WALTHAM, MA, USA I December 19, 2014 I Radius Health, Inc. (RDUS) announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application for its investigational drug RAD1901, a tissue-selective estrogen receptor degrader (SERD) being developed for potential use in metastatic breast cancer.
The Phase 1 study that is the subject of the IND is a 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, that is designed to determine the recommended phase 2 dose and include a preliminary evaluation of the potential anti-tumor effect of RAD1901. The details of the planned Phase 1 study of RAD1901 in breast cancer metastases will be posted on www.clinicaltrials.gov.
We also are continuing discussions with the European Organization for the Research and Treatment of Cancer (EORTC) to develop a protocol for the initiation of a European Phase1 trial. We anticipate initiation of the European trial following regulatory review and upon institutional review board approval.
About The Investigational Drug RAD1901
Radius is developing the investigational agent RAD1901 as a potential treatment for estrogen positive (ER+) cancers, like breast, ovarian or endometrial cancer. Currently we are focusing our clinical research activities in breast 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 ER. RAD1901 has demonstrated 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. In addition, we believe that RAD1901 also has the ability to cross the blood-brain barrier. In vitro, treatment of human breast cancer cell lines with the investigational drug RAD1901 resulted in degradation of the ER and inhibition of both basal and estradiol-stimulated proliferation.
A recent poster presented at the San Antonio Breast Cancer Symposium (SABCS) included preclinical data indicating that increasing doses of RAD1901 potently induced tumor regression. Tamoxifen and fulvestrant were the comparator drugs in this study. The poster also included data from the Phase 1 study in which 18F-estradiol positron emission tomography (FES-PET) was used to provide a pharmacodynamic assessment of estrogen receptor engagement/turnover. Following 6-days of daily treatment with the investigational drug RAD1901 at 200mg and 500mg doses, a complete suppression of FES-PET signal was observed, with standardized uptake values (SUV) comparable to background tissues. To date, the maximum tolerated dose of RAD1901 has not been determined.
The potential clinical significance, if any, of the data presented in the poster is currently unknown and will be evaluated further as the development program for the investigational drug RAD1901 continues.
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 (BA058) 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, including breast cancer brain metastases. www.radiuspharm.com.
SOURCE: Radius Health
Post Views: 27
WALTHAM, MA, USA I December 19, 2014 I Radius Health, Inc. (RDUS) announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application for its investigational drug RAD1901, a tissue-selective estrogen receptor degrader (SERD) being developed for potential use in metastatic breast cancer.
The Phase 1 study that is the subject of the IND is a 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, that is designed to determine the recommended phase 2 dose and include a preliminary evaluation of the potential anti-tumor effect of RAD1901. The details of the planned Phase 1 study of RAD1901 in breast cancer metastases will be posted on www.clinicaltrials.gov.
We also are continuing discussions with the European Organization for the Research and Treatment of Cancer (EORTC) to develop a protocol for the initiation of a European Phase1 trial. We anticipate initiation of the European trial following regulatory review and upon institutional review board approval.
About The Investigational Drug RAD1901
Radius is developing the investigational agent RAD1901 as a potential treatment for estrogen positive (ER+) cancers, like breast, ovarian or endometrial cancer. Currently we are focusing our clinical research activities in breast 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 ER. RAD1901 has demonstrated 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. In addition, we believe that RAD1901 also has the ability to cross the blood-brain barrier. In vitro, treatment of human breast cancer cell lines with the investigational drug RAD1901 resulted in degradation of the ER and inhibition of both basal and estradiol-stimulated proliferation.
A recent poster presented at the San Antonio Breast Cancer Symposium (SABCS) included preclinical data indicating that increasing doses of RAD1901 potently induced tumor regression. Tamoxifen and fulvestrant were the comparator drugs in this study. The poster also included data from the Phase 1 study in which 18F-estradiol positron emission tomography (FES-PET) was used to provide a pharmacodynamic assessment of estrogen receptor engagement/turnover. Following 6-days of daily treatment with the investigational drug RAD1901 at 200mg and 500mg doses, a complete suppression of FES-PET signal was observed, with standardized uptake values (SUV) comparable to background tissues. To date, the maximum tolerated dose of RAD1901 has not been determined.
The potential clinical significance, if any, of the data presented in the poster is currently unknown and will be evaluated further as the development program for the investigational drug RAD1901 continues.
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 (BA058) 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, including breast cancer brain metastases. www.radiuspharm.com.
SOURCE: Radius Health
Post Views: 27
