FDA Accepts IND Application for Radius Health's Investigational Drug RAD1901 Being Developed for Potential Use in Metastatic ...
December 19 2014 - 10:05AM
Radius Health, Inc. (Nasdaq:RDUS) announced today that the U.S.
Food and Drug Administration (FDA) has accepted the Company's
Investigational New Drug (IND) application for its investigational
drug RAD1901, a tissue-selective estrogen receptor degrader (SERD)
being developed for potential use in metastatic breast cancer.
The Phase 1 study that is the subject of the IND is a
multicenter, open-label, two-part, dose-escalation study of the
investigational drug RAD1901 in postmenopausal women with advanced
estrogen receptor positive and HER2-negative breast cancer, that is
designed to determine the recommended phase 2 dose and include a
preliminary evaluation of the potential anti-tumor effect of
RAD1901. The details of the planned Phase 1 study of RAD1901 in
breast cancer metastases will be posted on
www.clinicaltrials.gov.
We also are continuing discussions with the European
Organization for the Research and Treatment of Cancer (EORTC) to
develop a protocol for the initiation of a European Phase1 trial.
We anticipate initiation of the European trial following regulatory
review and upon institutional review board approval.
About The Investigational Drug RAD1901
Radius is developing the investigational agent RAD1901 as a
potential treatment for estrogen positive (ER+) cancers, like
breast, ovarian or endometrial cancer. Currently we are focusing
our clinical research activities in breast cancer. The National
Cancer Institute estimates that approximately 70% of breast cancers
are ER+ and may grow in response to exposure to estrogen. Endocrine
therapy is intended to block the estrogen signal or reduce the
production of estrogen. More information about breast cancer and
endocrine therapy may be found on the National Cancer Institute
website
http://www.cancer.gov/cancertopics/factsheet/Therapy/hormone-therapy-breast.
RAD1901 is an investigational, non-steroidal small molecule that
is designed to selectively bind and degrade the ER. RAD1901 has
demonstrated potent anti-tumor activity in xenograft models of ER+
breast cancer in preclinical testing and complete suppression of
the FES-PET signal after six days of dosing in a maximum tolerated
dose clinical study. In preclinical models thus far, RAD1901 has
shown good tissue selectivity, does not appear to stimulate the
uterine endometrium, and appears to protect against bone loss in an
ovariectomy-induced osteopenia rat model. In addition, we believe
that RAD1901 also has the ability to cross the blood-brain barrier.
In vitro, treatment of human breast cancer cell lines with the
investigational drug RAD1901 resulted in degradation of the ER and
inhibition of both basal and estradiol-stimulated
proliferation.
A recent poster presented at the San Antonio Breast Cancer
Symposium (SABCS) included preclinical data indicating that
increasing doses of RAD1901 potently induced tumor regression.
Tamoxifen and fulvestrant were the comparator drugs in this study.
The poster also included data from the Phase 1 study in which
18F-estradiol positron emission tomography (FES-PET) was used to
provide a pharmacodynamic assessment of estrogen receptor
engagement/turnover. Following 6-days of daily treatment with the
investigational drug RAD1901 at 200mg and 500mg doses, a complete
suppression of FES-PET signal was observed, with standardized
uptake values (SUV) comparable to background tissues. To date, the
maximum tolerated dose of RAD1901 has not been determined.
The potential clinical significance, if any, of the data
presented in the poster is currently unknown and will be evaluated
further as the development program for the investigational drug
RAD1901 continues.
About Radius Health
Radius is a science-driven biopharmaceutical company developing
new therapeutics for patients with advanced osteoporosis as well as
other serious endocrine-mediated diseases including hormone
responsive cancers. Radius' lead development candidate is the
investigational drug abaloparatide (BA058) for subcutaneous
injection, currently in Phase 3 development for potential use in
the reduction of fracture risk in postmenopausal women with severe
osteoporosis. The Radius clinical portfolio also includes an
investigational abaloparatide transdermal patch for potential use
in osteoporosis and the investigational drug RAD1901 for potential
use in hormone driven, or hormone resistant, metastatic breast
cancer, including breast cancer brain metastases.
