Navigation Links
Radius Announces Launch of RAD1901 Clinical Program for the Treatment of Hot Flashes
Date:1/30/2008

-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 Hayashi, Senior Vice President, Corporate Business Development, Eisai Co., Ltd. "There is a large underserved market for effective vasomotor symptom relief with a favorable side-effect profile. RAD1901's rapid progress is testimony to Radius' domain expertise in endocrinology and nuclear hormone receptors, and we are confident that this promising therapeutic agent for postmenopausal women will move forward into full clinical development."

About RAD1901

RAD1901 is a novel selective estrogen receptor modulator (SERM) discovered by Eisai Co., Ltd. and licensed by Radius (excluding Japan) in 2006. 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. In preclinical studies, Radius has 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.

About Vasomotor Symptoms (Hot Flashes)

Hot flashes are a common symptom during menopause, with more than 75% of women experiencing them during the menopause transition, for a median duration of four years. These symptoms can disrupt sleep and interfere with quality of life. An estimated two million women undergo menopause every year in the U.S., with a total population of 50 million postmenopausal women. In addition, most women receiving systemic therapy for breast cancer suffer hot flashes, often with more severe or prolonged symptoms. Treatment with estrogen or hormone replacement therapy (ERT or HRT) is the standard of care for many women suffering hot flashes, but due to concerns about potential long-term risks and contraindications, there is a significant need for new therapeutic options.

About Radius (http://www.radiuspharm.com)

Radius is a leading company in the discovery and development of a new generation of drug therapies for osteoporosis and women's health. Radius has raised $91.5 million in private equity financing since its establishment in 2003 and is based in Cambridge, Massachusetts.

About Eisai (www. eisai.co.jp)

Eisai Co., Ltd. is a research-based human health care company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; gastrointestinal disorders; and integrative oncology, including oncotherapy and supportive-care treatments. Through a global network of research facilities, manufacturing sites and marketing affiliates, Eisai actively participates in all aspects of the worldwide healthcare system.

(C) 2008 Radius Health Inc.

Contact:

Nick Harvey

Chief Financial Officer

(617) 551-4704


'/>"/>
SOURCE Radius
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Radius Ventures Announces Promotion of Dr. David Stoffel to Partner
2. Samarion(SM) Announces Formation of Outcome Based Study Team for Industrys Only Enterprise Quality Improvement System
3. STERIS Corporation Announces Fiscal 2008 Third Quarter Results
4. Anesiva Announces Hiring of Sales Force for FDA-Approved Product Zingo(TM)
5. Natural Nutrition Announces Forward Split of Common Stock
6. Asthma Foundation Announces 2008 Asthma Capitals, Knoxville on Top Again
7. Healthcare Realty Trust Announces Fourth Quarter Earnings Release Date and Conference Call
8. Wyeth Announces Launch of Own Generic Version of PROTONIX
9. Flextronics Announces Third Quarter Results
10. NightHawk Radiology Holdings, Inc. Announces Date for Fourth Quarter and Full-Year 2007 Earnings Conference Call
11. Healthcare Realty Trust Announces Fourth Quarter Dividend
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology: