HOME > Investors > Press Releases
Subject ViroMed proceeding with the World’s first phase III gene therapy clinical trial for diabetic peripheral neuropathy (DPN)
Writer ViroMed
Date 2016/09/08

We would like to deliver the current status of phase III clinical trial regarding gene therapy for diabetic peripheral neuropathy. Currently 78 subjects have been recruited within 4 months from the initiation of phase III trial. Since the first subject initiated the injection cycle in June, total of 23 subjects have begun their clinical trial participation to this day. The rest of 55 subjects are in the screening process to determine the eligibility for clinical trial participation.

We plan to conduct the phase III trial in 25 US clinical sites for 477 subjects. The trial initiation of the 22 subjects has been proceeded at 7 clinical sites where site initiation visit was complete. The pace of patient recruitment is expected to accelerate when all of the 25 designated clinical sites complete the trial initiation.

We have concluded clinical trial agreement with 21 clinical sites, and completed site initiation visit for 18 sites. Investigator Meeting will be held in Chicago, IL on 6th and 7th of October, where the attendees are the mix of participating principle investigators, clinical research coordinators, and CROs. The participants will discuss the trial progress from different sites during the meeting.

 

Current Status of VM202 development

Target Indication

Country

Clinical Phase

Status

 Note

Diabetic Peripheral Neuropathy

US

Phase III

In Progress

See Above

Non-healing Ischemic Diabetic Foot Ulcer

US

Phase III

Approved by US FDA

Planned to initiate in 2016 4Q

Amyotrophic Lateral Sclerosis

US

Phase II

IND planned

Ischemic Heart Disease (Coronary Artery Disease)

Korea

Phase II

Approved by Korea FDA

Planned to patient recruitment in 2016 4Q

 

VM202 position in therapeutics market

-          Cases of gene therapy drugs approved for clinical use: 1 in the US, 2 in Europe

-          The target diseases of gene therapy are of high unmet medical needs and left with little therapeutic option. The research is driven towards overcoming current medical limitations and addressing the fundamental cause of disease. If successful, the products will enter the market with first-in-class medicine label.

-          ViroMed is the only company conducting phase III trials on diabetic peripheral neuropathy, ischemic diabetic foot ulcer, and amyotrophic lateral sclerosis (also known as Lou Gehrig’s disease) with gene therapy approach.

-          Current treatment options of diabetic peripheral neuropathy mainly focus on pain relief such as glucose level control and pain management. The DPN pain killer prescription provides only temporary pain relief to the patients yet makes about US$ 4 to 5 billion dollars annually worldwide.

-          Current treatment options of non-healing ischemic foot ulcer would include debridement, use of anti-inflammatory/anti-bacterial agents against infection, wet dressings to promote wound healing (i.e., hydrocolloid, hydrogel), and skin substitutes or gel containing growth factor applied on the affected area. However, the limitations exist as the treatment effects cannot penetrate deep through the skin tissue but ameliorates ulcer only on the surface. More importantly the mentioned therapeutic options do not address at the fundamental level of ulcer occurrence. The direct medical cost occurs at more than 5 billion dollars in the US annually.


About VM202

-          VM202 is intramuscular injectable DNA drug containing human hepatocyte growth factor (HGF) gene of therapeutic use. The development purpose is to be an effective gene therapy on diabetic peripheral neuropathy, non-healing ischemic diabetic foot ulcer, and amyotrophic lateral sclerosis approaching from disease modifying drug perspectives.


About VM202 Mode of Action

-          Upon injection of VM202 on patient muscles and its entry into the cells, the drug produces two isotypes of HGF protein and activates cellular signaling involved in the formation of new blood vessels (angiogenesis) and peripheral neuron regeneration. The sequential biological events, driven by the activated cellular signals will restore damaged peripheral neuron network integrity and promote angiogenesis to address DPN at the fundamental level.