Multicenter Cohort Long-term Follow-up Study of Participants From Phase III Clinical Trials of Donaperminogene Seltoplasmid Injection for Critical Limb Ischemia

The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase III clinical study to treat their critical limb ischemia (CLI). The main questions it aims to answer are:
* First, what medical problems do participants have after taking drug NL003 to treat CLI?
* Second, does drug NL003 make CLI participants live longer without serious problems (amputations or target vessel revascularizations) ?
Participants who have already received drug NL003 for CLI will complete online surveys about their health conditions. This study will continue until at least 36 months after the participant's first dose.

Start Date30 Jun 2025

Sponsor / Collaborator

Beijing Northland Biotech.Co., Ltd.

NCT05968118

/ RecruitingPhase 3

A Double-Blind, Randomized, Placebo-Controlled, Single Center Study to Assess the Angiogenesis and Blood Perfusion Effect of NL003 in Patients With Critical Limb Ischemia by PETCT-RGD and MIBI

The purpose of this study is to evaluate whether PET/CT-RGD or MIBI can be used for the angiogenesis assessment of NL003 in PAD patients.

Start Date29 Jul 2022

Sponsor / Collaborator

Beijing Northland Biotech.Co., Ltd.

CTR20221646

/ CompletedPhase 3

联合 68Ga-RGD PET 和 99mTc-MIBI SPECT 影像学方法评估 NL003 在治疗慢性下肢缺血过程中对血管新生及下肢血流灌注量的影响，评价药物的有效性和安全性。

[Translation] Combined 68Ga-RGD PET and 99mTc-MIBI SPECT imaging methods were used to evaluate the effect of NL003 on angiogenesis and lower limb blood perfusion in the treatment of chronic lower limb ischemia, and to evaluate the efficacy and safety of the drug.

联合 68Ga-RGD PET 和 99mTc-MIBI SPECT 影像学方法评估 NL003 在治疗慢性下肢缺血过程中对血管新生及下肢血流灌注量的影响，评价药物的有效性和安全性。

[Translation]

Combined 68Ga-RGD PET and 99mTc-MIBI SPECT imaging methods were used to evaluate the effect of NL003 on angiogenesis and lower limb blood perfusion in the treatment of chronic lower limb ischemia, and to assess the efficacy and safety of the drug.

Start Date29 Jul 2022

Sponsor / Collaborator

Beijing Northland Biotech.Co., Ltd.

100 Clinical Results associated with Donaperminogene seltoplasmid(Viromed)

100 Translational Medicine associated with Donaperminogene seltoplasmid(Viromed)

100 Patents (Medical) associated with Donaperminogene seltoplasmid(Viromed)

Literatures (Medical) associated with Donaperminogene seltoplasmid(Viromed)

01 Sep 2022·Molecular and cellular neurosciences

Gabapentin inhibits the analgesic effects and nerve regeneration process induced by hepatocyte growth factor (HGF) in a peripheral nerve injury model: Implication for the use of VM202 and gabapentinoids for peripheral neuropathy

Article

Author: Nho, Boram ; Kim, Sunyoung ; Ko, Kyeong Ryang ; Lee, Nayeon ; Lee, Junghun

Hepatocyte growth factor (HGF) is a multifunctional protein that plays a critical role in the angiogenic, neurotrophic, antifibrotic, and antiapoptotic activities of various cell types. It has been previously reported that intramuscular injection of pCK-HGF-X7 (or VM202), a plasmid DNA designed to express both native isoforms of human HGF (Pyun et al., 2010), significantly reduced the level of neuropathic pain in clinical studies as well as in a variety of animal models. In clinical studies, it has been observed that pCK-HGF-X7 appeared to give much higher pain-relieving effects in subjects not taking pregabalin or gabapentin, α2δ1 calcium channel blockers frequently prescribed for reducing pain in patients with diabetic peripheral neuropathy. In this study, we tested the effects of gabapentin on HGF-mediated pain reduction and nerve regeneration in vivo. Consistent with the data from clinical studies, gabapentin administration inhibited the pain reduction and axon regeneration effects mediated by HGF expression from pCK-HGF-X7. In the context of nerve regenerative effects, treatment with gabapentin or EGTA, a Ca²⁺ chelator, inhibited HGF-mediated axon outgrowth of injured sciatic nerves in vivo. Taken together, i.m. injection of HGF-encoding plasmid DNA ameliorated pain symptoms and enhanced the regeneration of injured nerves, and these therapeutic effects of HGF were significantly hindered by gabapentin treatment, suggesting the possible involvement of Ca²⁺ in the pro-regenerative activities of native HGF derived from treatment with pCK-HGF-X7.

