By Akanksha, Pharmacology Correspondent, [RxPG] The BioBalance Corporation,a wholly owned subsidiary of New York Health Care, Inc. announced today that it has been in communication with the U.S. Food and Drug Administration (FDA) regarding BioBalance's filing of its first Investigational New Drug(IND)application 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.
The FDA has orally informed BioBalance that it has comments related to the IND that require additional information from BioBalance and has placed the proposed trials on clinical hold.Consistent with normal FDA procedures,the FDA is expected to formally communicate the precise nature of these issues in writing to BioBalance within 30 days.In the interim, BioBalance expects to be in communication with the FDA to address their outstanding issues.
"We look forward to working with the FDA with the goal of resolving all of their outstanding issues,"said Dennis O'Donnell, BioBalance's president & CEO.
The basic active component in BioBalance's product is M-17 Escherichia Coli (E.coli),the most competitive bacterium in healthy microflora of man and animals.
This is a 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 product is based on research and clinical studies by the inventors.The technology and the processes comprise conditions that preserve M-17 E.COLI in the biologically active form with a shelf life of one year at room temperature.
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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.
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