Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis

Status:	Archived
Conditions:	Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	September 2010
End Date:	September 2011

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.

IW001 is a therapeutic designed to treat anti-Col (V)-mediated autoimmune diseases via oral
tolerance. With the identification of the specific antigen involved in the autoimmune
disease process in IPF, IW001 induced oral tolerance may be an effective treatment. IW001
is taken orally, introduced into the mucosal immune system at the Peyer's Patches in the
distal small intestine, where antigen-presenting cells present the antigen to regulatory T
cells (Tregs). These antigen-specific Tregs enter the blood stream and traffic to areas
where the specific antigen has generated an autoimmune response. Thus, IW001 may produce
selective suppression of immune responses against Col (V).

We found this trial at

sites

University of Michigan Health Systems

1500 E Medical Center Dr
Ann Arbor, Michigan 48109

(734) 936-4000