There are dozens of major immune and other conditions for which the body’s excessive acute or chronic inflammatory responses are a primary cause of tissue damage, morbidity and mortality. Conditions in this category include MS, stroke, rheumatoid arthritis, traumatic brain injury, asthma, acute respiratory distress syndrome, and atherosclerosis among others. Sales of drugs to treat these diseases exceed $58 billion annually despite the fact that for many of these conditions the existing treatment options are inadequate. As an example, more than $6 billion was spent in 2005 to treat fewer than half of the approximately one million plus patients around the world who suffer from MS. The only effective treatments are injection biologic drugs that cost more than $10,000 per year, entail substantial side effects, are inconvenient and only offer modest relief to a subset of patients. More than half of the diagnosed MS patients are intolerant or not responsive to current MS biologic drugs and are not receiving any treatment for active and debilitating MS. Various research studies conducted by the Company demonstrate that a formulation administered orally may provide the patient a more convenient and better-tolerated treatment either alone or in conjunction with the specific drug currently utilized. Corresponding research indicates that this would apply to other acute and chronic inflammation mediated diseases as well.

Research results have shown that potential target indications for patient treatment for neurodegenerative diseases would include ataxia-telangiectasia (A-T), Alzheimer’s disease, amyotrophic lateral sclerosis and Friedreich’s ataxia (F-A). The Company will initially focus on A-T, a rare immunodeficiency disease, a recessive genetic disorder of childhood that affects males and females equally. This rare disease affects an estimated 1 out of 40,000 to 50,000 persons. The Company is planning to file an Orphan Drug application for A-T in both the US and European markets. The Company has been invited to participate in a funded human clinical trial that would evaluate the use of Bach's proprietary drugs in patients with A-T. Bach is working with Harvard Medical School and Children’s Hospital Boston to establish this multi-university clinical trial to be conducted throughout the US and potentially Europe.

A similar approach will be followed with respect to a clinical trial for F-A, another Orphan Drug disease. The Company intends to focus its clinical efforts through sponsored research. F-A is an inherited disease that causes progressive damage to the nervous system resulting in symptoms ranging from gait disturbance and speech problems to heart disease. F-A is the most prevalent inherited ataxia, effecting about 2 in 50,000 people in the United States. Males and females are affected equally.

Pre-clinical studies conducted at US universities have shown that Bach’s products are active in controlling neurodegeneration in A-T. Recent studies at The University of Texas, M.D Anderson Cancer Center are as follows:

1. "Mechanism and Therapies with Defective Neural Stem Cells in A-T Neurodegeneration." Dr. Paul K.Y. Wong (2009);
2. "Retrovirus-Induced Oxidative Stress with Neuroimmunodegeneration Is Suppressed by Antioxidant Treatment with a Refined Monosodium α-Luminol (Galavit®)" Dr. Yuhong Jiang, Journal of Virology (2006); and
3. “Prevention of Thymic Lymphoma Development in Atm -/- mice by Dexamethasone” - Dr. Mingshan Yan, Cancer Research (2002).

A-T is a rare disease listed by the Office of Rare Diseases (ORD) of the National Institutes of Health (NIH), meaning that A-T, or a subtype of ataxia-telangiectasia, affects less than 200,000 people in the US population. The American Society of Clinical Oncology estimates that A-T affects from 1 in 40,000 individuals to 1 in 100,000 individuals. The UK based Ataxia-Telangiectasia Society reports that 3 out of every million people have A-T in the UK.

The treatment of A-T would represent a significant breakthrough for thousands of individuals who seek a treatment for their specific disease. As a result, Bach should also be able to gain additional long term safety data that will add insight into the use of the product on chronic diseases and support the product profile in subsequent applications, including other neurodegenerative diseases, such as: Alzheimer’s, multiple sclerosis and Parkinson’s and autoimmune deficiencies such as AIDS and Crohn’s.

Currently there are no drug therapies that effectively and safely prevent further neuronal degeneration, control symptoms and ameliorate related complications in this important human disease area.

