PainRelief.com Interview with:
Sheila Yi, Helixmith
PainRelief.com: What is the background for this study? Would you explain how VM202 is unique?
- Response: Diabetic peripheral neuropathy is one of the most common complications of diabetes and many of DPN patients suffer from severe pain that affects their daily activities and life quality. Though there are medications, both Rx and OTC drugs, used to ameliorate pains from diabetic peripheral neuropathy, many of them fall short of analgesic efficacy or often lead to not so trivial side effects.
- Engensis (VM202) is plasmid DNA therapy, non-viral gene therapy, which encodes hepatocyte growth factor (HGF) gene that is designed to simultaneously express two isoforms of HGF protein at high levels. HGF is known to have angiogenic and neurotrophic effects and, when expressed in the human body, induces formation of new micro vessels and nerve regeneration through remyelination and axon outgrowth, resulting in improvement in peripheral neuropathy condition. Engensis does not integrate into the human genome.
- Historically, our research first focused on therapeutic angiogenesis of HGF with a proof of concept research in critical limb ischemia, an extreme form of peripheral artery disease. In the process, we realized that Engensis would also be effective for peripheral neuropathy, and a coffee chat with the current PI, Dr. Kessler of Northwestern University, led to an idea of using Engensis in neurological diseases.
- Throughout Phase 1 through 3 clinical trials for DPN in the US, Engensis has been observed safe and well-tolerated in patients, and, during the Phase 3 study, received RMAT (regenerative medicine advanced therapy) designation from the FDA.
PainRelief.com: What are the main findings?
- From the 12-month DPN Phase 3-1b study results, Engensis appeared to be safe and well-tolerated as was seen in the DPN 3-1 study. The occurrence of adverse events (AEs) was no different between the active treatment and placebo groups.
- Engensis showed clinically meaningful and statistically significant pain reduction vs. placebo at months 6,9, and 12.
- The difference in pain reduction between the active treatment and placebo groups was greater in the population not on gabapentinoids.
PainRelief.com:What should readers take away from your report?
- Engensis is not only an analgesic for DPN patients but also has regenerative potential that may be able to prevent people from getting progressive disease or even slow down the disease progression.
- The last follow-up visit of the study occurred at 12 months (Day 365) from the first injection and 8.7 months or 261 days from the last injection of Engensis (Day 104). In other words, the patients who received Engensis had pain reduction for more than 8 months in the absence of DNA and protein expressed from the gene. Given that 99.9999% of Engensis DNA disappears from patient’s blood within 3 days after injection and human hepatocyte growth factor (HGF) protein is expressed for merely 2 weeks following the injection, the study result strongly suggests Engensis may have nerve regeneration properties.
PainRelief.com: What recommendations do you have for future research as a result of this study?
Response: We are expecting that our future research will provide us, using various measures, with more evidence on Engensis’ potential as a neuropathy treatment that restores damaged nerve cells.
PainRelief.com:Is there anything else you would like to add? Any disclosures?
Response: According to our animal studies, Engensis, encoding hepatocyte growth factor gene, can induce not only angiogenesis and nerve regeneration but also can ameliorate muscle atrophic condition. In fact, our Phase1/2 study for ALS patients in the US showed a positive trend that Engensis may be able to slow down the progression of the disease, measured by r-ALSFRS, most at 3 months after the first injection. Engensis for ALS received fast track designation from the FDA and its Phase 2 clinical trial in the US is in preparation.
2019 Fall International Convention of the Pharmaceutical Society of Korea abstract discussing the long-term safety and efficacy of VM202 for painful diabetic peripheral neuropathy patients
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