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Enobosarm Meets Pre-Specified Primary Efficacy Endpoint in Ongoing Phase 2 Clinical Trial in ER+/AR+ Breast Cancer

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MEMPHIS, Tenn.–()–GTx, Inc. (Nasdaq: GTXI) at the moment introduced that enobosarm achieved the
pre-specified main efficacy endpoint in the 9 mg dose cohort from
sufferers in each stage 1 and the continued stage 2 of its Phase 2 medical
trial in ladies with superior, estrogen receptor constructive (ER+), androgen
receptor constructive (AR+) breast most cancers. The main efficacy endpoint
requires a minimum of 9 sufferers (out of a complete of 44 evaluable
sufferers) to realize medical profit, outlined as both an entire
response, partial response or secure illness, as measured by Response
Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks of remedy.
In this ongoing trial, the efficacy endpoint was achieved in the primary
22 confirmed evaluable sufferers, and the trial will proceed enrolling
and treating eligible sufferers with enobosarm till 44 evaluable
sufferers have accomplished the trial. Enobosarm has been properly tolerated
amongst sufferers handled up to now in the 9 mg dose cohort with the bulk
of hostile occasions being both grade 1 or 2.

The Company plans to report top-line medical outcomes from these 22
evaluable sufferers from the 9 mg dose cohort in December 2016, and
expects to report top-line medical outcomes from the complete research by the
center of 2017, following completion of the medical trial.

“Demonstrating success with the 9 mg dose cohort before anticipated in
22 sufferers is a big milestone for the enobosarm program and
GTx, and we sit up for seeing top-line response knowledge in all 44
evaluable sufferers,” stated Robert J. Wills, Ph.D., Executive Chairman of
GTx. “In addition, with these outcomes in hand, we might be discussing how
greatest to advance the event of enobosarm with potential companions.”

About the Phase 2 Clinical Trial in ER+/AR+ Breast Cancer

The open-label, multi-center, multinational Phase 2 medical trial
(NCT02463032) will assess the efficacy and security of orally administered
enobosarm in as much as 88 evaluable sufferers with metastatic or regionally
superior, ER+/AR+ breast most cancers. Patients will obtain
orally-administered enobosarm (9 mg or 18 mg) every day for as much as 24 months.
The two dose cohorts in the trial can be handled independently for the
function of assessing efficacy. The first stage of analysis will probably be
assessed among the many first 18 evaluable sufferers for every cohort. If at
least three of 18 sufferers obtain medical profit at week 24, then the
trial will proceed to the second stage of enrollment for that cohort to
assess medical profit in a complete of 44 evaluable sufferers per arm. As
reported in September and November, 2016, respectively, sufferers in each
the 9 mg and 18 mg cohorts demonstrated enough medical profit
among the many first 18 evaluable sufferers in every such cohort to advance to
the second and last stage of the medical trial. Clinical profit is
outlined as an entire response, partial response, or secure illness, 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 accomplished or ongoing medical trials enrolling over
1,500 topics, of which roughly 1,000 topics have been handled with
enobosarm at doses starting from zero.1 mg to 100 mg. At all evaluated dose
ranges, enobosarm was noticed to be usually protected and nicely tolerated.
Previously, enobosarm 9 mg has been examined in a Phase 2, proof of
idea medical trial of 22 postmenopausal ladies with ER+ metastatic
breast most cancers who’ve beforehand responded to endocrine remedy.
Seventeen of the 22 sufferers have been confirmed to be AR+, and 6 of these 17
sufferers demonstrated medical profit at six months. In complete, 7
sufferers (one affected person with indeterminate AR standing) achieved medical
profit at six months. The outcomes additionally demonstrated that, after a
median period on research of 81 days, 41 % of all sufferers (9/22)
achieved medical profit as greatest response and in addition had elevated PSA
which seems to be an indicator of AR exercise. Enobosarm was properly
tolerated. The commonest antagonistic occasions reported have been ache, fatigue,
nausea, scorching flash/night time sweats, and arthralgia.

