BioBalance Announces Key 2004 Milestones for PROBACTRIX-TM-.Business Editors/Health/Medical Writers NEW YORK--(BUSINESS WIRE)--April 22, 2004 The BioBalance Corporation, a subsidiary 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, Inc., announced today its clinical and regulatory milestones for PROBACTRIX(TM) for 2004. According to Dennis O'Donnell, President of The BioBalance Corporation, "The milestones for 2004, some of which were achieved during the first quarter, are being announced in order to help shareholders track BioBalance's progress with PROBACTRIX(TM), our lead biotherapeutic agent for various gastrointestinal (GI) disorders. On the science and regulatory fronts, BioBalance continues to make progress and we want to share our enthusiasm with our shareholders." In the first quarter of 2004, BioBalance announced the achievement of two significant milestones. It initiated a clinical trial as a medical food in 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. (IBS IBS Irritable bowel syndrome, see there ) patients at St. Michael's Hospital St. Michael's Hospital may refer to:
2nd Quarter Objectives -- Ongoing discussions with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) regarding the clinical development plan for a prescription drug formulation; -- Anticipated start of IBS clinical study at a major NY medical center; -- Poster Session presentation at the 2004 Digestive Disease Week (DDW DDW Digestive Disease Week DDW Diseases of the Developing World DDW Dimensional Data Warehouse DDW Digital Data Warfare DDW Darkness Does Wonders (bar slang) DDW Data Driven Workflow ) in New Orleans, the world's premier GI medical conference. 3rd Quarter Objectives -- Anticipated filing of an Investigational New Drug (IND) application for a prescription drug formulation; -- Completion of Phase I extended-term safety study in adult human volunteers. 4th Quarter Objectives -- Expected start of FDA-approved clinical study for prescription drug development; -- Anticipated completion of the double-blind, placebo-controlled IBS medical food clinical study. The Company plans to explore other strategic options as part of its efforts to enhance shareholder value. Achievement of these milestones will require significant expenditures, which are subject to the Company's obtaining of financing. There can be no assurance that any funds will be available to BioBalance or at acceptable terms. About The BioBalance Corporation The BioBalance Corporation is a specialty pharmaceutical company focused on the development of novel treatments for various gastrointestinal (GI) disorders that are poorly addressed by current therapies via accelerated regulatory pathways. These disorders include Irritable Bowel Syndrome (IBS), inflammatory bowel disease inflammatory bowel disease n. Abbr. IBD Any of several incurable and debilitating diseases of the gastrointestinal tract characterized by inflammation and obstruction of parts of the intestine. and diarrhea caused by antibiotics, chemotherapy or AIDS. BioBalance operates as 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 Health Care, a home healthcare company with which it merged on January 2, 2003 in a Stock Exchange Agreement. The combined entity trades on the OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). Pink Sheets under the symbol BBAL. Additional information is located on the company 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 2003 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. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion