HOME > Investors > Press Releases
Subject 2016.06 (IR letter) Business Updates
Writer ViroMed
Date 2016/07/06
On May 27th, a gene therapy drug StrimvelisTM (GSK) received market approval from European Medicines Agency for severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID). Gene therapy, once regarded as commercially unfruitful just a few years ago, has started emerging in medical field as more drugs receive market approval in Europe and the US. Expectations grow for ViroMed’s proprietary gene therapy drug as well. The general perception on gene therapy has been shifted from skepticism to enthusiasm recently. ViroMed will continue the efforts to expedite obtaining market approval in major markets for VM202, the drug that is first of its kind.

ViroMed currently operates the following three phase III studies in the US: diabetic peripheral neuropathy (VM202-DPN), amyotrophic lateral sclerosis (VM202-ALS), and ischemic diabetic foot ulcer (VM202-PAD).

VM202-DPN actively operates phase III clinical trial with the first patient injection on June 24th. The leading principle investigator Dr. John Kessler at Northwestern University Feinberg School of Medicine oversees the project of 477 patients at 25 clinical sites in the US. VM202-PAD phase III is being prepared with an aim to start recruiting ischemic diabetic ulcer patients at the end of this year. VM202-ALS received FAST TRACK designation from US FDA on May 16th. The designation will accelerate the market approval process, which will expedite its commercialization as ALS drug. The IND submission to US FDA is planned in the second half of this year.

ViroMed’s strategy is to continue pursuing licensing opportunities and simultaneously proceed with phase III clinical trials seamlessly so that licensing partners would receive product approval as soon as possible. The underlying strategy is to maximize the value of VM202 in the market.

Additionally, a number of research and development at preclinical and early stages of clinical trials are ongoing. For example, ViroMed is conducting government funded research regarding new drug candidate for motor neuron diseases.

The table below summarizes various development stages for different indications.

 

Product

Indication

Status

VM202-DPN

Diabetic Peripheral Neuropathy

US

Phase III (patient recruiting)

VM202-PAD

Peripheral Artery Disease

US

Phase III (not yet recruiting)

China

Phase II (paper preparation)

Phase III (IND preparation)

VM202-ALS

Amyotrophic Lateral Sclerosis

(Lou Gehrig’s disease)

US

FAST TRACK designation (US FDA)

Phase II IND submission (16Q3 planned)

VM202-CAD

Ischemic Heart Disease

Korea

Phase II (IND under review)

VM206

Breast Cancer

Korea

Phase II (IND preparation)