Radius Health Announces Conference Call And Webcast On New Data For Investigational Drug RAD1901 To Be Presented At San Antonio Breast Cancer Symposium 2015
WALTHAM, Mass., Dec. 07, 2015 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis and serious endocrine-related diseases, including hormone-responsive breast cancer, announced that it will host a conference call and webcast on Thursday, December 10, 2015, at 8 PM EST to provide an update on new data being presented on the investigational drug RAD1901 at the San Antonio Breast Cancer Symposium (SABCS) in San Antonio, TX, December 8-12.
RAD1901 is an investigational oral, selective estrogen receptor degrader (SERD) being evaluated for the potential treatment of hormone-driven, or hormone-resistant, metastatic breast cancer. RAD1901 has demonstrated potent single-agent and combination efficacy in ER+ primary patient derived xenograft animal models, including those harboring ESR1 mutations. These preclinical results, together with ongoing clinical data from Phase I monotherapy dose escalation trials, strongly support the further investigation of RAD1901 in patients with ER+ and endocrine-resistant disease. RAD1901 Poster Presentation Details:
Title: RAD1901, a Novel Oral, Selective Estrogen Receptor Degrader ("SERD") with Single Agent Efficacy in ER+ Primary Patient Derived ERS1 Mutant Xenograft Model
Abstract Number: P3-05-07
Session/Poster: Poster Session 3, Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Date and Time: Thursday, December 10, 2015, 5:00 PM – 7:00 PM CT (6:00 PM – 8:00 PM ET)
Location: Henry B. Gonzalez Convention Center, Halls A-B
Title: A Phase 1 Study of RAD1901, a Novel, Orally Available, Selective Estrogen Receptor Degrader, for the Treatment of ER Positive Advanced Breast Cancer
Abstract Number: OT2-01-10
Session/Poster: Ongoing Clinical Trials: Ongoing Trials -- Endocrine Therapies
Date and Time: Thursday, December 10, 2015 5:00 PM – 7:00 PM CT (6:00 PM – 8:00 PM ET)
Location: Henry B. Gonzalez Convention Center, Halls A-B
Title: A Phase 1 Dose Escalation Study of RAD1901, an Oral Selective Estrogen Receptor Degrader, in Healthy Postmenopausal Women
Abstract Number: P6-13-02
Session/Poster: Poster Session 6, Treatment: New Drugs and Treatment Strategies
Date and Time: Saturday, December 12, 2015, 7:30 AM – 9:00 AM CT (8:30 AM – 10:00 AM ET)
Location: Henry B. Gonzalez Convention Center, Hall C
Conference Call and Webcast
Radius will host a conference call and live audio webcast at 8:00 PM ET (7:00 PM CT) on Thursday, December 10, 2015 to provide an update on the RAD1901 data being presented at SABCS.
Conference Call and Webcast Information:
Date: Thursday, December 10, 2015
Time: 8:00 PM ET (7:00 PM CT)
Domestic Dial-in Number: 1-877-705-6003
International Dial-in Number: 1-201-493-6725
Live webcast: http://public.viavid.com/index.php?id=117520
Replay of the call information:
Domestic Dial-In Number: 1-877-870-5176
International Dial-in Number: 1-858-384-5517
Replay Pin Number 13626630
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 may also have 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 drug’s 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 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.
RAD1901 is an investigational oral, selective estrogen receptor degrader (SERD) being evaluated for the potential treatment of hormone-driven, or hormone-resistant, metastatic breast cancer. RAD1901 has demonstrated potent single-agent and combination efficacy in ER+ primary patient derived xenograft animal models, including those harboring ESR1 mutations. These preclinical results, together with ongoing clinical data from Phase I monotherapy dose escalation trials, strongly support the further investigation of RAD1901 in patients with ER+ and endocrine-resistant disease. RAD1901 Poster Presentation Details:
Title: RAD1901, a Novel Oral, Selective Estrogen Receptor Degrader ("SERD") with Single Agent Efficacy in ER+ Primary Patient Derived ERS1 Mutant Xenograft Model
Abstract Number: P3-05-07
Session/Poster: Poster Session 3, Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Date and Time: Thursday, December 10, 2015, 5:00 PM – 7:00 PM CT (6:00 PM – 8:00 PM ET)
Location: Henry B. Gonzalez Convention Center, Halls A-B
Title: A Phase 1 Study of RAD1901, a Novel, Orally Available, Selective Estrogen Receptor Degrader, for the Treatment of ER Positive Advanced Breast Cancer
Abstract Number: OT2-01-10
Session/Poster: Ongoing Clinical Trials: Ongoing Trials -- Endocrine Therapies
Date and Time: Thursday, December 10, 2015 5:00 PM – 7:00 PM CT (6:00 PM – 8:00 PM ET)
Location: Henry B. Gonzalez Convention Center, Halls A-B
Title: A Phase 1 Dose Escalation Study of RAD1901, an Oral Selective Estrogen Receptor Degrader, in Healthy Postmenopausal Women
Abstract Number: P6-13-02
Session/Poster: Poster Session 6, Treatment: New Drugs and Treatment Strategies
Date and Time: Saturday, December 12, 2015, 7:30 AM – 9:00 AM CT (8:30 AM – 10:00 AM ET)
Location: Henry B. Gonzalez Convention Center, Hall C
Conference Call and Webcast
Radius will host a conference call and live audio webcast at 8:00 PM ET (7:00 PM CT) on Thursday, December 10, 2015 to provide an update on the RAD1901 data being presented at SABCS.
Conference Call and Webcast Information:
Date: Thursday, December 10, 2015
Time: 8:00 PM ET (7:00 PM CT)
Domestic Dial-in Number: 1-877-705-6003
International Dial-in Number: 1-201-493-6725
Live webcast: http://public.viavid.com/index.php?id=117520
Replay of the call information:
Domestic Dial-In Number: 1-877-870-5176
International Dial-in Number: 1-858-384-5517
Replay Pin Number 13626630
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 may also have 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 drug’s 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 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.