ViroMed announces positive phase I results from angiogenic gene therapy in peripheral artery disease
ViroMed Co., Ltd. today announced final results in the phase I trial to explore the safety of VMDA-3601, a naked DNA angiogenic gene-medicine for peripheral artery disease.
High potential efficacy as well as safety data in nine patients with critical limb ischemia was reported by the principal investigator, Duk-Kyung Kim, MD, PhD., Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine. The results indicate that VMDA-3601 injections were well tolerated without significant side effects. During the study, there were no significant clinical side effect and laboratory abnormalities related with gene transfer. In addition, various potential therapeutic benefits were observed.
Semi-quantitative analysis of collateral vessels of angiographic images indicated +1.33 increase (9 patients) and +0.88 increase (8 patients) at 3 and 9 months post-treatment, respectively. Overall, the increase of collateral vessels was observed in 7 of 9 patients.
The increase in the Ankle-brachial index (ABI) value by 0.1 compared to the baseline was observed in all of 9 patients at least once during the study period and considered to be a clinically significant improvement. Among 7 patients, who were considered to require amputation of their lower limb at baseline, 3 patients no longer required amputation following the treatment due to improvement of symptoms, and amputation was delayed in the other 4 patients, confirming the effectiveness of the treatment.
This study, conducted in collaboration with Dong-A Pharmaceutical Company and Samsung Medical Center is scheduled to enter the phase 2 clinical trial by the end of this year.
ViroMed President and Chief Executive Officer, Daeyon Kang, remarked, "We are very pleased with the initial success of VMDA-3601. This is the first officially approved gene therapy clinical trial in Korea and the results are very promising compared with other angiogenic gene therapy trials. ViroMed will become one of the world’s first companies to commercialize angiogenic gene-medicine."
ViroMed Co., Ltd. ViroMed is a Korean biotech company founded by Dr. Sunyoung Kim of Seoul National University. ViroMed develops gene-based medicines for the treatment of major human diseases, such as cardiovascular disease, genetic disorders, immune diseases, and cancer. Since its incorporation in 1996, ViroMed has pursued gene therapy based on its proprietary vector technology and is working toward rapid market entry for gene-based products that address severe, life-threatening diseases for which alternative treatments are either unsatisfactory or non-existent. ViroMed is actively establishing and maintains collaborations with corporate and academic partners worldwide to effectively and economically leverage its resources to develop and market products. ViroMed initiated Korea’s first gene therapy clinical trial for its peripheral artery disease drug, VMDA3601. The trial carried out at Samsung Seoul Hospital shows promising results and is scheduled to enter into the second phase by the end of 2003.