Posts tagged OneStep-2
Dipexium updates availability of Phase 3 data

Dipexium Pharmaceuticals (NASDAQ:DPRX) updated the status of results from two pivotal Phase 3 clinical trials - OneStep-1 and OneStep-2- of its topical antimicrobial peptide, Locilex, for the treatment of diabetic foot ulcers.

Data tables and listings from both of these trials are currently being produced and evaluated by the company's scientific advisors according to a pre-specified data review procedure. 

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Dipexium gets SME designation in Europe

Dipexium Pharmaceuticals (NASDAQ:DPRX) has been granted small and medium enterprise (SME) designation by the European Medicines Agency (EMA). 

The company recently completed its pivotal Phase 3 clinical trials - OneStep-1 and OneStep-2 - with its topical antimicrobial peptide, Locilex, in mild infections of diabetic foot ulcers in the U.S. under a special protocol assessment agreement from FDA. 

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Dipexium completes enrollment in second Phase 3 trial

Dipexium Pharmaceuticals (NASDAQ:DPRX) has completed patient enrollmentin the OneStep-1 pivotal Phase 3 clinical trial of its Locilex broad-spectrum, topical antibiotic peptide.

Last week, the company reached the enrollment objective in the OneStep-2 pivotal trial.

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Dipexium completes enrollment in one Locilex Phase 3 trial

Dipexium Pharmaceuticals (NASDAQ:DPRX) has completed the patient enrollment objective in the OneStep-2 Phase 3 clinical trial of its Locilex topical antibiotic peptide.

The company’s OneStep-1 Phase 3 clinical trial has passed the 98% enrollment mark and is expected to reach the 180-patient enrollment objective soon.

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Dipexium reaches 75% enrolment in Phase 3 trials

Dipexium Pharmaceuticals’ (NASDAQ:DPRX) OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials have reached the 75% enrollment milestone in total, with each study having enrolled nearly the same number of patients.

OneStep-1 and OneStep-2 are identical Phase 3 trials, with 180 patients per clinical trial. They are being conducted under a SPA with the FDA for evaluation of Locilex for the treatment of patients with mild infections of diabetic foot ulcers.

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