-CTA Acceptance in the Netherlands Triggers Milestone Payment to Eisai-
CAMBRIDGE, Mass., Jan. 30 /PRNewswire/ -- Radius Health ("Radius") announced today that the Dutch regulatory authority has accepted its Clinical Trial Application (CTA) for RAD1901, Radius' novel tissue-selective SERM (selective estrogen receptor modulator) designed to relieve vasomotor symptoms (hot flashes). 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 Co., Ltd.
"We are pleased that the Netherlands regulatory authorities have accepted the CTA for RAD1901 and look forward to advancing into Phase I studies," said Louis O'Dea, MD, Chief Medical Officer of Radius. "Our preclinical data demonstrated RAD1901's potential to relieve hot flashes while preventing postmenopausal bone loss, without estrogenic effects on breast and uterus. If those findings are borne out in our clinical studies, we will have an important new medical option to offer women entering menopause."
"Acceptance of this CTA to initiate clinical development of RAD1901 is an important milestone for Radius," said C. Richard Lyttle, PhD, President and CEO of Radius. "This is particularly exciting because RAD1901 has the potential to be the first in a new class of SERMs 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."
"We are pleased with the progress of our partner, Radius, in achieving
acceptance of the CTA filing," said Hideki Hayash
Copyright©2008 PR Newswire.
All rights reserved