NEW YORK, Oct. 20, 2016 /PRNewswire/ -- Dipexium
Pharmaceuticals, Inc. (Nasdaq: DPRX) ("Dipexium" or the "Company"),
a late-stage pharmaceutical company focused on the development and
commercialization of Locilex® (pexiganan cream 0.8%), a novel,
broad spectrum, topical antimicrobial peptide in development for
the treatment of mild infections of diabetic foot ulcers, today
provided an update on the status of results from the two pivotal
Phase 3 clinical trials (OneStep-1 and OneStep-2). Data tables and
listings from both of these trials are currently being produced and
evaluated by the Company's scientific advisors according to our
pre-specified data review procedure.
David P. Luci, President and
Chief Executive Officer of Dipexium stated, "We believe the process
is nearing completion and anticipate announcing the data later this
month after the scientific advisory team informs us of the
unblinded results."
About Dipexium Pharmaceuticals
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. Initially, Locilex
is targeted for the treatment of mild infections of diabetic foot
ulcers. Based on a compilation of available clinical and
microbiology data, Locilex is also considered a promising product
candidate to treat other mild and moderate skin and skin structure
infections, including infected decubitus ulcers, infected burns,
infected surgical wounds, infected animal bites and nasal
colonization of methicillin-resistant staphylococcus aureus (MRSA).
For more information, visit www.dipexiumpharmaceuticals.com.
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.
Forward-Looking Statements
This press release may contain, in addition to historical
information, forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements may include statements relating to our
anticipated clinical and regulatory development; European
Development, I.V. formulation, cash position; cash flows; business
strategies and initiatives; and other matters. We have based these
forward-looking statements on the assumptions, expectations and
projections about future events that we hold at the time the
statements are made. We use words like "believe," "anticipate,"
"intend," "estimate," "expect," "project" and similar expressions
to identify forward-looking statements, although not all
forward-looking statements contain these words. These
forward-looking statements are necessarily estimates reflecting the
best judgment of our senior management and involve a number of
risks and uncertainties that could cause actual results to differ
materially from those suggested by the forward-looking
statements.
Investors should consider the information contained in our
filings with the U.S. Securities and Exchange Commission (the
"SEC"), including our Annual Report on Form 10-K, especially in the
"Management's Discussion and Analysis of Financial Condition and
Results of Operations" and "Risk Factors" sections, our most recent
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and our
Current Reports on Form 8-K. Other unknown or unpredictable factors
also could have material adverse effects on our future results,
performance or achievements. In light of these risks,
uncertainties, assumptions and factors, the forward-looking events
discussed in this press release may not occur. You are cautioned
not to place undue reliance on these forward-looking statements,
which reflect our beliefs at the time the statements are made.
We do not undertake any obligation to update or revise publicly
any forward-looking statements, whether as a result of new
information, future events or otherwise, nor any other information
provided in a conference call, webcast, news release, SEC filing or
website.
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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SOURCE Dipexium Pharmaceuticals, Inc.