[Translation] A randomized, double-blind, placebo-controlled, single/multiple-dose phase I clinical trial of the safety, tolerability and pharmacokinetics of recombinant human nerve growth factor eye drops in healthy Chinese subjects

主要目的：评价在健康受试者中单次、多次局部给予ZX1305滴眼液后的全身系统安全性、耐受性。次要目的：1.评价在健康受试者中单次、多次局部给予ZX1305滴眼液后全身系统的药代动力学特征；2.评价在健康受试者中单次、多次局部给予ZX1305滴眼液后全身系统免疫原性。

[Translation]

Primary objective: To evaluate the systemic safety and tolerability of single and multiple topical administration of ZX1305 eye drops in healthy subjects. Secondary objectives: 1. To evaluate the pharmacokinetic characteristics of the systemic system after single and multiple topical administration of ZX1305 eye drops in healthy subjects; 2. To evaluate the systemic immunogenicity of ZX1305 eye drops in healthy subjects after single and multiple topical administration.

Start Date27 Aug 2024

Sponsor / Collaborator

Jiangsu Zhongxin Pharmaceutical Co., Ltd.

CTR20230387 / RecruitingPhase 2

重组人神经生长因子（ZX1305）注射液治疗视神经损伤有效性、安全性和免疫原性的Ⅱ 期临床研究

[Translation] Phase II clinical study on the efficacy, safety and immunogenicity of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage

主要研究目的：探索肌肉注射不同剂量的重组人神经生长因子（ZX1305）注射液治疗视神经损伤的有效性，为Ⅲ期临床试验设计提供依据。次要研究目的：探索肌肉注射不同剂量的重组人神经生长因子（ZX1305）注射液治疗视神经损伤的安全性和免疫原性。

[Translation]

The main purpose of the study is to explore the effectiveness of intramuscular injection of different doses of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage, and to provide a basis for the design of Phase III clinical trials. Secondary purpose of the study is to explore the safety and immunogenicity of intramuscular injection of different doses of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage.

Start Date26 Jun 2023

Sponsor / Collaborator

Jiangsu Zhongxin Pharmaceutical Co., Ltd.

CTR20230957 / RecruitingPhase 2

重组人神经生长因子（ZX1305）注射液治疗开角型青光眼导致的视神经损伤有效性、安全性和免疫原性的II期临床研究

[Translation] Phase II clinical study on the efficacy, safety and immunogenicity of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage caused by open-angle glaucoma

主要研究目的：探索肌肉注射重组人神经生长因子（ZX1305）注射液治疗开角型青光眼导致的视神经损伤的有效性，为后期临床试验设计提供依据。次要研究目的：探索肌肉注射重组人神经生长因子（ZX1305）注射液治疗开角型青光眼导致的视神经损伤的安全性和免疫原性。

[Translation]

The main purpose of the study is to explore the effectiveness of intramuscular injection of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage caused by open-angle glaucoma, and to provide a basis for the design of later clinical trials. Secondary purpose of the study is to explore the safety and immunogenicity of intramuscular injection of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage caused by open-angle glaucoma.

Start Date10 May 2023

Sponsor / Collaborator

Jiangsu Zhongxin Pharmaceutical Co., Ltd.

100 Clinical Results associated with Recombinant human nerve growth factor(Jiangsu Zhongxin Medicine Co Ltd)

100 Translational Medicine associated with Recombinant human nerve growth factor(Jiangsu Zhongxin Medicine Co Ltd)

100 Patents (Medical) associated with Recombinant human nerve growth factor(Jiangsu Zhongxin Medicine Co Ltd)

150

Literatures (Medical) associated with Recombinant human nerve growth factor(Jiangsu Zhongxin Medicine Co Ltd)

01 Oct 2024·The Ocular Surface

Preventing and treating neurotrophic keratopathy by a single intrastromal injection of AAV-mediated gene therapy

Article

Author: Xie, Lixin ; Qi, Benxiang ; Ma, Wenhui ; Ren, Zhongmei ; Cong, Lin ; Zhang, Bi Ning ; Liang, Qian ; Zhou, Qingjun

PURPOSENeurotrophic keratopathy (NK) is a degenerative corneal condition resulting from corneal nerve injury. Current therapies, including the recombinant human nerve growth factor (rhNGF) therapy, requires continuous administration. This study aims to develop a novel and highly effective gene therapy strategy for the prevention and treatment of NK.METHODSAdeno-associated virus (AAV) was transduced into corneal stromal cells by intrastromal injection. Three dimensional corneal wholemount imaging with co-immunostaining of ZO-1 and tubulin was utilized to assess the transduction of AAV.rh10. The efficacy of prevention and treatment of NK by a single intrastromal injection of AAV-Ngf was tested using capsaicin mouse model, herpes simplex keratitis (HSK) model, type Ⅱ diabetes model and alkali burn model. rhNGF eye drops served as the positive control.RESULTSIntrastromal injection of AAV.rh10 efficiently transduced the subepithelial nerve plexus and retrogradely transported to the trigeminal ganglion (TG). A single injection of AAV.rh10-Ngf can significantly promote corneal nerve repair, accelerate corneal epithelial repair, reduce corneal stromal edema, and improve corneal sensitivity across the four NK models. The therapeutic effects were consistent with those achieved by continuous administration of rhNGF drops by 6 times daily.CONCLUSIONSThis proof-of-concept study demonstrates that AAV.rh10-Ngf gene therapy is a promising method for preventing and treating of NK. Our results underline the potential for developing clinical trials to further explore the safety and efficacy of such gene therapy.