01 Jun 2022·Biochemical and biophysical research communicationsQ3 · BIOLOGY

Intramuscular injection of a plasmid DNA vector expressing hepatocyte growth factor (HGF) ameliorated pain symptoms by controlling the expression of pro-inflammatory cytokines in the dorsal root ganglion

Q3 · BIOLOGY

Article

Author: Lee, Junghun ; Nho, Boram ; Kim, Sunyoung ; Ko, Kyeong Ryang

Hepatocyte growth factor (HGF) is a secretory protein that is involved in various biological activities such as angiogenesis, neuroprotection, and anti-inflammatory effects. Intramuscular injection of an HGF-encoding plasmid DNA (pCK-HGF-X7) has been shown to produce pain-relieving effects in a rodent model and patients with neuropathic pain.To further investigate the underlying mechanism, we investigated the anti-inflammatory effects of HGF in the context of neuropathic pain. Consistent with previous data, intramuscular injection of pCK-HGF-X7 showed pain relieving effects up to 8 weeks and pharmacological blockade of the c-Met receptor hindered this effect, which suggest that the analgesic effect was c-Met receptor-dependent. At the histological level, macrophage infiltration in the dorsal root ganglion (DRG) was significantly decreased in the pCK-HGF-X7 injected group. Moreover, HGF treatment significantly downregulated the LPS-mediated induction of pro-inflammatory cytokines in primary cultured DRG neurons. Taken together, these data suggest that HGF-encoding plasmid DNA attenuates neuropathic pain via controlling the expression of pro-inflammatory cytokines.

01 May 2021·Clinical and translational scienceQ3 · MEDICINE

Gene therapy for diabetic peripheral neuropathy: A randomized, placebo‐controlled phase III study of VM202, a plasmid DNA encoding human hepatocyte growth factor

Q3 · MEDICINE

ArticleOA

Author: Shaibani, Aziz ; Vinik, Aaron ; Kudrow, David ; Kessler, John A. ; Shin, Nari ; Sang, Christine N. ; Christiansen, Mark

Abstract:

VM202 is a plasmid DNA encoding two isoforms of hepatocyte growth factor (HGF). A previous phase II study in subjects with painful diabetic peripheral neuropathy (DPN) showed significant reductions in pain. A phase III study was conducted to evaluate the safety and efficacy of VM202 in DPN. The trial was conducted in two parts, one for 9 months (DPN 3‐1) with 500 subjects (VM202: 336 subjects; and placebo: 164) and a preplanned subset of 101 subjects (VM202: 65 subjects; and placebo: 36) with a noninterventional extension to 12 months (DPN 3‐1b). VM202 or placebo was administered to calf muscles on days 0 and 14, and on days 90 and 104. The primary end point in DPN 3‐1 was change from baseline in the mean 24‐h Numerical Rating Scale (NRS) pain score. In DPN 3‐1b, the primary end point was safety, whereas the secondary efficacy end point was change in the mean pain score. VM202 was well‐tolerated in both studies without significant adverse events. VM202 failed to meet its efficacy end points in DPN 3‐1. In DPN 3‐1b, however, VM202 showed significant and clinically meaningful pain reduction versus placebo. Pain reduction in DPN 3‐1b was even greater in subjects not receiving gabapentin or pregabalin, confirming an observation noted in the phase II study. 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.

