Interim Clinical Trial Results Confirm Safety of Renadyl(TM), a Probiotic Dietary Supplement for the Support of Healthy Kidney Function
NEWTOWN SQUARE, Pa., March 8, 2012 /PRNewswire/ — On the occasion of World Kidney Day, Kibow Biotech, Inc. is pleased to announce that interim data from an expanded clinical trial of Renadyl(TM) (http://www.Renadyl.com) confirms the positive results for safety and improved quality of life (QOL) previously established in a pilot-scale study for kidney failure patients. The probiotic microbial strains in the product formulation are “Generally Recognized As Safe” (“GRAS – status”) as per US FDA regulations.
Renadyl(TM), originally marketed under the registered name of Kibow® Biotics, is a probiotic dietary supplement which is currently being tested to determine its ability to help reduce the build-up of uremic toxins, and thus help maintain healthy kidney function.
Following-up on the encouraging results obtained in a multisite, pilot-scale study with chronic kidney disease (CKD) Stage III and IV patients, the Company is actively sponsoring an expanded study of Renadyl(TM), administered at higher dosage levels to both predialysis and dialysis patients. These clinical trials, which began in April of 2011, are being performed at Thomas Jefferson University, Philadelphia, PA, Downstate Medical Center (State University of New York) and at Kings County Hospital in Brooklyn, NY. More information is available at http://www.clinicaltrials.gov, under Kibow Biotech Inc – (NCT 01450670, 01450657 and 01450709).
About Kibow Biotech
Founded in 1997, Kibow Biotech specializes in research and development of probiotic dietary supplements. The Company’s primary mission is to offer affordable, readily available and easily administered dietary supplements in support of kidney health. The Company’s flagship product, Renadyl(TM), is currently marketed in the US and Canada, and will progressively be made available worldwide, according to individual countries’ governmental rules and regulatory authorities.
About Uremic Toxin Reduction Technology
Kibow’s novel “uremic toxin removal technology” addresses the diffusion of various uremic toxins into the bowel as a consequence of failing kidney function. The Company’s patented and proprietary dietary supplements, Renadyl(TM) (for CKD patients) and Azodyl(TM) (veterinary formulation) consist of a combination of three specific probiotic microbial strains. The results of a randomized, double-blind, crossover, pilot scale clinical trial completed in 2010 provided encouraging preliminary evidence that the Company’s technology could be effective when the formulation is taken together with the standard therapy according to individual patient conditions.
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, Renadyl(TM), for kidney health in the USA and the possibility of its approval as a drug in some other countries according to respective governmental authorities. 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 Renadyl(TM) 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 Renadyl(TM) 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 Renadyl(TM). 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 may 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.
For further information, contact:
Natarajan Ranganathan, Ph.D.,
Managing Director (R&D)
1 (610) 353 5130
SOURCE Kibow Biotech, Inc.