September 29, 2017 Radius Health, Inc. (Nasdaq:RDUS) reported that the first patient has been enrolled in the company’s Phase 1 study of RAD140, a nonsteroidal selective androgen receptor modulator (SARM) undergoing clinical evaluation for the treatment of hormone receptor positive breast cancer (Press release, Radius, SEP 29, 2017, View Source [SID1234520703]). The clinical trial is designed to evaluate the safety and maximum tolerated dose of RAD140 in approximately 40 patients.
“The RAD140 mechanism of action is differentiated from both selective estrogen receptor modulators (SERMs) and selective estrogen receptor degraders (SERDs). We expect RAD140 to play a broad role in endocrine resistance, including a genetically defined population, in patients with tumors that are resistant to treatment with the current standard of care,” said Gary Hattersley, PhD, Chief Scientific Officer of Radius Health.
“RAD140 has significant potential to complement future applications of elacestrant (RAD1901) by targeting distinct mechanisms of endocrine resistance,” commented Jesper Høiland, President and CEO of Radius. “We will provide additional details in peer-reviewed publications and plan to report results from the trial at upcoming scientific conferences.”
The Phase 1 clinical trial is a safety and dose-ranging study in approximately 40 patients with progressive metastatic or locally advanced or metastatic breast cancer. In Part A of the trial, postmenopausal women with metastatic hormone receptor positive breast cancer will receive escalating doses of RAD140 by oral administration over a period of 28 days. Primary safety outcomes include rate of dose-limiting toxicities, adverse events related to treatment, and tolerability as measured by dose interruptions or adjustments. In addition, pharmacokinetics, pharmacodynamics and tumor response will also be evaluated.
About RAD140
RAD140 is an internally discovered nonsteroidal selective androgen receptor modulator, or SARM, which is under investigation for potential use in hormone receptor positive breast cancer. The androgen receptor, or AR, is highly expressed in hormone receptor positive breast cancers. An investigational new drug application, or IND, submitted to the FDA for RAD140 has been accepted.
Emerging clinical data suggest that androgen receptor positivity is associated with favorable clinical outcome in breast cancer. RAD140 selectively targets the AR receptor and has shown significant preclinical activity in endocrine resistant models as a single agent and in combination with standard of care.