Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis

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).

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all of the following to be included in the study:

  1. Diagnosis of IPF (ATS criteria) prior to the Baseline visit.
  2. Forced Vital Capacity (FVC) ≥ 50% of predicted.
  3. Lung Diffusion Capacity (DLCO) ≥ 35% of predicted.
  4. Ages 35-75 years inclusive.
  5. Positive for anti-Col (V) antibodies.
  6. White blood cell count (WBC) ≥ 2500 mm3.
  7. Hematocrit ≥ 25% and ≤ 59%.
  8. Platelets ≥ 100,000 mm3.
  9. Creatinine ≤ 1.5x Upper Limits of Normal (ULN).
  10. Bilirubin ≤ 1.5x ULN.
  11. Aspartate aminotransferase (AST, SGOT) ≤ 1.5x ULN.
  12. Females of child-bearing potential (defined as less than one year post-menopausal or not surgically sterile) must be using an acceptable method of birth control or practicing abstinence from the time consent is signed until 30 days after treatment discontinuation. If sexually active, female patients must use a double barrier method of birth control, such as a condom and spermicidal. Patient must have a negative pregnancy test at the Screening and Baseline visits.
  13. Willing and able to provide adequate written informed consent.

      Exclusion Criteria:
* Patients will be excluded from the study for any of the following:

  1. Concurrent use of systemic corticosteroids or immunosuppressives within 30 days of the Baseline visit.
  2. Chronic NSAID use (limited, i.e., up to 72 hours continuous use of NSAIDs will be permitted during the study), (see Section 9, concomitant medications).
  3. N-acetyl cysteine (NAC) use within 14 days of the Baseline visit.
  4. Any disease, condition or surgery (e.g. inflammatory bowel disease, surgical resection) that may cause malabsorption of IW001.
  5. Known or suspected allergy to bovine products.
  6. Concurrent or prior use of any experimental medication within 30 days of the Baseline visit.
  7. History of smoking within three months prior to the Baseline visit.
  8. Known Hepatitis C or Human Immunodeficiency Virus (HIV) infections.
  9. Evidence of active infection at the Baseline visit.
  10. History of unstable or deteriorating cardiac disease.
  11. Myocardial infarction, coronary artery bypass, or angioplasty within 6 months of the Baseline visit.
  12. Unstable angina pectoris or congestive heart failure requiring hospitalization within 6 months of the Baseline visit.
  13. Uncontrolled arrhythmia.
  14. Patient has a history of illicit drug or alcohol abuse in the past year or current evidence of such abuse or addiction in the opinion of the Investigator.
  15. Patient has positive findings on urine drug screen.
  16. Any other clinically significant illness, that, in the opinion of the Investigator, might put the patient at risk of harm during the study or might adversely affect the interpretation of the study data.
  17. Females who are pregnant and/or lactating.