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date, more than 500 patients have been treated with
Engensis across ten clinical trials in six different diseases and conditions. Data from previous clinical studies suggest that Engensis is well tolerated and has the potential to provide durable analgesic and/or symptomatic relief in a variety of disease settings. Beyond potentially alleviating pain, Engensis is designed to target the underlying causes of neuropathy through its predicted angiogenic and neuroregenerative properties.
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the benefits afforded by the fast track and breakthrough designations, including priority review, to
Engensis. Helixmith currently has multiple target indications under the Engensis pipeline: diabetic peripheral neuropathy (DPN, phase 3), diabetic foot ulcers (DFU, phase 3), amyotrophic lateral sclerosis (ALS, phase 2), coronary artery disease (CAD, phase 2), claudication (phase 2) and Charcot-Marie-Tooth disease (CMT, phase 1/2a).
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590:(HGF receptor). An antibody is an immune protein that binds to an antigen to inhibit its activity or stimulate neutralization or activation. Although it is a protein generated in the immune system originally, an antibody is available to be mass-produced, purified, and analyzed into monoclonal antibody, regarding specific antibodies with selectivity and specificity against specific antigens.
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big market size. The US FDA granted orphan drug and fast track designation for
Engensis (VM202-ALS) in 2016. Engensis (VM202) is currently under development as a possible treatment for chronic DFU with the hope to potentially heal the ulcer by supplying sufficient blood through new blood vessel formation around occluded or narrowed blood vessels towards the lower extremities.
656:. In addition, it has been founded that it can prevent cartilage destruction by regulating the expression of cartilage degradation enzymes unlike conventional anti-inflammatory analgesic drugs such as NSAIDs. PG201 has proved its safety and efficacy on patients with osteoarthritis by conducting phase II and phase III clinical trials.
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granted a RMAT (Regenerative
Medicine Advanced Therapy) designation to VM202-DPN in 2018. This is the first RMAT designation for a drug product based in Korea, and the first and the only RMAT designation worldwide in pain area. Engensis has been attracting huge attention in painful DPN because of its
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The US FDA recognized the potential for
Engensis to meet the unmet need for this condition in 2018 by designating it as a Regenerative Medicine Advanced Therapy (RMAT), making it the first RMAT-designated gene therapy for a prevalent disease with over one million patients. This designation grants all
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Helixmith’s pipeline extends to CAR-T cell therapy and AAV gene therapy. In CAR-T cell therapy, the company aims at eradicating various solid tumors. The CAR-T program is in pre-clinical stage through a separate subsidiary called
Cartexell. In AAV gene therapy, the company has a number of early stage
593:
VM507 is an antibody that can detect and activate c-MET, receptor of hepatocyte growth factor (HGF). As a fully human antibody, it has the potential to be safe immunologically, transmissible via blood vessel injection or local injection to other various tissues and organs, and the longer half-life
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A single injection of
Helixmith’s proprietary plasmid DNA product expresses the HGF gene at levels 30-40 times higher than conventional plasmid DNA and provides sustained gene expression in mouse models for 2 weeks, with peak protein expression at Day 7 and a gradual decrease over the next week To
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Helixmith currently has two target indications under its phytotherapeutics pipeline: PG201 (Osteoarthritis), and HX204 (Inflammatory bowel disease). PG201 is a prescription drug for osteoarthritis and is the 7th botanical drug that has ever been approved by the
601:. VM507 showed therapeutic efficacies such as inhibition of renal fibrosis and improvement of functional index by binding with c-MET receptor in the renal tissue when injected intravenously in the mouse model of renal disease.
475:(KOSDAQ: 084990) since 2006. In April 2019, the company was renamed to Helixmith, and moved its headquarters from its previous research facility in Seoul National University to Magok, Seoul.
558:(5 minutes or less) and is quickly removed from the body by the liver, creating an obstacle to effective treatment with previous injectable recombinant HGF protein products.
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in 2012. It is being sold under the brand name “LAYLA Tab” and has been generating a domestic annual revenue of 20 billion KRW since it has been licensed out to PMG Pharma.
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523:. Helixmith also has an antibody pipeline including VM507, an antibody that can detect and activate c-MET, receptor of hepatocyte growth factor (HGF).
