On October 18, 2017 Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq:RDUS), reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for elacestrant, an investigational oral selective estrogen receptor down-regulator/degrader (SERD) as a treatment of women with ER+ and HER2- advanced or metastatic breast cancer (Press release, Radius, OCT 18, 2017, View Source [SID1234521010]). Fast Track designation is a process designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.

“It is estimated that about 1 in 8 women will develop invasive breast cancer over the course of their lifetime,” said Jesper Høiland, President and Chief Executive Officer of Radius Health. “If approved, elacestrant could offer a hormonal therapy alternative and potentially delay the use of chemotherapy in patients with estrogen receptor positive breast cancer. Early results of our Phase 1 trial show an encouraging efficacy and safety profile. We look forward to working closely with the FDA as we rapidly advance the development of elacestrant.”

The elacestrant clinical development program is currently ongoing with two Phase I studies in patients with ER+, HER2- advanced or metastatic breast cancer who have been heavily pre-treated (median of three prior lines of therapy) and have evaluable disease.

“The Company will provide updates on both Phase 1 studies and present two preclinical posters at the 2017 San Antonio Breast Cancer Symposium in December,” said Gary Hattersley, PhD, Chief Scientific Officer. “The FDA has indicated that, depending on the Phase 2 study results, the single-arm Phase 2 trial could be considered a pivotal study with a confirmatory study on-going at the time of NDA submission. We expect to enroll the first patient in the Phase 2 study in early 2018.”

For more information on ongoing clinical trials of elacestrant, visit www.clinicaltrials.gov.