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GTx Provides Corporate Update and Reports Third Quarter 2015 Financial Results
– Two Phase 2 clinical trials of enobosarm are enrolling patients for the treatment of advanced breast cancer –
– Conference call today at
In October, the Company received
“While our primary focus continues to be the development of enobosarm to
treat advanced breast cancer, we are expanding the potential utility of
our SARM portfolio with the initiation of a proof of concept trial in
SUI,” said Dr.
Enobosarm, a selective androgen receptor modulator (SARM), is the Company’s lead product candidate and is being developed as a targeted treatment for two advanced breast cancer indications for (i) estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer, and (ii) AR+ triple negative breast cancer (TNBC). For both clinical studies, the primary efficacy objective will be clinical benefit, which is defined as a complete response, partial response or stable disease. Preliminary data from the first stage of both Phase 2 clinical trials are expected by the end of 2016.
SARMs ability to increase muscle mass may prove beneficial in other non-oncology indications. The Company is exploring SARMs as potential treatments for stress urinary incontinence (SUI) in postmenopausal women where pelvic floor muscle weakness leads to incontinence, as well as Duchenne muscular dystrophy (DMD), a rare genetic disorder characterized by progressive muscle degeneration and weakness.
Selective Androgen Receptor Degrader (SARD) technology is being evaluated as a potentially novel treatment for men with castration-resistant prostate cancer, including those who do not respond or are resistant to currently approved therapies. The Company believes that its SARD compounds will degrade multiple forms of the androgen receptor, including AR variants, such as AR-V7.
Third Quarter and Nine Months 2015 Financial Results
Conference Call and Webcast
There will be a conference call today at
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 commencement and enrollment of GTx’s planned clinical study of
enobosarm (GTx-024) to treat stress urinary incontinence (SUI) and GTx’s
ongoing Phase 2 clinical trials of enobosarm for the treatment of
advanced breast cancer, as well as the potential preclinical and other
future development of GTx’s licensed SARD technology and the development
of selective androgen receptor modulators (SARMs) for the treatment of
Duchenne muscular dystrophy (DMD) and the timing thereof, including the
anticipated identification of clinical SARD candidates and the potential
evaluation thereof in clinical studies; the potential therapeutic
applications for, and potential benefits of SARM (including enobosarm)
and SARD technology; and GTx’s expectation that it will recognize
non-cash gains or losses resulting from the revaluation of the warrants