Updated on 1 August 2012
ViroMed has already completed a phase I/II trial for DPN in the US, a phase I trial for CLI in the US and China, and a phase I for CAD in Korea. When a DNA-based drug is tested, patients with actual symptoms are enrolled at the first stage of the phase I trial, in order to observe for both efficacy and safety. Therefore, the data pertaining to VM202's efficacy as well as safety has been obtained from a total of 54 subjects, with three different indications, in three different countries, using test drugs produced by two different manufacturing facilities.
Safety-wise, no significant drug-related adverse effects have been found in VM202-injected patients until date. Furthermore, no antibodies to newly expressed HGF proteins were observed, and the serum level of HGF protein remained virtually unchanged.
Efficacy-wise, VM202 has produced very encouraging data showing its powerful pain relieving effects in a dose-dependent manner during each trial. In the phase I/II PDPN clinical trial, the percentage of pain reduction experienced by the participants was 47 percent in average. The percentage of patients experiencing more than 50 percent in pain reduction was 75 percent. In the case of the phase I CLI trial, VM202 injection improved the ischemic ulcers, reduced the resting pain, and increased ABI in patients in both the US and China trials.
Moreover, data from the phase I CAD trial showed that VM202 injection increased myocardial perfusion and myocardial wall thickness in patients with angina pectoris.
Currently, a phase II trial for PDPN are smoothly underway in the US and Korea, and the same is also the case for CLI in the US, Korea and China, with final results expected in 2013. For CAD indication, a phase II or II/III trial for acute myocardial infarction is expected to start in 2013, with its completion aimed in 2015.