NEW YORK, Aug. 20, 2015 /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 its OneStep-1 Phase 3 clinical trial has passed the 50% enrollment milestone. OneStep-1 and OneStep-2 are identical, pivotal Phase 3 clinical trials (180 patients per clinical trial) being conducted under a Special Protocol Assessment (SPA) agreement between the U.S. Food and Drug Administration and Dipexium for evaluation of Locilex for the treatment of patients with mild infections of diabetic foot ulcers.
"Completion of the 50 percent mark in the One-Step-1 trial brings us one step closer to finalizing these pivotal Phase 3 clinical trials and moving toward a timely submission to obtain FDA approval of Locilex," said David P. Luci, President and CEO of Dipexium Pharmaceuticals. "This milestone is an important accomplishment for Dipexium and our medical and scientific development team with whom we have been working since the studies' inception."
As of today, 43 clinical trial centers, out of a total of 60 currently open for enrollment across both pivotal Phase 3 clinical studies, OneStep-1 and OneStep-2, have enrolled at least one patient. New clinical trial sites are being added to the program in the coming weeks. The Company anticipates completing enrollment and filing a New Drug Application for FDA approval in 2016. More information about the OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials is available at www.clinicaltrials.gov.
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 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).
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.
David P. Luci President & Chief Executive Officer Dipexium Pharmaceuticals, Inc. 212-269-2834 firstname.lastname@example.org
David Garrett Vice President, Finance & Corporate Development Dipexium Pharmaceuticals, Inc. 212-269-2834 email@example.com
Investor Relations Contact:
Donna L. LaVoie or Kristina Coppola LaVoie Health Science 617-374-8800 X107/105 firstname.lastname@example.org
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