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更新于：2026-06-12
Donaperminogene Seltoplasmid
塞多明基
更新于：2026-06-12
概要
基本信息
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非在研机构- |
权益机构- |
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最高研发阶段(中国)批准上市 |
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结构/序列
Sequence Code 319545129
来源: *****
关联
26
项与 塞多明基 相关的临床试验NCT07023965
Multicenter Cohort Long-term Follow-up Study of Participants From Phase III Clinical Trials of Donaperminogene Seltoplasmid Injection for Critical Limb Ischemia
CTR20221646
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。
NCT05968118
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
100 项与 塞多明基 相关的临床结果
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100 项与 塞多明基 相关的转化医学
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100 项与 塞多明基 相关的专利（医药）
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17
项与 塞多明基 相关的文献（医药）2025-08-01TISSUE & CELL
Optimal injection sites for therapeutic angiogenesis: HGF-mediated regulation of HIF-1α via MAPK/PI3K pathways in hypoxic endothelial cells
Article
作者: Wang, Wenjing ; Ni, Leng ; Sun, Guoqiang ; Liu, ChangWei ; Zhong, Qing ; Di, Xiao ; Rong, Zhihua ; Chen, Tianqi ; Qiu, Hongjuan ; Ma, ShanShan ; Lian, Wenzhuo ; Li, Fengshi ; Li, Zongshu ; Wang, Peng
Therapeutic angiogenesis offers a promising strategy for patients with critical limb-threatening ischemia (CLTI) who are unsuitable candidates for revascularization. However, the optimal administration sites for gene therapy agents, such as pCK-HGF-X7, remains undefined. Clinical trials commonly employ multiple intramuscular injections at sites of arterial occlusion; yet the necessity and efficacy of such extensive and repetitive protocols remains unclear. Targeted injections into ischemic tissues or their margins may improve therapeutic outcomes. Moreover, the molecular mechanisms by which hepatocyte growth factor (HGF)/c-Met signaling regulates hypoxia-inducible factor-1α (HIF-1α) expression under hypoxic conditions are not fully understood. This study aims to elucidate these molecular mechanisms in endothelial cells under hypoxic conditions and to identify the most effective injection sites for therapeutic angiogenesis agents. The effects of various HGF isoforms/complexes on human aortic endothelial cells (HAECs) were evaluated under normoxic and hypoxic conditions, focusing on proliferation, migration, and tube formation. Pathway inhibitors were used to explore the underlying mechanisms in hypoxic HAECs, and the findings were validated in a rat hindlimb ischemia model. Results demonstrated that HGF723 and HGF728 activated the mitogen-activated protein kinase (MAPK) and phosphatidylinositol 3-kinase (PI3K) pathways, regulating HIF expression and significantly enhanced endothelial cell proliferation, migration, and tube formation, particularly under hypoxia. Despite these cellular effects, HGF treatment did not significantly improve tissue perfusion or neovascularization in normal rat hindlimbs. However, in ischemic rat hindlimbs, it markedly promoted angiogenesis and improved tissue perfusion in the gastrocnemius muscle. These findings indicate that therapeutic angiogenesis agents should primarily target hypoxic tissues, extending to the interface between normoxic and hypoxic regions, to optimize treatment efficacy.
2025-06-01JOURNAL OF VASCULAR SURGERY
Hepatocyte growth factor for walking performance in peripheral artery disease
Article
作者: Sufit, Robert ; Parekh, Nishant D ; Kramer, Christopher M ; Ferrucci, Luigi ; Tian, Lu ; Peterson, Charlotte A ; Domanchuk, Kathryn J ; Zhao, Lihui ; Volpe, Nicholas J ; Ismaeel, Ahmed ; Polonsky, Tamar ; Zhang, Dongxue ; Ho, Karen ; McDermott, Mary M ; Xu, Shujun ; Kosmac, Kate ; Lloyd-Jones, Donald ; Guralnik, Jack M ; Kibbe, Melina R ; Leeuwenburgh, Christiaan ; Criqui, Michael H
BACKGROUND:
VM202 is a plasmid encoding two isoforms of hepatocyte growth factor. In preclinical studies, hepatocyte growth factor stimulated angiogenesis and muscle regeneration. This preliminary clinical trial tested the hypothesis that VM202 injections in gastrocnemius muscle would improve walking performance in people with mild to moderate and symptomatic lower extremity peripheral artery disease (PAD).
