Dear NADF Members and Friends:

Corcept Therapeutics has initiated a study into the eficacy and safety their new drug Corlux (mifepristone) in relation to treatment of the signs and symptoms of endogenous Cushing's Syndrome. (www.cushingsstudy.com)

Source: http://www.corcept.com/background.htm

Researcher: Corcept Therapeutics Incorporated is a pharmaceutical company focused on the development of medications for the treatment of severe psychiatric and metabolic diseases. The product the company has developed, CORLUX, "modulates the effect of cortisol by selectively blocking the binding of cortisol to one of its two known receptors, the GR-II receptor, also known as the Type II or GR receptor."

In July 2007, the FDA granted Corcept received Orphan Drug Designation from the FDA for CORLUX for the treatment of Cushing's Syndrome - a disorder caused by prolonged exposure of the body's tissues to high levels of the hormone cortisol. Orphan drugs obtain seven years of marketing exclusivity from the date of approval, as well as tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process.

In September 2007, the Company received notification that the FDA has opened the Investigational New Drug application (IND) for CORLUX for the treatment of Cushing's Syndrome. The FDA has indicated that a single study may provide a reasonable basis for the submission of a New Drug Application (NDA) for this indication.

In addition to the above, Corcept also owns or has exclusively licensed issued patents and patent applications relating to the treatment of several disorders that the Company believes also result from, or are negatively affected by, prolonged exposure to elevated cortisol including early dementia associated with Alzheimer's disease, mild cognitive impairment, stress disorders and psychosis associated with cocaine addiction. The Company also has filed patent applications for additional diseases that may benefit from treatment with a drug that blocks the GR-II receptor.

Research specifics:

The SEISMIC Study is a US based clinical research trial designed to test mifepristone in the treatment of the clinical manifestations of endogenous Cushing's Syndrome over a 6 month period of treatment.

Subjects must:

Be at least 18 years of age

Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or ACTH independent etiologies, including:

a. Cushing's Disease that

I. recurred after primary pituitary surgery or

II. has persisted despite pituitary surgery (failed pituitary surgery) or

III. has been treated with radiation therapy to the pituitary

IV. is not treatable with surgery

V. exists in patients who are not candidates for surgery

b. Ectopic ACTH

c. Ectopic CRF secretion

d. Adrenal adenoma

e. Adrenal carcinoma

f. Adrenal autonomy

Require medical treatment of hypercortisolemia

Have diabetes mellitus type 2 or glucose intolerance AND/OR have hypertension caused by, or aggravated by hypercortisolemia

Have two or more of the following signs or symptoms related to hypercortisolemia:

Cushinoid appearance

Increased body weight or central obesity

Proximal muscle weakness

Low bone mass (DXA T < -1.0)

Psychiatric symptoms (including depression or psychosis)

Hirsutism and/or violaceous striae and/or acne

SEISMIC Study - Main Exclusion Criteria

Subjects must not:

Have de novo Cushing's disease or be surgical candidates for pituitary surgery

Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment

Be currently taking medications known to significantly induce or inhibit CYP3A4, or have taken these medications within 7 days of Screening

Be pregnant or unable or unwilling to use medically acceptable, non-hormonal methods of contraception during the study (female patients of reproductive potential)

Have received investigational treatment (drug, biological agent or device) within 30 days of Screening

Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)

Have a non-endogenous source of hypercortisolemia such as factious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factious or therapeutic use of ACTH

Have Pseudo-Cushing's Syndrome

Receive PPARg agonist drugs (e.g. pioglitazone, rosiglitazone) within 4 months of screening

Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL

Be a postmenopausal woman with an intact uterus who has experienced unexplained vaginal bleeding within 12 months of Screening

For more information about the SEISMIC Study, please email us at info@cushingsstudy.com or call
1 (877) 367-6550 1 (877) ENROLL-0