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.

NCT05176093 / CompletedPhase 2

A 6-Month Extension Study Following Protocol VMALS-002-2 (A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis)

The purpose of this study is to evaluate the long-term safety of intramuscular (IM) administration of Engensis in Participants with Amyotrophic Lateral Sclerosis (ALS) who were previously randomized, received treatment, and completed the Day 180 Visit of Study VMALS-002-2. Safety will be assessed by incidences of treatment-emergent adverse events (TEAEs), treatment emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and the clinically significant laboratory values. See the table below for additional, exploratory endpoints.

Start Date14 Nov 2021

Sponsor / Collaborator

Helixmith 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)

227

Literatures (Medical) associated with Donaperminogene seltoplasmid(Viromed)

01 Nov 2024·GENE

HGF ameliorates cardiomyocyte apoptosis and inflammatory response in sepsis via the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT) pathway

Article

Author: Su, Li-Ye ; Lao, Jian-le ; Huang, Zhao-He ; Liang, Liu-Dan ; Huang, Mei-Jin ; Liu, Yan ; Huang, Jia-Wei ; Peng, Hui-Xin

OBJECTIVE:

This study aimed to analyze the impact of HGF on cardiomyocyte injury, apoptosis, and inflammatory response induced by lipopolysaccharide (LPS).

METHODS:

Enzyme-linked immunosorbent assay (ELISA) was utilized to quantify the levels of HGF, interleukin (IL)-6, IL-10, creatine phosphokinase-isoenzyme-MB (CK-MB), and cardiac troponin I (cTnI) in the samples. qPCR and Western blotting (WB) were employed to assess the mRNA and protein expressions of HGF, IL-10, IL-6, PI3K, AKT, p-PI3K, and p-AKT.

RESULTS:

The outcomes of the in vivo experiment revealed that serum levels of IL-6, IL-10, HGF and SOFA scores in the SC group were elevated in contrast to the non-SC group. The correlation analysis indicated a substantial and positive association among serum HGF, IL-6, and IL-10 levels and SOFA scores. Relative to IL-6, IL-10 levels, and SOFA scores, serum HGF demonstrated the highest diagnostic value for SC. Following LPS administration to stimulate H9c2 cells across various periods (0, 12, 24, 48, and 72 h), the levels of myocardial injury markers (CK-MB and cTnI) in the cell supernatants, intracellular inflammatory factors (mRNA and protein levels of IL-10 and IL-6), apoptosis and ROS levels, exhibited a gradual increase followed by a subsequent decline. Following the overexpression of HGF, there was an increase in cell viability, and a decrease in apoptosis, inflammation, oxidative stress injuries, and the protein phosphorylation expressions of PI3K and AKT. After knockdown of HGF expression, the activity of LPS-induced H9c2 cells was further reduced, leading to increased cell injury, apoptosis, inflammation, oxidative stress,and the expression levels of PI3K and Akt protein phosphorylation were further elevated.

CONCLUSION:

HGF was associated with decreased LPS-induced H9c2 apoptosis and inflammation in H9c2 cells, alongside an improvement in cell viability, indicating potential cytoprotective effects. The mechanism underlying these impacts may be ascribed to the suppression of the PI3K/AKT signaling pathway.

01 Jul 2024·EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY

Recombinant Human Hepatocyte Growth Factor Plasmids for Treating Patients with Chronic Limb Threatening Ischaemia: A Systematic Review and Meta-analysis

Review

Author: Ni, Leng ; Di, Xiao ; Liu, Chang-Wei ; Wang, Peng ; Han, Wei ; Li, Fengshi

OBJECTIVE:

Recombinant human hepatocyte growth factor (HGF) plasmids are novel alternatives to salvage limbs in patients with chronic limb threatening ischaemia (CLTI). A systematic review and meta-analysis of data was conducted to assess the therapeutic efficacy of HGF plasmids in patients with CLTI.

DATA SOURCES:

Randomised controlled studies evaluating HGF plasmid efficacy in patients with CLTI were identified using MEDLINE, Embase, Cochrane Database of Systematic Reviews, and ClinicalTrials.gov databases.

REVIEW METHODS:

Meta-analyses of the reported relative risk (RR) or mean difference (MD) were conducted. Subgroup analyses were performed to determine the efficacy of HGF plasmids in cohorts excluding Buerger's disease. Certainty of evidence for each outcome was assessed.

