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Novartis Drug SOM230 is First Medical Therapy to Show Efficacy in a Phase III Trial in Cushing's Disease, a Debilitating Hormonal Disorder
Date:9/21/2010

ebilitating disease," said William H. Ludlam, MD, PhD, Director, Seattle Pituitary Center at the Swedish Neuroscience Institute in Seattle, WA.  "The results of this study suggest that pasireotide may help patients achieve biochemical control of their Cushing's disease and its symptoms by directly targeting the pituitary tumor that triggers excess cortisol production."

PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease) is the largest randomized study to evaluate a medical therapy in patients with Cushing's disease(1). The trial is part of a large-scale global clinical development program to assess the efficacy and safety of SOM230 in a range of pituitary and neuroendocrine tumors(6).

"Positive results from this trial bring us one step closer to providing physicians with a new treatment option to offer people living with the physically and emotionally debilitating symptoms associated with Cushing's disease," said Herve Hoppenot, President, Novartis Oncology.

These data will form the basis for the first regulatory filing of SOM230 planned this year. SOM230 has orphan drug designation for Cushing's disease in the US and Europe(7),(8). In the US, orphan drugs are those developed to treat diseases affecting fewer than 200,000 people(9). In Europe, orphan drugs are those developed to treat conditions affecting fewer than five in 10,000 people(8).

Study detailsPASPORT-CUSHINGS is a prospective Phase III study of 162 patients conducted at 68 sites in 18 countries. The study evaluated the efficacy and safety of SOM230 in patients with persistent or recurrent Cushing's disease, as well as in patients with newly diagnosed Cushing's disease who are not candidates for surgery(1),(10).

Patients with primarily moderate to severe hypercortisolism were randomized to receive SOM230 subcutaneous (sc) injection in doses of 600ug (n=82) or 900ug (n=80) twice daily. The primary endpoint was the proportion of patients who
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SOURCE Novartis Pharmaceuticals Corporation
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