Remedisc(Remedisc) - 药物靶点：TGF-β1_在研适应症：椎间盘退化_专利_临床

概要

基本信息

药物类型

合成多肽

别名

Vicatertide

+ [4]

靶点

TGF-β1

作用机制

TGF-β1调节剂(转化生长因子β1调节剂)

治疗领域

皮肤和肌肉骨骼疾病

在研适应症

椎间盘退化

非在研适应症-

原研机构

Ensol Biosciences, Inc.

在研机构

Spine BioPharma, Inc.初创企业Yuhan Corp.

非在研机构

Ensol Biosciences, Inc.

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式C42H66N10O10

InChIKeyMLCMYVUVOHSNFD-WVMYFBOZSA-N

CAS号1251838-01-3

序列信息

Sequence Code 15960518

来源: *****

关联

3

项与 Remedisc 相关的临床试验

NCT05516992 / Active, not recruiting临床3期

A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Safety and Efficacy of SB-01 For Injection for the Treatment of Lumbar Degenerative Disc Disease

The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to control in terms of the percentage of subjects improving in pain-related disability.

开始日期2022-08-19

申办/合作机构

Spine BioPharma, Inc.初创企业

[+1]

NCT02320019 / Completed临床2期

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Trial to Evaluate the Efficacy and Safety of YH14618 in Patients With Lumbar Degenerative Disc Disease

Research Hypothesis:
There will be a greater proportion of VAS responders defined as those who achieve ≥ 50% reduction from baseline in VAS for low back pain at week 12 following intradiscal injection of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic lumbar degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have suffered from persistent low back pain with at least 3 months of conservative therapy and must have low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI) ≥30% at the baseline.

开始日期2015-03-01

申办/合作机构

Yuhan Corp.

NCT01526330 / Completed临床1/2期

A Double-blind, Randomized, Parallel, Placebo Controlled, Phase I/II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH14618 Following Single Intradiscal Injection in Patients With Degenerative Disc Disease

The objective of this study is to assess the safety and tolerability of YH14618 during 24 weeks of follow-up period after single administration in patients with degenerative disc disease.

开始日期2012-05-01

申办/合作机构

Yuhan Corp.

100 项与 Remedisc 相关的临床结果

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100 项与 Remedisc 相关的转化医学

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100 项与 Remedisc 相关的专利（医药）

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2

项与 Remedisc 相关的文献（医药）

2013-01-01·Spine2区 · 医学

Anabolic Effects of Peniel 2000, a Peptide That Regulates TGF-β1 Signaling on Intervertebral Disc Degeneration

2区 · 医学

Article

作者: Chung, Yeon Gu ; Kim, Ok-Soon ; Kwon, Young-Joon ; Kim, Hae-Jin ; Lee, Je-Wook ; Moon, Eun-Joung

STUDY DESIGNAn in vitro study with bovine intervertebral disc (IVD) cells and an in vivo study with a rabbit disc degeneration model on the extracellular matrix metabolism by a biglycan-derived peptide (Peniel 2000; P2K).OBJECTIVETo investigate the mechanism for P2K-induced increases in extracellular matrix and in vitro and in vivo effects of the peptide on IVD.SUMMARY OF BACKGROUND DATATransforming growth factor-β (TGF-β) has a functional versatility on the metabolism of IVD cells, suggesting that the regulation of TGF-β signaling is important in IVD degeneration. P2K was explored by an in silico drug discovery strategy to regulate TGF-β signaling.METHODSThe putative target of P2K was verified by Biacore 3000 analysis and affinity purification using biotin-P2K. A monolayer culture system of bovine IVD cells was used to demonstrate the mechanism underlying the anabolic effects of P2K. Smad signaling and extracellular matrix metabolism of the IVD cells were investigated by Western blot and reverse transcription-polymerase chain reaction, respectively. The in vivo effect of P2K on degenerated disc was investigated using a rabbit model of disc degeneration. In 14 New Zealand white rabbits, disc degeneration was induced by percutaneous annular punctures. After 4 weeks, 3 consecutive discs in the same animal were treated with 5% lactose or P2K per disc. Twelve weeks after the treatment, the regenerative activity in the disc was examined by radiography, magnetic resonance imaging, and biochemical and histological analyses.RESULTSDirect binding of P2K to an active form of TGF-β1 was shown. Type II collagen and aggrecan were increased in TGF-β1/P2K-treated bovine IVD cells, compared with nontreated and TGF-β1-treated cells.In in vivo analysis, a single injection of P2K increased the disc height (P < 0.001) on the radiographs and improved the magnetic resonance imaging grade (P < 0.05) compared with controls. Biochemical analysis, showed a significant increase in PG content because of P2K treatment (P < 0.05). Histological analysis using disc degeneration grades demonstrated improvement in P2K-treated discs (P <0.01).CONCLUSIONA novel peptide, P2K, regulating TGF-β1 signaling had an anabolic effect on bovine IVD cells and rabbit degenerated discs. The results suggest that P2K has considerable potential as a treatment of degenerative disc disease.

2001-08-01·AIDS2区 · 医学

`Chemical condoms’ for the prevention of HIV infection: evaluation of novel agents against SHIV89.6PDin vitro and in vivo

2区 · 医学

Article

作者: Darbyshire, Janet ; Stone, Alan ; Almond, Neil ; McCormack, Sheena ; Nunn, Andrew ; Stott, Jim ; O'Connor, Tim ; Weber, Jonathan ; Jeffries, Don ; Kitchen, Valerie

BACKGROUNDVaginal agents which are antiviral and/or inhibit the entry of HIV into the cell could prevent heterosexual transmission of HIV, and protect women who cannot negotiate condom use.METHODSFour agents have been investigated for activity in vitro and in vivo against SHIV(89.6PD): two anionic polymers, dextrin-2-sulphate (D2S) and PRO 2000 (P2K), and two virucidal agents; a non-ionic detergent, nonoxynol-9 (N9) and a cyclic peptide ionophore, gramicidin-D (GD). All four agents were investigated in rhesus macaques, using an intra-vaginal challenge of two inoculations of 1 x 104 50% tissue culture infectious doses (TCID)50 of SHIV(89.6PD).RESULTSD2S, P2K, GD and N9 all inhibited SHIV(89.6PD) in vitro. In vivo, three out of four control macaques were infected as judged by viral culture, seroconversion, DNA and RNA PCR; infection was confirmed in four out of eight macaques pre-treated with P2K, two out of four pre-treated with D2S, one out of four pre-treated with N9, two out of four pre-treated with GD and four out of four pre-treated with D2S + GD, a combination additive in vitro.INTERPRETATIOND2S and PRO-2000, novel inhibitors of HIV entry, showed evidence of protection in vivo, comparable to that seen with the virucide, N9. These data, together with the results of phase I and phase II studies in healthy women which have shown minimal toxicity, support plans for a phase III efficacy trial of chemically simple inhibitors of HIV entry with low toxicity, for the prevention of HIV infection in women.

100 项与 Remedisc 相关的药物交易

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