Radius Initiates Phase 2a Clinical Trial of RAD1901 in Menopausal H... ( --Study will evaluate proof of concep...)

Radius Initiates Phase 2a Clinical Trial of RAD1901 in Menopausal Hot Flashes

Date:3/24/2009

--Study will evaluate proof of concept for company's first-in-class SERM designed to relieve vasomotor symptoms without side effects associated with hormone therapy--

CAMBRIDGE, Mass., March 24 /PRNewswire/ -- Radius Health ("Radius") announced today that the first patient has been dosed in the company's proof-of-concept Phase 2a study of RAD1901, an investigational selective estrogen receptor modulator (SERM) undergoing clinical evaluation for treatment of vasomotor symptoms (menopausal hot flashes). The clinical trial is designed to evaluate the ability of RAD1901 to relieve menopausal hot flashes without the administration of estrogen. RAD1901 has demonstrated positive effects in preclinical models of vasomotor symptoms and a favorable safety profile in Phase I human clinical studies.

"The initiation of this proof-of-concept trial is a significant milestone for Radius," said C. Richard Lyttle, PhD, President and CEO of Radius. "A positive outcome of this Phase 2a clinical trial would further position RAD1901 as a next-generation SERM that provides an alternative to estrogen in alleviating menopausal hot flashes, without the side effects associated with hormone therapy. We look forward to reporting the results of this trial later in 2009."

"RAD1901 represents an ideal candidate for the potential treatment of postmenopausal vasomotor symptoms, given its unique clinical profile demonstrated in preclinical and Phase I studies--estrogen-agonist effects on the central nervous system while protecting against breast and uterine tissue stimulation," said Louis O'Dea, MD, Chief Medical Officer of Radius. "This Phase 2 trial will provide us with critical insight into the dose-response relationship between increasing doses of RAD1901 and efficacy in the treatment of hot flashes."

Clinical Trial Details

The Phase 2a clinical trial, which is being conducted at approximately six sites i
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SOURCE Radius Health
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