ViroMed Co. Ltd. announced the publication of the results from successfully completed phase II clinical study of VM202 for the treatment of critical limb ischemia in the January issue of Gene Therapy. The study, 'A Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Trial of the Safety and Efficacy of Plasmid DNA Expressing two Isoforms of Hepatocyte Growth Factor in Patients with Critical Limb Ischemia', examined VM202 in 52 patients with critical limb ischemia (CLI) at 16 hospitals and research centers in the United States and Korea.

Results from the clinical study showed VM202 to be safe and well tolerated with clinical benefits in CLI patients. VM202 was intramuscularly injected in four series in the muscle of diseased leg in patients, spaced 2 weeks apart, and observed for 12 months. Patients were randomly divided into three groups of placebo, low-dose (8 mg total), high-dose (16 mg total).

While both VM202 treated groups showed better improvement compared to the placebo group, patients treated with high-dose VM202 showed significantly better ulcer healing and tissue oxygenation (TcPO2 levels) than patients from the placebo group. For ulcer healing, 62% of ulcers treated with high-dose VM202 healed completely compared with only 11% of ulcers treated with placebo, a statistically meaningful difference. Tissue oxygenation also showed statistically meaningful difference with 71% of high-dose VM202 patients showed increased TcPO2 levels while only 33% of the placebo patients showed better TcPO2 levels.

VM202 is a plasmid DNA that contains the human HGF gene that produces two isoforms of HGF proteins that are naturally found in the human body. HGF is a growth factors that induces angiogenesis and acts as a neurotrophic factor. After VM202 is injected into a patient's muscle, it is taken up by a cell and produces the HGF proteins, which are then released from the cell and may induce new blood vessel formation by activating various signaling pathways.

In this way, VM202 may provide clinical benefits to CLI patients. Chronic non-healing ischemic foot ulcers in diabetes patients is an ulcer(s) on or around the foot area that is unresponsive to standard therapies and persists despite 4 weeks of appropriate care. Ulcer formation can be caused by various reasons including diabetes, unhealthy dietary habits, drinking, and smoking.

ViroMed has already received IND approval from the US FDA to initiate a phase III study targeting chronic non-healing ischemic foot ulcer in diabetic patients. The study will involve 300 subjects divided into VM202 treatment group and placebo group. The injection scheme will be the same as phase II study, but with shorter follow-up period of 7 months.

Both safety and efficacy will be evaluated with complete wound closure as the primary efficacy endpoint.