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ViroMed Gene Therapy for Non-Healing Diabetic Foot Ulcers Starts Phase III Trial

05:19 EDT 4 Aug 2017 | Genetic Engineering News

The first patient has been dosed in a Phase III trial assessing ViroMed’s VM202, the first pivotal study of a gene therapy indicated for patients with non-healing diabetic foot ulcers (NHU) and concomitant peripheral artery disease (PAD). The Phase 3 trial ( NCT02563522 ) is a double-blind, placebo-controlled, multicenter study designed to evaluate VM202 for safety and efficacy in 300 adults with a diabetic foot ulcer and concomitant PAD. Two hundred patients will be randomized to VM202; the other 100, to placebo, ViroMed’s US division VM BioPharma said yesterday. Patients will receive ongoing wound care for the duration of the trial, the company added. The primary clinical endpoint will be the proportion of subjects with confirmed target wound closure by the 4-month follow-up. Secondary endpoints will include changes in ankle-brachial index and toe-brachial index. The trial is the second Phase III study of VM202; the ...

Original Article: ViroMed Gene Therapy for Non-Healing Diabetic Foot Ulcers Starts Phase III Trial

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