[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of SMR001 eye drops in the treatment of patients with moderate to severe dry eye disease.

1.评估SMR001滴眼液治疗中重度干眼患者的有效性和安全性 2.观察SMR001滴眼液治疗中重度干眼患者的症状和体征变化 3.观察SMR001滴眼液治疗中重度干眼患者的共聚焦显微镜检查中央6mm角膜直径的角膜神经密度变化

[Translation]

1. Evaluate the efficacy and safety of SMR001 eye drops in the treatment of patients with moderate to severe dry eyes 2. Observe the changes in symptoms and signs of patients with moderate to severe dry eyes treated with SMR001 eye drops 3. Observe the changes in corneal nerve density in the central 6mm corneal diameter by confocal microscopy in patients with moderate to severe dry eyes treated with SMR001 eye drops

Start Date05 Jul 2023

Sponsor / Collaborator

Sinobioway Biomedicine Co., Ltd.

CTR20201934 / CompletedPhase 1

一项单中心、随机、双盲、安慰剂对照、剂量递增 I 期临床研究评价局部给予重组人神经生长因子（SMR001）在中国健康受试者中单次和多次给药的安全性、耐受性及药代动力学特征。

[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical study evaluated the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of topically administered recombinant human nerve growth factor (SMR001) in healthy Chinese subjects.

● 评价在中国健康受试者中单次、多次局部给予SMR001滴眼液后的局部（眼部）和系统的安全性和耐受性。 ● 评价在中国健康受试者中单次、多次局部给予SMR001滴眼液后的药代动力学（Pharmacokinetics, PK）特征。

[Translation]

● To evaluate the local (ocular) and systemic safety and tolerability of SMR001 eye drops after single and multiple topical administration in healthy Chinese subjects. ● To evaluate the pharmacokinetic (PK) characteristics of SMR001 eye drops after single and multiple topical administration in healthy Chinese subjects.

Start Date23 Dec 2020

Sponsor / Collaborator

Sinobioway Biomedicine Co., Ltd.

100 Clinical Results associated with Recombinant human nerve growth factor(Shandong Sinobioway Biomedicine Co., Ltd.)

100 Translational Medicine associated with Recombinant human nerve growth factor(Shandong Sinobioway Biomedicine Co., Ltd.)

100 Patents (Medical) associated with Recombinant human nerve growth factor(Shandong Sinobioway Biomedicine Co., Ltd.)

Literatures (Medical) associated with Recombinant human nerve growth factor(Shandong Sinobioway Biomedicine Co., Ltd.)

01 Apr 2009·Neuroscience LettersQ4 · MEDICINE

Recombinant human NGF-loaded microspheres promote survival of basal forebrain cholinergic neurons and improve memory impairments of spatial learning in the rat model of Alzheimer's disease with fimbria-fornix lesion

Q4 · MEDICINE

Article

Author: Haigang Gu ; Xiaobin Li ; Dahong Long ; Cunxian Song

Neurotrophic factors are used for the experimental treatment of neurological disorders, such as Alzheimer's disease. However, delivery of the neurotrophic factors into the brain remains a big challenge. Recombinant human nerve growth factor (NGF)-loaded microspheres were fabricated and characterized in vitro and in vivo in our previous study. The present study was to assess the therapeutic benefit of rhNGF-loaded microspheres in treating the rat model of Alzheimer's disease with fimbria-fornix lesion. Recombinant human NGF-loaded microspheres were implanted into the basal forebrain of the rats with fimbria-fornix lesion. Four weeks after implantation in the basal forebrain, immunohistochemical analysis showed that rhNGF-loaded microspheres had a significant effect on the survival of axotomized cholinergic neurons in the medial septum (MS) and vertical diagonal branch (VDB) (p<0.05). Y-maze tests showed rhNGF-loaded microspheres can significantly improve the ability of spatial learning and memory of the rats with fimbria-fornix lesion (p<0.05). These results indicate that rhNGF-loaded microspheres are an effective means for the treatment of Alzheimer's disease.

01 Jul 1990·CytokineQ3 · MEDICINE

Leukemia inhibitory factor (LIF) inhibits basal bone resorption in fetal rat long bone cultures

Q3 · MEDICINE

Article

Author: Joseph A. Lorenzo ; Christina L. Leahy ; Sandra L. Sousa

Leukemia inhibitory factor (LIF) has a wide variety of biologic actions. In vivo, its net effect on bone is to increase new bone formation. Recently, the sequence of human LIF was found to differ by only a single amino acid from that of human differentiation-inducing factor (D-factor). The effects of LIF on bone appear to be complex since purified murine D-factor and recombinant LIF stimulate bone resorption in cultured newborn mouse calvaria. To examine further the responses of bone to LIF, we studied the effects of recombinant human LIF (glycosylated and nonglycosylated) and recombinant human D-factor (non-glycosylated) on resorption in another in vitro organ culture model, fetal rat long bones. Both LIF preparations and D-factor inhibited basal bone resorption rates by 25% to 44% in these cultures. Resorption rates in maximally inhibited LIF-treated cultures were similar to those in devitalized bones. Inhibitory effects typically occurred at concentrations of greater than or equal to 10 ng/mL (0.5 nM) for the non-glycosylated LIF and D-factor and 1000 U/mL for glycosylated LIF. Neither LIF nor D-factor blocked the resorptive response to interleukin 1 (IL 1) or parathyroid hormone (PTH) nor did they alter total DNA synthesis. Hence, their inhibitory effects appeared to be specific for the mechanisms regulating basal resorptive activity. These results demonstrate that LIF has potent inhibitory actions on basal resorption rates in these cultures. These effects may be important for the anabolic responses that LIF has on bone in vivo. In addition, they may also be involved in the interactions between inflammatory or tumor cells and bone.

100 Deals associated with Recombinant human nerve growth factor(Shandong Sinobioway Biomedicine Co., Ltd.)

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Indication	Highest Phase	Country/Location	Organization	Date
Xerophthalmia	Phase 2	CN	Sinobioway Biomedicine Co., Ltd.	05 Jul 2023
Diabetic foot ulcer	Phase 2	CN	Sinobioway Biomedicine Co., Ltd.	24 Sep 2020

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