Trauma from injury and/or wounds whether self inflicted in the form of lacerations, burns and severe muscle sprains or intentionally inflicted, e.g. surgical procedures, most often result in inflammation, edema (swelling) and pain. These symptoms have been shown to signify an underlying condition of cellular oxidative stress and over-activation of biological functions. Pre-clinical studies have indicated that delivery of the redox buffer GVT® to the trauma site results in relief of pain and redness, reduced swelling, reduced time to repair, limited scarring and reduced complications from complex surgical procedures.

The current global wound care market is estimated to exceed $7B and is projected to exceed $9B by 2011. The advanced wound care market which includes hydrogels, hydrocolloids, alginates, foams, transparent films, active dressings and wound healing devices was estimated to be worth $4.1B in 2006 and is expected to exceed $7B in 2011. Advanced technologies, such as GVT®, are being investigated with the goal to augment standard treatment regimens in order to reduce the effect of trauma related sequelae including inflammation, scarring, adhesions, infections, and edema. Target indications where GVT® could be indicated include high volume surgical procedures such as coronary artery bypass surgery (CABS), joint replacement and tonsillectomies. Other indications include adjunct therapy for healing broken bones and burns, and for faster healing of lacerations (soft tissue damage) resulting from injuries.

For proper wound care, host defenses and repair mechanisms must be activated and then at least partially suppressed to maintain homeostasis. The right balance must be established to aid healing but at the same time prevent the inevitable cellular, tissue, organ or whole body damage that can occur from prolonged or over-reactive inflammatory responses. Several cell types must collaborate in order to complete the healing process in the human body. Published peer-reviewed literature supports the thesis that these wide-ranging cell types located throughout the organism in different tissue types require multiple redox-sensitive signaling pathways to collaborate in a timely way. Controlling these highly reactive redox signals has historically been biologically and therapeutically difficult. This makes proper wound care, especially in major wounds caused by trauma such as surgery, infection, accidents and injuries highly unpredictable. Exposure of tissues and blood to oxygen, bacteria, viruses and a number of xenobiotic materials used in surgery (e.g. plastic and metal medical devices) exacerbate the health issues commonly seen in wound care.

Redox-sensitive signals for wound care can work quickly. At high concentrations, these same mediators can irreversibly bind to cellular macromolecules and destroy their functions. In contrast, at low doses (of these modifiers) wound care can be slow and may be inadequate. This allows for opportunistic infections that trigger their own type of immune and inflammatory responses to delay the healing even more.

The therapeutic goal for Bach’s wound care products is to augment standard treatment regimens and reduce the effect of wound related sequelae including inflammation, scarring, adhesions, infections and edema. Target indications where Bach’s products would be indicated include high volume surgical procedures, such as coronary artery bypass surgery (CABG), joint replacement and tonsillectomies. Other indications include adjunct therapy for faster healing of soft tissue damage resulting from trauma.

Bach has data from the following studies regarding the use of its technology in wound care.

Wound care incorporates a broad range of indications for preventing cell damage resulting from surgery, trauma and burns. Complications in wound care are currently addressed by a number of means. Steroids are used to suppress the body’s general inflammatory responses. Anti-coagulants are administered for prophylactic care. Anti-infectives are used to suppress opportunistic invasions by bacteria and viruses. Medical devices are coated to reduce contact of blood and tissue with oxygen and other stress-inducing agents. These approaches reduce intracellular stresses if administered correctly and in a timely way. When administered too slowly or inadequately, persistent chronic imbalance in the redox potential leads to poor healing at the site of injury, and eventually to cell death, tissue loss and generalized hyper-inflammation in otherwise-healthy patients. Several current therapeutic approaches have been linked to adverse events.

In coronary artery, bypass surgery (CABG) there is strong documented evidence to support the relationship between inflammation and the occurrence of cardiovascular events. Furthermore, intracellular oxidative stress and inflammation have been linked to the development of postoperative atrial fibrillation (PAF) in patients receiving CABG. PAF represents a commercially important unmet medical need, as the incidence of PAF is 20% to 45%.

The risk of PAF has been reported to increase the length of hospital stay up to 5 days, which increases costs by approximately $11,000 per stay. It has also been associated with a 2 to 3-fold increase in postoperative strokes, which adds further medical costs, as well as a number of other variable costs due to changes in the patients’ lifestyles and productivity. Current treatments for PAF include anti-arrhythmic devices and drugs, as well as, anticoagulation drugs.

