"
"potential" or similar expressions. These statements are
based upon the current beliefs and expectations of the Company's
management and are subject to significant risks and uncertainties,
including those detailed in the Company's filings with the
Securities and Exchange Commission and those that relate to the
Company's ability to leverage the expertise of employees and
partners to assist the Company in the execution of its
strategy. Actual results (including, without limitation, the
timing for and results of the clinical trials and proposed NDA
submission for Locilex®) may differ significantly from those set
forth in the forward-looking statements. These
forward-looking statements involve certain risks and uncertainties
that are subject to change based on various factors (many of which
are beyond the Company's control). The Company undertakes no
obligation to publicly update any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by applicable law.
Company Contacts:
David Garrett
Vice President, Finance & Corporate Development
Dipexium Pharmaceuticals, Inc.
212-269-2834
info@dipexium.com
Lisa Wilson
Investor Relations
In-Site Communications, Inc.
212-452-2793
lwilson@insitecony.com
© 2016 Dipexium Pharmaceuticals, Inc. All rights
reserved.
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