NEW YORK, July 17, 2014 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) today announced successful completion and initial results of DPX-110, a Phase 1 skin irritation clinical trial of Locilex® (pexiganan cream 0.8%), the company's novel, broad-spectrum topical antibiotic peptide. Dipexium conducted DPX-110 and the company is conducting DPX-120, a Phase 1 skin sensitization clinical trial, in parallel with two required pivotal Phase 3 clinical trials for Locilex®. The Company's pivotal Phase 3 clinical program is subject to a Special Protocol Assessment (SPA) agreement with FDA.
DPX-110 was a single-center, double-blind study in healthy adult subjects with the primary objective of evaluating the cumulative skin irritation observed with Locilex® and vehicle (placebo) topical cream following an extended period of continuous exposure. Volunteers received applications of Locilex®, vehicle cream, a positive control, and a negative (low irritant) control, for 21 days on both intact and abraded skin. Visual skin irritation assessments were performed by trained and blinded evaluators using a well-established, FDA-recognized standardized rating scale.
Forty-two subjects were enrolled and assessed for skin irritation. The results for positive and negative controls were those expected, indicating a successful trial. Study results demonstrated that Locilex®, as well as vehicle cream, are not topical irritants. There was no statistical difference between Locilex®, vehicle cream, and the negative control on intact or abraded skin.
Dipexium's Chief Executive Officer, David P. Luci stated: "We are pleased with the results of this Phase 1 trial. We expect these data will satisfy the regulatory requirement for evaluating the cumulative skin irritation potential of Locilex® in a contemporarily designed and executed study with our new formulation." Dipexium's Executive Chairman, Robert J. DeLuccia added: "The absence of topical irritant potential further supports the favorable safety and tolerability profile of our novel topical antibiotic. We look forward to completion of our Phase 1 skin sensitization trial in the coming months."
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 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).
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.
Vice President, Finance & Corporate Development
Dipexium Pharmaceuticals, Inc.
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