A Phase One, Open Label, Multi-Dose Study to Evaluate the Safety, Tolerability, and Biologic Effects of Three Doses of IW001 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This is an open label, Phase One, multicenter study, designed to evaluate the safety, tolerability, to explore the biologic effects, and to explore the clinical effects of the following doses of IW001: 0.1mg/day, 0.5 mg/day, and 1.0 mg/day, when administered once a day orally for 24 weeks in patients with IPF.

开始日期2010-09-01

申办/合作机构

ImmuneWorks, Inc.

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项与 Type V Collagen Oral Solution(ImmuneWorks) 相关的文献（医药）

2022-08-01·Analytica Chimica Acta

Activatable near-infrared fluorescent probe triggered by nitroreductase for in vivo ulcerative colitis hypoxia imaging

Article

作者: Chen, Qian ; Cao, Xiao-Qun ; Dong, Han ; Zhang, Xiao-Fan ; Shen, Shi-Li ; Wang, He-Song

Ulcerative colitis is a prevalent inflammatory disease caused by the intestinal bacterial infection. And it is related to the hypoxic degrees in the colon microenvironment. Hypoxia, a condition of imbalance in O₂ supply and consumption, is accompanied by the overexpressed level of nitroreductase (NTR). Therefore, the NTR detection has been widely applied for the diagnosis of hypoxia-related diseases. In this study, we developed a novel near-infrared fluorescent probe (IW-1) for NTR. Upon reaction with NTR, IW-1 exhibited a significant fluorescence off-on response at 740 nm with a low detection limit of 0.043 μg/mL. Confocal fluorescence imaging verified its ability to detect the overexpression of NTR in cancer cells. More significantly, IW-1 was applied for in vivo hypoxia imaging in tumors and dextran sulphate sodium (DSS)-induced ulcerative colitis mouse model. We expect that the probe may present a new tool for better understanding the biological functions of NTR as well as revealing essential information about hypoxia-related pathological processes, including cancer and ulcerative colitis.

2015-05-01·European Respiratory Journal1区 · 医学

Oral immunotherapy with type V collagen in idiopathic pulmonary fibrosis

1区 · 医学

Article

作者: Wilkes, David S ; Kaminski, Naftali ; Noth, Imre ; Chew, Terrence ; Frye, Sarah ; Klemsz, Michael J ; Rothhaar, Katia ; Lange, Wade ; Gibson, Kevin F ; Flaherty, Kevin R

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with poor prognosis. IPF appears to be heterogeneous in pathobiology with ∼40% of IPF patients found to have elevated levels of circulating antibodies to the autoantigen type V collagen (col(V)).Following a targeted, precision medicine approach, we conducted a phase 1 study to test the safety and explore potential efficacy of IW001, a col(V) oral immunotherapeutic developed to treat antibody-positive IPF patients. We divided 30 antibody-positive IPF patients into three cohorts for daily dosing over a 24-week period.All patients completed treatment without serious adverse events, acute exacerbations or IPF-related hospitalisations. A decline in lung function occurred in the lowest-dose cohort that was comparable to that reported in placebo arms of published IPF trials. In contrast, the highest-dose cohort showed a trend toward stabilisation of forced vital capacity and matrix metalloproteinase 7, and a reduction in binding of C1q to anti-col(V) antibodies.IW001 may modulate the immune response to col(V) and may represent a new therapeutic for col(V)- reactive IPF patients.

2009-09-01·Rheumatology2区 · 医学

Sensitivity to change of the modified Rodnan skin score in diffuse systemic sclerosis--assessment of individual body sites in two large randomized controlled trials

2区 · 医学

Article

作者: James R. Seibold ; Puja P. Khanna ; Daniel E. Furst ; Marian Kaldas ; Weng Kee Wong ; Arnold E. Postlethwaite ; Philip J. Clements ; Dinesh Khanna

OBJECTIVEThe modified Rodnan skin score (MRSS) is a standard outcome measure for skin disease in SSc and calculated by summation of skin thickness in 17 different body sites (total score = 51). Our objective was to evaluate the sensitivity of change over time of individual body sites used in the calculation of total MRSS.METHODSWe analysed two randomized placebo controlled clinical trials investigating the effect of either recombinant human relaxin or type I oral collagen in dcSSc. Both trials used MRSS as the primary outcome measure. We used a change of >10 mm (on a 0-100 VAS) in the patient global assessment (PGA) as the clinically important improvement. We calculated the mean change and the effect size (ES) for each individual body site used in the total MRSS for each study. Magnitude of ES was assessed using Cohen's rule of thumb for ES.RESULTSIn the relaxin and collagen studies, 71 of 199 patients (36%) and 54 of 129 (42%) of patients had an improvement >10 mm on the PGA at 6 and 12 months, respectively. Total MRSS had large ES in both studies (0.85-0.98); the chest, forearms and hands had moderate ES (0.50-0.74); and the lower extremities, face, abdomen and fingers had small ES (0.16-0.49).CONCLUSIONCertain body sites (hands, forearms and chest) are more sensitive to change compared with other body sites in two randomized clinical trials. It remains to be seen whether decreasing the number of body sites by exclusion of relatively static areas would further increase the sensitivity to change over time of the total MRSS.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
特发性肺纤维化	临床1期	-	Lung Biotechnology PBC	-
肺移植排斥反应	临床1期	美国	-	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


IAS2005	N/A	-	-	Zidovudine 10mg/ml oral solution	衊衊鹹觸製醖繭糧鹽淵(襯壓夢願艱築衊窪選願) = 選壓膚夢醖醖廠願衊積衊繭遞鑰蓋夢膚獵憲糧 (繭範憲選積構鬱遞醖餘, -10.8, ~ 1.6)	-	2005-01-01
				Zidovudine 100mg capsules	衊衊鹹觸製醖繭糧鹽淵(襯壓夢願艱築衊窪選願) = 選獵鑰艱醖艱鹽選選積衊繭遞鑰蓋夢膚獵憲糧 (繭範憲選積構鬱遞醖餘, -21.4 ~ +14.7)