OXIS International Inks Deal with Cambridge Major Laboratories To Produce Its Potent Antioxidant Ergothioneine
Portland, OR - OXIS International, Inc. today announced that it has entered into a manufacturing agreement with Cambridge Major Laboratories (Germantown, WI) to produce Ergothioneine, which OXIS plans to make available as an over-the-counter nutraceutical supplement in 2005. The potent antioxidant will be manufactured in compliance with the FDA's strict Drug GMPs (Good Manufacturing Practices), which provides quality levels suitable for use in human clinical studies.
"We've selected Cambridge Major as our Ergothioneine manufacturing source because of its ability to meet the demands of the FDA's drug-quality standards, far exceeding the typical Food GMP standards of many nutritional supplements on the market today," stated Steven T. Guillen, President and CEO of OXIS. "Our goal is to bring to market the industry's first synthetic source of Ergothioneine in tablet, capsule, cream, or gel-cap forms with the highest level of quality to help combat many age-related diseases ranging from Alzheimer's to cancer."
Ergothioneine is an important antioxidant supplement because it concentrates in tissues and organs that undergo the most oxidative stress in humans, yet ergothioneine must be ingested in humans because the body does not produce it. OXIS has developed a synthetic source that matches the natural Ergothioneine used as an antioxidant in humans. OXIS has 15 patents, either issued or pending, within the U.S. and around the world on this unique compound.
"Ergothioneine is one of the most advanced antioxidants to be brought to the market and I believe its potential is equal to or greater than that of Vitamin C, " said Dr. Michael W. Major, President and CEO of Cambridge Major Laboratories. "From our point of view, the agreement with OXIS represents another milestone in our long term growth strategy. The agreement will allow us to utilize our expertise in synthesis to advance it to plant-scale manufacturing, and to become a commercial supplier for years to come. Furthermore, manufacturing Ergothioneine is an ideal application for our new 50,000 square-foot, state-of-the-art GMP facility which has been in operation since January of this year."
The positive effects of antioxidants were recently highlighted in the journal Science, featuring results from a University of Washington study that found mice with a higher level of antioxidants had healthier heart tissue than normal mice. This new study provided some of the most compelling evidence that oxidative stress plays a crucial role in age-related diseases.
The role of Ergothioneine as an antioxidant and cellular protectant has been well documented in peer-reviewed journals. Ergothioneine localizes within certain cells, such as erythrocytes, making it unique among other naturally occurring antioxidants such as vitamin C and E. The antioxidant properties of Ergothioneine appear to be related to at least four molecular activities: the ability to scavenge free radicals; to chelate, or combine with, various divalent metallic cations (positively charged ions); to activate antioxidant enzymes such as glutathione peroxidase (Se-GPx) and MnSOD and to inhibit superoxide-generating enzymes such as NADPH-Cytochrome c reductase; and to affect the oxidation of various hemoproteins such as hemoglobin and myoglobin.
OXIS plans on exploring alternative Ergothioneine formulations for use in products designed to address a variety of diseases, including dermal protectants in sunscreens and protective cosmetics, and topical ophthalmic preparations to replenish the loss of antioxidants experienced during cataract development.
SOURCE: OXIS International, Inc.