18 Jun 2024·Translational Vision Science & Technology

Development and Characterization of a Photocrosslinkable, Chitosan-Based, Nerve Growth Factor–Eluting Hydrogel for the Ocular Surface

Article

Author: Boychev, Nikolay ; Kanu, Levi N ; Hutcheon, Audrey E K ; Ross, Amy E ; Ciolino, Joseph B ; Farhat, Wissam ; Mudigunda, Sushma V ; Kuang, Liangju

PurposeRecombinant human nerve growth factor (rhNGF; cenegermin-bkbj, OXERVATE) is the first and only U.S. Food and Drug Administration-approved treatment for moderate to severe neurotrophic keratopathy. The aim of this study was to determine the feasibility of incorporating a version of rhNGF in a mucoadhesive hydrogel capable of sustained drug release to the ocular surface.MethodsHydrogels loaded with rhNGF were synthesized by conjugating chitosan with azidobenzoic acid (Az-Ch), adding rhNGF, and exposing the solution to ultraviolet (UV) radiation to induce photocrosslinking. Az-Ch hydrogels were evaluated for physical properties and rhNGF release profiles. Cytocompatbility of Az-Ch was assessed using immortalized human corneal limbal epithelial (HCLE) cells. TF1 erythroleukemic cell proliferation and HCLE cell proliferation and migration were used to assess the bioactivity of rhNGF released from Az-Ch hydrogels.ResultsAz-Ch formed hydrogels in <10 seconds of UV exposure and demonstrated high optical transparency (75-85 T%). Az-Ch hydrogels exhibited good cytocompatibility with no demonstratable effect on HCLE cell morphology or viability. rhNGF was released gradually over 24 hours from Az-Ch hydrogels and retained its ability to induce TF1 cell proliferation. No significant difference was observed between rhNGF released from Az-Ch and freshly prepared rhNGF solutions on HCLE cell proliferation or percent wound closure after 12 hours; however, both were significantly better than control (P < 0.01).ConclusionsrhNGF-loaded Az-Ch hydrogels exhibited favorable physical, optical, and drug-release properties, as well as retained drug bioactivity. This drug delivery system has the potential to be further developed for in vivo and translational clinical applications.Translational RelevanceAz-Ch hydrogels may be used to enhance rhNGF therapy in patients with NK.

01 May 2024·Kidney International

Assessment of epidemiology and outcomes of adult patients with kidney-limited thrombotic microangiopathies

Article

Author: Chauvet, Sophie ; Titeca-Beauport, Dimitri ; Halimi, Jean-Michel ; Fage, Nicolas ; Maisons, Valentin ; Caillard, Sophie ; Mesnard, Laurent ; Gatault, Philippe ; Servais, Aude ; Quérard, Anne-Hélène ; Schurder, Juliet ; Cartery, Claire ; Seret, Guillaume ; Grangé, Steven ; Delmas, Yahsou ; Duval, Anna ; Ville, Simon ; Fakhouri, Fadi ; Le Quintrec, Moglie ; Martins, Manon ; Bobot, Mickaël ; von Tokarski, Florent ; Sautenet, Bénédicte ; Wynckel, Alain ; Fauchier, Laurent ; Vuiblet, Vincent ; Barbet, Christelle ; Coppo, Paul ; Frimat, Marie

Thrombotic microangiopathies (TMA) are usually associated with hematological features (RH-TMA). The epidemiology of TMA limited to kidneys (RL-TMA) is unclear Therefore, patients with TMA and native kidney biopsies were identified during 2009-2022 in 20 French hospitals and results evaluated. RL-TMA was present in 341/757 (45%) patients and associated with lower creatinine levels (median 184 vs 346 μmol/L) than RH-TMA. RL-TMA resulted from virtually all identified causes, more frequently from anti-VEGF treatment and hematological malignancies but less frequently from shigatoxin-associated hemolytic uremic syndrome (HUS), systemic sclerosis, gemcitabine and bacterial infection, and even less frequently when three or more causes/triggers were combined (RL-TMA: 5%; RH-TMA: 12%). RL-TMA was associated with significantly lower major cardiovascular events (10% vs 20%), kidney replacement therapy (23% vs 43%) and death (12% vs 20%) than RH-TMA during follow-up (median 28 months). Atypical HUS (aHUS) was found in 326 patients (RL-TMA: 43%, RH-TMA: 44%). Among the 69 patients with proven complement-mediated aHUS, eculizumab (anti-C5 therapy) was used in 43 (62%) (RL-TMA: 35%; RH-TMA: 71%). Among the 257 other patients with aHUS, including 51% with RL-TMA, eculizumab was used in 29 but with unclear effects of this treatment. Thus, RL-TMA represents a very high proportion of patients with TMA and results from virtually all known causes of TMA and includes 25% of patients with complement-mediated aHUS. Adverse outcomes of RL-TMA are lower compared to RH-TMA but remain significant. Anti-C5 therapy was rarely used in RL-TMA, even in proven complement-mediated aHUS, and its effects remain to be assessed.

100 Deals associated with Recombinant human nerve growth factor(Jiangsu Zhongxin Medicine Co Ltd)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Glaucoma, Open-Angle	Phase 2	CN	Jiangsu Zhongxin Pharmaceutical Co., Ltd.	10 May 2023
Optic Nerve Injuries	Phase 2	CN	Jiangsu Zhongxin Pharmaceutical Co., Ltd.	10 May 2023
Glaucoma	Phase 2	US	Dompé Pharmaceutici Spa	01 Dec 2016
Neurotrophic keratitis	Phase 1	CN	Jiangsu Zhongxin Pharmaceutical Co., Ltd.	27 Aug 2024

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