FDAnews
www.fdanews.com/articles/67109-biobalance-files-ind-for-probactrix-to-treat-pouchitis

BIOBALANCE FILES IND FOR PROBACTRIX TO TREAT POUCHITIS

January 3, 2005

BioBalance, a wholly owned subsidiary of New York Health Care, has submitted an investigational new drug application with the FDA to seek approval to conduct clinical trials of its proprietary biotherapeutic agent, Probactrix, in patients suffering from pouchitis.

Pouchitis is an inflammation of the ileal reservoir which can occur after bowel reconstructive surgery for ulcerative colitis. Gastrointestinal symptoms include incontinence, bleeding, fever and urgency.