NEW YORK, Jan 29, 2004 -- The BioBalance Corp., a wholly owned subsidiary of New York Health Care (Nasdaq: BBAL), announced today that it has completed a safety trial of its proprietary biotherapeutic agent, PROBACTRIX(TM), in 125 healthy adult human volunteers at an intake level ten times higher than normal for eight weeks. PROBACTRIX(TM) was found to be well tolerated and no adverse events attributable to the product were reported. The trial was conducted at Bikur Cholim Hospital in Jerusalem by Dr. Samuel N. Adler, Chief of Gastroenterology at the hospital.
The topline results of this study further support the findings of the recent expert panel review of PROBACTRIX(TM) which determined that the product is generally recognized as safe (GRAS) under the conditions of its intended use for the dietary management of Irritable Bowel Syndrome and other gastrointestinal disorders. The GRAS panel results were announced earlier this month.
"It's not surprising that PROBACTRIX(TM) was found to be safe at high intake levels, based on the extensive clinical history of the agent," said Dr. Adler, the principal investigator of this study. Dr. Adler added, "What was surprising was that a fairly large number of the study volunteers, who were healthy to start, actually felt better at the conclusion of the study."
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.