VM BioPharma, the U.S subsidiary of ViroMed, announced Tuesday that it has launched a trial to investigate the effect of VM202 on mobility and calf perfusion in older adults with peripheral artery disease (PAD).
The study, which is named Hepatocyte Growth Factor to Improve Functioning in PAD (HI-PAD), will evaluate whether the VM202 treatment can improve symptomatic PAD, as measured by calf muscle perfusion using arterial spin labeling (ASL) cardiovascular magnetic resonance (CMR). The study will confirm the results through walking performance and skeletal muscle damage using calf muscle biopsy.
VM202 is a plasmid DNA produces hepatocyte growth factor (HGF) protein that induces angiogenesis and acts as a neurotrophic factor. Such effects lead to the formation of new microvasculature and inducing regeneration of nerve cells.
PAD is an illness where the blood vessels in the legs narrow. It affects 10 to 15 percent of men and women aged 65 and older and 15 to 20 percent of those aged 75 and older. Symptoms include painful muscle cramps when walking or exercising, cold feet and lower legs and feet wounds that do not easily heal.
The research, which aims assess the safety and efficacy of VM202, will examine 36 adult patients with symptomatic PAD in a double-blind, randomized, placebo-controlled, single-center study clinical trial at Northwestern University for six months. The National Institute on Aging, which is a division of the U.S. National Institutes of Health (NIH), will fund the research.
“Lower extremity peripheral artery disease is a common problem which severely impacts mobility and increases rates of functional decline in older adults,” said Mary McDermott, professor of medicine and preventive medicine at Northwestern University and the head of the trial. “We are delighted to initiate this study, which may provide important information on the potential benefits of HGF gene therapy for PAD.”
ViroMed also showed enthusiasm towards the clinical trials.
“The National Institute on Aging and McDermott team are providing the company with a unique opportunity to observe the implications on quality of life that VM202 may confer to PAD patients,” said Kim Sun-young, the chief scientific officer of ViroMed. “The research also assesses the therapeutic mechanism objectively with muscle biopsies and cutting-edge arterial spin labeling CMR imaging.”
The company believes that this study will yield valuable information on both understanding the physical and physiological pathology of PAD and its treatment, Kim added.
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