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Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia
- Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia
- Kibbe, M. R.; Hirsch, A. T.; Mendelsohn, F. O.; Davies, M. G.; Pham, H.; Saucedo, J.; Marston, W.; Pyun, W-B; Min, S-K; Peterson, B. G.; Comerota, A.; Choi, D.; Ballard, J.; Bartow, R. A.; Losordo, D. W.; Sherman, W.; Driver, V.; Perin, E. C.
- Ewha Authors
- SCOPUS Author ID
- Issue Date
- Journal Title
- GENE THERAPY
- 0969-7128; 1476-5462
- vol. 23, no. 3, pp. 306 - 312
- NATURE PUBLISHING GROUP
- SCI; SCIE; SCOPUS
- 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 (450%) 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 TcPO2 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.
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