- Demonstration of Clinical Benefit in a
pre-defined number of evaluable patients in Stage 1 of study
triggers enrollment for the second and final Stage of study; Stage
1 data expected in Q4 2016 -
- Enobosarm may offer a novel hormonal
treatment prior to chemotherapy for women who are ER+/AR+,
representing the largest population of breast cancer patients -
GTx, Inc. (Nasdaq: GTXI) today announced the achievement of the
Stage 1 milestone for the 9 mg cohort of its Phase 2 clinical trial
of enobosarm (GTx-024) to treat women with advanced, estrogen
receptor positive (ER+), androgen receptor positive (AR+) breast
cancer. A pre-defined number of patients demonstrated clinical
benefit per protocol to allow the clinical trial to advance to the
second and final stage of the trial (Stage 2). GTx also expects to
provide an update on Stage 1 of the second dosing cohort (18 mg) in
the clinical trial once there are sufficient evaluable patients to
assess clinical benefit in this cohort. The Company anticipates
reporting Stage 1 data from the clinical trial in the fourth
quarter of 2016.
“The demonstration of clinical benefit among a pre-defined
number of evaluable patients in Stage 1 of the 9 mg cohort of our
ER+/AR+ breast cancer study represents an important milestone for
GTx since we have met the protocol specified success criteria to
continue with enrollment in Stage 2 of this cohort,” said Robert J.
Wills, Ph.D., Executive Chairman of GTx. “We believe enobosarm may
provide a new hormonal approach for the treatment of estrogen
receptor positive breast cancer and may delay the need for
chemotherapy in these women.”
About the Phase 2 Clinical Trial in ER+/AR+ Breast
Cancer
The open-label, multi-center, multinational Phase 2 clinical
trial (NCT02463032) will assess the efficacy and safety of orally
administered enobosarm in up to 88 evaluable patients with
metastatic or locally advanced, ER+/AR+ breast cancer. Patients
will receive orally-administered enobosarm (9 mg or 18 mg) daily
for up to 24 months. The two cohorts in the trial will be treated
independently for the purpose of assessing efficacy. The first
stage of evaluation will be assessed among the first 18 evaluable
patients for each cohort. If at least 3 of 18 patients achieve
clinical benefit at week 24, then the trial will proceed to the
second stage of enrollment for that cohort to assess clinical
benefit in a total of 44 evaluable patients per arm. Clinical
benefit is defined as a complete response, partial response, or
stable disease, as measured by Response Evaluation Criteria in
Solid Tumors (RECIST) at 24 weeks. The lead investigator for the
trial is Dr. Beth Overmoyer from the Dana Farber Cancer Institute
and the Harvard Medical School.
About enobosarm
Enobosarm, a selective androgen receptor modulator (SARM), has
been evaluated in 24 completed or ongoing clinical trials enrolling
over 1,500 subjects, of which approximately 1000 subjects were
treated with enobosarm at doses ranging from 0.1 mg to 100 mg. At
all evaluated dose levels, enobosarm was observed to be generally
safe and well tolerated.
Previously, enobosarm 9 mg has been tested in a Phase 2, proof
of concept clinical trial of 22 postmenopausal women with ER+
metastatic breast cancer who have previously responded to endocrine
therapy. 17 of the 22 patients were confirmed to be AR+, and 6 of
those 17 patients demonstrated clinical benefit at six months. In
total, 7 patients (one patient with indeterminate AR status)
achieved clinical benefit at six months. The results also
demonstrated that, after a median duration on study of
81 days, 41 percent of all patients (9/22) achieved
clinical benefit as best response and also had increased PSA which
appears to be an indicator of AR activity. Enobosarm was well
tolerated. The most common adverse events reported were pain,
fatigue, nausea, hot flash/night sweats, and arthralgia.
