A Novartis AG experimental drug reduced abnormally high hormone levels in patients with Cushing’s disease, a condition linked to a benign tumor of the pituitary gland.
After six months, the treatment, called SOM230, reduced the amount of cortisol in the urine in quarter of the patients receiving a higher dose of the drug, the Basel, Switzerland- based company said today in an e-mailed statement.
The illness is caused by a tumor or excessive growth of the pituitary gland at the base of the brain. This triggers the release of a hormone that makes the body produce too much cortisol, a stress hormone that controls the body’s use of food and helps handle the immune system’s response to swelling, according to the National Institute of Health.
“Up to half of patients with Cushing’s disease cannot be cured with currently available options, which include surgery or radiotherapy of the tumor, leaving a critical need for medical treatments,” Annamaria Colao of the University of Naples and one of the study investigators, said in the Novartis release.
The study, the last of three usually needed for U.S. regulatory approval, included 162 patients. A quarter of those receiving SOM230 at the higher of two possible doses had normal urinary free cortisol levels, a measure of the disease.
Novartis plans to ask U.S. regulators for marketing authorization by the end of this year.