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.

Start Date01 Sep 2010

Sponsor / Collaborator

ImmuneWorks, Inc.

100 Clinical Results associated with Type V Collagen Oral Solution(ImmuneWorks)

100 Translational Medicine associated with Type V Collagen Oral Solution(ImmuneWorks)

100 Patents (Medical) associated with Type V Collagen Oral Solution(ImmuneWorks)

Literatures (Medical) associated with Type V Collagen Oral Solution(ImmuneWorks)

01 Aug 2022·Analytica Chimica Acta

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

Article

Author: 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.

01 May 2015·European Respiratory JournalQ1 · MEDICINE

Oral immunotherapy with type V collagen in idiopathic pulmonary fibrosis

Q1 · MEDICINE

Article

Author: 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.

01 Sep 2009·RheumatologyQ2 · MEDICINE

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

Q2 · MEDICINE

Article

Author: 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.

100 Deals associated with Type V Collagen Oral Solution(ImmuneWorks)

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Pulmonary Fibrosis	Phase 1	-	Lung Biotechnology PBC	-
Lung transplant rejection	Phase 1	US	-	-

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IAS2005	Not Applicable	-	-	Zidovudine 10mg/ml oral solution	tekbdidfph(ptxedckuzp) = tyyegqvrtb kovhbvylun (mdkjwfnbdb, -10.8, - 1.6)	-	01 Jan 2005
				Zidovudine 100mg capsules	tekbdidfph(ptxedckuzp) = bgpssmllqp kovhbvylun (mdkjwfnbdb, -21.4 to +14.7)

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