About ER+/AR+ Breast Cancer
Breast cancer is the most commonly diagnosed cancer in women,
and one in eight women will develop invasive breast cancer in their
lifetime. In 2012, 1.7 million women world-wide were diagnosed with
breast cancer, and there were 6.3 million women alive who had been
diagnosed with breast cancer in the previous five years. Clinical
assessment of breast cancer provides for routine characterization
of receptor status, including the presence or absence of estrogen
receptor (ER), progesterone receptor, and human epidermal growth
factor receptor 2 (HER2) in the tumor tissue. Receptor status is
used to assess metastatic potential as well as to guide treatment
decisions. The majority of breast cancers are considered hormone
receptor positive (expressing ER or progesterone receptor).
Approximately 70 percent of women in the U.S. with breast cancer
have ER+ tumors, and 75 to 90 percent of these cancers are also
AR+.
Estrogen promotes the growth of breast cancers that are hormone
receptor positive. Therefore, treatment is directed at blocking the
effects of estrogen on the breast cancer either through blocking
the estrogen receptor or minimizing the production of estrogen.
This endocrine therapy is the cornerstone of treatment for the
majority of women with hormone receptor positive advanced breast
cancer and is the preferred initial treatment over alternative
approaches such as chemotherapy, due to its efficacy and favorable
safety profile. Patients who respond to one endocrine therapy are
likely to respond to subsequent hormonal therapies. Therefore, the
standard of care for women with hormone receptor positive breast
cancer typically involves the sequencing of endocrine agents until
intolerance or development of resistance occurs, or metastatic
progression necessitates a transition to chemotherapy.
Enobosarm may offer an alternate hormonal approach for the
treatment of endocrine sensitive advanced breast cancer prior to
the introduction of chemotherapy.
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a
biopharmaceutical company dedicated to the discovery, development
and commercialization of small molecules for the treatment of
cancer, including treatments for breast and prostate cancer, and
other serious medical conditions.
Forward-Looking Information is Subject to Risk and
Uncertainty
This press release contains forward-looking statements based
upon GTx's current expectations. Forward-looking statements involve
risks and uncertainties, and include, but are not limited to,
statements relating to the enrollment and conduct of GTx’s ongoing
Phase 2 clinical trials of enobosarm for the treatment of advanced
breast cancer and the timing thereof, including the potential
therapeutic applications for, and potential benefits of its SARM
(including enobosarm) technology. GTx's actual results and the
timing of events could differ materially from those anticipated in
such forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, the risks (i)
that if GTx determines to move forward with additional development
of enobosarm for the treatment of advanced breast cancer, GTx will
require additional funding, which it may be unable to raise, in
which case, GTx may fail to realize the anticipated benefits from
its SARM technology; (ii) that the clinical trials of enobosarm to
treat advanced breast cancer being conducted by GTx may not be
completed on schedule, or at all, or may otherwise be suspended or
terminated; (iii) related to the difficulty and uncertainty of
pharmaceutical product development, including the time and expense
required to conduct clinical trials and analyze data, and the
uncertainty of clinical success; and (iv) related to issues arising
during the uncertain and time-consuming regulatory process,
including the risk that GTx may not receive any approvals to
advance the clinical development of one or more potential clinical
SARM candidates. In addition, GTx will continue to need additional
funding and may be unable to raise capital when needed, which would
force GTx to delay, reduce or eliminate its product candidate
development programs and potentially cease operations. GTx’s actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties. You should not place undue reliance on
these forward-looking statements, which apply only as of the date
of this press release. GTx’s quarterly report on Form 10-Q for the
period ending June 30, 2016, contains under the heading, “Risk
Factors,” a more comprehensive description of these and other risks
to which GTx is subject. GTx expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in its expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are
based.
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version on businesswire.com: http://www.businesswire.com/news/home/20160908005442/en/
InvestorsGTx, Inc.Lauren Crosby,
901-271-8622lcrosby@gtxinc.comorMediaRed House ConsultingDenise
Powell, 510-703-9491denise@redhousecomms.com
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