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news.Radius Health has reported that the Dutch regulatory authority has accepted its clinical trial application for RAD1901, the company's novel tissue-selective SERM designed to relieve vasomotor symptoms in postmenopausal women.
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Radius plans to begin a Phase I clinical trial of RAD1901 in healthy postmenopausal women in the Netherlands in March 2008. The study will evaluate the safety, tolerability, and pharmacokinetics of escalating doses of RAD1901. Radius licensed worldwide rights (excluding Japan) to RAD1901 and its analogs from Eisai in June 2006. The acceptance of the CTA triggered an undisclosed milestone payment by Radius to Eisai.
Richard Lyttle, president and CEO of Radius, said: “This is particularly exciting because RAD1901 has the potential to be the first in a new class of SERMs (selective estrogen receptor modulator) that could simultaneously address critical unmet needs of postmenopausal women-a treatment option that would alleviate hot flashes without the administration of an estrogen, while improving bone integrity and preventing or treating breast cancer.”