Radius Health Inc. (NASDAQ: RDUS) shares climbed higher on Friday after the firm provided an update on its early-stage clinical study in patients with estrogen receptor positive (ER+) breast cancer. Specifically, the update was from its Phase 1 0005 clinical study of elacestrant (RAD1901).
Keep in mind that elacestrant recently received Fast Track designation from the U.S. Food and Drug Administration (FDA).
There are 40 patients that have been treated at the 400 mg dose in the elacestrant Phase 1 dose escalation and expansion cohorts. All study participants are heavily pretreated ER+, HER2-negative, advanced breast cancer patients that have received a median of three prior lines of systemic therapy and have evaluable advanced or metastatic disease.
Out of the enrolled patients, 22 met the RECIST measurable disease criteria at baseline and there were six confirmed partial responses in this group. Elacestrant was well-tolerated with the most common adverse events being low-grade nausea, dyspepsia and vomiting. Also 10 of the 40 patients remain on treatment as of the cutoff date.
Radius plans to initiate its Phase 2 clinical study, a potentially pivotal study, for women with advanced or metastatic ER+/HER2- breast cancer early in 2018.
Gary Hattersley, PhD, chief scientific officer, commented:
Patients cycle through and generally do not repeat treatment regimens, limiting treatment options as their disease advances. We are pleased about the potential to offer patients who have progressed or relapsed during their current standard of care with a new treatment option. Radius is committed to developing and to providing breast cancer patients with the next generation of hormonal treatment options, as a single agent and in combination, across all lines of therapy.
Shares of Radius were last seen trading up about 15% at $31.45, with a consensus analyst price target of $50.71 and a 52-week range of $24.66 to $49.39.