Entia Biosciences, Inc Begins Multi-site Clinical Trial of Medical Food for Treatment of Diabetes and Anemia
June 06, 2012 at 09:30 am EDT
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Entia Biosciences Inc. announced 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(TM) 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(TM) 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(TM)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. Trial Objectives: The Study investigators will be measuring how ErgoD2(TM) 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(TM) (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.
Entia Biosciences, Inc. develops pharmaceutical-grade organic compounds, including a foundational compound called ErgoD2. The Company also develops and markets health-related nutraceuticals and cosmeceuticals. ErgoD2 is a pharmaceutical-grade organic compound created from whole foods that contain the micro-nutrients L-ergothioneine, an amino acid that has a transporter (SLC22A4) in every human being, and vitamin D2. ErgoD2 improves iron homeostasis and mitigates iron-related disorders presenting in anemia, chronic kidney disease and select neurodegenerative diseases. The Company's ErgoD2 formulations utilize organically cultivated specialty mushrooms available from various domestic and international suppliers. These mushroom-based products are generally regarded as safe (GRAS). The Company's market and scientific research has identified mushroom species and suppliers to provide the nutritional profiles for its ErgoD2 formulations.