Non-Viral Gene Therapy Offers Hope for Pain Relief from Diabetic Neuropathy

PainRelief.com Interview with:  
Sheila Yi, Helixmith

PainRelief.com: What is the background for this study? Would you explain how VM202 is unique?

  • ResponseDiabetic 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.
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Neck and Back Pain More Common in Diabetes

PainRelief.com Interview with:

Manuela L. Ferreira PhD
Institute of Bone and Joint Research
The Kolling Institute, Sydney Medical School

Paulo H. Ferreira PhD
Musculoskeletal Health Research Group
Faculty of Health Sciences
University of Sydney, Sydney, NSW, Australia

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: One in four Australians experience back pain or neck pain. Diabetes is also a worldwide prevalent condition, and currently affects over 382 million people. These two diseases often co-exist and have very similar underlying mechanisms, such as obesity and physical inactivity. We were unsure whether having one condition would lead to developing the other, however.

We have found 11 studies published to date, and assessing the relation between back or neck pain and diabetes. The studies included over 165,000 participants published in the USA, Canada, Finland, Denmark, Iran and Spain.

When we pooled the results of these studies together, we observed that people with type 2 diabetes are 35% more likely to also have low back pain (compared to people without diabetes). The risk of having severe back pain symptoms in people with type 2 diabetes is 63% higher and the risk of having severe neck pain is almost 30% higher, than in people with no diabetes.  We could not identify, however, whether type 2 diabetes can lead to back or neck pain, and it is possible that the two conditions are associated via other underlying mechanisms such as obesity and physical inactivity.

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