NEW YORK, Feb 5, 2004 (BUSINESS WIRE) -- The BioBalance Corp., a wholly owned subsidiary of New York Health Care (NASDAQ:BBAL), announced today that it has begun enrolling patients in a randomized, double-blind, placebo-controlled trial of its proprietary biotherapeutic agent, PROBACTRIX(TM), in the dietary management of patients with Irritable Bowel Syndrome (IBS). The study will be conducted at St. Michael's Hospital, a teaching hospital affiliated with the University of Toronto. Dr. Jeffrey P. Baker, a board-certified gastroenterologist, is the principal investigator for this site. Additional sites for this study include leading medical centers in United States and Israel. The trial will be conducted in approximately 210 IBS patients to demonstrate the ability of PROBACTRIX(TM) to improve bowel-related symptoms and improve quality of life when incorporated in the dietary management of these individuals.
Irritable Bowel Syndrome affects over 100 million adults worldwide who suffer from abdominal pain, bloating and gas, which are often combined with bouts of constipation, diarrhea, or both. While not life-threatening, IBS can be a life-altering disorder. According to the IBS Self Help Group, IBS is more prevalent than depression, asthma, diabetes and heart disease.
PROBACTRIX(TM) is a patented strain of non-pathogenic ("healthy") E.coli M-17 in a liquid suspension that helps restore the microbial balance in the digestive tract. Recent scientific studies have linked the intestinal overgrowth of pathogenic bacteria to symptoms of IBS and other GI disorders.
The BioBalance Corporation
BioBalance is a development stage specialty pharmaceutical company focused on the discovery, development and commercialization of proprietary treatments for gastrointestinal (GI) disorders including irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis and various diarrheas caused by antibiotics, chemotherapy or AIDS. BioBalance operates as a wholly owned subsidiary of New York Health Care, a home healthcare company with which it merged on January 2, 2003. Additional information regarding BioBalance, which is not part of this press release, is located on its website at www.thebiobalancecorp.com.
SAFE HARBOR STATEMENT In addition to historical information, certain of the statements in the preceding paragraphs, particularly those anticipating future events, financial performance, business prospects and growth and operating strategies constitute forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements may be identified by words such as anticipate, believe, estimate, expect, intend, predict, hope or similar expressions. Such statements are based on management's current expectations and are subject to a number of factors and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements, including, without limitation, satisfaction of approvals and conditions applicable to the transaction described above, the company's ability to implement its strategies and achieve its objectives and the risks and uncertainties described in reports filed by the company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation, cautionary statements made in New York Health Care's 2002 Annual Report on Form 10-K, its Form S-4 Registration Statement, its latest quarterly report on Form 10-Q and current reports on Form 8-K.