BioPharma announced the first patient was dosed in the recently initiated Phase 3 clinical study evaluating VM202, a proprietary, DNA-based biopharmaceutical product, in patients with non-healing diabetic foot ulcers (NHU) and concomitant peripheral artery disease (PAD). This is the first pivotal gene therapy trial specifically targeting diabetic foot ulcers with underlying involvement of peripheral arteries. Foot ulcers are a significant complication of diabetes in which neuropathy, PAD and mechanical changes in the bony architecture of the foot result in skin and soft tissue breakdown. Results of a Phase 2 trial published in the journal Gene Therapy [1]Â demonstrated that VM202 injections have the potential to treat foot ulcers in patients with critical limb ischemia, with complete wound closure occurring in 52 and 62% of treated patients. VM202 is a plasmid DNA that contains the human hepatocyte growth factor (HGF) gene, which in vivo produces two isoforms of HGF proteins that are naturally found in the human body. HGF is a growth factor that induces angiogenesis and acts as a neurotrophic factor to the peripheral nervous system. After VM202 is injected into a patient's muscle, it is taken up by cells which produce HGF protein. When released from skeletal muscle cells, HGF may induce new blood vessel formation locally by activating various signaling pathways. In this way, VM202 is believed to provide clinical benefit to patients with diabetic NHU. The Phase 3, double-blind, randomized, placebo-controlled, multicenter study is designed to assess the safety and efficacy of VM202 in 300 adult patients with a diabetic foot ulcer and concomitant PAD. Patients will be randomized in a 2:1 ratio to either VM202 (n=200) or placebo (n=100) and will receive ongoing wound care for the duration of the trial. The primary clinical efficacy outcome 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.