Radius Health Receives FDA Fast Track Designation for Elacestrant (RAD1901)
19 October 2017 - 12:00AM
- Radius plans to initiate Phase 2 clinical study
of elacestrant as a third-line therapy for women with ER+ and HER2-
breast cancer early in 2018 -
Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS),
today announced 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. 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.
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. Radius' Marketing Authorisation Application
(MAA) for abaloparatide-SC for the treatment of postmenopausal
women with osteoporosis is under regulatory review in Europe. The
Radius clinical pipeline includes an investigational abaloparatide
transdermal patch for potential use in osteoporosis; the
investigational drug elacestrant (RAD1901) for potential use in
hormone-driven and/or hormone-resistant breast cancer, and
vasomotor symptoms in postmenopausal women; and RAD140, a
non-steroidal, selective androgen receptor modulator (SARM) under
investigation for potential use in hormone receptor positive breast
cancer. For more information, please visit www.radiuspharm.com.
About Elacestrant (RAD1901)
Elacestrant is a selective estrogen receptor
down-regulator/degrader (SERD), which at high doses is being
evaluated for potential use as an oral non-steroidal treatment for
hormone-driven or hormone-resistant breast cancer. Elacestrant is
currently being investigated for potential use in postmenopausal
women with estrogen receptor positive breast cancer, the most
common form of the disease. Studies completed to date indicate that
the compound has the potential for use as a single agent or in
combination with other therapies for the treatment of breast
cancer.
Additional information on the clinical trial program of
elacestrant (RAD1901) is available on www.clinicaltrials.gov.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do
not relate to matters of historical fact should be considered
forward-looking statements, including without limitation statements
regarding the timing of providing updates on our ongoing studies of
elacestrant and timing of initiating a Phase 2 study of
elacestrant; the progress of abaloparatide-SC in the regulatory
process with the EMA, and the potential clinical uses and
therapeutic and other benefits of our product candidates, including
elacestrant, abaloparatide-TD and RAD140.
These forward-looking statements are based on management's
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: we expect to need to raise additional funding, which may
not be available; risks related to raising additional capital; our
limited operating history; quarterly fluctuation in our financial
results; our dependence on the success of TYMLOS, and our inability
to ensure that TYMLOS will obtain regulatory approval outside the
U.S. or be successfully commercialized in any market in which it is
approved, including as a result of risk related to coverage,
pricing and reimbursement; risks related to competitive products
and any collaboration agreements failing to be successful; risks
related to clinical trials, including our reliance on third parties
to conduct key portions of our clinical trials and uncertainty that
results will support our product candidate claims; the risk that
adverse side effects will be identified during the development of
our product candidates or during commercialization, if approved;
risks related to manufacturing, supply and distribution; and the
risk of litigation or other challenges regarding our intellectual
property rights. These and other important risks and uncertainties
discussed in our filings with the Securities and Exchange
Commission, or SEC, including under the caption "Risk Factors" in
our most recent Quarterly Report on Form 10-Q and subsequent
filings with the SEC, could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. Any such forward-looking
statements represent management's estimates as of the date of this
press release. While we may elect to update such
forward-looking statements at some point in the future, we disclaim
any obligation to do so, even if subsequent events cause our views
to change. These forward-looking statements should not be
relied upon as representing our views as of any date subsequent to
the date of this press release.
Investor & Media Relations contact:
Alex FudukidisEmail: alex.fudukidis@russopartnersllc.comPhone:
646-942-5632
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