RESULTS:

Seven studies (n = 655 participants) were included. Based on low certainty evidence, patients treated with HGF had a significantly higher complete ulcer healing rate (RR 1.99, 95% confidence interval [CI] 1.30 - 3.04; p = .002) than patients treated with placebo. HGF treatment was associated with reduced visual analogue scale (VAS) scores of pain severity (MD -1.56, 95% CI -2.12 - -1.00; p < .001) vs. placebo in patients with CLTI assessed at three month follow up (low certainty evidence); no significant differences were observed in major amputation (RR 0.91, 95% CI 0.48 - 1.73; p = .77) (low certainty evidence) or all cause mortality rate (RR 0.93, 95% CI 0.38 - 2.27; p = .87) (low certainty evidence) between patients treated with HGF and placebo. Low certainty evidence suggested no significant differences in change in ankle brachial index at six months (MD 0.00, 95% CI -0.09 - 0.09; p = 1.0) between patients treated with HGF and placebo. The complete ulcer healing rate and improved three month VAS scores of pain severity benefits persisted in subgroup analyses (low certainty evidence).

CONCLUSION:

Low certainty evidence suggested that HGF treatment is associated with an increased complete ulcer healing rate and reduced ischaemic pain in patients with CLTI.

01 Jan 2024·Journal of Clinical Pediatric Dentistry

Cytotoxicity of two fluoride-releasing adhesive tapes

Article

Author: Nam, Ok Hyung ; Shin, Jonghyun ; Chae, Yong Kwon ; Park, Tae-Young ; Jeong, Seo-Rin ; Jih, Myeong-Kwan

Sodium fluoride-polyvinyl alcohol (NaF-PVA) tape was developed to deliver fluoride to teeth by adding fluoride to polymer tape. Previous studies have demonstrated that tapes are effective and have antimicrobial properties. This study aimed to evaluate the cytotoxicity of two fluoride-releasing adhesive tapes. We investigated two polyvinyl alcohol (PVA) tapes: (i) a fluoride-PVA (F-PVA) tape, and (ii) a pullulan-incorporated F-PVA (PF-PVA) tape. The cytotoxicity test was conducted on human gingival fibroblasts (HGF) and human periodontal ligament (PDL) cells. Using an adhesive tape containing fluoride, we performed the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay on these cells. Genetic analysis of the cells was performed to conduct a stability test on humans. In the MTT assay, PF-PVA had 66% greater cytotoxicity than control by PDL and 69% by HGF. F-PVA showed less cytotoxicity than PF-PVA by 29% in PDL and 33% in HGF. Gene ontology (GO) analysis and gene set enrichment analysis (GSEA) were performed as gene expression analyses. GO analysis indicated that PF-PVA displayed more expression changes of genes related to cytotoxicity than F-PVA. In addition, GSEA found more inflammatory response associations in PF-PVA than in F-PVA. MTT and genetic testing yielded comparable results.

News (Medical) associated with Donaperminogene seltoplasmid(Viromed)

23 Jun 2023

·www.prnewswire.com

United States Cell & Gene Therapy - Focused Insights 2023-2028: Approval of Over 20 Cell Therapy and 31 Gene Therapy Launches in the Pipeline for 2024

