SHERWOOD, Ore., Feb. 1, 2012 (GLOBE NEWSWIRE) -- Entia Biosciences, Inc. (OTCBB:ERGO) (ENTIA) announced today that it has successfully completed an acute oral toxicity study (LD50) with its proprietary ErgoD2™ whole-food formulation. ErgoD2™ is a 100% USDA organic formulation from mushrooms that are enhanced with the Company's patent pending UV light technology and contain naturally high concentrations L-Ergothioneine and Ergocalciferol (vitamin D2). ENTIA currently uses this formulation in its Groh™ hair and nail nutritional supplement and in its new line of ErgoD2™ branded medical foods that it intends to offer to healthcare providers treating patients with anemia, diabetes, and potentially other serious conditions. In August, ENTIA announced it had entered into a research agreement with Dr. Jack Rogers, Ph.D., Associate Professor of Psychiatry and Neuroscience at Harvard Medical School and Director of the Neurochemistry Laboratory at Massachusetts General Hospital, to evaluate the therapeutic and prophylactic potential of ErgoD2™ as a dietary therapy or as a palliative therapy for Parkinson's disease patients. Successful completion of the LD50 is an important milestone for the commencement of human trials and ENTIA's medical foods launch.
LD50 is a measurement used in toxicology studies to determine the potential impact of toxic substances on different types of organisms. This test provides an objective measure to compare and rank the toxicity of substances. The LD50 measurement is usually expressed as the amount of toxin per kilogram or pound of body weight. When comparing LD50 values, a lower value is regarded as more toxic, as it means a smaller amount of the toxin is required to cause death. ENTIA's LD50 study was conducted by Wil Research in compliance with the United States FDA GLP Regulations (21 CFR Part 58), 5 October 1987. The objective of the study was to determine the maximum tolerated dose and/or well tolerated dose of ErgoD2™ when administered as a single oral dose, via gavage, to five male and five female albino (CD-1) mice. The dose level was 2858 mg/kg for each mouse and the mortality, clinical observations, and body weight changes were evaluated over a 14 day observation period.
"We are extremely pleased to report such a positive result from this important safety study," said Dr. Marvin S. Hausman MD, ENTIA's Chairman and CEO. "The mice received the maximum dose of 100% pure ErgoD2™ that can be humanely fed in a single serving, which is 50-100 times the dose recommended for humans, and there were no illnesses, weight changes, or other clinical side effects observed in any of the mice treated. Our ErgoD2™ technology enhances the same popular specialty mushroom species that people around the world have been eating safely for centuries, so we are not surprised by the results."
About Entia Biosciences, Inc.
ENTIA is an emerging leader in food science biotechnology that identifies, scientifically validates, and commercializes solutions that address multi-billion dollar markets for organic health, beauty and agriculture. Formerly named Total Nutraceutical Solutions, the Company's growing portfolio of intellectual property includes extraction, enhancement, and uses for some of the most powerful antioxidants and bio-nutrients occurring in nature.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties including, but not limited to, the risks associated with the transaction described in this press release, and other risks identified in the filings by Entia Biosciences (ENTIA) and/or Total Nutraceutical Solutions (TNS), Inc. with the Securities and Exchange Commission. Further information on risks faced by ENTIA and TNS are detailed in the Form 10-K for the year ended December 31, 2010 and in its subsequent Quarterly Reports on Form 10-Q. These filings are or will become available on a website maintained by the Securities and Exchange Commission at http://www.sec.gov. The information contained in this press release is accurate as of the date indicated. Actual results, events or performance may differ materially. ENTIA and TNS does not undertake any obligation to publicly release the result of any revision to these forward- looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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