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OXIS International

Regions
North America
Countries
United States
Size
n.e.
Specialty
Biopharmaceuticals, Cosmeceuticals, …
Specialty
Biopharmaceuticals, Cosmeceuticals, Nutraceuticals
Service category
Contract manufacturing, filling and packaging
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ERGOTHIONEINE…THE SUPER ANTIOXIDANT FOR NUTRACEUTICAL, COSMECEUTICAL AND THERAPEUTICS

ERGO is naturally occurring, water soluble, amino acid multifaceted antioxidant produced by microbes in the soil and most commonly found in (but not produced by) various species of mushrooms and grapes, meats and dairy products. However, it is not commercially practical to extract ERGO from these natural sources and it essentially impossible to ingest a diet that provides enough ERGO to take full advantage of its potential health benefits. Humans and most animals typically have low levels of ERGO since the amount of ERGO in the diet is relatively small.

 

INTELLECTUAL PROPERTY AND SCIENCE BACKGROUND

Our intellectual property for ERGO includes three patents and two patent pending applications that cover the synthesis of highly-purified ERGO and the protective effect of ERGO on mitochondria and other pivotal body structures and functions. A number of peer reviewed scientific papers referenced in the Monograph [create link] on this website indicate that ERGO is one of the most potent, multifaceted biological compounds with both appreciable antioxidant, anti-inflammatory, neuroprotective and other protective properties. ERGO acts by itself, or in combination with other natural compounds to improve the body’s own intrinsic defenses against oxidative stress. Accordingly, Oxis is focusing its efforts on developing products that deliver the benefits of ERGO taken by itself and in combination with other elements that enhance various health protective systems.

 

BENEFITS OF ERGO

Some of the potential benefits of ERGO include its ability to:

  • Conserve and maintain the levels of other antioxidants such as Vitamin E, Vitamin C and glutathione;
  • Increase respiration and the oxidation of fat (possibly contributing to increased energy and exercise capacity);
  • Protect mitochondria from damage (this is important because potentially damaging reactive oxygen species are generated when oxygen is normally metabolized in mitochondria,
  • Reduce the damaging effects of environmental ultraviolet radiation (likely to be important in protecting the eyes against cataract producing oxidative injury);
  • Neutralize increased oxidative stress by providing an ROS (reactive oxygen species) and RNS (reactive nitrogen species) scavenging capacity, a property that protects key molecules in the body; and,

Protect against the effects of neurotoxins that are believed to have a casual role in the development and progression of cognitive decline.

 

Therapeutic compounds

Therapeutic compounds and clinical products are actual remedies that can be used to treat diseases. Oxis has several therapeutic compounds that are available to be licensed including anti-inflammatory and several therapeutic antioxidant mimics with potential applications in the treatment of neurodegenerative (Alzheimer’s and Parkinson’s), cardiovascular diseases, diabetes and other conditions.

 

TREATING OXIDATIVE STRESS

Oxidative stress is caused by the unchecked activities of reactive oxygen species (ROS) and reactive nitrogen species (RNS). Both ROS and RNS are highly reactive, unstable molecules that, in healthy cells, are created and neutralized as part of normal cell life. However, if the production of free radicals and ROS/RNS exceeds the body's natural defense mechanisms, oxidative damage to vital molecules in the body can occur and may lead to cell dysfunction and cell death.  Oxidative stress is also caused by inflammation, exposure to cigarette smoke, pollution, UV light, radiation, certain drugs and other conditions.  Oxidative stress also increases as we age.

OXIS' goal is to control both direct cellular abnormalities and damage from ROS and RNS.  One of ways that this can be accomplished is by using OXIS’s compounds to modulate the activation of certain molecules called transcription factors. Transcription factors are the central control switches in the body that can trigger and modulate a cascade of interrelated events.   Activation of transcription factors by ROS/RNS can accelerate inflammatory responses that can cause and contribute to cell death in degenerative and other diseases.  OXIS is in the process of early stage development of therapeutic molecules that have the ability to counteract some of these unwanted responses and perhaps be able to counteract different health abnormalities.

