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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 ...NEXT ARTICLE
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Gene therapy is the use of DNA as a pharmaceutical agent to treat disease. It derives its name from the idea that DNA can be used to supplement or alter genes within an individual's cells as a therapy to treat disease. The most common form of gene th...