BioBalance Announces Completion of PROBACTRIX Safety Clinical Trial.Business Editors NEW YORK--(BUSINESS WIRE)--Jan. 29, 2004 The BioBalance Corp., a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of 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 Generally Recognized as Safe (GRAS) is a United States of America Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food (GRAS GRAS - A public domain graph-oriented database system for software engineering applications from RWTH Aachen. ) under the conditions of its intended use for the dietary management of Irritable Bowel Syndrome irritable bowel syndrome (IBS), condition characterized by frequently alternating constipation and diarrhea in the absence of any disease process. It is usually accompanied by abdominal pain, especially in the lower left quadrant, bloating, and flatulence. 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 microbial pertaining to or emanating from a microbe. microbial digestion the breakdown of organic material, especially feedstuffs, by microbial organisms. balance in the digestive tract digestive tract n. See alimentary canal. Digestive tract The organs that perform digestion, or changing of food into a form that can be absorbed by the body. . Recent scientific studies have linked the intestinal overgrowth overgrowth Rapid growth in the sales of a mutual fund's shares to the extent that the fund has difficulty finding promising new investments or it must take such large positions in individual investments that its trading flexibility is reduced. of pathogenic bacteria to symptoms of IBS IBS Irritable bowel syndrome, see there 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
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