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Radius Initiates Phase 2a Clinical Trial of RAD1901 in Menopausal Hot Flashes
Date:3/24/2009

n Argentina, is a double-blind, placebo-controlled, dose-ranging study in 100 otherwise healthy menopausal women experiencing recurrent moderate-to-severe hot flashes who will be randomized to receive one of four doses of RAD1901 and placebo. The duration of treatment after screening and baseline will be 28 days. The primary endpoint of the study is the frequency and severity of hot flashes relative to baseline. In addition, data on changes in pharmacodynamic markers of estrogen effect--follicle-stimulating hormone (FSH), luteinizing hormone (LH), and lipid profile effect--will be collected.

About RAD1901

RAD1901 is a novel selective estrogen receptor modulator (SERM) under development at Radius as a new class of menopausal therapy. SERMs are small molecules that bind to and selectively modulate estrogen receptors. These molecules have the ability to stimulate or block estrogen's activity in different types of tissue, functioning as estrogen receptor agonists in some tissues and as estrogen receptor antagonists in others. Currently available SERMS are approved for the treatment and prevention of breast cancer and osteoporosis but tend to respectively increase the frequency and severity of hot flashes. In preclinical studies, Radius demonstrated RAD1901's potential to reduce vasomotor symptoms, along with a simultaneous bone-protective effect, without stimulating breast or uterine tissues. RAD1901 is distinctive from other SERMs in its unique biological profile, combined with its significant ability to penetrate the blood-brain barrier, which enables RAD1901 to function as an estrogen agonist within the central nervous system and thereby relieve hot flashes. RAD1901 was discovered by Eisai Co., Ltd. and licensed by Radius (excluding Japan) in 2006.

About Vasomotor Symptoms (Hot Flashes)

Hot flashes are a common symptom during menopause, experienced by more than 75% of women during the menopause transit
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SOURCE Radius Health
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