Study Highlights:

WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?Current therapies for painful diabetic peripheral neuropathy (DPN) are palliative and do not target the underlying mechanisms. Moreover, symptomatic relief is often limited with existing neuropathic pain drugs. Thus, there is a great medical need for safer and effective treatments for DPN. WHAT QUESTION DID THIS STUDY ADDRESS?Can nonviral gene delivery of hepatocyte growth factor reduce pain in patients with DPN and potentially modify progression of the disorder? WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?Nonviral gene therapy can be used safely and practically to treat DPN. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE?As the first gene medicine to enter advanced clinical trials for the treatment of DPN, this study provides the proof of concept of an entirely new potential approach to the disorder.

News (Medical) associated with Donaperminogene seltoplasmid(Viromed)

04 Oct 2022

·www.prnewswire.com

Helixmith to Present New ALS-Focused Development Program at Upcoming Conferences

LA JOLLA, Calif., Oct. 4, 2022 /PRNewswire/ -- Helixmith announced today that their CEO, Dr. Sunyoung Kim, will be presenting an overview of their ALS-focused program, named DART, Defeating ALS through Regenerative Therapeutics, at both the 2022 Cell & Gene Meeting on the Mesa and the 2022 BIO-Europe Conference. DART is unique in that it capitalizes on cell signaling pathways important in ALS pathogenesis and that three modalities are being investigated virtually simultaneously for ALS. The first DART platform utilizes HGF/c-Met signaling pathway. Hepatocyte Growth Factor (HGF) is a multifunctional factor associated with neurotrophic, anti-fibrotic, anti-inflammatory and angiogenic activities. Its receptor, c-Met, is present in all major cell types important in ALS, including motor neurons, inflammatory macrophages, and skeletal muscles (such as the diaphragm and accessory muscles of respiration). Data from pre-clinical research demonstrated that HGF/c-Met signaling could produce strong anti-neuroinflammatory effects as well as promote axon outgrowth and motor neuron survival, restoring damaged upper and spinal motor neurons (UMN, SMN) and neuromuscular junction (NMJ), and improve muscle atrophy and motor functions. The rationale of such a multi-modal parallel approach is as follows: First, the cause of most ALS cases is unknown. Therefore, it is unlikely that the deployment of a single molecule (whether it be a small molecule or a biologic) will effectively treat all ALS cases, even if it were to work for a subset of patients. Helixmith is hence using an HGF that binds to key cell types involved in ALS pathogenesis, including motor neurons, macrophages, and skeletal muscles. Second, it takes nearly 10 years to develop one drug candidate and have it tested in a phase 1 clinical trial. If Helixmith was to start working on the second product only after the first candidate fails, this is too slow for ALS patients' urgent need for treatment. Therefore, Helixmith is testing three products almost simultaneously. Their aim is to get the results from the three clinical programs, including the phase 1 and phase 2 trials, within 5 years. In DART, three modalities (plasmid DNA, AAV, and humanized antibodies) are being investigated, in parallel, at both clinical and pre-clinical stages. Helixmith recently completed a Phase 1 and a Phase 2a clinical trial using Plasmid DNA-encoding HGF modality (Engensis or VM202). A small-scale phase 1/2 is planned in which plasmid DNA will be injected into the muscles involved in respiration, including the diaphragm. Having obtained encouraging data on survival rates, motor neuron function, and motor function in animal models, an optimized AAV vector modality (NM301) has also been developed for clinical studies. Additionally, a fully humanized antibody modality (VM507) that binds to c-Met receptors and activates signaling has shown its effectiveness in a variety of disease models. The AAV and antibody modalities will be tested in phase 1 studies between 2024 and 2026. Helixmith has the funding for a clinical study testing the effect of VM202 on respiration in ALS patients. To achieve their goal to complete clinical studies with two other modalities, Helixmith will need to raise additional capital. The following are specific details regarding Helixmith's presentation at the two conferences: Dr. Kim's Presentation is available on-demand to conference registrants at . About Helixmith Helixmith is a clinical-stage gene therapy company headquartered in Seoul, Korea, developing new and innovative biopharmaceuticals to address previously untreated diseases, and is listed on the KOSDAQ. 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 diabetic foot ulcers (DFU), claudication, amyotrophic lateral sclerosis (ALS), and diabetic peripheral neuropathy (DPN). Media Contact: Jennifer Guzman [email protected] 7602917245 SOURCE Helixmith USA Inc.

