Business Services Industry
OXIS International Inks Deal with Cambridge Major Laboratories to Produce Its Potent Antioxidant Ergothioneine; Company On Schedule To Offer Nutritional Supplement By End Of Year
Business Wire, July 19, 2005
PORTLAND, Ore. -- OXIS International, Inc. (OTCBB:OXIS) (Nouveau Marche:OXIS) 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.
About Cambridge Major Laboratories
Cambridge Major Laboratories, Inc. is a service-based chemistry outsourcing partner to the world's leading pharmaceutical and biotechnology companies, producing pharmaceutical intermediates, API's, and other fine organic chemicals. Specializing in chemical process development and advanced multi-step organic synthesis, the Company operates a new, state-of-the-art facility near Milwaukee, Wisconsin including process chemistry laboratories, GMP kilo labs, GMP production plants and complete analytical laboratories. The Company has been FDA inspected and approved for cGMP manufacturing. Visit us at www.c-mlabs.com.
About OXIS
OXIS International Inc., headquartered in Portland, Oregon, focuses on developing technologies and products to research, diagnose, treat and prevent diseases associated with damage from free radical and reactive oxygen species -- diseases of oxidative stress. The company holds the rights to three therapeutic classes of compounds in the area of oxidative stress, and develops, manufactures and markets products and technologies to diagnose and treat diseases caused by oxidative stress.
Statements in this release that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, any statements regarding beliefs, plans, estimates, projections, expectations, goals or intentions regarding the future. Forward-looking statements in this release include statements regarding the Company's commercialization plans to launch ergothioneine in 2005, with the first products available as over-the-counter supplements to help combat many age-related diseases ranging from Alzheimer's to cancer; ergothioneine being manufactured in compliance with the FDA's strict Drug GMPs (Good Manufacturing Practices), which provides quality levels suitable for use in human clinical studies; Cambridge Major's ability to meet the demands of the FDA's drug-quality standards and being able to far exceed the typical Food GMP standards of many nutritional supplements on the market today; Ergothioneine's potential being equal to or greater than that of Vitamin C; the ability to plant scale the manufacture of Ergothioneine; the antioxidant properties of ergothioneine; the Company's plans to explore alternative formulations that will allow patients to utilize ergothioneine in products designed for a variety of diseases, including dermal protectants in sunscreens and protective cosmetics, and as a topical ophthalmic to replenish the loss of antioxidants experienced during cataract development. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties such as unforeseen difficulties related to the manufacture of Ergothioneine in FDA quality commercial quantities, the acceptance of Ergothioneine as an over-the-counter nutraceutical;; decreases in the rate of spending by the Company's customers; the development by the company's competitors of new competing products; and other risks indicated in the Company's filings with the Securities and Exchange Commission. It is important to note that actual outcomes could differ materially from those in such forward-looking statements. Readers should also refer to the documents filed by the company with the Securities and Exchange Commission, specifically the annual report on Form 10-KSB for the year ended December 31, 2004, filed with the Securities and Exchange Commission on February 25, 2005 (SEC File No. 000-08092), and the Company's Amendment No. 1 to Form SB-2 Registration Statement filed with the Securities and Exchange Commission on April 29, 2005 (SEC File No. 333-123008).
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