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| Kibow Biotech Launches Limited Human Clinical Trial in North America of Its Probiotic, Kibow Biotics®, in Kidney Failure |
PHILADELPHIA, PA, July 16, 2007 /PRIME NEWSWIRE/ -- Kibow Biotech announced today that it has initiated a limited, pilot-scale, double-blind, placebo-controlled, cross-over, six-month human clinical trial in North America of its probiotic formulation, Kibow Biotics® for slowing the progression of kidney failure. |
| For each site, the trial will recruit 30 patients with Stage III or stage IV chronic kidney failure (CKF). Patients will be randomized to receive either Kibow Biotics® alone or a placebo. Having been administered to healthy individuals during four months without any noticeable side effects, the oral formulation of Kibow Biotics® is already deemed by the U.S. Food and Drug Administration as GRAS (Generally Recognized as Safe) for general wellness or intestinal applications. The primary objective of this study is to clinically verify the safety and clinically validate the GRAS status as per the U.S. FDA for our intended uremic syndrome applications. The secondary objective is to demonstrate the stabilization and/or reduction in the level of uremic toxin levels in Chronic Kidney Failure stage III and IV patients. |
| This North American trial will be conducted in centers in Canada and in the U.S. The Canadian trial will be led by Dr. Paul Tam at Nephrology Associates, Toronto. The U.S. trial will be led by Dr. Eli Friedman, State University of New York (SUNY), Brooklyn, N.Y. and Dr. David S. Goldfarb at VA Medical Center, Manhattan, N.Y. Kibow has also obtained approval for the study from Mexican, Argentinean and Nigerian health authorities. |
| Pari Ranganathan, MS, MT, ASCP., Director of Clinical Affairs at Kibow, commented, "The orally administered formulation of Kibow Biotics® is intended as a dietary supplement incorporating specially developed strains of naturally occurring bacteria which metabolize targeted toxins and incorporate them as nutrients for growth. We anticipate that it may reduce bloodstream concentrations of urea, uric acid, creatinine, indoles and phenols, nitrosamines and related uremic metabolites. We also anticipate that Kibow Biotics® will promote maintenance of normal healthy gut flora. These two effects together could translate to a slower disease progression and a better quality of life for the patients enrolled in our trials." |
For additional information, contact:
Dr. Natarajan Ranganathan, CEO and VP Research and Development
Kibow Biotech, Inc.
4629 West Chester Pike
Newtown Square, PA 19073 USA
Tel: (610) 353 5130
Fax: (610) 353 5110
Email address: info@kibowbiotech.com
Web site: http://www.kibow.com
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About Chronic Kidney Failure (CKF)
Chronic kidney failure is usually a secondary disease resulting from a ``primary'' illness such as cardiovascular disease, hypertension or diabetes. CKF is progressive and irreversible. No cure is available except a total organ transplant. Globally, an estimated 200 million patients are victims of kidney failure. In the US, kidney failure is the 9th leading cause of death. More than 21 million Americans are reported to have kidney disease/failure. Of these, an estimated 80,000 patients will die this year due to kidney failure or related complications. |
About Kibow Biotics®
Kibow Biotics® is a patented and proprietary dietary supplement product formulation developed during a nine-year research program by Kibow Biotech, Inc. Produced in GMP contract laboratories certified by the U.S. FDA, the investigational dietary supplement consists of naturally occurring beneficial bacteria (probiotics) targeted to pre-dialysis patients and to those at high risk of kidney failure. |
About Kibow
Kibow is an emerging biotech company focused on the development of innovative probiotics and prebiotics that help slow disease progression and improve the quality of life for kidney failure patients. Kibow is currently developing three types of probiotics products: Kibow Biotics® for kidney failure patients, a formulation to help strengthen the immune system of the elderly, and a veterinary formulation for kidney failure companion animals.
Kibow's most advanced product, the veterinary formulation of Kibow Biotics® is marketed in the U.S. and in Canada under the name of Azodyl(tm) by Vetoquinol US.
For more information, visit http://www.kibow.com |
Forward-looking statements:
This press release contains forward-looking statements that reflect management's current views of future events, including the status of development of the dietary supplement formulation, Kibow Biotics®, for kidney failure applications, and the possible benefits of Kibow Biotics® in slowing the progression of chronic kidney failure or helping patients feel better. Kibow is not a pharmaceutical company. Kibow products are not drugs and may not be considered as a treatment or a therapy. The dietary supplement formulation of Kibow Biotics® will not cure, prevent or mitigate any disease. Actual results may differ significantly from the above forward-looking statements due to a number of factors including but not limited to the possibility that Kibow Biotics® may not prove to be safe or show evidence of clinical activity in the current limited human trials or that data from patients enrolled in the study may not be useful or conclusive or sufficient to guide future development of Kibow Biotics®. Other factors that could cause or contribute to differences in actual results include, but are not limited to, whether or not the Company or any of its collaborators will be able to develop dietary supplements using the technologies of the Company, risks associated with completing clinical trials of product candidates, the possibility that clinical testing may reveal to be undesirable and unintended side effects or other characteristics that my prevent or limit the commercial use of proposed products; whether the cash resources of the Company will be sufficient to fund operations as planned; reliance on key employees, especially senior management; the uncertainty of the Company's future access to capital; the risk that the Company may not secure or maintain relationships with collaborators, and the Company's dependence on intellectual property. The Company expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. |
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