SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome

Inclusion Criteria:

• Male or non-menstruating female

• 18 years or older

• Active and consistent cortisol excess

• Documented diagnosis of ACTH-dependent Cushing's syndrome including Cushing'sdisease, ectopic ACTH secretion, and ectopic CRH secretion.

Exclusion Criteria:

• Recent (within 6 weeks) surgery for Cushing's or surgery planned within 24 weeks ofrandomization.

• History of any fractionated radiation therapy for Cushing's within the past 2 yearsor conventional radiation therapy within 4 years.

• History of bilateral adrenalectomy or exogenous, pseudo, cyclic, ornon-ACTH-dependent Cushing's syndrome (including certain inherited conditions).

• High risk of acute morbidity from corticotroph adenoma growth (similar to that whichoccurs with Nelson's syndrome) defined as current evidence of macroadenoma at riskof impingement of vital structures.

• Any current or prior medical condition, medical or surgical therapies, or clinicaltrial participation expected to interfere with the conduct of the study or theevaluation of its results, including but not limited to poor venous access or recentreceipt or donation of blood products.

• Women who are currently pregnant, lactating or planning fertility and unwilling toadhere to approved contraceptives or abstinence.