-Elacestrant 400mg single agent Objective
Response Rate (ORR) was 27.3% in heavily pre-treated patients with
advanced ER+ breast cancer at the pre-determined study cutoff date
of October 30, 2017-
Radius Health, Inc. (Nasdaq:RDUS) today provided an update on data
from the Phase 1 005 clinical study of elacestrant (RAD1901), an
oral selective estrogen receptor degrader (SERD), in patients with
estrogen receptor positive (ER+) breast cancer. The data were
presented at a Spotlight Presentation (Abstract 1410) during the
2017 San Antonio Breast Cancer Symposium (SABCS). Elacestrant
recently received Fast Track designation from the U.S. Food and
Drug Administration.
There are 40 patients that have been treated at the 400 mg dose
in the elacestrant Phase I 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. Of the enrolled patients, 22 patients met
the RECIST measurable disease criteria at baseline and there were 6
confirmed partial responses in this group. Elacestrant was
well-tolerated with the most common adverse events being low grade
nausea, dyspepsia and vomiting.
"It is quite encouraging to see the clinical activity with
elacestrant in the heavily pretreated advanced patient population,
and further therapeutic development is warranted for patients
with hormone receptor positive breast cancer",
commented 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.
Radius plans to initiate a Phase 2 clinical study of elacestrant
monotherapy, a potentially pivotal study, for women with advanced
or metastatic ER+/HER2- breast cancer early in 2018.
“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,” said Gary Hattersley, PhD, Chief Scientific
Officer. "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."
An update on data from the elacestrant FES PET 106 Phase I
clinical study in the EU was presented yesterday and demonstrated
that elacestrant reduces 18F-FES uptake in patients with advanced
ER+ breast cancer who progressed on prior endocrine therapy. The
reduction in FES uptake supports elacestrant dose selection for
further clinical development and was similar in patients harboring
mutant or wildtype ESR-1. Three preclinical poster presentations
further highlighting and demonstrating elacestrant activity, as a
single agent and in combination with other targeted therapies, will
be presented tomorrow morning at SABCS.
Following a strategic review, Radius has decided to discontinue
further evaluation of elacestrant for vasomotor symptoms and will
focus instead on the continued clinical development of the compound
as a potential treatment option in breast cancer.
WEBCAST/CONFERENCE CALL
In conjunction with today's elacestrant Spotlight presentation
at SABCS, Radius will host a conference call and live webcast at
8:00 p.m. CT today to discuss the results of the Phase I program as
of the cutoff date of October 30, 2017 and provide a company
update.
The live webcast titled “Oncology Program Update from San
Antonio Breast Cancer Symposium – 2017” will be available at
https://edge.media-server.com/m6/p/ycgfk3pd or by visiting the
Investors section of Radius' website at
http://ir.radiuspharm.com/events.cfm.
Conference call information:
Domestic Dial-in Number: (866) 323-7965 International Dial-in
Number: (346) 406-0961 Conference ID: 9089206
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 Elacestrant (RAD1901)Elacestrant is a
selective estrogen receptor degrader (SERD), which is being
evaluated for potential use as a once daily oral treatment for
hormone-receptor positive breast cancer. Elacestrant is currently
being investigated for potential use in women with advanced
estrogen receptor positive, HER2 negative, 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 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-receptor positive breast cancer; and the investigational
drug 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.
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 progress of abaloparatide-SC in the regulatory
process with the EMA, the progress in the development of our
product candidates, including abaloparatide-TD, elacestrant
(RAD1901) and RAD140, 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 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 Quarterly Report on Form 10-Q for the period ending June 30,
2017 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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