Keystone Symposia is a well-known conference in molecular cell biology and medical science. It is a conference where many scientists want to participate and announce as the best scientists are invited and stayed for more than 3 days in intensive discussion to share high-level information.
VM202 is a plasmid DNA designed to simultaneously express two isoforms of hepatocyte growth factor (HGF), HGF 728 and HGF 723. It is optimized to produce HGF protein at a high level when delivered to the muscle. Through simple intramuscular injections, Engensis is being studied in clinical trials to determine whether it can provide safe and efficacious treatment effects for various ischemic diseases or neurodegenerative diseases, including diabetic peripheral neuropathy (DPN), diabetic foot ulcer (DFU), and coronary artery disease (CAD).
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The titles and summaries of three presentations are as follows.
➀ Title: New concept regenerative medicine for neuropathic pain using plasmid DNA encoding human hepatocyte growth factor (HGF), Engensis® (VM202): Scientific basis and results from clinical studies.
It is about the result of phase III (3-1B) and pharmacological principles using VM202 in detail. The presentation will include the procedure of selecting two drug concentrations in phase I clinical trials and confirming drug concentration by observing superior analgesic effects, long-term analgesic effects, and more remarkable drug effects for patients who do not take gabapentinoids in phase II clinical trials.
In phase III clinical trials (3-1B), the results were very similar to those in phase II clinical trials, confirming the effectiveness of the drug, thus highlighting its great potential as a next-generation neuropathy drug. At this time, the difficulties and considerations in pain clinicals will be also honestly explained by describing the problems in phase 3-1.
In addition, by introducing reverse translational research results conducted immediately after each phase I, II, and III clinical trials and showing that almost all of the phenomena observed during clinical trials were repeated in animal experiments and cell culture systems, Helixmith will prove how great it is for VM202 as a disease modifying drug (DMD) or regenerative medicine.
➁ Title: Hepatocyte growth factor (HGF) promotes regeneration of damaged peripheral nerves by directly interacting with sensory neurons and Schwann cells: Implication for developing novel treatment methods for peripheral neuropathy.
In phase II clinical trials, it has been observed that a single treatment (injection on day 0 and day 14) had analgesic effects for at least 3 months up to 9 months. In phase III (3-1B), analgesic effects persisted for as long as 261 days (8.7 months) after two treatments (injection on day 0, 14, 90, and 104).
On the other hand, since the expression of the VM202 DNA and HGF proteins almost disappears (more than 99.99%) only two weeks after the injection, the only way to explain this long-term effectiveness is that VM202 healed the pain by fundamentally repairing the broken nervous system. In other words, VM202 is a regenerative medicine or DMD. Helixmith will present the results of its research so far and explain the principles.
➂ Title: Gabapentin, a calcium channel inhibitor, inhibits nerve regeneration process induced by hepatocyte growth factor (HGF) in in vivo and in vitro: Implication for the use of gabapentinoids as analgesics for peripheral neuropathy.
In phase II and phase III, it was found that the effect of VM202 was halved in those who use gabapentin drugs. Later, as part of a reverse translational research, Helixmith examined whether gabapentin interferes with the activity of VM202 or HGF in animal models and cell culture systems.
As a result, the results in the human body were surprisingly repeated. This suggests that the gabapentin drugs may have long-term negative effects if used in the treatment of painful neuropathy, which is consistent with some researchers' arguments in the past. Helixmith will present the results of the molecular cell biology experiment and the principles on this phenomenon. It is expected to have a huge impact on the overall painful diabetic neuropathy drugs market as well as the great commercial potentials of VM202.
Through these three presentations, Helixmith will highlight the remarkable safety and efficacy of VM202 as a regenerative medicine, which can be a great help for technology exports, marketing permits, and promotions in the future.
