CAMBRIDGE, Mass., Jan. 30 Radius Health ("Radius")announced today that the Dutch regulatory authority has accepted its ClinicalTrial 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 inhealthy postmenopausal women in the Netherlands in March 2008. The study willevaluate the safety, tolerability, and pharmacokinetics of escalating doses ofRAD1901.
Radius licensed worldwide rights (excluding Japan) to RAD1901 and itsanalogs from Eisai in June 2006. The acceptance of the CTA triggered anundisclosed milestone payment by Radius to Eisai Co., Ltd.
"We are pleased that the Netherlands regulatory authorities have acceptedthe CTA for RAD1901 and look forward to advancing into Phase I studies," saidLouis O'Dea, MD, Chief Medical Officer of Radius. "Our preclinical datademonstrated RAD1901's potential to relieve hot flashes while preventingpostmenopausal bone loss, without estrogenic effects on breast and uterus. Ifthose findings are borne out in our clinical studies, we will have animportant new medical option to offer women entering menopause."
"Acceptance of this CTA to initiate clinical development of RAD1901 is animportant milestone for Radius," said C. Richard Lyttle, PhD, President andCEO of Radius. "This is particularly exciting because RAD1901 has thepotential to be the first in a new class of SERMs that could simultaneouslyaddress critical unmet needs of postmenopausal women-a treatment option thatwould alleviate hot flashes without the administration of an estrogen, whileimproving bone integrity and preventing or treating breast cancer."
"We are pleased with the progress of our partner, Radius, in achievingacceptance of the CTA filing," said Hideki Hayashi, Senior Vice President,Corporate Business Development, Eisai Co., Ltd. "There is a large underservedmarket for effective vasomotor symptom relief with a favorable side-effectprofile. RAD1901's rapid progress is testimony to Radius' domain expertise inendocrinology and nuclear hormone receptors, and we are confident that thispromising therapeutic agent for postmenopausal women will move forward intofull clinical development."
RAD1901 is a novel selective estrogen receptor modulator (SERM) discoveredby Eisai Co., Ltd. and licensed by Radius (excluding Japan) in 2006. SERMs aresmall molecules that bind to and selectively modulate estrogen receptors.These molecules have the ability to stimulate or block estrogen's activity indifferent types of tissue, functioning as estrogen receptor agonists in sometissues and as estrogen receptor antagonists in others. In preclinicalstudies, Radius has demonstrated RAD1901's potential to reduce vasomotorsymptoms, along with a simultaneous bone-protective effect, withoutstimulating breast or uterine tissues. RAD1901 is distinctive from other SERMsin its unique biological profile, combined with its significant ability topenetrate the blood-brain barrier, which enables RAD1901 to function as anestrogen agonist within the central nervous system and thereby relieve hotflashes.
About Vasomotor Symptoms (Hot Flashes)
Hot flashes are a common symptom during menopause, with more than 75% ofwomen experiencing them during the menopause transition, for a median durationof four years. These symptoms can disrupt sleep and interfere with quality oflife. An estimated two million women undergo menopause every year in the U.S.,with a total population of 50 million postmenopausal women. In addition, mostwomen receiving systemic therapy for breast cancer suffer hot flashes, oftenwith more severe or prolonged symptoms. Treatment with estrogen or hormonereplacement therapy (ERT or HRT) is the standard of care for many womensuffering hot flashes, but due to conc