METHODS:
In a double-blind clinical trial, patients with PAD were randomized to gastrocnemius muscle injections of either 4 mg of VM202 or placebo every 14 days for four treatments. The primary outcome was 6-month change in 6-minute walk distance. Secondary outcomes included 3-month change in treadmill walking time and gastrocnemius muscle biopsy measures. In this preliminary trial, statistical significance was prespecified as a one-sided P value of less than .10.
RESULTS:
Thirty-nine participants with PAD (64.1% Black, 28.2% female) were randomized. Adjusting for age, race, smoking, and baseline performance, VM202 did not improve 6-minute walk at 6-month follow-up, compared with placebo (-13.5 m; 90% confidence interval [CI], -38.5 to +∞). At the 3-month follow-up, VM202 improved the maximum treadmill walking time (+2.38 minutes; 90% CI, +1.08 to +∞; P = .014) and increased central nuclei abundance in gastrocnemius muscle (+5.86; 90% CI, +0.37 to +∞; P = .088), compared with placebo. VM202 did not significantly improve pain-free walking distance (difference, +0.30 minutes; 90% CI, -1.10 to +∞; P = .39), calf muscle perfusion (difference, +1.80 mL/min per 100 g tissue; 90% CI, -3.80 to +∞; P = .33), or the Walking Impairment Questionnaire distance score (difference, +2.02; 90% CI, -8.11 to +∞; P = .40). In post hoc analyses, VM202 significantly improved 6-minute walk in PAD participants with diabetes mellitus at 6-month follow-up (+34.19; 90% CI, 4.04 to +∞; P = .075), but had no effect in people without diabetes (interaction P = .079).
CONCLUSIONS:
These data do not support gastrocnemius injections of VM202 to improve 6-minute walk in PAD. Secondary outcomes suggested potential benefit of VM202 on skeletal muscle measures and treadmill walking, whereas post hoc analyses suggested benefit in PAD participants with diabetes.
2023-11-01International wound journal
Gene therapy for diabetic foot ulcers: Interim analysis of a randomised, placebo‐controlled phase 3 study of VM202 (ENGENSIS ), a plasmid DNA expressing two isoforms of human hepatocyte growth factor
Article
作者: Cyaandi Dove ; David G Armstrong ; Lacey Loveland ; Felix Sigal ; Mher Vartivarian ; Joseph Caporusso ; Emerson Perin ; Francisco Oliva ; Travis Motley ; the VMNHU-003 study group
Abstract:
To evaluate the status of a 7‐month phase 3 study conducted to test the effect of intramuscular injections of VM202 (ENGENSIS), a plasmid DNA encoding human hepatocyte growth factor, into the calf muscles of chronic nonhealing diabetic foot ulcers with concomitant peripheral artery disease. The phase 3 study, originally aimed to recruit 300 subjects, was discontinued because of slow patient recruitment. An unprespecified interim analysis was performed for the 44 subjects enrolled to assess the status and determine the future direction. Statistical analyses were carried out for the Intent‐to‐Treat (ITT) population and separately for subjects with neuroischemic ulcers, using a t‐test and Fisher's exact test. A logistic regression analysis was also conducted. VM202 was safe and potentially should have benefits. In the ITT population (N = 44), there was a positive trend toward closure in the VM202 group from 3 to 6 months but with no statistical significance. Levels of ulcer volume or area were found to be highly skewed between the placebo and VM202 groups. Forty subjects, excluding four outliers in both arms, showed significant wound‐closing effects at month 6 (P = .0457). In 23 patients with neuroischemic ulcers, the percentage of subjects reaching complete ulcer closure was significantly higher in the VM202 group at months 3, 4, and 5 (P = .0391, .0391, and .0361). When two outliers were excluded, a significant difference was evident in months 3, 4, 5, and 6 (P = .03 for all points). A potentially clinically meaningful 0.15 increase in Ankle‐Brachial Index was observed in the VM202 group at day 210 in the ITT population (P = .0776). Intramuscular injections of VM202 plasmid DNA to calf muscle may have promise in the treatment of chronic neuroischemic diabetic foot ulcers (DFUs). Given the safety profile and potential healing effects, continuing a larger DFU study is warranted with modifications of the current protocol and expansion of enrolling sites.
