South Korean-based ViroMed’s US biopharmaceutical division VM BioPharma has secured Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety in Korea (MFDS) to conduct the Phase II clinical trial of VM202 for ischemic heart disease (IHD).
VM202 is VM BioPharma’s patented gene therapy drug, which generates two isoforms of hepatocyte growth factor (HGF) protein after being injected into the cardiac muscles of the patient.
The protein triggers angiogenesis and acts as a neurotrophic factor resulting to the formation of new microvasculature thereby inducing regeneration of nerve cells.
The trial has been designed to assess the safety and tolerability of VM202, while its secondary efficacy endpoint is to determine the cardiac function and output.
It will involve 108 patients with IHD who previously received a percutaneous coronary intervention (PCI) for acute myocardial infarction before 30 days of enrolment within the study.
The patients will be injected with VM202 percutaneously through the endocardial route using an innovative therapeutic catheter.
ViroMed chief scientific officer Dr Sunyoung Kim said: "Data from the Phase I trial of VM202 in IHD suggests that VM202 may be a promising option for IHD treaters and patients, where there is currently an unmet need for those that have developed necrosis and / or fibrosis of the myocardium despite reperfusion therapy such as percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)."
Two Phase III studies are currently evaluating the safety and efficacy of VM202 by individually treating adult patients with painful diabetic peripheral neuropathy (DPN) and ischemic diabetic foot ulcer.