- Scientific Poster Presentation Highlights Design of Locilex® Phase 3 Pivotal Trials in Mild DFI
NEW YORK, May 21, 2015 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX), a late stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), and clinical research collaborators, today announced a scientific poster presentation highlighting the innovative design of the Company's Phase 3 pivotal trials evaluating Locilex®, its novel, broad spectrum, topical antibiotic peptide, for the treatment of patients with mild infections of diabetic foot ulcers (Mild DFI), OneStep-1 and OneStep-2. The poster is being presented as a "late-breaker" at the 7th International Symposium on the Diabetic Foot (ISDF), the largest diabetic foot meeting in the world, May 20-23 in The Hague, The Netherlands.
The presentation, co-authored by Drs. Benjamin A. Lipsky (OneStep clinical trials' Chair), Michael Silverman (OneStep clinical trials' Medical Monitor), and Warren Joseph (OneStep clinical trials' Vice-Chair) and presented by Professor Lipsky, reported on the challenges associated with the design and implementation of a US FDA-mandated placebo-controlled trial of treatment of mild infections of diabetic foot ulcers. The authors highlighted the substantial consideration given to: protecting subject safety in a placebo-treated infection; selecting and characterizing an appropriate patient population; extensively training clinician investigators in standardized wound care techniques and trial procedures; quality monitoring oversight; and, rigorous definition of clinical assessments and endpoints.
The resulting OneStep trials' primary efficacy objective is to establish the clinical superiority of Locilex® versus placebo cream, with both groups receiving standard local wound care. Subjects with a mildly infected diabetic foot ulcer, as assessed by the standardized criteria of the 2012 Infectious Diseases Society of America Guideline for the Diagnosis and Treatment of Diabetic Foot Infections, and amenable to outpatient treatment, are randomized 1:1 to Locilex® or placebo cream. Standard local wound care consists of sharp debridement and pressure off-loading; investigators also take standardized wound photographs and digital measurements of wound area. Study medication is applied twice daily for 14 days, with subjects assessed for safety and efficacy during the treatment period, and at day 28. Investigators at 55 clinical trial sites in the U.S. have been trained and these sites are currently open for enrollment with more being added. The OneStep trials have been successfully enrolling and treating patients, and have surpassed the 25% enrollment milestone toward a total of 360 patients across both trials. For quality assurance, trial coordinators regularly review photographs and measurements taken at wound entry and follow-up. An independent expert Data Safety Monitoring Committee reviews cases of progression of infection and monitors for serious adverse events.
According to Dr. Lipsky, Emeritus Professor of Medicine, University of Washington, Visiting Professor, University of Geneva and University of Oxford, "This is the first large-scale, randomized, clinical trial to be conducted to assess the effect of adding antibiotic therapy to standard local wound care alone in the treatment of patients with mild diabetic foot infection. The OneStep clinical trial program is a groundbreaking study that has the potential to change the paradigm of treatment of this common and frequently limb-threatening infection. I am pleased to be able to present the trial design details at the ISDF and complement Dipexium for their effort in bringing these clinical trials to fruition."
Robert J. DeLuccia, Executive Chairman of Dipexium, stated "We believe the OneStep trial design is state of the art, and as evidenced by our Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), a successful outcome will serve to fulfill the regulatory requirement to file a New Drug Application in the U.S. as a promising, first-in-class, broad-spectrum, non-systemic antibiotic treatment option for patients with mild DFI."
A copy of the ISDF poster presentation can be found in the "Investor Relations" section of Dipexium's website at www.dipexiumpharmaceuticals.com/locilex/key-publications.
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 antibiotic peptide. Initially, Locilex® is targeted for the treatment of Mild DFI. 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).
About the International Symposium on the Diabetic Foot (ISDF)
Sponsored by the International Working Group on the Diabetic Foot (IWGDF), the quadrennial International Symposium on the Diabetic Foot (ISDF) is one of the largest multidisciplinary scientific symposia in the world dedicated to advancing knowledge in the prevention, diagnosis and treatment of lower extremity complications in diabetes. At this year's symposium, over 1,300 international participants from more than 80 countries are in attendance for state-of-the-art lectures, workshops, and presentations of scientific abstracts in oral and poster formats.
About the International Working Group on the Diabetic Foot (IWGDF)
Founded in 1996, The International Working Group on the Diabetic Foot (IWGDF) is a non-profit foundation dedicated to create awareness of this disease and to improve the management and prevention of complications of the diabetic foot. Since 1999 the IWGDF produces quadrennial Practical, Specific and Consensus guidelines on the management and prevention of diabetic foot disorders. To date, this publication has been translated into 26 languages. In order to implement the International Consensus, the IWGDF has recruited local champions as members of the IWGDF representing over 100 countries. Coinciding with this year's ISDF, the IWGDF will host a meeting of its members to finalize an updated version of the International Consensus and Practical Guidelines to be published in 2015.
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 FDA 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.
David P. Luci
President & Chief Executive Officer
Dipexium Pharmaceuticals, Inc.
Vice President, Finance & Corporate Development
Dipexium Pharmaceuticals, Inc.
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