Last $9.76 USD
Change Today -0.03 / -0.31%
Volume 8.3K
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As of 5:20 PM 07/30/14 All times are local (Market data is delayed by at least 15 minutes).

dipexium pharmaceuticals inc (DPRX) Snapshot

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03/13/14 - $15.86
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dipexium pharmaceuticals inc (DPRX) Details

Dipexium Pharmaceuticals, LLC operates as a biopharmaceutical company that develops and commercializes, pexiganan, a small peptide anti-infective agent. It provides Locilex, a small peptide topical antibiotic for the treatment of mild and moderate skin infections in superficial wounds, including infected decubitus ulcers, infected burns, infected surgical wounds, and nasal colonization of methicillin-resistant staphylococcus aureus. The company was founded in 2010 and is based in White Plains, New York.

2 Employees
Last Reported Date: 03/13/14
Founded in 2010

dipexium pharmaceuticals inc (DPRX) Top Compensated Officers

Co-Founder, Chief Executive Officer, Presiden...
Total Annual Compensation: $219.3K
Co-Founder, Executive Chairman and Managing P...
Total Annual Compensation: $219.3K
Compensation as of Fiscal Year 2013.

dipexium pharmaceuticals inc (DPRX) Key Developments

Dipexium Pharmaceuticals, LLC Initiates Pivotal Phase 3 Clinical Trial of Locilex(R) in Patients with Mild Infections of Diabetic Foot Ulcers

Dipexium Pharmaceuticals Inc. announced it has initiated patient enrollment in the first of two pivotal Phase 3 clinical trials, known as OneStep-1 and OneStep-2, evaluating Locilex(R) (pexiganan cream 0.8%), the company's novel, broad-spectrum, topical antibiotic peptide, for the treatment of patients with mild infections of diabetic foot ulcers, or Mild DFI. According to medical literature, approximately 47% of all patients with diabetic foot infections first present at the mild stage. Currently, there are no antibiotics, systemic or topical, which are FDA approved specifically to treat patients with Mild DFI. The U.S. Food and Drug Administration has agreed to a Special Protocol Assessment (SPA) with Dipexium for Locilex(R)'s pivotal Phase 3 clinical trial program in Mild DFI. OneStep-1 and OneStep-2 are identical, double-blind, placebo-controlled clinical trials conducted simultaneously that will each enroll approximately 180 patients at 20 separate centers in the United States. The primary objective is to establish the clinical superiority and safety of topical Locilex(R) plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of Mild DFI. Patients will be randomized 1:1 to receive either topical Locilex(R) 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.

Dipexium Pharmaceuticals, LLC Announces Completion of Phase 1 Skin Irritation Trial of Locilex(R)

Dipexium Pharmaceuticals Inc. announced successful completion and initial results of DPX-110, a Phase 1 skin irritation clinical trial of Locilex(R) (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(R). 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(R) and vehicle (placebo) topical cream following an extended period of continuous exposure. Volunteers received applications of Locilex(R), 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(R), as well as vehicle cream, are not topical irritants. There was no statistical difference between Locilex(R), vehicle cream, and the negative control on intact or abraded skin.

Dipexium Pharmaceuticals, LLC Announces Board Changes

On July 3, 2014, Christopher Coughlin resigned as a director Dipexium Pharmaceuticals Inc. to pursue other commitments. Mr. Coughlin also resigned as the Chairman of the company's audit committee. Mr. Coughlin's decision to resign from the board of directors of the company was not based upon any disagreement with the company on any matter relating to the company's operations, policies or practices. On July 3, 2014, the company's board of directors appointed Barry Kagan as a Director of the company and as the new Chairman of the company's audit committee.


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