Gene TherapyAntibodySmall molecular drug

06 Sep 2022

·www.prnewswire.com

Helixmith Announces Topline Results from Phase 2A Study of Engensis for Treatment of ALS (Amyotrophic Lateral Sclerosis)

LA JOLLA, Calif., Sept. 6, 2022 /PRNewswire/ -- Helixmith announced topline results today from a Phase 2A study in individuals with ALS (Amyotrophic Lateral Sclerosis). ALS is a fatal neurodegenerative disorder of upper and lower motor neurons that causes progressive paralysis and eventual death due to respiratory failure. This Phase 2A was a double-blind placebo controlled multi-center study involving 5 sites (4 in the US and 1 in Korea) and 18 subjects randomized to a 2:1 ratio of Engensis to placebo. In this Phase 2A study, three treatments of Engensis, a plasmid DNA encoding human HGF, or placebo were injected in the upper and lower limbs on months 0, 2 and 4. One treatment consisted of two cycles of injections, on 2-week intervals, of 64 mg of Engensis or placebo in total. Therefore, a total of 192 mg of Engensis was given to each subject over a 4-month period. In addition, there was a follow-up period of 6 months after the first injection on Day 0. The results of the study demonstrated that Engensis was safe and well tolerated at this dosing regimen. There was no difference in the frequency of TEAEs (83% for each group) between the Engensis and the placebo groups. One TEAE, bronchitis, was reported in the Engensis group but was determined to not be related to the study drug. Injection site reactions were reported by 50% of the Engensis group and by 66.7% of the placebo group. Most of the injection site reactions were Grade 1 or 2 and resolved within a short time, and none of the participants in the study discontinued due to the number of injections. These data suggest that high dose, repeated treatments of Engensis, were safe and well tolerated, providing a great deal of flexibility in designing dosing schemes for future clinical studies. Given the primary endpoint of this study was to test safety and tolerability, efficacy was measured only as an exploratory parameter. ALSFRS-R scores, muscle functions using handheld dynamometry, and ALSAQ-40 were among the measurements collected. Since the study size was small and 4 subjects dropped out early, we were unable to compare efficacy between the Engensis and placebo groups. An important component of this study was the collection of biopsy samples from the participants' injections sites. Engensis is an intramuscularly delivered gene therapy. The bulk of the data collected to date, showing effects of HGF expressed from Engensis, has been from animal models. Data collected from clinical trials has been limited thus far. Thanks to our dedicated clinical trial participants, muscle biopsy samples were collected during the course of the trial and will be subjected to histological and molecular biological analyses using RNA-Seq. Helixmith greatly appreciates the generous and eager participation of the ALS patients. Data from these results are expected to provide valuable information on the understanding of the mechanisms of actions of Engensis, and its effects on the expression of human genes, which will greatly help in the development of innovative medicines based on HGF/c-Met signaling. Helixmith will continue the analysis of the Phase 2A data upon the receipt of the full report and plan to present results at a future conference and determine next steps for Engensis in ALS at that time. About Helixmith Helixmith is a clinical-stage gene therapy company headquartered in Seoul, Korea, developing new and innovative biopharmaceuticals to address previously untreated diseases, and is listed on the KOSDAQ. 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 painful diabetic peripheral neuropathy, diabetic foot ulcers, claudication, amyotrophic lateral sclerosis, coronary artery disease, and Charcot-Marie-Tooth disease. SOURCE Helixmith USA Inc.