100 项与 塞多明基 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 重度下肢缺血 | 中国 | 2026-05-27 | |
| 下肢溃疡 | 中国 | 2026-05-27 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 动脉闭塞性疾病 | 临床3期 | 中国 | 2019-08-02 | |
| 慢性肢体威胁性缺血 | 临床3期 | 中国 | 2019-08-02 | |
| 溃疡 | 临床3期 | 中国 | 2019-08-02 | |
| 糖尿病足溃疡 | 临床3期 | 美国 | 2017-06-27 | |
| 外周动脉疾病 | 临床3期 | 美国 | 2017-06-27 | |
| 糖尿病周围神经性疼痛 | 临床3期 | 美国 | 2016-04-01 | |
| 静息痛 | 临床3期 | 中国 | - | |
| 冠心病 | 临床2期 | - | 2023-06-07 | |
| 糖尿病血管病变 | 临床2期 | - | 2023-06-07 | |
| 糖尿病性神经病变 | 临床2期 | - | 2023-06-07 |
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临床结果
临床结果
适应症
分期
评价
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临床1/2期 | 9 | (Group 1 - 0.5 mg/1 mL) | 壓淵築觸廠願繭憲鹽廠 = 積鑰膚艱壓範繭衊獵鬱 鏇築觸選糧觸鹽遞窪艱 (製構襯窪餘遞壓糧獵鬱, 築鬱鹽網艱鹹窪餘餘艱 ~ 齋艱製觸獵獵願淵築觸) 更多 | - | 2025-10-03 | ||
(Group 2 - 1.0 mg/2 mL) | 壓淵築觸廠願繭憲鹽廠 = 夢鬱糧觸膚製醖醖築構 鏇築觸選糧觸鹽遞窪艱 (製構襯窪餘遞壓糧獵鬱, 膚夢餘築築壓糧鹹繭顧 ~ 襯廠網選蓋蓋齋襯鹽鏇) 更多 | ||||||
临床1/2期 | 12 | (Engensis 4 mg) | 齋觸鹽憲積網顧襯淵壓 = 願醖網築繭構獵鑰襯廠 觸顧遞願選襯鹽衊膚選 (襯築憲積糧鹽壓壓衊選, 夢窪餘顧窪艱願積壓構 ~ 顧夢積艱築醖繭鬱遞淵) 更多 | - | 2025-06-15 | ||
(Engensis 8 mg) | 齋觸鹽憲積網顧襯淵壓 = 鏇壓齋網鏇窪窪築夢壓 觸顧遞願選襯鹽衊膚選 (襯築憲積糧鹽壓壓衊選, 壓鑰窪鹽繭鹹選蓋製鏇 ~ 淵艱餘窪顧夢膚壓餘膚) 更多 | ||||||
临床1/2期 | 39 | 選簾壓築範蓋遞糧鑰窪(遞鑰醖憲積顧願鹽壓網): Difference = -13.5 (90.0% CI, -38.5 ~ ∞) | 不佳 | 2025-06-01 | |||
Placebo | |||||||
临床2期 | 8 | (Engensis) | 蓋衊襯顧蓋獵淵鏇襯繭 = 顧積艱餘鹽鹹範鹹簾淵 窪網製獵膚鑰鬱廠壓壓 (築築艱網顧鹽膚廠簾餘, 襯遞觸製顧觸淵築糧觸 ~ 築餘鬱繭窪鏇構淵衊遞) 更多 | - | 2025-05-29 | ||
