WALTHAM, Mass., Nov. 02, 2015 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases, including hormone responsive breast cancer, announced today that it will present new data on investigational oral drug RAD1901 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics to be held at the Hynes Convention Center in Boston, Massachusetts USA on November 7 and 8, 2015.
The company will present one oral and one poster presentation showing promising activity for its investigational oral drug RAD1901, a selective estrogen receptor degrader (SERD), in preclinical models of advanced estrogen-receptor-positive (ER+) breast cancer. Data showed that the investigational drug RAD1901 has potent anti-tumor activity in multiple patient-derived xenograft models including those that were insensitive to other hormonal agents as well as models that harbor ESR1 mutations.
“These encouraging data solidify the potential promise of investigational drug RAD1901 and we look forward to continuing its development in breast cancer,” said Dinesh Purandare, SVP and Head of Global Oncology, Radius Health. “We believe there is significant unmet need for innovative therapies for metastatic breast cancer, particularly in patients with tumors that are resistant to current hormonal agents, and we are committed to bringing this medicine forward to the patients who need it most.”
According to the World Health Organization, breast cancer is the second most common cancer in the world and the most prevalent cancer in women, accounting for sixteen percent of all female cancers. Approximately seventy percent of breast cancer patients are ER+ with tumors that depend on estrogen signaling for growth and survival. SERDs, such as the investigational drug RAD1901, are an emerging class of endocrine therapies that directly induce ER degradation, potentially enabling them to treat ER-dependent tumors without allowing treatment resistance to develop.
Poster and Oral Presentation Information:
Title: RAD1901, an orally available selective estrogen receptor downregulator, has potent anti-tumor activity in in vitro and in vivo models of ER+ breast cancer
Abstract Number: PR10
Session/Poster: Oral Presentation
Date and Time: Saturday, Nov 7, 2015, 5:54 PM - 6:06 PM
Location: Boston Hynes Convention Center, Ballroom C
Title: RAD1901, an orally available selective estrogen receptor downregulator, has potent anti-tumor activity in in vitro and in vivo models of ER+ breast cancer
Abstract Number: C100
Session/Poster: Poster Board Number C100
Date and Time: Sunday, Nov 8, 2015, 12:30 PM - 3:30 PM
Location: Boston Hynes Convention Center, Session C, Hall C-D
About Radius Health
Radius is a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive cancers. Radius’ lead development candidate is the investigational drug abaloparatide for subcutaneous injection, currently in Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with severe osteoporosis. The Radius clinical portfolio also includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug RAD1901 for potential use in hormone driven, or hormone resistant, metastatic breast cancer, and vasomotor symptoms.www.radiuspharm.com
About the Investigational Drug RAD1901
Radius is developing the investigational drug RAD1901 as a potential treatment for estrogen-receptor-positive (ER+) breast cancer. The drug also has potential as a treatment for other ER+ cancers, such as ovarian or endometrial cancer. The National Cancer Institute estimates that approximately 70% of breast cancers are ER+ and may grow in response to exposure to estrogen. Endocrine therapy is intended to block the estrogen signal or reduce the production of estrogen. More information about breast cancer and endocrine therapy may be found on the National Cancer Institute website http://www.cancer.gov/cancertopics/factsheet/Therapy/hormone-therapy-breast.
RAD1901 is an investigational, non-steroidal small molecule that is designed to selectively bind and degrade the estrogen receptor. RAD1901 has shown potent anti-tumor activity in xenograft models of ER+ breast cancer in preclinical testing and complete suppression of the FES-PET signal after six days of dosing in a maximum tolerated dose clinical study. In preclinical models thus far, RAD1901 has shown good tissue selectivity, does not appear to stimulate the uterine endometrium and appears to protect against bone loss in an ovariectomy-induced osteopenia rat model. Radius recently reported preclinical data for RAD1901 in combination with either mTOR or CDK inhibitors, which showed potent tumor shrinkage in a patient-derived tumor explant animal model.
Radius has begun a Phase 1 multicenter, open-label, two-part, dose-escalation study of the investigational drug RAD1901 in postmenopausal women with advanced estrogen receptor positive and HER2-negative breast cancer. The study is designed to determine the recommended Phase 2 dose of RAD1901, and includes a preliminary evaluation of the potential anti-tumor effects. The incidence of dose limiting toxicities will be assessed during the first 28 days. Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines every 8 weeks until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months of treatment. Plasma concentrations of RAD1901 will be assessed every 28 days for up to 12 months of treatment. The details of the Phase 1 study of RAD1901 are posted on www.clinicaltrials.gov.
Radius is also developing RAD1901 at lower doses as a selective estrogen receptor modulator (“SERM”), for the potential treatment of vasomotor symptoms. Historically, hormone replacement therapy (“HRT”) with estrogen or progesterone was considered the most efficacious approach to relieving menopausal symptoms such as hot flashes. However, because of the concerns about the potential long-term risks and contraindications associated with HRT, Radius believes a significant need exists for new therapeutic treatment options to treat vasomotor symptoms. In a Phase 2 proof of concept study, RAD1901 at lower doses showed a reduction in the frequency and severity of moderate and severe hot flashes. Radius intends to commence a Phase 2b trial in vasomotor symptoms in the second half of 2015.
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