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 statements regarding the
potential clinical significance of the data presented in the poster
presentation at SABCS, the ability of RAD1901 to cross the
blood-brain barrier, and the timing of the initiation of clinical
trials of RAD1901.
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; our need for additional
funding, which may not be available; we are not currently
profitable and may never become profitable; restrictions imposed on
our business by our credit facility, and risks related to default
on our obligations under our credit facility; risks related to
raising additional capital; our limited operating history;
quarterly fluctuation in our financial results; our dependence on
the success of abaloparatide-SC, and our inability to ensure that
abaloparatide-SC will obtain regulatory approval or be successfully
commercialized; 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; product candidates for which we obtain
marketing approval, if any, could be subject to restrictions or
withdrawal from the market and we may be subject to penalties;
failure to achieve market acceptance of our product candidates;
risks related to the use of our limited resources on particular
product candidates and not others; delays in enrollment of patients
in our clinical trials, which could delay or prevent regulatory
approvals; the dependence of our drug development program upon
third-parties who are outside our control; the risk that a
regulatory or government official will determine that third-parties
with a financial interest in the outcome of the Phase 3 study of
abaloparatide-SC affected the reliability of the data from the
study; our reliance on third parties to formulate and manufacture
our product candidates; failure to establish additional
collaborations; our lack of experience selling, marketing and
distributing products and our lack of internal capability to do so;
failure to compete successfully against other drug companies;
developments by competitors may render our products or technologies
obsolete or non-competitive; risks related to the fact that our
drugs may sell for inadequate prices or patients may be unable to
obtain adequate reimbursement; effects of product liability
lawsuits on commercialization of our products; failure to comply
with obligations of our intellectual property licenses; failure to
protect our intellectual property or failure to secure necessary
intellectual property related to abaloparatide-SC,
abaloparatide-TD, RAD-1901 and/or RAD-140; our or our licensors'
inability to obtain and maintain patent protection for technology
and products; risks related to our compliance with patent
application requirements; failure to protect the confidentiality of
our trade secrets; risks related to our infringement of third
parties' rights; risks related to employees' disclosure of former
employers' trade secrets; risks associated with intellectual
property litigation, including expending substantial resources and
distracting personnel from their normal responsibilities; risks
associated with healthcare reform; our failure to comply with
healthcare laws and regulations; our exposure to claims associated
with the use of hazardous materials and chemicals; inability to
successfully manage our growth; risks relating to business
combinations and acquisitions; our reliance on key executive
officers and advisors; our inability to hire additional qualified
personnel; volatility in the price of our common stock; capital
appreciation is the only source of gain for our common stock; risks
related to increased costs and compliance initiatives associated
with operating as a public company; our directors, executive
officers and principal stockholders have substantial control over
us and could delay or prevent a change in control; future sales of
our common stock could depress the price of our common stock;
inaccurate or unfavorable information about us could cause the
price of our common stock to decline; provisions in our charter
documents and Delaware law could discourage takeover attempts; and
our ability to use our net operating loss carryforwards and certain
other tax attributes may be limited. These and other important
factors discussed under the caption "Risk Factors" in our Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission, or SEC, on November 10, 2014, 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.
CONTACT: Investor Relations
Barbara Ryan
FTI Consulting
Managing Director
212-850-5679
Barbara.Ryan@fticonsulting.com
Media Relations
Kimberly Ha
FTI Consulting
Senior Director
212-850-5612
Kimberly.Ha@fticonsulting.com
Radius Recycling (NASDAQ:RDUS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Radius Recycling (NASDAQ:RDUS)
Historical Stock Chart
From Sep 2023 to Sep 2024