DUBLIN, June 23, 2023 /PRNewswire/ -- The "US Cell & Gene Therapy Market - Focused Insights 2023-2028" report has been added to ResearchAndMarkets.com's offering. This report offers market size & forecast data for the cell & gene therapy market in the US. The report covers commercial cell & gene therapy products, such as conventional cell therapies, CAR-T cell therapies, gene therapies, cell-based immunotherapies, and oncolytic virus therapies. Cell therapies sourced from mesenchymal stem cells, cell-based immune modulation therapies, and cell/tissue-based products derived from patients' blood are also covered in the report. Tissue-engineered products and tissue grafts/scaffolds with synthetic mechanical structures are excluded from the report's scope. This report provides a comprehensive and current market scenario of the US cell & gene therapy market, including the US cell & gene therapy market size, anticipated market forecast, relevant market segmentations, and industry trends. The study considers a detailed scenario of the present cell and gene therapy market and its market dynamics for 2023-2028 in the US. It covers a detailed overview of several market growth enablers, restraints, and trends. The report offers both the demand and supply aspects of the market. It profiles and examines leading companies and other prominent players operating in the market. In recent years, growth in the cell and gene therapy market has fueled some high-profile mergers and acquisitions, including bluebird bio/BioMarin, Bristol-Myers Squibb/Celgene/Juno Therapeutics, Gilead Sciences/Kite, Novartis/AveXis and the CDMO CELLforCURE, Roche/Spark Therapeutics, and Smith & Nephew/Osiris Therapeutics. Over 20 cell therapy launches and as many as 31 gene therapy launches - including more than 29 Adeno-associated viruses (AAV) therapies - are projected to be approved by 2024. KEY HIGHLIGHTS OF THE REPORT The US cell and gene therapy market was valued at $3.22 billion in 2022 and is projected to reach $25.58 billion in 2028, with a compound annual growth rate (CAGR) of 41.25%, during the study period. Among all commercial cell & gene therapies, Zolgensma is the first and only product to achieve the blockbuster drug tag. Zolgensma generated a revenue of $1.37 billion in 2022 and could reach around $5.00 billion by 2026. Drug developers are prioritizing developing and commercializing CAR-T cell-based gene therapies. Globally, more than 1,000 clinical trials are being conducted on CAR T-cell therapies, of which at least 500 clinical trials are for cancer alone. Kymriah (Novartis), Yescarta (Gilead Sciences), Tecartus (Gilead Sciences), Breyanzi (Bristol Myers Squibb), Abecma (Bristol Myers Squibb), and Carvykti (Janssen Biotech / Legend Biotech) are the commercial CAR-T therapies available in the market. In 2022, the US was the fastest-growing market with a high market share in North America. The market is driven by an increased target patient population, regulatory body support, and higher access to healthcare due to well-established healthcare infrastructure. The Food and Drug Administration (FDA) has approved over twenty cell and gene therapy drugs. Still, the new product pipeline has approximately 365 investigational therapies, with more than half of these in Phase 2 clinical trials. Oncology and rare diseases remain the top areas targeted by gene therapies from preclinical through pre-registration. Approximately 1,604 clinical trials are under investigation for various cell and gene therapies in the US. This increase could be because of increased funding for cell and gene therapy. The industry-sponsored trials are continued to dominate with a share of 51.81%. Novartis, Gilead Sciences, Spark Therapeutics, Amgen, Orchard Therapeutics, Bristol-Myers Squibb, BioMarin, PTC Therapeutics, and Organogenesis are the leading players in the US cell and gene therapy market. The market offers tremendous growth opportunities for existing and future/emerging players because of a large pool of target patient populations with chronic diseases such as cancer, genetic and rare diseases, and other complex disorders. Key Topics Covered: CHAPTER - 1: Cell & Gene Therapy Market Overview Executive Summary Introduction Key Findings Key Developments CHAPTER - 2: Cell & Gene Therapy Market Segmentation Data US: Projected Revenue of Cell & Gene Therapy (2022-2028; $Billions) Product type Application type End-user type CHAPTER - 3: Cell & Gene Therapy Prospects & Opportunities Cell & Gene Therapy Market Drivers Cell & Gene Therapy Market Trends Cell & Gene Therapy Market Constraints CHAPTER - 4: Cell & Gene Therapy Industry Overview Cell & Gene Therapy - Marketed Drugs Overview Cell & Gene Therapy - Pipeline Drugs Overview Cell & Gene Therapy - Competitive Landscape Cell & Gene Therapy - Key Players Cell & Gene Therapy - Key Company Profiles Cell & Gene Therapy - Mergers & Acquisitions Cell & Gene Therapy - Key Strategic Recommendations CHAPTER - 5: Pricing and Reimbursement Scenario Pricing, Reimbursement and Market Access Contract Manufacturing Organizations (CMOs) CHAPTER - 6: Appendix Research Methodology Abbreviations Companies Mentioned Novartis Gilead Sciences Amgen Roche bluebird bio Legend Biotech Bristol-Myers Squibb UniQure Ferring Pharmaceuticals Organogenesis Vericel Corp Dendreon Mallinckrodt Enzyvant Avita Medical Fibrocell 4DMT Abeona Therapeutics Autolus Therapeutics Candel Therapeutics Castel Creek Biosciences Cellectis Evox Therapeutics Freeline Therapeutics Generation Bio Gensight Biologics Krystal Biotech MeiraGTx Pfizer Gamida Cell Iovance Biotherapeutics Sarepta Therapeutics PTC Therapeutics Atara Bio Adaptimmune CRISPR Therapeutics Carsgen Therapeutics Orchard Therapeutics Biomarin StemCyte Helixmith For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Gene TherapyPhase 2Cell TherapyImmunotherapy

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

100 Deals associated with Donaperminogene seltoplasmid(Viromed)

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Indication	Highest Phase	Country/Location	Organization	Date
Lower limb ischemia	NDA/BLA	CN	Beijing Northland Biotech.Co., Ltd.	15 Jul 2024
Lower limb ischemia	NDA/BLA	CN	Jiangsu Yaohai Biological Pharmaceutical Co., Ltd.	15 Jul 2024
Chronic Limb-Threatening Ischemia	Phase 3	CN	Beijing Northland Biotech.Co., Ltd.	02 Aug 2019
Ischemia	Phase 3	CN	Beijing Northland Biotech.Co., Ltd.	02 Aug 2019
Ulcer	Phase 3	CN	Beijing Northland Biotech.Co., Ltd.	02 Aug 2019
Diabetic foot ulcer	Phase 3	US	Helixmith Co., Ltd.	27 Jun 2017
Peripheral Arterial Disease	Phase 3	US	Helixmith Co., Ltd.	27 Jun 2017
Diabetic Foot	Phase 3	US	Helixmith Co., Ltd.	01 Jan 2017
Diabetic peripheral neuropathy	Phase 3	US	Helixmith Co., Ltd.	01 Apr 2016
Diabetic Nephropathies	Phase 3	CN	Beijing Northland Biotech.Co., Ltd.	-

