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Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia
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Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia
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Journal Article
Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia
2016
Overview
VM202, a plasmid DNA that expresses two isoforms of hepatocyte growth factor, may elicit angiogenic effects that could benefit patients with critical limb ischemia (CLI). In a phase 2, double-blind trial in 52 CLI patients, we examined the safety and potential efficacy of intramuscular injections of low-dose (
n
=21) or high-dose (
n
=20) VM202 or placebo (
n
=11) in the affected limb (days 0, 14, 28 and 42). Adverse events and serious adverse events were similar among the groups; no malignancy or proliferative retinopathy was seen. In exploratory efficacy analyses, we found no differences in ankle or toe-brachial index, VAS, VascuQuol or amputation rate among the groups. Complete ulcer healing was significantly better in high-dose (8/13 ulcers;
P
<0.01) versus placebo (1/9) patients. Clinically meaningful reductions (>50%) in ulcer area occurred in high-dose (9/13 ulcers) and low-dose (19/27) groups versus placebo (1/9;
P
<0.05 and
P
<0.005, respectively). At 12 months, significant differences were seen in TcPO
2
between the high-dose and placebo groups (47.5±17.8 versus 36.6±24.0 mm Hg, respectively;
P
<0.05) and in the change from baseline among the groups (
P
<0.05). These data suggest that VM202 is safe and may provide therapeutic bioactivity in CLI patients.
Publisher
Nature Publishing Group UK,Nature Publishing Group
Subject
/ 13/44
/ 38/39
/ Aged
/ Analysis
/ Ankle
/ Biomedical and Life Sciences
/ DNA
/ Female
/ Genetic Vectors - adverse effects
/ Hepatocyte Growth Factor - adverse effects
/ Hepatocyte Growth Factor - genetics
/ Humans
/ Ischemia
/ Isoforms
/ Male
/ Placebos
/ Protein Isoforms - adverse effects
/ Ulcers