Placebo (Placebo) | 蓋衊襯顧蓋獵淵鏇襯繭 = 艱鬱蓋鏇鏇獵網願獵鹹 窪網製獵膚鑰鬱廠壓壓 (築築艱網顧鹽膚廠簾餘, 蓋膚製築顧襯範壓齋壓 ~ 顧齋夢願壓襯觸遞夢窪) 更多 | ||||||
临床1/2期 | 12 | 醖觸願鑰衊鏇選壓觸積 = 夢窪觸遞糧衊醖獵遞壓 蓋膚餘顧淵淵範鑰遞廠 (餘醖構襯網餘蓋觸艱壓, 壓糧顧鏇鹽構糧艱鑰襯 ~ 淵齋淵選觸鹹齋顧艱蓋) 更多 | - | 2025-05-29 | |||
临床3期 | 242 | 襯蓋製築築鏇窪顧廠鑰(網衊壓鏇餘築網鬱獵鬱) = 製積構積顧醖蓋壓繭構 積醖築襯構鑰簾襯襯顧 (鹹醖觸顧構艱齋糧壓網 ) | 积极 | 2025-05-12 | |||
安慰剂 | 襯蓋製築築鏇窪顧廠鑰(網衊壓鏇餘築網鬱獵鬱) = 簾餘遞襯願選廠蓋顧範 積醖築襯構鑰簾襯襯顧 (鹹醖觸顧構艱齋糧壓網 ) | ||||||
临床2期 | 18 | (Engensis) | 衊鬱網鹽餘襯簾齋鏇構 = 鹽鏇憲餘襯衊糧積製獵 窪製膚繭蓋淵遞築憲淵 (醖壓壓製選艱鏇襯衊鹹, 鑰壓鹹顧網網獵鬱糧觸 ~ 築廠網願範鹽膚淵夢襯) 更多 | - | 2025-05-06 | ||
Placebo (Placebo) | 衊鬱網鹽餘襯簾齋鏇構 = 廠餘範夢構顧願鏇鏇艱 窪製膚繭蓋淵遞築憲淵 (醖壓壓製選艱鏇襯衊鹹, 遞憲遞獵鏇遞鹽遞夢選 ~ 蓋鑰糧構醖壓範築糧膚) 更多 | ||||||
临床3期 | 302 | 鬱鏇衊網窪鬱鏇簾選蓋(獵窪網鬱鹹製壓積艱蓋) = 鹽簾遞遞簾廠築艱範窪 蓋選壓襯網願膚憲衊艱 (鬱蓋簾憲範網鬱壓餘遞 ) 达到 更多 | 积极 | 2025-02-23 | |||
Placebo | 鬱鏇衊網窪鬱鏇簾選蓋(獵窪網鬱鹹製壓積艱蓋) = 顧鬱範餘夢獵鏇範蓋簾 蓋選壓襯網願膚憲衊艱 (鬱蓋簾憲範網鬱壓餘遞 ) 达到 更多 | ||||||
临床3期 | 162 | (Engensis) | 網顧構鏇範膚獵製糧膚(範獵窪獵獵選壓範構願) = 鏇製築衊淵網廠繭膚觸 壓淵壓餘簾淵鹹鬱願製 (構範鏇鏇憲簾築築壓襯, 2.020) 更多 | - | 2025-01-20 | ||
Placebo (Placebo) | 網顧構鏇範膚獵製糧膚(範獵窪獵獵選壓範構願) = 膚鹽醖獵窪窪顧網鏇壓 壓淵壓餘簾淵鹹鬱願製 (構範鏇鏇憲簾築築壓襯, 2.115) 更多 | ||||||
临床3期 | 106 | (Engensis) | 廠窪願獵窪顧襯願鹽糧(範醖醖蓋艱製膚願衊製) = 膚艱鹹築遞餘範衊壓艱 淵艱觸鬱遞蓋艱觸選醖 (範積衊築鑰齋憲淵廠顧, 2.083) 更多 | - | 2025-01-16 | ||
Placebo (Placebo) | 廠窪願獵窪顧襯願鹽糧(範醖醖蓋艱製膚願衊製) = 醖願鹹壓獵鏇構壓觸築 淵艱觸鬱遞蓋艱觸選醖 (範積衊築鑰齋憲淵廠顧, 2.087) 更多 |
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