-3 patients had confirmed partial responses by RECIST criteria from ongoing Phase I studies with RAD1901 in patients with advanced estrogen receptor positive breast cancer-
-In the Phase 1 dose escalation and expansion study, 14 heavily pretreated patients remained on RAD1901 for equal to or greater than 4 months, 5 for equal to or greater than 6 months, and 7 continued on study drug as of the October cut-off date-
-46% of these patients previously received fulvestrant; 42% received palbociclib or another CDK inhibitor; 58% had an ESR1 mutation-
-Investor Webcast today at 8 pm CT with leading KOLs-
WALTHAM, Mass., Dec. 08, 2016 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq: RDUS ), a science-driven biopharmaceutical company focused on developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced data from two ongoing Phase 1 studies of RAD1901, an oral selective estrogen receptor degrader (SERD), in patients with estrogen receptor positive (ER+) breast cancer, which were presented this morning at the San Antonio Breast Cancer Symposium 2016.
As of the cut-off date of October 7, 2016, 20 patients have been treated in the RAD1901 Phase IB safety expansion cohort at the 400 mg dose. These patients are heavily pretreated ER+, HER2-negative advanced breast cancer patients who have received a median of 3 prior lines of therapy . Of the enrolled patients, 19 out of 20 had measurable disease at baseline and there were two confirmed partial responses by RECIST criteria. Across the Part A dose escalation (n=13) and safety expansion cohort (n=20), 14 patients were on study drug for greater than or equal to 4 months, 5 patients for greater than or equal to 6 months, and 7 patients remained on study drug. RAD1901 was well-tolerated with the most common adverse events being low grade nausea and dyspepsia.
In the ongoing European Phase I RAD1901 FES-PET trial, the first three-patients were enrolled at 400 mg as of the October 7 th cut-off date and achieved a reduction in 18 F-FES uptake ranging from 79%-91% at day 14 compared to baseline. One patient had a confirmed partial response by RECIST criteria. All three patients remained on study drug with mean duration of treatment of 5.64 cycles. Adverse events reported to date have been grade 1 and 2 and manageable. This study will enroll 5 additional patients in the 400 mg QD cohort followed by 8 patients in the 200 mg QD cohort. No dose limiting toxicities have been reported across any of the studies in the RAD1901 program.
“The single-agent clinical activity and duration of response demonstrated with RAD1901 in the heavily pretreated population may be important in addressing the major challenge of resistance facing patients with ER positive advanced breast cancer,” said Dr. Virginia Kaklamani, Professor of Medicine, UT Health Science Center San Antonio, leader of the Breast Cancer Program, Cancer Therapy & Research Center, and investigator on the study.
“An oral, well-tolerated and effective SERD could become an important adjunct in combination therapy for patients and we look forward to the results of additional studies,” said Professor George W. Sledge Jr., Professor and Chief of Medical Oncology at Stanford University Medical Center, and member of Radius’ Oncology Clinical Advisory Board.
Dr. Virginia Kaklamani and Dr. George Sledge will participate in a Radius hosted investor meeting and webcast later today to highlight the RAD1901 data presented at SABCS at 8 p.m. CT. The webcast and a replay can be accessed on the company’s website, www.radiuspharm.com .
The posters presented this morning from the RAD1901 clinical development program were:
Abstract Title: A Phase 1 Study of RAD1901, a Novel, Oral, Selective Estrogen Receptor Degrader, for the Treatment of ER-Positive Advanced Breast Cancer, Poster # 1454
Abstract Title: A Phase 1 Study of RAD1901, an Oral Selective Estrogen Receptor Degrader, to Determine Changes in the F-FES Uptake and Tumor Responses in ER-Positive, HER-2-Negative, Advanced Breast Cancer Patients, Poster # 1604
Radius will also present later the following poster later today from the RAD1901 preclinical program:
Abstract Title: RAD1901 Demonstrates Anti-Tumor Activity in Multiple Models of ER-Positive Breast Cancer Treatment Resistance, Poster # 1378 Poster Session 3 Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance Session Date: 12/8/2016 Session Time: 5:00 PM — 7:00 PM Location: Hall 1
About Radius
Radius is a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius' lead product candidate, the investigational drug abaloparatide for subcutaneous injection, has completed Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with osteoporosis. Radius' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under regulatory review in Europe and a New Drug Application (NDA) has been accepted for filing by the FDA with a PDUFA date of March 30, 2017. The Radius clinical pipeline also includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug RAD1901 for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Radius' preclinical pipeline includes RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in cancer. For more information, please visit www.radiuspharm.com
About RAD1901
RAD1901 is a selective estrogen receptor degrader (SERD), which at high doses is being evaluated for potential use as an oral non-steroidal treatment for hormone-driven, or hormone-resistant, breast cancer. RAD1901 is currently being investigated for potential use in postmenopausal women with estrogen receptor positive (ER+), HER2-negative advanced 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.
RAD1901 also is being evaluated in a Phase 2b study at low doses for potential reduction of the frequency and severity of moderate to severe hot flashes in postmenopausal women. Additional information on the clinical trial program of RAD1901 is available on www.clinicaltrials.gov .
RAD140
RAD140 is a nonsteroidal selective androgen receptor modulator. The androgen receptor (AR) is highly expressed in many estrogen receptor (ER)-positive, ER-negative, and triple-negative receptor 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, which is highly expressed in many breast cancers.
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 without limitation expectations regarding the significance of preclinical and clinical data for RAD 1901 obtained to date, the potential of RAD 1901, as a monotherapy or in combination with other anti-cancer therapies, for the treatment of breast cancer, and the potential clinical uses for abaloparatide-TD, RAD1901 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 no product revenues 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; any collaboration agreements failing to be successful; 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; and delays in enrollment of patients in our clinical trials, which could delay or prevent regulatory approvals. These and other important factors discussed under the caption "Risk Factors" in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 25, 2016, 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.
Investor Relations Contact: Barbara Ryan Email: bryan@radiuspharm.com Phone: 203-274-2825 Media Contact: Lori Gorski Email: Lgorski@radiuspharm.com Phone: 617-551-4096
