-Elacestrant single agent Objective Response Rate
(ORR) was 23% in heavily pre-treated patients with advanced ER+
breast cancer at the cut off date of April 28, 2017-
Radius Health, Inc. (Nasdaq:RDUS), a fully integrated
science-driven biopharmaceutical company that is committed to
developing innovative therapeutics in the areas of osteoporosis,
oncology and endocrine diseases, today announced positive data from
a fully enrolled ongoing Phase 1 study of elacestrant (RAD1901), an
oral selective estrogen receptor degrader (SERD), in patients with
estrogen receptor positive (ER+) breast cancer. These data were
presented this morning at the 2017 American Society of Clinical
Oncology Meeting in Chicago, Illinois.
As of the cut-off date of April 28, 2017, 40
patients have been treated in the fully enrolled elacestrant Phase
I dose escalation and expansion cohorts at the 400 mg dose. These
patients are all heavily pretreated ER+, HER2-negative advanced
breast cancer patients who have received a median of 3 prior lines
of systemic therapy and have evaluable advanced or metastatic
disease. Of the enrolled patients, 22 patients met the RECIST
measurable disease criteria at baseline and there were five
confirmed partial responses in this group. Elacestrant was
well-tolerated with the most common adverse events being low grade
nausea and dyspepsia.
“While still early, the single-agent clinical activity and
safety profile demonstrated with elacestrant in this heavily
pretreated advanced hormone receptor positive breast cancer patient
population is encouraging when compared to the results shown for
other agents in a similar setting,” said Dr. Aditya Bardia,
Director of Precision Medicine and attending physician at Center
for Breast Cancer, Massachusetts General Hospital Cancer Center,
Harvard Medical School, Boston, MA. “This is important for patients
because it could potentially offer another endocrine therapy option
even upon progression on standard endocrine therapy and could
potentially delay the use of toxic chemotherapy, which is a
meaningful clinical goal, and additional studies are needed.”
On June 4, 2017, at the 2017 ASCO Annual Meeting, the following
abstract was presented as a poster and will be included in the
Poster Discussion Session later today: Abstract 1014
- “Evaluation of Elacestrant (RAD1901), a novel investigational,
selective estrogen receptor degrader (SERD), for the treatment of
ER-positive (ER+) advanced breast cancer” Abstract 1014, 8:00 AM -
11:30 AM, Hall A, Poster Board #6, POSTER SESSION, Breast
Cancer-Metastatic
- Discussed at the Poster Discussion Session, 4:45 PM - 6:00 PM,
Hall B1, Aditya Bardia, MD, MPH - First Author, Massachusetts
General Hospital Cancer Center and Harvard Medical School
WEBCAST
In connection with today’s elacestrant presentation at ASCO,
Radius will host a conference call and live webcast at 7:00 p.m. CT
on Sunday, June 4 2017 to discuss the results of the Phase I
program as of the cut off date of April 28, 2017.
Webcast Information: Date: Sunday, June 4, 2017 Time: 7:00 p.m.
CT Live webcast:
http://edge.media-server.com/m/p/acpzpzcu
A replay of the webcast will be available on the company’s
website, www.radiuspharm.com in the Investor section under Events
and Presentations for 7 days following the live webcast.
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 and the
investigational drug elacestrant (RAD1901) for potential use in
estrogen receptor positive breast cancer, and vasomotor symptoms in
postmenopausal women. Radius' RAD140, a non-steroidal, 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.
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
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.
About RAD140
RAD140 is a non-steroidal selective androgen receptor modulator
(SARM). The androgen receptor (AR) is frequently expressed in many
estrogen receptor (ER)-positive, ER-negative, and triple-negative
breast cancers. Because of its receptor and tissue selectivity,
potent activity, oral bioavailability, and long half-life, RAD140
could have clinical potential in the treatment of breast cancer.
RAD140 resulted from an internal drug discovery program focused on
the androgen receptor pathway, and exhibits a differentiated
mechanism of action compared to ER-targeted therapy.
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 significance of clinical data for
elacestrant obtained to date; the potential of elacestrant, as a
monotherapy or in combination with other anti-cancer therapies, for
the treatment of breast cancer; and the potential clinical uses and
therapeutic and other benefits of our product candidates, including
abaloparatide-TD, elacestrant 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 have only recently started to commercialize TYMLOS in
the U.S.and may 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,
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;
risk 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 Annual Report on Form 10-K 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 Relations Contact:
Barbara Ryan
Email: bryan@radiuspharm.com
Phone: 203-274-2825
Media Contact:
Lori Gorski
Email: Lgorski@radiuspharm.com
Phone: 617-551-4096
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