NEW YORK, May 16, 2016 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (Nasdaq: DPRX), a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad-spectrum, topical antibiotic peptide, today announced that it has completed the patient enrollment objective in the OneStep-1 pivotal Phase 3 clinical trial in accordance with the requirements set forth in the OneStep-1 clinical trial protocol. The Company recently announced that it had reached the enrollment objective in the OneStep-2 pivotal Phase 3 clinical trial in accordance with the requirements set forth in the OneStep-2 clinical trial protocol. OneStep-1 and OneStep-2 are identical, pivotal Phase 3 clinical trials conducted under a Special Protocol Assessment (SPA) agreement between the U.S. Food and Drug Administration (FDA) and Dipexium for evaluation of Locilex for the treatment of patients with mild infections of diabetic foot ulcers (Mild DFI).
Across both clinical trials, clinical trial sites are now in the process of being closed, with certain trial centers continuing enrollment for approximately 30 days to collect the required number of blood samples for pharmacokinetic (PK) analysis as set forth in the OneStep clinical trial protocols.
The Company anticipates announcing top-line data from both pivotal Phase 3 clinical trials in the third quarter of 2016 and is targeting a New Drug Application (NDA) submission with the FDA and a Marketing Authorization Application (MAA) submission with the European Medicines Agency in the first half of 2017.
"We thank all our colleagues who participated in the design and implementation of these landmark OneStep clinical trials for their support and dedication to our new topical antibiotic development program. We also thank the patients who volunteered to be part of this important, ground-breaking research study. We can now shift our resources to compiling, analyzing and incorporating these clinical trial results into our currently on-going parallel New Drug Application and Marketing Authorization Application filing packages for the US and Europe, respectively," said Robert J. DeLuccia, Executive Chairman of Dipexium.
Mr. DeLuccia continued, "If these trials are successful, we anticipate that Locilex will become the antibiotic standard of care for treatment of mild infections of diabetic foot ulcers. We believe it will also represent a significant contribution to public health in view of the current worldwide crisis of bacterial resistance and the antibiotic stewardship efforts by the medical community to curtail the overuse of systemic antibiotics."
OneStep-1 and OneStep-2 Trial Design
OneStep-1 and OneStep-2 are identical, double-blind, placebo-controlled clinical trials conducted simultaneously. The primary objective is 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 are 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. More information about the OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials is available at www.clinicaltrials.gov.
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 antibiotic 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 and nasal colonization of methicillin-resistant staphylococcus aureus (MRSA). For more information, visit www.dipexiumpharmaceuticals.com.
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 P. Luci
President & Chief Executive Officer
Dipexium Pharmaceuticals, Inc.
212-269-2834
info@dipexium.com
David Garrett
Vice President, Finance & Corporate Development
Dipexium Pharmaceuticals, Inc.
212-269-2834
info@dipexium.com
© 2016 Dipexium Pharmaceuticals, Inc. All rights reserved.
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SOURCE Dipexium Pharmaceuticals, Inc.
