What is VM202 gene therapy?
Mar 09, 2015 · Researchers at Northwestern University, United States conducted a study that involved 84 participants who all suffered from painful diabetic neuropathy. They found administering two low dose rounds of VM202 – a non-viral gene therapy – significantly improved their pain relief for up to a year. VM202 contains human hepatocyte growth factor ...
What is engensis (VM202)?
Feb 10, 2021 · In DPN 3-1, 72.6% of those treated with VM202 and 68.9% of those treated with placebo reported at least 1 treatment-emergent adverse event. The most common adverse events were infections and ...
Is VM202 effective for peripheral neuropathy?
Sep 15, 2017 · The investigational gene therapy VM202, developed by VM BioPharma and intended for the treatment of amyotrophic lateral sclerosis (ALS), has been shown to be safe and well-tolerated in a small Phase 1/2 clinical trial, according to data published in the journal Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. While the study, sponsored …
Is VM202 as effective as pregabalin or gabapentin?
In DPN 3-1b, symptomatic relief was maintained for 8 months after the last injection suggesting that VM202 treatment might change disease progression. Despite the perplexing discrepancy between the two studies, the safety and long-lasting pain-relieving effects of VM202 observed in DPN 3-1b warrant another rigorous phase III study.
What is VM202?
VM202 is a DNA plasmid that contains novel genomic cDNA hybrid human hepatocyte growth factor (HGF) coding sequence (HGF-X7) expressing two isoforms of HGF, HGF 728 and HGF 723.Sep 12, 2019
What is Engensis?
Engensis is a non-viral gene therapy that uses a plasmid — a small circular DNA molecule — to deliver the hepatocyte growth factor (HGF) gene directly to patients' nerve and nerve-supporting cells.Jun 4, 2021
Is VM202 a gene therapy?
The investigational gene therapy VM202, developed by VM BioPharma and intended for the treatment of amyotrophic lateral sclerosis (ALS), has been shown to be safe and well-tolerated in a small Phase 1/2 clinical trial, according to data published in the journal Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration.
Who is Magdalena Kegel?
She writes about medical science and drug discovery. She holds an MS in Pharmaceutical Bioscience and a PhD — spanning the fields of psychiatry, immunology, and neuropharmacology — from Karolinska Institutet in Sweden.
What is phase 3 diabetic neuropathy?
Phase 3. Detailed Description: Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries a high risk of pain, trophic changes and autonomic dysfunction. Treatment of diabetic peripheral neuropathy (DPN) is based on either pathogenetic mechanisms or symptomatic relief.
Is gabapentin stratified?
Randomization will be stratified by current use of gabapentin and/or pregabalin. Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries a high risk of pain, trophic changes and autonomic dysfunction. Treatment of diabetic peripheral neuropathy (DPN) is based on either pathogenetic mechanisms or symptomatic ...
What is phase 3 gene therapy?
Results from the phase 3 gene therapy trial for painful diabetic peripheral neuropathy (DPN) have been published online by Clinical and Translational Science and suggest excellent safety profile and promising efficacy.
Where is Helixmith based?
Helixmith is a gene therapy company based in Seoul and San Diego, developing new and innovative biopharmaceuticals to tackle previously untreated diseases. The company has an extensive gene therapy pipeline, including a CAR-T program targeting several different types of solid tumors and an AAV vector program targeting neuromuscular diseases. Engensis (VM202), the most advanced pipeline candidate, is a plasmid DNA therapy being studied for DPN, diabetic foot ulcers, claudication, amyotrophic lateral sclerosis (Phase 2 beginning in early 2021), coronary artery disease, and Charcot-Marie-Tooth disease. The company is listed on KOSDAQ.
Is DPN a complication of diabetes?
Painful DPN is a common and debilitating complication of diabetes mellitus that has a profound negative impact on quality of life, sleep, and mood. Current therapies are palliative and do not target the mechanisms underlying painful DPN. Moreover, symptomatic relief is often limited, and many patients with painful DPN still use opioids.
Who is Cade Hildreth?
Cade Hildreth is the Founder of BioInformant.com, the world's largest publisher of stem cell industry news. Cade is a media expert on stem cells, recently interviewed by the Wall Street Journal, Los Angeles Business Journal, Xconomy, and Vogue Magazine.
What is the most common subtype of CMT?
CMT1A is the most common subtype of CMT, accounting for about two-thirds of all cases . It is caused by a duplication of the PMP22 gene, ultimately resulting in symptoms such as muscle weakness and atrophy of the lower legs beginning in adolescence, followed by hand weakness and decreased sensations later in life.
Where is Forest Ray?
Forest Ray PhD Forest Ray received his PhD in systems biology from Columbia University, where he developed tools to match drug side effects to other diseases. He has since worked as a journalist and science writer, covering topics from rare diseases to the intersection between environmental science and social justice. He currently lives in Long Beach, California.
How long does it take for a calf to recover from a VM202 injection?
The last follow-up visit occurred at 12 months from the first injection of VM202 and 8.7 months, or 261 days, from the last injection of VM202, which occurred at Day 104. Bioanalytical data showed that 99.9999% of VM202 DNA disappeared from the systemic blood circulation at 3 days after injecting VM202 into the calf muscle, and the human HGF gene was expressed for merely 2 weeks after injection, suggesting that the therapy may offer nerve regeneration properties.
Is VM202 safe?
The extension study showed that VM202 appeared safe and well-tolerated. The occurrence of adverse events was no different between the VM202 and placebo groups; treatment-emergent adverse event occurrence rate was lower in the VM202 group (21.5%) than in the placebo group (25.0%). No serious adverse events were observed.