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01064440 (CTgov)	Phase 2	Chronic Limb-Threatening Ischemia	52	Placebo	ipywgxtqmd(zzovepolpb) = yocwfzortw vxlqpsygtk (bqjzsfihjt, gwtyntsogn - pmflvddtis) View more	-	19 Sep 2024
NCT03363165 (HI-PAD, CTgov)	Phase 2	Peripheral Arterial Disease	39	Placebo (Placebo)	ddpaytseig(uxsulvfyro) = ovzucletbt pcrhseufqs (jfkokgakhc, bzsdrjjize - seklxditai) View more	-	30 May 2024
				VM202 (VM202)	ddpaytseig(uxsulvfyro) = ncldjmijaq pcrhseufqs (jfkokgakhc, tkgxnsklbp - sozopbdeax) View more
NCT04274049 (NL003-CLI-III-2, Corporate Publications) Manual	Phase 3	Lower limb ischemia	242	NL003	ftithzrggr(uorfkdjxbo): P-Value = <0.0001 Met	Positive	02 Feb 2024
				Normal Saline
NCT01475786 (CTgov)	Phase 2	Diabetic peripheral neuropathy	104	High Dose: 32 mg Engensis (VM202) (High Dose 32mg Engensis (VM202))	txbzkhuafh(scgzwpican) = hrftkrrmej djstuotvxs (gwqqdqfnbt, zhcelamzdq - tnbfqqlwup) View more	-	03 Jul 2023
				Control- Placebo (normal saline)+Low Dose: 16 mg Engensis (VM202) (Low Dose 16mg Engensis (VM202) and Placebo)	txbzkhuafh(scgzwpican) = xfabklsjak djstuotvxs (gwqqdqfnbt, ywdwhyexos - sjywqfwvee) View more
NCT04055090 (CTgov)	Phase 3	Diabetic peripheral neuropathy	101	Long-Term Follow-Up of Patients who Received Engensis (VM202) (Subjects Who Received Engensis (VM202))	rjajcmpcqj(xdtrqdgzrf) = ngzoqsnucm lcegqfkikn (smeepnahsf, mbaqlwxkvl - gclmbblfpd) View more	-	08 Mar 2023
				Long-Term Follow-Up of Patients who Received Placebo (Subjects Who Received Placebo)	rjajcmpcqj(xdtrqdgzrf) = odxvafcrcf lcegqfkikn (smeepnahsf, blxnqpamyi - vbsooadkbl) View more
NCT02563522 (CTgov)	Phase 3	Diabetic foot ulcer \| Peripheral Arterial Disease	44	Engensis (VM202) (Active)	kxisegiopd(mdnkhhdiwe) = ogfksroxfv lwrgpvypvw (cduohderaq, blghgmpyzj - stbvuqxofi) View more	-	22 Feb 2023
				Placebo (Control)	kxisegiopd(mdnkhhdiwe) = xthgghztij lwrgpvypvw (cduohderaq, ueksioxmnc - lqxafxgiuj) View more
NCT05176093 (PRNewswire) Manual	Phase 2	Amyotrophic Lateral Sclerosis	18	Engensis	geetxzafjp(vqwfommuyv) = fofqnmoudv tcftkejlho (cxxvegfvxn ) View more	Positive	06 Sep 2022
				Placebo	geetxzafjp(vqwfommuyv) = svxblcjmeb tcftkejlho (cxxvegfvxn ) View more
NCT02427464 (CTgov)	Phase 3	Diabetic peripheral neuropathy	507	Engensis (VM202) (Engensis (VM202))	qqvaxkzowk(xgqutnzans) = dpyouiqkmk hkxbmxsfts (ftxevtpmug, rhsrryqtgy - tmglzhzrpf) View more	-	22 Aug 2022
				placebo (Placebo)	qqvaxkzowk(xgqutnzans) = jvvclnrajb hkxbmxsfts (ftxevtpmug, zdyfsgphpm - cgqihnqfly) View more
NCT04055090 (Biospace) Manual	Phase 3	Diabetic peripheral neuropathy	101	VM202	dkffqhtspq(tosuojqfbx) = vuygawjxjy pcursoompw (plmhaiqzxa ) View more	Positive	07 Oct 2019
				Placebo	dkffqhtspq(tosuojqfbx) = urziertpfb pcursoompw (plmhaiqzxa ) View more
NCT01475786 (Pubmed \| Ann Clin Transl Neurol) Manual	Phase 2	Diabetic Neuropathies	84	VM202	vvgduhswws(tfzyahsigw) = significant reduction ambctopbfs (jlfsjfnbzk )	Positive	01 May 2015
				Placebo

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