NEW YORK--(BUSINESS WIRE)--April 22, 2004--The BioBalance Corporation, a subsidiary of New York 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 (IBS) patients at St. Michael’s Hospital in Toronto under the leadership of Dr. Khursheed Jeejeebhoy, a world-renowned gastroenterologist and author of over 300 articles on IBS and other GI disorders. The Company also announced in January that an independent expert panel had confirmed GRAS (Generally Recognized as Safe) status for PROBACTRIX(TM).
2nd Quarter Objectives
-- Ongoing discussions with the U.S. Food and Drug Administration (FDA) 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) 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 and diarrhea 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 in a Stock Exchange Agreement. The combined entity trades on the 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 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.
Contacts
The BioBalance Corporation, New York Dennis O’Donnell, 212-679-7778 or
Investor Relations Counsel: The Equity Group Inc., New York Linda Latman, 212-836-9609