BioBalance Corp. (BioBalance), a wholly owned subsidiary of New York Health Care (OTC BB: BBAL), announced that it has received approval from the U.S. Food and Drug Administration (FDA) to begin U.S. clinical trials of its proprietary biotherapeutic agent, Probactrix, as a prescription drug for pouchitis. Pouchitis is a debilitating complication that can develop following corrective surgical treatment of ulcerative colitis, in which an ileal reservoir, or pouch, is constructed to enable normal bowel movements after removal of the diseased colon. This ileal reservoir can become inflamed, leading to debilitating gastrointestinal symptoms including diarrhea, incontinence, bleeding, fever and urgency. The cause of pouchitis is not known, though it is believed to result from an immune response to pathogenic bacteria in the pouch flora. There are no currently approved treatments for pouchitis. Current management involves short-term and occasionally chronic treatment with antibiotics.