CABG results in initial hospital costs in excess of $30,000 per patient because current therapeutic regimens do not fully address the medical need. Applied to more than 400,000 patients annually in the United States alone, this produces total costs of more than $12 billion per year. New therapeutic regimens that reduce or prevent oxidative stress and the associated inflammatory responses would help reduce the incidence of post intervention cardiac events, and produce significant economic and medical benefits to patients, insurers and hospitals. In published scientific data, Bach’s products have been shown to alleviate intracellular oxidative stress and to control inflammation.

Treatments of early aneuploidy (before the cancer adaptation) with redox agents that suppress both the excess protein/DNA synthesis and the oxidative stress have been able to slow the rate of missegregation and prevent the subsequent cancer adaptations with its pathological consequences.

ASTRO, the American Society for Therapeutic Radiology and Oncology, projects that more than one million patients will be treated in the US making over 23 million visits for radiation therapy treatments per year.

Similar to the way oxidative stress is involved in the pathogenesis of other diseases, its role in the progression of metabolic disease syndromes has been well characterized as a result of recent research at a number of US institutions. Accumulation of fatty acids in adipose tissue as a result of over eating and obesity triggers intracellular redox stress. The loss of redox homeostasis leads to a host of inflammatory responses including up-regulation of certain genes and gene products, and down-regulation of others. These medicinal and other pathogenic conditions include non-alcoholic fatty livers, insulin resistance, Type 2 diabetes, changes in phospholipid metabolism, hyperlipidemia, and generalized inflammatory responses in the circulatory system and heart. This syndrome is manifested by the formation of plaques, arterial sclerosis and cardiovascular events. Restoring intracellular redox homeostasis has been shown to ameliorate intracellular and tissue inflammatory responses as determined by changes in biomarkers present in the cells, as well as, in the general circulatory system. There is a substantial and growing need for treating metabolic syndrome, particularly as the US and worldwide epidemic of obesity continues to rapidly materialize. The increasing prevalence of metabolic syndrome in Western-type societies has elevated it to a high priority public health issue. A recent study published in late July, 2009 puts a dollar estimate on this epidemic of $140 billion a year in extra medical costs in the US alone with two-thirds of American adults and one out of five children above what doctors consider a healthy weight for their size. It was also reported that on average obese patients spend for medical care an additional $1,500 a year more than a patient of healthy weight.

Novel drugs are now essential to halt and treat the underlying pathogenesis of the disease, which is sub-optimally controlled on a symptomatic basis with agents targeting the component diseases and disorders. Ideally, treatments that globally address multiple components of the syndrome would satisfy a high unmet medical need, and will be the focus of future research and development. Inflammatory processes are tightly linked to oxidative stress and the endothelial dysfunction associated with metabolic syndrome and its progression. As a result, given the growing recognition among scientists and clinicians of the relationship between oxidative stress and the development of metabolic syndrome, GVT® represents a promising candidate for combating multiple components of this disease. It is the Company’s intent to seek collaborations with other companies as a means of accelerating the development and use for these indications.

For the therapeutic treatment of most ocular related issues, topical administration of a substance appears to be the preferred route for ophthalmic applications given that only a small fraction of an administered dose will reach the eye from the general regulatory system. Research at Colorado State University has demonstrated the effectiveness of GVT® in its ability to pass through the blood-retinal barrier. This research, coupled with recent results demonstrating its ability to cross the blood-brain barrier, makes GVT® a viable candidate for ophthalmic applications. Recent results of a sponsored research program have confirmed the potential for this specific application.

Research shows that Bach’s technology has potential for development of applications in a variety of human healthcare and other products. These applications include inflammatory diseases, metabolic disease syndromes, immuno-deficient diseases, auto-immune diseases, radiation exposure and ophthalmic indications. Bach has performed certain preliminary research, development and regulatory activities in some of these potential product areas. However, Bach’s ability to continue the important work to develop and commercialize these applications will depend in large part on entering into product development and commercialization agreements with corporate partners. Bach intends to pursue clinical development of certain of these applications as resources allow. In addition, the Company, as a result of product utilization, will also out license when appropriate the technologies for use in non-therapeutic/medical fields such as food supplements and cosmetics.