Gene Therapy

14 Mar 2022

·www.biospace.com

Paper Reporting Results from Helixmith's Phase 3 Gene Therapy Trial for Painful Diabetic Neuropathy was One of the Top-10 Most-Downloaded Articles in Clinical and Translational Science

Helixmith announced today that their publication, "Gene therapy for diabetic neuropathy: A randomized, placebo-controlled phase III study of VM202, a plasmid DNA encoding human hepatocyte growth factor," was one of the top-10 most-downloaded articles in Clinical and Translational Science (CTS) in 2021. CTS is the official publication of the American Society for Clinical Pharmacology & Therapeutics (ASCPT) and highlights original research that helps bridge laboratory discoveries with the diagnosis and treatment of human diseases. Dr. John Kessler, Professor of Neurology at Northwestern was the lead author on this study. This was the first gene therapy phase 3 that has ever been done for pain. According to Alethea Gerding, Managing Editor, ASCPT, "The article has been downloaded more than 3,000 times, meaning that it has reached a wide-ranging worldwide readership. The primary goal of CTS is to become the beacon of translational science, and articles such as yours clearly show the value of translational science." According to Alethea Gerding, Managing Editor, ASCPT, "The article has been downloaded more than 3,000 times" In the paper, VM202 (donaperminogene seltoplasmid), a plasmid DNA encoding the human HGF (hepatocyte growth factor) gene, developed by Helixmith Co. Ltd, authors reported that in VMDN-003b, intramuscular injections of VM202 provided pain reduction for more than 8 months after the last cycle of treatment and that the safety and tolerability was highly favorable, consistent with previous studies. One of the most clinically important findings in both VMDN-003b and the phase II study is that VM202 was more effective in subjects not on pregabalin or gabapentin, two of the most prescribed medicine in the DPN field. These results have important clinical implications as more than 4.2 million people in the US are known to suffer from painful DPN and nearly 1.3 million patients are considered to be refractory, meaning currently available medications do not work for them (Painful Diabetic Neuropathy, GlobalData 2018). Helixmith launched a second phase 3 trial for DPN, REGAiN-1A (VMDN-003-2), in the US and are targeting release of top line results by the end of 2022. The company is planning to start a third phase 3 for DPN in the second half of 2022.

Donaperminogene seltoplasmid(Viromed)Helixmith Co., Ltd.Diabetic NeuropathiesGene Therapy

