-3 patients had confirmed partial responses
by RECIST criteria from ongoing Phase I studies with RAD1901 in
patients with advanced estrogen receptor positive breast
cancer-
Radius Health, Inc. (Nasdaq:RDUS), a science-driven
biopharmaceutical company focused on developing innovative
therapeutics in the areas of osteoporosis, oncology and endocrine
diseases, today announced data from two ongoing Phase 1 studies of
RAD1901, an oral selective estrogen receptor degrader (SERD), in
patients with estrogen receptor positive (ER+) breast cancer, which
were presented this morning at the San Antonio Breast Cancer
Symposium 2016.
As of the cut-off date of October 7, 2016, 20 patients have been
treated in the RAD1901 Phase IB safety expansion cohort at the 400
mg dose. These patients are heavily pretreated ER+, HER2-negative
advanced breast cancer patients who have received a median of 3
prior lines of therapy. Of the enrolled patients, 19 out of 20 had
measurable disease at baseline and there were two confirmed partial
responses by RECIST criteria. Across the Part A dose escalation
(n=13) and safety expansion cohort (n=20), 14 patients were on
study drug for greater than or equal to 4 months, 5 patients for
greater than or equal to 6 months, and 7 patients remained on study
drug. RAD1901 was well-tolerated with the most common adverse
events being low grade nausea and dyspepsia.
In the ongoing European Phase I RAD1901 FES-PET trial, the first
three-patients were enrolled at 400 mg as of the October 7th
cut-off date and achieved a reduction in 18F-FES uptake ranging
from 79%-91% at day 14 compared to baseline. One patient had a
confirmed partial response by RECIST criteria. All three patients
remained on study drug with mean duration of treatment of 5.64
cycles. Adverse events reported to date have been grade 1 and
2 and manageable. This study will enroll 5 additional patients in
the 400 mg QD cohort followed by 8 patients in the 200 mg QD
cohort. No dose limiting toxicities have been reported across any
of the studies in the RAD1901 program.
“The single-agent clinical activity and duration of response
demonstrated with RAD1901 in the heavily pretreated population may
be important in addressing the major challenge of resistance facing
patients with ER positive advanced breast cancer,” said Dr.
Virginia Kaklamani, Professor of Medicine, UT Health Science Center
San Antonio, leader of the Breast Cancer Program, Cancer Therapy
& Research Center, and investigator on the study.
“An oral, well-tolerated and effective SERD could become an
important adjunct in combination therapy for patients and we look
forward to the results of additional studies,” said Professor
George W. Sledge Jr., Professor and Chief of Medical Oncology at
Stanford University Medical Center, and member of Radius’ Oncology
Clinical Advisory Board.
Dr. Virginia Kaklamani and Dr. George Sledge will
participate in a Radius hosted investor meeting and webcast later
today to highlight the RAD1901 data presented at SABCS at 8 p.m.
CT. The webcast and a replay can be accessed on the company’s
website, www.radiuspharm.com.
The posters presented this morning from the RAD1901
clinical development program were:
Abstract Title: A Phase 1 Study of RAD1901, a Novel,
Oral, Selective Estrogen Receptor Degrader, for the Treatment of
ER-Positive Advanced Breast Cancer, Poster # 1454
Abstract Title: A Phase 1 Study of
RAD1901, an Oral Selective Estrogen Receptor Degrader, to Determine
Changes in the F-FES Uptake and Tumor Responses in ER-Positive,
HER-2-Negative, Advanced Breast Cancer Patients, Poster #
1604
Radius will also present later the following poster
later today from the RAD1901 preclinical
program:
Abstract Title: RAD1901 Demonstrates Anti-Tumor Activity
in Multiple Models of ER-Positive Breast Cancer Treatment
Resistance, Poster # 1378
Poster Session 3 Session Title: Tumor Cell
and Molecular Biology: Endocrine Therapy and Resistance
Session Date: 12/8/2016 Session Time: 5:00
PM — 7:00 PM Location: Hall 1
About Radius
Radius is a science-driven biopharmaceutical company that is
committed to developing innovative therapeutics in the areas of
osteoporosis, oncology and endocrine diseases. Radius' lead product
candidate, the investigational drug abaloparatide for subcutaneous
injection, has completed Phase 3 development for potential use in
the reduction of fracture risk in postmenopausal women with
osteoporosis. Radius' Marketing Authorisation Application (MAA) for
abaloparatide-SC for the treatment of postmenopausal women with
osteoporosis is under regulatory review in Europe and a New Drug
Application (NDA) has been accepted for filing by the FDA with a
PDUFA date of March 30, 2017. The Radius clinical pipeline also
includes an investigational abaloparatide transdermal patch for
potential use in osteoporosis and the investigational drug RAD1901
for potential use in hormone-driven and/or hormone-resistant breast
cancer, and vasomotor symptoms in postmenopausal women. Radius'
preclinical pipeline includes RAD140, a non-steroidal, selective
androgen receptor modulator (SARM) under investigation for
potential use in cancer. For more information, please
visit www.radiuspharm.com
About RAD1901
RAD1901 is a selective estrogen receptor 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. RAD1901 is currently being investigated for
potential use in postmenopausal women with estrogen receptor
positive (ER+), HER2-negative advanced 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.
RAD1901 also is being evaluated in a Phase 2b study at low doses
for potential reduction of the frequency and severity of moderate
to severe hot flashes in postmenopausal women. Additional
information on the clinical trial program of RAD1901 is available
on www.clinicaltrials.gov.
RAD140
RAD140 is a nonsteroidal selective androgen receptor modulator.
The androgen receptor (AR) is highly expressed in many estrogen
receptor (ER)-positive, ER-negative, and triple-negative receptor
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, which is highly expressed in many
breast cancers.
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
expectations regarding the significance of preclinical and clinical
data for RAD 1901 obtained to date, the potential of RAD 1901, as a
monotherapy or in combination with other anti-cancer therapies, for
the treatment of breast cancer, and the potential clinical uses for
abaloparatide-TD, RAD1901 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 no product revenues 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; any collaboration
agreements failing to be successful; risks related to clinical
trials, including having most of our products in early stage
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; and
delays in enrollment of patients in our clinical trials, which
could delay or prevent regulatory approvals. These and other
important factors discussed under the caption "Risk Factors" in our
most recent Annual Report on Form 10-K filed with the Securities
and Exchange Commission, or SEC, on February 25, 2016, and our
other reports filed 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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