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based on natural plant extracts with therapeutic potential. The company has unique experience in areas including natural medicine, health
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development. Helixmith’s lead gene therapy product is
Engensis (VM202), a non-viral plasmid DNA that encodes the therapeutic gene called
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Helixmith’s non-viral plasmid DNA product, Engensis, is designed to express recombinant HGF protein in nerve and
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HX204 is currently under pre-clinical development and is expected to enter clinical phase in 2022.
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to promote nerve system regeneration and induce the formation of microvascular blood vessels.
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According to its website, the company is involved in the following clinical trials:
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in 1996, and later renamed to ViroMed in 1999. The company has been listed on the
428:(HGF), HGF 728 and HGF 723. In addition to DPN, Engensis is also being studied in
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The c-Met level is especially high in patients with chronic/acute
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program targeting several different types of solid tumors, and an
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PG201 showed significant improvement in various animal models of
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495:(DPN, phase 3) in the US. The product is also being studied for
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VM202-ALS, Lou Gehrig's
Disease - Phase 2 clinical trial (US)
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products targeting neuromuscular diseases such as ALS and
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Sunyoung Kim (CEO), Seungshin Yu (CTO), Sinyoung Kim (COO)
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treatment, is an antibody that can detect and activate
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204:, and by adding encyclopedic content written from a
424:designed to simultaneously express two isoforms of
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631:VM507-Chronic Kidney Disease - Preclinical stage
619:VM202-Claudication - Phase 2 clinical trial (US)
534:and cosmetic products using botanical sources.
473:Korean Securities Dealers Automated Quotations
455:Helixmith headquarters located in Magok, Seoul
628:VM202-CMT - Phase 1/2a clinical trial (Korea)
737:Pharmaceutical companies established in 1996
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707:Biotechnology companies established in 1996
94:. Unsourced material may be challenged and
53:Learn how and when to remove these messages
742:South Korean companies established in 1996
625:VM202-CAD - Phase 2 clinical trial (Korea)
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334:21, Magokjungang 8-ro 7-gil, Gangseo-gu,
242:Learn how and when to remove this message
224:Learn how and when to remove this message
158:Learn how and when to remove this message
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643:MFDS (Ministry of Food and Drug Safety)
616:VM202-DFU - Phase 3 clinical trial (US)
613:VM202-DPN - Phase 3 clinical trial (US)
491:(HGF). Engensis is being developed for
420:(DPN) in the US. Engensis (VM202) is a
727:Biotechnology companies of South Korea
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185:contains content that is written like
594:may contribute to improved efficacy.
483:Helixmith’s main business area is in
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92:adding citations to reliable sources
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34:This article has multiple issues.
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418:diabetic peripheral neuropathy
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526:Helixmith is also developing
501:amyotrophic lateral sclerosis
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513:Charcot-Marie-Tooth disease
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717:Life sciences industry
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414:neuromuscular diseases
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326:Sunyoung KIM, D. Phil
206:neutral point of view
654:rheumatoid arthritis
497:diabetic foot ulcers
430:diabetic foot ulcers
396:with US presence in
88:improve this article
732:South Korean brands
515:(CMT, phase 1/2a).
388:company located in
357:Number of employees
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198:promotional content
691:South Korea portal
521:multiple sclerosis
465:Helixmith Co. LTD.
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192:Please help
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422:plasmid DNA
394:South Korea
340:South Korea
280:(1999–2019)
276:(1996–1999)
107:"Helixmith"
701:Categories
663:References
410:AAV vector
347:Key people
194:improve it
148:April 2021
118:newspapers
39:improve it
556:half-life
398:San Diego
371:helixmith
257:Helixmith
75:does not
45:talk page
584:antibody
543:Engensis
538:Products
479:Overview
295:Industry
271:Formerly
214:May 2022
569:The US
460:History
448:(CMT).
440:(CAD),
436:(ALS),
432:(DFU),
366:Website
323:Founder
315:1996-11
313: (
305:Founded
278:ViroMed
132:scholar
96:removed
81:sources
444:, and
289:Public
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578:VM507
406:CAR-T
390:Seoul
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139:JSTOR
125:books
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