Entia Biosciences Begins Multi-site Clinical Trial of Medical Food for Treatment of Diabetes and Anemia
SHERWOOD, Ore., June 6, 2012 /PRNewswire/ -- Entia Biosciences, Inc. (OTCBB: ERGO) (ENTIA) announced today that it has commenced an exploratory study at a nationally recognized teaching/research hospital on the West Coast to evaluate the clinical tolerability and potential therapeutic benefits of ErgoD2™ Hemo in patients being treated for Diabetes and Anemia. A second international site, in a region where diabetes has become epidemic in proportions, has also agreed to participate in the clinical trial and is expected to start dosing patients later this month.
ErgoD2™ Hemo is a proprietary medical food formulation containing naturally high concentrations of the powerful antioxidants L-Ergothioneine and Ergocalciferol (vitamin D2). These two ingredients work together to naturally elevate red blood cell production and decrease insulin resistance, which enables the body to more easily respond to symptoms experienced by the vast majority of patients taking prescription drugs to treat these conditions. Entia has previously announced that it had filed patents covering the use of these ingredients to treat diabetes, anemia, metabolic syndrome, and associated comorbid states.
Scientists have hypothesized that the innate immune response of pre-diabetic individuals creates an internal inflammatory response in fat tissue, liver and muscle which leads to insulin resistance and diabetes. Certain natural bionutrients, such as those contained in ErgoD2™Hemo, have the ability to inactivate these inflammatory signaling molecules (called cytokines or free radicals) which are a major contributing factor in insulin resistance. Moreover, the potency of L-Ergothioneine as a positive electron donor helps to stabilize iron in the normal (non-toxic) physiologic +2 state within the hemoglobin molecule which increases oxygen carrying capacity of the red blood cells.
"This is the first exploratory human study of ErgoD2™ by Entia and is expected to scientifically validate the efficacy of our formulations in the prevention and amelioration of human diseases," stated Marvin S. Hausman MD, CEO. "Our strategy at Entia is to develop cost-effective new medical food products that are scientifically proven to help preserve and maintain normal innate immune function, while at the same time reduce the production of toxic pro-inflammatory molecules that cause disease."
The Study investigators will be measuring how ErgoD2™ Hemo affects each patient's normal standard of care over 90-120 days. Clinical response biomarkers will include Vitamin D2 and D3 levels, hemoglobin A1C (stable marker of diabetes severity), changes in diabetic drug dosing, dosing of red blood cell substitutes, such as Epogen™ (manufactured by Amgen) in dialysis patients, and patient symptomatic response. Healthcare providers interested in participating in the clinical trial are asked to contact Dr. Hausman at Entia Biosciences.
About Medical Foods and ErgoD2™ Hemo
As regulated by the FDA, medical foods are specially formulated to manage a specific disease or condition for which medical evaluation, based on recognized scientific principles, has established distinct nutritional requirements. All components of a medical food must have GRAS status (Generally Recognized as Safe) as designated by the FDA or independent review. ErgoD2™ Hemo is an encapsulated medical food that is certified organic and may be dispensed by a medical practitioner as indicated for the distinct nutritional requirements of patients being treated for diabetes and/or anemia.
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, 2011 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.
Devin Andres, Vice President
Entia Biosciences, Inc.
13565 SW Tualatin-Sherwood Rd
Sherwood, OR 97140
Phone: 503-334-3575 Email: firstname.lastname@example.org