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Subject ViroMed Publishes Results from Critical Limb Ischemia (CLI) Phase II Clinical Study
Writer ViroMed
Date 2016/01/22

ViroMed Publishes Results from Critical Limb Ischemia (CLI) Phase II Clinical Study

January 22, 2016 03:30 AM Eastern Standard Time

SEOUL, Korea--(BUSINESS WIRE)--ViroMed Co., Ltd. (KOSDAQ:084990) has 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 (TcPO2levels) 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.

“These positive results are exciting, and VM202 shows great promise for treating patients with this debilitating disease who often have limited therapeutic options,” said Dr. Emerson C. Perin, Director of the Stem Cell Center at the Texas Heart Institute and the principal investigator of the study. “We are looking forward to conducting a phase III trial to better understand the potential of this novel approach, especially in treating non-healing ulcers, which is a serious symptom that often leads to amputation because of the lack of medical therapies available.”

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.

Dr. Jae-Gyun Jeong, director of R&D department at ViroMed stated “VM202 expresses two isoforms of HGF protein to induce the formation of collateral blood vessels to treat ischemic diseases. We belive that through this phase II study targeting CLI patients we have successfully shown VM202’s concept mechanism. In phase III study, utilizing the same mechanism, we will confirm VM202’s efficacy in treating chronic non-healing ischemic foot ulcers in diabetes patients and launch the product in the market as soon as possible.”

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.

Phse II study was supported by a grant from the Korean Ministry of Trade, Industry and Energy (grant no. 10031644).

About CLI

CLI is a serious form of peripheral artery disease (PAD)–a cardiovascular disease caused by narrowing of the peripheral arteries, most commonly in the legs. If not managed properly in the early stages, PAD can progress to CLI where the blood flow in the arteries becomes severely obstructed or blocked by plaque build-up and advanced atherosclerosis. As blood flow to the limb decreases, oxygenation of the tissues also decreases. This restricted blood flow reduces oxygenation of the tissues, which leads to chronic pain, ulcer formation, and possibly gangrene. As the tissue dies, amputation can become a last resort in extreme cases of CLI.

About VM202

VM202 is a proprietary gene therapy from ViroMed targeting four different indications. When injected into patients, VM202 produces hepatocyte growth factor (HGF) protein, which induces angiogenesis and acts as a neurotrophic factor, leading to the formation of new microvasculature and induces regeneration of nerve cells. The results from a phase I clinical study showed the possibility of VM202 as a new concept drug for the treatment of critical limb ischemia, and the results have been published (Gene Therapy 2011, 18: 788–794). VM202 is also currently being studied in phase III for diabetic peripheral neuropathy in the US and have successfully completed phase I/II study for amyotrophic lateral sclerosis in the US. Phase II is also planned for coronary artery disease in Korea.

About ViroMed Co., Ltd.

ViroMed Co., Ltd. dba VM BioPharma in Atlanta, USA; is an R&D focused biopharmaceutical company founded in 1996 and located in Seoul, Korea. ViroMed is developing new and innovative biopharmaceuticals for the treatment of currently untreatable diseases.