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Results from phase 3 gene therapy trial for diabetic peripheral neuropathy published online by Clinical and Translational Science

Results from phase 3 gene therapy trial for diabetic peripheral neuropathy published online by Clinical and Translational Science
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VM202 (donaperminogene seltoplasmid) is a first-in-class, proprietary, non-viral, potentially regenerative plasmid DNA gene therapy. The Phase 3 study for painful DPN, led by Professor John (Jack) Kessler at Northwestern University, was conducted in two parts, one for 9 months (VMDN-003; 500 subjects) and one with a 3-month extension to 12 months (VMDN-003b; 101 subjects). This is the first gene therapy phase 3 trial that has ever been done for pain. Phase 3 data, published in Clinical and Translational Science, present latest clinical outcomes for VM202 (Engensis) in painful diabetic peripheral neuropathy (DPN), suggesting excellent safety and promising efficacy. VMDN-003 study achieved safety endpoints, while VMDN-003b showed clinically meaningful pain reduction vs. placebo. Safety and tolerability of Engensis continues to a ....

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