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HIGH CORTISOL DISEASE DRUG (SP-6300)

SP-6300 has shown the ability to modulate excessive cortisol levels by lowering the hormone-stimulated corticosteroid formation in adrenal cells, and as a result could be a potentially new treatment for Cushing's Syndrome.

Cushing's Syndrome is a disorder of the adrenal glands leading to excess cortisol secretion. This means that there is too much cortisol hormone in the blood. Cushing's Syndrome is a hormonal disorder caused by prolonged exposure of the body's tissues to high levels of the hormone cortisol. It is sometimes called "hypercortisolism,'' and an estimated 10 to 15 of every million people are affected each year.

Long-term (chronic) use of corticosteroid medications, for the treatment of conditions such as lupus, asthma, and rheumatoid arthritis, is the most common cause of Cushing's Syndrome. Patients who develop Cushing's exhibit a variety of symptoms including weight gain, fatigue, muscle weakness, diabetes, high blood pressure, depression, and osteoporosis. If left untreated, Cushing's Syndrome can lead to death.

Dr. Greeson, CEO of Samaritan Pharmaceuticals stated, "There is an urgent need to develop new therapeutic agents, with a new and different mechanism of action, for Cushing's. It is commonly held that the cause of Cushing's is related to patients taking too much corticosteroid medications. We believe the addition of SP-6300 to normally prescribed medications might allow doctors to prescribe smaller doses of corticosteroid medications; to possibly decrease corticosteroid side effects, and increase their efficacy, at the same time."

Cushing's syndrome affects adults 20 to 50 with an estimated 10 to 15 of every million people affected each year. Hypercortisolism occurs when the body's tissues are exposed to excessive levels of cortisol for long periods of time.

Many people suffer the symptoms of exogenous hypercortisolism because they take glucocorticoid hormones such as prednisone, dexamethasone (Decadron) and methylprednisolone (Medrol), for asthma, rheumatoid arthritis, lupus and other inflammatory diseases or for immunosuppression after transplantation. People can also develop exogenous hypercortisolism from injectable corticosteroids -- for
example, repeated injections for joint pain, bursitis and back pain. While certain inhaled steroid medicines (taken for asthma) and steroid skin creams (for skin disorders such as eczema) are in the same general category of drugs, they're generally not implicated in hypercortisolism unless taken in very high doses.

People also develop endogenous hypercortisolism because of overproduction of cortisol by the body. Normally, the production of cortisol follows a precise chain of events. First, the hypothalamus sends corticotrophin releasing hormone (CRH) to the pituitary gland. CRH causes the pituitary to secrete ACTH
(adrenocorticotropin), a hormone that stimulates the adrenal glands. When the adrenals receive the ACTH, they respond by releasing cortisol into the bloodstream. Cortisol performs vital tasks in the body. It helps maintain blood pressure and cardiovascular function, reduces the immune system's inflammatory
response, balances the effects of insulin in breaking down sugar for energy, and regulates the metabolism of proteins, carbohydrates, and fats. When the amount of cortisol in the blood is adequate, the hypothalamus and pituitary release less CRH and ACTH. This ensures that the amount of cortisol released by the adrenal glands is precisely balanced to meet the body's daily needs.