100 Deals associated with Donaperminogene seltoplasmid(Viromed)

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Indication	Highest Phase	Country/Location	Organization	Date
Lower limb ischemia	NDA/BLA	China	Jiangsu Yaohai Bio-pharmaceutical Co., Ltd.	15 Jul 2024
Lower limb ischemia	NDA/BLA	China	Beijing Northland Biotech.Co., Ltd.	15 Jul 2024
Ulcer	NDA/BLA	China	Beijing Northland Biotech.Co., Ltd.	-
Arterial Occlusive Diseases	Phase 3	China	Beijing Northland Biotech.Co., Ltd.	02 Aug 2019
Chronic Limb-Threatening Ischemia	Phase 3	China	Beijing Northland Biotech.Co., Ltd.	02 Aug 2019
Diabetic foot ulcer	Phase 3	United States	Helixmith Co., Ltd.	27 Jun 2017
Peripheral Arterial Disease	Phase 3	United States	Helixmith Co., Ltd.	27 Jun 2017
Diabetic peripheral neuropathic pain	Phase 3	United States	Helixmith Co., Ltd.	01 Apr 2016
Diabetic Nephropathies	Phase 3	China	Beijing Northland Biotech.Co., Ltd.	-
Diabetic Nephropathies	Phase 3	-	Viromed, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01422772 (Engensis, CTgov)	Phase 1/2	Myocardial Ischemia	9	VM202 (Engensis) (Group 1 - 0.5 mg/1 mL)	dqrlktgirl = jsdajrlqpc ailyywhrho (ptghaohnsm, zlnuhfkvuy - acsmswmjqb) View more	-	03 Oct 2025
				VM202 (Engensis) (Group 2 - 1.0 mg/2 mL)	dqrlktgirl = sispxibtwr ailyywhrho (ptghaohnsm, gnipbfvwqg - exazzltyat) View more
NCT01002235 (CTgov)	Phase 1/2	Diabetic peripheral neuropathic pain	12	Engensis (VM202) (Engensis 4 mg)	nhxweaoajr = mmrkkxbrvs oosydxeown (pukskdqqhy, iejpifrzai - lghijfysyx) View more	-	15 Jun 2025
				Engensis (VM202) (Engensis 8 mg)	nhxweaoajr = ktivqpbwea oosydxeown (pukskdqqhy, bnomjzbqtk - tjvtmzxndc) View more
NCT05176093 (REViVALS-1B, CTgov)	Phase 2	Amyotrophic Lateral Sclerosis	8	Engensis (Engensis)	gczevzloaa = hnwoscybpm jocdgljwrq (poipofjvfo, paeztsvdyk - kvkoqvjbiy) View more	-	29 May 2025
				Placebo (Placebo)	gczevzloaa = mjkwlxtdsl jocdgljwrq (poipofjvfo, qtzqaturtr - fkjxwgmari) View more
NCT05361031 (CTgov)	Phase 1/2	Charcot-Marie-Tooth Disease, Type Ia	12	Engensis	jjtdfixamo = lnnitifdzf xetrtlonpx (emsxjdwvvl, lseuyeesaq - vpjwuyukmu) View more	-	29 May 2025
NCT04274049 (HOPE CLTI-2, Company_Website) Manual	Phase 3	Critical lower limb ischemia	242	塞多明基注射液	rknmftqscp(uskazpvqaq) = ivtgeiqsae adzjoykyfi (yfogpapkcj )	Positive	12 May 2025
				安慰剂	rknmftqscp(uskazpvqaq) = iqrmixyuvy adzjoykyfi (yfogpapkcj )
NCT04632225 (REViVALS-1A, CTgov)	Phase 2	Amyotrophic Lateral Sclerosis	18	Engensis (Engensis)	ufdjdovljt = ffdgsqtkbj rsmkqvgnho (vmujrqqchd, dtaokibqka - jzuchlpjth) View more	-	06 May 2025
				Placebo (Placebo)	ufdjdovljt = idccjuedzl rsmkqvgnho (vmujrqqchd, qsngvschoe - pssavgqucz) View more
NCT04275323 (NL003-CLI-III-1, NEWS) Manual	Phase 3	Lower limb ischemia	302	NL003	htxvjqbsde(vprrqtlcni) = suvclzlmsn rppstnhmhs (dtrkieytsj ) Met View more	Positive	23 Feb 2025
				Placebo	htxvjqbsde(vprrqtlcni) = llobgrlpdo rppstnhmhs (dtrkieytsj ) Met View more
NCT04469270 (REGAiN-1A, CTgov)	Phase 3	Diabetic peripheral neuropathic pain	162	Engensis (Engensis)	cntlvgzbnx(hatduxpgmr) = hutprapkwt xlipgvlebd (nhrzpxdrva, 2.020) View more	-	20 Jan 2025
				Placebo (Placebo)	cntlvgzbnx(hatduxpgmr) = uxxeymtfjb xlipgvlebd (nhrzpxdrva, 2.115) View more
NCT04873232 (REGAiN-1B, CTgov)	Phase 3	Diabetic peripheral neuropathic pain	106	Engensis (Engensis)	onwmajampn(rrklqiavcc) = gnyzcokrkq eessrqlphs (kzwjbvcwiz, 2.083) View more	-	16 Jan 2025
				Placebo (Placebo)	onwmajampn(rrklqiavcc) = xbhqfdvzol eessrqlphs (kzwjbvcwiz, 2.087) View more
NCT00696124 (CTgov)	Phase 1	Lower limb ischemia	12	VM202 2 mg (Cohort 1)	eefbduvrob = defoqzmfuw unwatlwlon (gdtxegmncj, sobsobnwrs - rykhkqyjlk) View more	-	18 Oct 2024
				VM202 4 mg (Cohort 2)	eefbduvrob = awskptpuas unwatlwlon (gdtxegmncj, embdtrjtna - zvyptumohu) View more

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