WALTHAM, Mass., Aug. 28, 2014 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius") (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing novel differentiated therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases, reports that the positron emission tomography (PET) imaging from the RAD1901 maximum tolerated dose study ("MTD") has demonstrated potent selective estrogen receptor degradation ("SERD") activity. In the ongoing MTD study, we observed via 18F-fluroestradiol positron emission tomography that a well tolerated dose of RAD1901 strongly suppressed positive baseline estrogen receptor imaging sites in the first healthy volunteer in the PET imaging cohort of the study. The study will continue to test higher doses to determine the maximum tolerated doses and to extend the PET imaging correlation with the pharmacokinetic/pharmacodynamic response to RAD1901.
Radius will present these findings as a RAD1901 poster at the 4th Annual Brain Metastases Research and Emerging Therapy Conference, which takes place on September 19-20, 2014 in Marseille, France.
Title: RAD1901, A Novel Tissue-Selective Estrogen Receptor Degrader (SERD) Optimized For Blood-Brain Barrier
Presentation date: September 19th, 2014, 18:00 hours
In June 2014, Radius initiated a Phase 1 MTD study in healthy volunteers, RAD1901, a SERD, for the treatment of metastatic breast cancer, including breast cancer brain metastases ("BCBM"). The study is designed to evaluate the tolerability, safety and pharmacokinetics of RAD1901, and also use 18F-fluroestradiol positron emission tomography to provide a pharmacodynamic assessment of estrogen receptor turnover following RAD1901 treatment. Levels of RAD1901 in cerebrospinal fluid samples taken from the study subjects will be measured to confirm that RAD1901 has crossed the blood brain barrier. Radius believes there is a significant therapeutic opportunity for RAD1901 as it may offer the following advantages over the current standard of care for patients with metastatic breast cancer:
- ability to penetrate the blood-brain barrier;
- oral administration; and
- treatment of hormone driven, or hormone resistant, metastatic breast cancers.
Radius is also developing RAD1901 as a selective estrogen receptor modulator, or SERM, for the treatment of vasomotor symptoms. In a Phase 2 proof of concept study, RAD1901 at lower doses demonstrated a reduction in the frequency and severity of moderate and severe hot flashes.
Anticipated Upcoming Corporate Milestones
- Report of top-line fracture data from Abaloparatide-SC Phase 3 clinical study in late December 2014.
- Submit a New Drug Application/NDA and a European Marketing Authorization Application/MAA for Abaloparatide-SC in mid-2015.
- Initiate a Phase 1 clinical study of RAD1901 in metastatic breast cancer in late 2014.
- Report results of MTD study in RAD1901.
- American Society of Bone and Mineral Research 2014 annual meeting in September 2014.
- 4th Annual Brain Metastases Research and Emerging Therapy Conference September 19-20, 2014.
- BioCentury Annual NewsMakers Conference (September 2014), BIO Investor Forum (October 2014) and Jefferies 2014 Global Healthcare Conference (November 2014).
About Radius Health
Radius Health, Inc. is a science-driven biopharmaceutical company developing novel differentiated therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases. The company's lead development candidate is abaloparatide (BA058) for subcutaneous injection, currently in Phase 3 development for the reduction of fracture risk in postmenopausal women with severe osteoporosis. The Radius clinical portfolio also includes an abaloparatide transdermal patch for osteoporosis and RAD1901 for hormone driven, or hormone resistant, metastatic breast cancer, including breast cancer brain metastases. www.radiuspharm.com
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the potential for development of RAD1901 as a treatment of breast cancer, the therapeutic opportunity for RAD1901, expectations regarding the advantages for RAD-1901, anticipated upcoming milestones and upcoming events and presentations.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have no product revenues; our need for additional funding, which may not be available; we are not currently profitable and may never become profitable; restrictions imposed on our business by our credit facility, and risks related to default on our obligations under our credit facility; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of Abaloparatide-SC, and our inability to ensure that Abaloparatide-SC will obtain regulatory approval or be successfully commercialized; risks related to clinical trials, including having most of our products in early stage clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates; product candidates for which we obtain marketing approval, if any, could be subject to restrictions or withdrawal from the market and we may be subject to penalties; failure to achieve market acceptance of our product candidates; risks related to the use of our limited resources on particular product candidates and not others; delays in enrollment of patients in our clinical trials, which could delay or prevent regulatory approvals; the dependence of our drug development program upon third-parties who are outside our control; the risk that a regulatory or government official will determine that third-parties with a financial interest in the outcome of the Phase 3 study of Abaloparatide-SC affected the reliability of the data from the study; our reliance on third parties to formulate and manufacture our product candidates; failure to establish additional collaborations; our lack of experience selling, marketing and distributing products and our lack of internal capability to do so; failure to compete successfully against other drug companies; developments by competitors may render our products or technologies obsolete or non-competitive; risks related to the fact that our drugs may sell for inadequate prices or patients may be unable to obtain adequate reimbursement; effects of product liability lawsuits on commercialization of our products; failure to comply with obligations of our intellectual property licenses; failure to protect our intellectual property or failure to secure necessary intellectual property related to Abaloparatide-SC, Abaloparatide-TD, RAD-1901 and/or RAD-140; our or our licensors' inability to obtain and maintain patent protection for technology and products; risks related to our compliance with patent application requirements; failure to protect the confidentiality of our trade secrets; risks related to our infringement of third parties' rights; risks associated with intellectual property litigation, including expending substantial resources and distracting personnel from their normal responsibilities; risks related to employees' disclosure of former employers' trade secrets; risks associated with healthcare reform; our failure to comply with healthcare laws and regulations; our exposure to claims associated with the use of hazardous materials and chemicals; inability to successfully manage our growth; risks relating to business combinations and acquisitions; our reliance on key executive officers and advisors; our inability to hire additional qualified personnel; volatility in the price of our common stock; capital appreciation is the only source of gain for our common stock; risks related to increased costs and compliance initiatives associated with operating as a public company; our directors, executive officers and principal stockholders have substantial control over us and could delay or prevent a change in control; future sales of our common stock could depress the price of our common stock; inaccurate or unfavorable information about us could cause the price of our common stock to decline; provisions in our charter documents and Delaware law could discourage takeover attempts; and our ability to use our net operating loss carryforwards and certain other tax attributes may be limited. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on August 12, 2014, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. CONTACT: Investor Relations Barbara Ryan FTI Consulting Managing Director 212-850-5679 Barbara.Ryan@fticonsulting.com Media Relations Kimberly Ha FTI Consulting Senior Director 212-850-5612 Kimberly.Ha@fticonsulting.com
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