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Subject Disclosure of Clinical Trial Entry • Exit (Voluntary Disclosure)
Writer ViroMed
Date 2014/11/21

 

1.     Stage and phase of clinical study

US VM202-DPN 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 painful diabetic peripheral neuropathy

3.       Background and purpose of clinical study

(1) VM202-DPN is a new drug candidate in clinical trials for the treatment of diabetic peripheral neuropathy. The candidate has the characteristic of inducing the formation of new blood vessels and regenerate nerve cells by producing two isoforms of hepatocyte growth factor (HGF) protein when injected into the muscles.

 

(2) Purpose of clinical study:

Diabetic peripheral neuropathy is a major complication associated with diabetes causing neurological pain. Patients suffer from severe pain caused by damaged nerve cells sending abnormal signals, which can cause continuous or spasmodic pain of tingling sensation in the toes, feeling of being pricked by a needle, or electrical stimulation. These pains interfere with every day activities and in cases where immediate treatment to external stimulation is difficult, it can lead to formation of ulcer, infection, and finally amputation in extreme cases. Currently, there are no treatments approved to stop the disease progression or fundamentally treat the disease. Symptomatic treatment methods such as glucose control and foot care are used to slow the disease from getting worse along with painkillers for coping with pain and antidepressants for regulating psychological stress.

 

For the fundamental treatment of the disease, ViroMed has been conducting clinical studies with VM202-DPN that has the capability for peripheral nerve cell regeneration. This phase II clinical study was conducted to evaluate the safety and efficacy of VM202 by injecting leg muscles of both legs and using diabetic peripheral neuropathy patients with pains. The study was conducted in total of 17 locations from the US and Korea with 3 groups of placebo, low dose VM202 (16 mg), and high dose VM202 (32 mg).

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 the follow-up study of 103 patients over 9 months, we were able to confirm improvements in various efficacy parameters for diabetic peripheral neuropathy in patients injected with VM202. Improvements in efficacy parameters were confirmed by analyzing the comparison to placebo group and the comparison before/after injection. We confirmed that there are no directly related adverse events in patients injected with VM202.

(3)   Clinical Study Report (CSR) containing above results has been submitted to the US FDA and the reviews for VM202-DPN’s safety and efficacy results have been completed by the US FDA.

 

2) Future plans: Phase II clinical study results for VM202-DPN have been submitted to an international scientific journal and are currently under review. Details regarding next clinical study will be decided after a meeting with the US FDA.