Phase III trials of DSC 127 (Derma Sciences) start for Diabetic Foot Ulcers
Derma Sciences, Inc. has announced enrollment of patients has commenced in the first of two Phase III clinical trials with the Company�s investigational topical drug candidate DSC 127.
DSC 127 is an analog of a naturally occurring peptide, Angiotensin. It has been shown to increase keratinocyte proliferation, increase extracellular matrix production, and increase vascularization.
The two pivotal trials are expected to enroll a total of 1,055 patients, and are designed to assess the safety and efficacy of DSC 127 in chronic, non-healing Diabetic Foot Ulcers and to support the filing of a New Drug Application (NDA) with the FDA. Both trials will evaluate a 0.03% formulation of DSC 127 against a topical vehicle, while one will include an additional arm of patients treated with a standard of care hydrogel. This second trial is expected to begin enrolling patients by the end of March 2013. In addition, approximately 200 patients will be enrolled in a chronic use safety study.
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