Study will evaluate safety, dose and tumor response in postmenopausal women with metastatic disease
WALTHAM, MA, USA I September 29, 2017 I Radius Health, Inc. (Nasdaq:RDUS) announced today 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. 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.
About Hormone Receptor Positive Breast Cancer
Approximately 70 percent of breast cancers are hormone receptor positive, expressing either estrogen receptors or progesterone receptors. Although some hormone receptor positive breast cancers respond to hormone therapies that lower hormone levels or block hormone receptors, these cancers often develop resistance to therapy.
About Radius
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius’ lead product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug elacestrant (RAD1901) for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Radius’ RAD140, a nonsteroidal, selective androgen receptor modulator (SARM), is under investigation for potential use in hormone receptor positive breast cancer. For more information, please visit www.radiuspharm.com.
SOURCE: Radius
Post Views: 105
Study will evaluate safety, dose and tumor response in postmenopausal women with metastatic disease
WALTHAM, MA, USA I September 29, 2017 I Radius Health, Inc. (Nasdaq:RDUS) announced today 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. 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.
About Hormone Receptor Positive Breast Cancer
Approximately 70 percent of breast cancers are hormone receptor positive, expressing either estrogen receptors or progesterone receptors. Although some hormone receptor positive breast cancers respond to hormone therapies that lower hormone levels or block hormone receptors, these cancers often develop resistance to therapy.
About Radius
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius’ lead product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug elacestrant (RAD1901) for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Radius’ RAD140, a nonsteroidal, selective androgen receptor modulator (SARM), is under investigation for potential use in hormone receptor positive breast cancer. For more information, please visit www.radiuspharm.com.
SOURCE: Radius
Post Views: 105
