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July 17, 2014
08:04 EDTDPRXDipexium Pharmaceuticals begins Phase 3 clinical trial of Locilex for foot ulcer
Dipexium Pharmaceuticals has initiated patient enrollment in the first of two pivotal Phase 3 clinical trials evaluating Locilex, the company's novel, broad-spectrum, topical antibiotic peptide, for the treatment of patients with mild infections of diabetic foot ulcers, or Mild DFI. Currently, there are no antibiotics, systemic or topical, which are FDA approved specifically to treat patients with Mild DFI. The FDA has agreed to a Special Protocol Assessment with Dipexium for Locilex's pivotal Phase 3 clinical trial program in Mild DFI.
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July 21, 2014
08:06 EDTDPRXDipexium Pharma' begins patient enrollment for clinical trial with Locilex
Dipexium Pharmaceuticals announced it has initiated patient enrollment in the second of two pivotal Phase 3 clinical trials, known as OneStep-1 and OneStep-2, evaluating Locilex, 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.
July 17, 2014
08:06 EDTDPRXDipexium Pharmaceuticals completion Phase 1 skin irritation trial of Locilex
Dipexium Pharmaceuticals completed DPX-110, a Phase 1 skin irritation clinical trial of Locilex, the company's novel, broad-spectrum topical antibiotic peptide. Dipexium 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 agreement with FDA. 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.
08:04 EDTDPRXDipexium Pharmaceuticals begins Phase 3 clinical trial of Locilex for foot ulcer
Dipexium Pharmaceuticals has initiated patient enrollment in the first of two pivotal Phase 3 clinical trials evaluating Locilex, the company's novel, broad-spectrum, topical antibiotic peptide, for the treatment of patients with mild infections of diabetic foot ulcers, or Mild DFI. Currently, there are no antibiotics, systemic or topical, which are FDA approved specifically to treat patients with Mild DFI. The FDA has agreed to a Special Protocol Assessment with Dipexium for Locilex's pivotal Phase 3 clinical trial program in Mild DFI.

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