About ER+/AR+ Breast Cancer

Breast most cancers is probably the most generally recognized most cancers in ladies, and one in
eight ladies will develop invasive breast most cancers in their lifetime. In
2012, 1.7 million ladies world-wide have been recognized with breast most cancers,
and there have been 6.three million ladies alive who had been recognized with
breast most cancers in the earlier 5 years. Clinical evaluation of breast
most cancers supplies for routine characterization of receptor standing,
together with the presence or absence of estrogen receptor (ER),
progesterone receptor, and human epidermal progress issue receptor 2
(HER2) in the tumor tissue. Receptor standing is used to evaluate metastatic
potential in addition to to information remedy selections. The majority of
breast cancers are thought-about hormone receptor constructive (expressing ER
or progesterone receptor). Approximately 70 % of girls in the U.S.
with breast most cancers have ER+ tumors, and 75 to 90 % of those
cancers are additionally AR+.

Estrogen promotes the expansion of breast cancers which are hormone receptor
constructive. Therefore, remedy is directed at blocking the consequences of
estrogen on the breast most cancers both by means of blocking the estrogen
receptor or minimizing the manufacturing of estrogen. This endocrine
remedy is the cornerstone of remedy for almost all of girls with
hormone receptor constructive superior breast most cancers and is the popular
preliminary remedy over various approaches similar to chemotherapy, due
to its efficacy and favorable security profile. Patients who reply to
one endocrine remedy are possible to answer subsequent hormonal
therapies. Therefore, the usual of care for ladies with hormone
receptor constructive breast most cancers sometimes includes the sequencing of
endocrine brokers till intolerance or improvement of resistance happens,
or metastatic development necessitates a transition to chemotherapy.
Enobosarm might supply an alternate hormonal strategy for the remedy of
endocrine delicate superior breast most cancers previous to the introduction of
chemotherapy.

About GTx

GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical
firm devoted to the invention, improvement and commercialization of
small molecules for the remedy of most cancers, together with remedies for
breast and prostate most cancers, and different critical medical circumstances.

Forward-Looking Information is Subject to Risk and Uncertainty

This press launch accommodates forward-looking statements based mostly upon
GTx’s present expectations. Forward-looking statements contain dangers and
uncertainties, and embrace, however are usually not restricted to, statements relating
to the enrollment and conduct of GTx’s ongoing Phase 2 medical trial of
enobosarm for the remedy of ER+/AR+ breast most cancers and the timing
thereof, together with the potential therapeutic purposes for, and
potential advantages of its SARM (together with enobosarm) know-how. GTx’s
precise outcomes and the timing of occasions might differ materially from
these anticipated in such forward-looking statements because of
these dangers and uncertainties, which embrace, with out limitation, the
dangers (i) that if GTx determines to maneuver ahead with further
improvement of enobosarm for the remedy of ER+/AR+ breast most cancers, GTx
would require further funding, which it might be unable to boost, in
which case, GTx might fail to comprehend the anticipated advantages from its
SARM know-how; (ii) that the medical trial of enobosarm to deal with
ER+/AR+ breast most cancers being carried out by GTx is probably not accomplished on
schedule, or in any respect, or might in any other case be suspended or terminated; (iii)
associated to the problem and uncertainty of pharmaceutical product
improvement, together with the time and expense required to conduct medical
trials and analyze knowledge, and the uncertainty of medical success; and
(iv) associated to points arising through the unsure and time-consuming
regulatory course of, together with the danger that GTx might not obtain any
approvals to advance the medical improvement of a number of potential
medical SARM candidates. In addition, GTx will proceed to wish
further funding and could also be unable to boost capital when wanted, which
would drive GTx to delay, scale back or remove its product candidate
improvement packages and probably stop operations. GTx’s precise
outcomes and the timing of occasions might differ materially from these
anticipated in such forward-looking statements because of these
dangers and uncertainties. You shouldn’t place undue reliance on these
forward-looking statements, which apply solely as of the date of this
press launch. GTx’s quarterly report on Form 10-Q for the interval
ending September 30, 2016, accommodates underneath the heading, “Risk Factors”, a
extra complete description of those and different dangers to which GTx is
topic. GTx expressly disclaims any obligation or enterprise to
launch publicly any updates or revisions to any forward-looking
statements contained herein to mirror any change in its expectations
with regard thereto or any change in occasions, circumstances or circumstances
on which any such statements are based mostly.



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