The BioBalance Corporation Files IND for PROBACTRIX(TM) as a Prescription Drug for Pouchitis
January 03 2005 - 8:30AM
PR Newswire (US)
The BioBalance Corporation Files IND for PROBACTRIX(TM) as a
Prescription Drug for Pouchitis NEW YORK, Jan. 3
/PRNewswire-FirstCall/ -- The BioBalance Corporation, a
wholly-owned subsidiary of New York Health Care, Inc. (OTC:BBAL.PK)
announced that it has submitted an Investigational New Drug (IND)
application with the U.S. Food and Drug Administration (FDA) to
seek approval to conduct clinical trials of its proprietary
biotherapeutic agent, PROBACTRIX, in patients suffering from
pouchitis. Pouchitis is an inflammation of the ileal reservoir
which can occur after bowel reconstructive surgery for ulcerative
colitis. Gastrointestinal (GI) symptoms include incontinence,
bleeding, fever and urgency. There are no currently approved
treatments for pouchitis. "The filing of an IND for our lead
product candidate represents a major milestone for the company,"
said Dennis O'Donnell, BioBalance's president & CEO. "We
believe that our strategy of pursuing regulatory approval to market
PROBACTRIX as a prescription drug will generate the greatest return
to our shareholders." PROBACTRIX is a patented, single strain of
non-pathogenic E.coli that was originally isolated from the
intestinal microflora of a healthy volunteer. It is formulated in a
pleasant tasting liquid suspension. The mechanism of action is
believed to work by inhibiting the growth of pathogenic bacteria in
the digestive tract and preventing their re-colonization. The
active ingredient in PROBACTRIX has a long history of use for a
variety of gastrointestinal conditions, which has been well
documented in foreign published studies. Dr. Robert A. Hoerr,
BioBalance's Director of Medical and Regulatory Affairs, commented,
"We believe that PROBACTRIX will prove beneficial in pouchitis
patients as well as a number of other GI indications which we plan
to pursue in the future". 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 under the
symbol BBAL.PK. Additional information is located on the company
website at http://www.biobalancecorp.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 latest quarterly report on Form 10-Q and current
reports on Form 8-K. CONTACT: Dennis O'Donnell Stanley Wunderlich
President & CEO Consulting For Strategic Growth Tel: (212)
679-7778 Tel: (800) 625-2236 Fax: (212) 679-7774 Fax: (212)
337-8089 Email: DATASOURCE: The BioBalance Corporation CONTACT:
Dennis O'Donnell, President & CEO, +1-212-679-7778, fax:
+1-212-679-7774, or ; or Stanley Wunderlich, Consulting For
Strategic Growth, +800-625-2236, fax: +1-212-337-8089, or Web site:
http://www.biobalancecorp.com/
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