Safety/Efficacy Study of Bovine Intestinal Alkaline Phosphatase in Patients With Moderate to Severe Ulcerative Colitis
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
Ulcerative colitis is characterized by abnormal activation of, and damage to, the colon
epithelium, which is considered to be a central pathogenic mechanism. Activation of colon
epithelium cells in UC is associated with an abnormal high expression of Toll-like receptors,
including TLR-4, the major transducer of LPS, binding specifically the lipid A portion of
LPS. Alkaline Phosphatase binds and subsequently dephosphorylates LPS, thereby eliminating
the ability of LPS to activate TLR-4. This is expected to 1) prevent activation of the
intestinal epithelium and 2) prevent systemic inflammatory responses that result from
transmigration of endotoxin though the leaky inflamed intestinal mucosa. Therefore, it is
expected that administration of BIAP may attenuate or prevent the local and systemic
inflammatory response in patients with severe ulcerative colitis.
Phase:
Phase 2
Details
Lead Sponsor:
AM-Pharma
Collaborators:
CRM Biometrics GmbH Sintesi Research Srl Vigilex BV