Researchers from Northwestern Medicine administered the non-viral gene therapy or a placebo in order to evaluate the safety and efficacy of a plasmid (VM202) containing 2 human hepatocyte growth factor isoforms given by intramuscular injections in patients with PDN. There were 84 patients included in the study who were randomized to either receive injections of 8 or 16 mg VM202 per leg or placebo. Doses were administered on days zero and 14. The researchers asked the participants to evaluate their mean pain scores measured by a 7 day pain diary. The researchers had secondary objectives in this study, such as assessing quality of life and pain measures and intraepidermal nerve fiber density.
The patients who received 8 mg VM202 per leg improved the most in all efficacy measures, the researchers said, including a significant reduction at 3 months in the mean pain score. This continued, but was not statistically significant, and at 6 and 9 months the pain was still somewhat reduced.
“Those who received the therapy reported more than a 50 percent reduction in their symptoms and virtually no side effects,” lead author of the study Jack A. Kessler, MD, said in a press release. “Not only did it improve their pain, it also improved their ability to perceive a very, very light touch.”
By Rachel Lutz
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