-Elacestrant single agent Objective Response Rate (ORR) was 23% in heavily pre-treated patients with advanced ER+ breast cancer at the cut off date of April 28, 2017-
-In the 400 mg patient group with mature data, median PFS was 4.5 months and Clinical Benefit Rate at 24 weeks was 42%-
-38% of these patients previously received fulvestrant; 40% received palbociclib or another CDK inhibitor; 50% had an ESR1 mutation-
-15 of the 40 patients remain on treatment as of the cutoff date-
-Investor Webcast today at 7 pm CT-
WALTHAM, Mass., June 04, 2017 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS), a fully integrated science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced positive data from a fully enrolled ongoing Phase 1 study of elacestrant (RAD1901), an oral selective estrogen receptor degrader (SERD), in patients with estrogen receptor positive (ER+) breast cancer. These data were presented this morning at the 2017 American Society of Clinical Oncology Meeting in Chicago, Illinois.
As of the cut-off date of April 28, 2017, 40 patients have been treated in the fully enrolled elacestrant Phase I dose escalation and expansion cohorts at the 400 mg dose. These patients are all heavily pretreated ER+, HER2-negative advanced breast cancer patients who have received a median of 3 prior lines of systemic therapy and have evaluable advanced or metastatic disease. Of the enrolled patients, 22 patients met the RECIST measurable disease criteria at baseline and there were five confirmed partial responses in this group. Elacestrant was well-tolerated with the most common adverse events being low grade nausea and dyspepsia.
"While still early, the single-agent clinical activity and safety profile demonstrated with elacestrant in this heavily pretreated advanced hormone receptor positive breast cancer patient population is encouraging when compared to the results shown for other agents in a similar setting," said Dr. Aditya Bardia, Director of Precision Medicine and attending physician at Center for Breast Cancer, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA. "This is important for patients because it could potentially offer another endocrine therapy option even upon progression on standard endocrine therapy and could potentially delay the use of toxic chemotherapy, which is a meaningful clinical goal, and additional studies are needed."
On June 4, 2017, at the 2017 ASCO Annual Meeting, the following abstract was presented as a poster and will be included in the Poster Discussion Session later today: Abstract 1014
In connection with today's elacestrant presentation at ASCO, Radius will host a conference call and live webcast at 7:00 p.m. CT on Sunday, June 4 2017 to discuss the results of the Phase I program as of the cut off date of April 28, 2017.
Date: Sunday, June 4, 2017
Time: 7:00 p.m. CT
Live webcast: http://edge.media-server.com/m/p/acpzpzcu
A replay of the webcast will be available on the company's website, www.radiuspharm.com in the Investor section under Events and Presentations for 7 days following the live webcast.
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius' lead product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Radius' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under regulatory review in Europe. The Radius clinical pipeline includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug elacestrant (RAD1901) for potential use in estrogen receptor positive breast cancer, and vasomotor symptoms in postmenopausal women. Radius' RAD140, a non-steroidal, selective androgen receptor modulator (SARM), is under investigation for potential use in hormone receptor positive breast cancer. For more information, please visit www.radiuspharm.com.
About Elacestrant (RAD1901)
Elacestrant is a selective estrogen receptor down-regulator/degrader (SERD), which at high doses is being evaluated for potential use as an oral non-steroidal treatment for estrogen receptor positive breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.
Additional information on the clinical trial program of elacestrant (RAD1901) is available on www.clinicaltrials.gov.
RAD140 is a non-steroidal selective androgen receptor modulator (SARM). The androgen receptor (AR) is frequently expressed in many estrogen receptor (ER)-positive, ER-negative, and triple-negative breast cancers. Because of its receptor and tissue selectivity, potent activity, oral bioavailability, and long half-life, RAD140 could have clinical potential in the treatment of breast cancer. RAD140 resulted from an internal drug discovery program focused on the androgen receptor pathway, and exhibits a differentiated mechanism of action compared to ER-targeted therapy.
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 without limitation statements regarding the significance of clinical data for elacestrant obtained to date; the potential of elacestrant, as a monotherapy or in combination with other anti-cancer therapies, for the treatment of breast cancer; and the potential clinical uses and therapeutic and other benefits of our product candidates, including abaloparatide-TD, elacestrant and RAD140.
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 only recently started to commercialize TYMLOS in the U.S.and may need to raise additional funding, which may not be available; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products, any collaboration agreements failing to be successful; risks related to clinical trials, including our reliance on third parties to conduct key portions of our 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 or during commercialization, if approved; risk related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings 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.
Investor Relations Contact: Barbara Ryan Email: email@example.com Phone: 203-274-2825 Media Contact: Lori Gorski Email: Lgorski@radiuspharm.com Phone: 617-551-4096