 

BXT 51072 (OUR LEAD COMPOUND) AND GLUTATHIONE PEROXIDASE (GPX) MIMICKING COMPOUNDS

BXT-51072 is a low molecular weight, orally active, organoselenium catalytic mimic of one of the major cellular protective antioxidant enzyme, glutathione peroxidase (GPx) which uses glutathione as substrate.  BXT-51072 can be taken orally or administered intravenously. In addition to its direct hydrogen peroxide (a central reactive oxygen species) neutralizing capabilities, BXT-51072 regulates secondary inflammatory processes by preventing the activation and release of inflammatory mediators such as cytokines, adhesion molecules and inflammatory enzymes. The exact mechanism is unclear but there is evidence that BXT-51072 may function by inhibiting fundamental nuclear transcription mechanisms that govern and regulate inflammation and other significant processes.   BXT-51072 was initially developed for use in the treatment of inflammatory bowel diseases, and has demonstrated efficacy and safety in a preliminary Phase 2 study for ulcerative colitis.

 

LIPID SOLUBLE ANTIOXIDANT (LSA) COMPOUNDS

OXIS' LSA Molecules are designed to mimic the activity of the body's natural cell membrane-protecting antioxidant, Vitamin E.  LSA molecules are 20 to 40 times more potent than Vitamin E and move into cell membranes much more quickly, giving them the opportunity to be effective in areas not necessarily penetrated by the natural Vitamin E. The primary disease targets for this series of molecules will include neurodegenerative diseases such as Alzheimer and Parkinson disease and cardiovascular diseases in additional to other possibilities.

Superoxide Dismutase (SOD) is a naturally occurring enzyme found in essentially all living organisms. SOD catalyzes the destruction of the “Superoxide” molecule. This enzyme has been used in Spain for many years in the treatment of Chronic Inflammatory Joint Diseases and in the prevention of Radiation Fibrosis and scarring in patients with Colorectal Carcinoma undergoing radiation treatment. Oxis has several patents related to SOD uses and continues to enhance its IP portfolio with additional SOD related technologies.

 

FDA APPROVED CLINICAL PRODUCT

Palosein (Orgotein) is an OXIS FDA approved drug for the treatment of arthritic inflammation in veterinary use called Palosein (NAD/NADA # 045-863).  Palosein is a form of Superoxide Dismutase (SOD) that is derived from bovine liver. Oxis is currently in the process of re-certifying its manufacturing process and is actively seeking partnerships with distributors to sell Palosein into the veterinary channel. Oxis will provide additional information on Palosein as further progress is achieved

 

 

 

CONSUMER PRODUCTS

OXIS is developing and plans to sell Nutraceutical and Cosmecuetical products featuring natural ingredients believed to have beneficial effects on human health. OXIS’ first products will include L-Ergothioneine (ERGO) as a key component. ERGO is a very powerful, multifaceted antioxidant. The remarkable properties of ERGO are described in detail in the Ergothioneine section of this website. OXIS has patented the synthesis process for L-Ergothioneine and has outsourced product manufacturing to a company that can provide ERGO in commercial and GMP produced quantities to meet our product needs.

OXIS’ consumer products strategy addresses very important health concerns including aging and age-related disorders that are increasing with trends in US demographics.  These concerns include:

  • Brain health
  • Immunity against diseases
  • Anti-aging/skin health
  • Inflammation
  • Detoxification
  • Blood sugar regulation

Our market entry and expansion strategy includes potential alliances with highly respected, credible and iconic thought leaders in each product category. Typically, these individuals or companies have established consumer followings or the ability to build meaningful and loyal customer bases.

Our plan is to develop on-going relationships with our customers and to be regarded as a health partner to individuals of all ages based on the products and educational content that we provide to them.

Channels for communicating our message and building sales being established include:

  • Multi-level marketing
  • Internet sales
  • TV Infomercials
  • Long and short form radio infomercials
  • Direct mail
  • Traditional retail approaches

We are planning two product launches for summer 2010

  • “Ergo-Pur™”  - ERGO-Pur is a pure form of our highly potent multifaceted antioxidant which we anticipate will be used in some cases in concert with:
  • “Ergo-Flex™” – ERGO-Flex is a combination of ERGO plus other functional nutraceutical ingredients directed at Joint Health.

Other products are being evaluated and include a line of skin care products. In addition we will develop other nutraceuticals and functional foods such as nutrition bars, energy beverages and single serve shots that lend themselves to traditional retail distribution

Approvals, Certificates, Authorisations

  • FDA

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