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Subject Disclosure of Clinical Trial Entry & Exit (Voluntary Disclosure)
Writer ViroMed
Date 2014/05/16

 

1.     Stage and phase of clinical study

US/Korea VM202-PAD phase II clinical study complete

2.     Clinical study title

A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter, study to assess the safety and efficacy of VM202 in subjects with critical limb ischemia

3.     Background and purpose of clinical study

(1) VM202-PAD is a new drug candidate in clinical trials for the treatment of peripheral artery disease. The candidate has the characteristic of inducing the formation of new blood vessels by producing two isoforms of hepatocyte growth factor (HGF) protein when injected into the muscles.

(2) Purpose of clinical study:

We are conducting various clinical studies to develop a treatment for cardiovascular diseases (#1 -2 cause of death in major developed countries) using therapeutic angiogenesis treatment property of VM202. This phase II clinical study targeted patients with peripheral artery disease (critical limb ischemia). The study involved placebo, low dose (8mg), and high dose (16mg) groups. The drug was injected into patients’ leg muscles to evaluate VM202’s safety and efficacy. This study was conducted in total of 16 sites between US and Korea.

4.     Impact and future plans

1)     Impact

(1)   VM202 is a biopharmaceutical developed exclusively with Korea’s technology. With the safety and efficacy results confirmed through this phase II study, we were able to confirm the potential of VM202 to be developed as a treatment to fundamentally treat diseases.

(2)   After 12 months follow-up ViroMed observed clinically and statistically meaningful and consistent improvements in all efficacy parameters (ulcer healing, TcPO2, ABI, and rest pain (VAS)) compared to placebo and baseline. For safety, there were no directly drug-related adverse effects

(3)   Based on these results, ViroMed submitted VM202-PAD phase II final report to US FDA in March 19th, 2014. US FDA reviewed the final report for 1 month after submission and did not raise any objections regarding safety and efficacy results.

(4)   ViroMed’s consultant in the US recommended detailed preparation for next clinical study (phase III) since the final report submitted to the US FDA met FDA’s criteria.

 

2)     Future plans: We are planning to publish VM202-PAD’s phase II study results in an international scientific journal. We also plan to hold meetings with US FDA to discuss and determine detailed contents for next clinical development.