SHERWOOD, Ore., Feb. 24, 2012 (GLOBE NEWSWIRE) -- Entia Biosciences, Inc. (OTCBB:ERGOD) (ENTIA) announced today that it is developing a line of medical food products based on its proprietary ErgoD2™ whole-food formulations. ErgoD2™ is a 100% vegan and USDA certified organic formulation from mushrooms that have been enhanced with the Company's patent pending UV light technology and contain naturally high concentrations of the powerful antioxidants Ergothioneine and Ergocalciferol (vitamin D2). Entia recently announced that it had successfully completed an LD50 toxicity study with the ErgoD2™ formulation and intends to now conduct human studies to further validate the therapeutic and safety claims of its initial medical food products: ErgoD2™ "Hemo" for treatment of anemia and diabetes and ErgoD2™ "Hair" for treatment of Alopecia (hair loss). Other new medical food products are expected to be added to the development pipeline in the coming months.
In November, Entia announced a strategic relationship with Lifespan Biosciences to determine where Entia's proprietary Ergothioneine Transporter (ETT; human gene symbol SLC22A4) is over and under expressed in a wide variety of normal and diseased human tissues. Ergothioneine is an important amino acid that is not manufactured in mammals but acquired exclusively from food. Research at The Johns Hopkins University School of Medicine has shown that cells lacking ETT are more susceptible to damage and death from free radicals and oxidative stress and the fact that there is a specific transporter that exclusively carries Ergothioneine suggests an essential physiological purpose for this nutrient. Entia acquired the ETT patent from the University of Cologne, Cologne, Germany, in 2010 and the Lifespan research is confirming high concentrations of ETT at the sites of major diseases. Entia has already filed patents covering the nutritional control of several of these diseases, including anemia, diabetes, and Alopecia, and intends to provide similar protections for its future medical food products.
Nutritional Intervention, Disease Management, and Medical Foods
Nutrients are required to drive the basic physiological activities that sustain life. All innate cellular functions, defenses, and repair systems require a continuous supply of nutrients provided by nutrient reserves to make up the shortfall as dietary intakes fluctuate due to disease and other external causes. Among the critical nutrient-dependent cellular defenses are free radical and cellular antioxidant enzymes, acute inflammatory responses, phagocytic and bactericidal activity, lymphocyte activation and proliferation, humoral and cell-mediated immunity, and the initiation and promotion of the coagulation cascade. Additional defensive roles supported by nutrients involve protein synthesis, reversal and repair of DNA and chromosomal damage, integrity of immune cell structure and function, and a whole host of other activities at the molecular level.
If nutrient intakes are not sufficient to adequately support these basic physiological activities, adaptive mechanisms are triggered to conserve the available nutrient supply. Among these mechanisms are increased efficiency of intestinal absorption, enhanced renal re-absorption, adjustment of metabolic rate, and a compensatory shift to ancillary pathways that minimize nutrient demand. Although effective as temporary corrective measures, these adaptive responses will begin to lose effectiveness over time if inadequate intakes are not corrected.
Nutrient deficiencies may be classified as absolute or relative and are believed to be the causative and/or accelerating factors in many major diseases and the process of aging. Absolute deficiencies are caused by chronic inadequate consumption of nutrients that eventually results in depletion of reserves. Depleted nutrient reserves leave cells vulnerable to daily fluctuations in nutrient intakes or to sudden increases in demand that occur with unintended exposure to environmental stressors such as pathogens, chemical irritants, and oxygen free radicals, or to cellular injury from infection or trauma. Relative deficiencies can occur even if nutrients are consumed in adequate amounts to meet basic physiological requirements and maintain reserves, when these intakes are not sufficient to satisfy increases in metabolic demand.
Medical foods are a unique category of FDA regulated products that are specifically formulated to meet the distinctive nutritional requirements or metabolic deficiencies of a particular disease state. Medical foods contain the same nutrients that are found in regular foods and dietary supplements, but have been enhanced or concentrated for oral administration under a physician's orders. Medical foods supply the body with the necessary amino acids required to make specific neurotransmitters, which are the chemical messengers that allow one neuron to communicate with other neurons or effector organs. The autonomic nervous system, operating through its neurotransmitters, controls important body functions, such as heart rate, respiratory rate, gastrointestinal function, appetite, sleep, sexual performance, blood pressure, and mood. Additionally, neurotransmitters and neuromodulators play a crucial role in regulating the function of the cardiovascular, reproductive, musculoskeletal, immune, respiratory, and memory systems.
Medical Foods work through a different pathway from many prescription pharmaceuticals and do not normally interfere with these medications. The nutritional management of disease states allows physicians additional flexibility in the use of pharmaceutical agents. Randomized Double Blind Clinical Trials have shown that when certain Medical food products are used in conjunction with low dose pharmaceutical agents, efficacy is improved and the negative side effects associated with these pharmaceuticals are potentially reduced.
About ErgoD2™ Hemo
ErgoD2™ Hemo is an encapsulated medical food product formulated to improve blood cell counts, hemoglobin levels, and insulin sensitivity in patients with anemia and/or diabetes. Ergothioneine is a natural electron donor that has been shown to help to maintain iron in the +2 oxidation state required for oxygen binding in red blood cells within the blood. Ergothioneine also stimulates progenitor bone marrow stem cells which are required for red blood cell production. Ergocalciferol (Vitamin D2) helps to regulate bone marrow erythropoietic cells involved in red blood cell production and additionally has been shown to increase insulin sensitivity and Adiponectin levels which regulate glucose metabolism and fatty acid catabolism in type 1 and 2 diabetes. The product may have the potential to reduce or delay costly Epogen therapy in dialysis patients and Metformin or Glucotrol therapy in diabetes patients.
About ErgoD2™ Hair
ErgoD2™ Hair is an encapsulated medical food product formulated to improve hair growth, health, and coloring in patients with Alopecia. Hair loss is associated with reduced insulin sensitivity and iron and oxygen deficiency which are conditions that can potentially be improved by supplementation with Ergothioneine and Ergocalciferol. Ergothioneine and Ergocalciferol also reduce oxidative stress and the associated free radical reactions have been linked to premature greying. Ergocalciferol has been shown to stimulate proliferation and differentiation of keratinocytes and the mushrooms used in the ErgoD2™ formulation also contain high concentrations of natural melanin and selenium, which are involved in hair coloring and health. ErgoD2™ Hair is the prescription strength version of the popular dietary supplement Groh™, which is marketed by Entia's Total Nutraceutical Solutions subsidiary to leading hair salons throughout North America.
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.
The Entia Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=11778
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. Some portions of this press release were adapted from other sources including http://www.ptlcentral.com. 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.
For more information, please visit our web sites at www.entiabio.com and www.totalnutraceutical.com.