TORONTO, Oct. 29, 2015 /PRNewswire/ - Transition
Therapeutics Inc. ("Transition" or the "Company") (NASDAQ:
TTHI, TSX: TTH) announced today that Transition Therapeutics
Ireland Limited ("TTIL") has entered into an agreement for an
investigator-led clinical study of drug candidate, TT701, with
Brigham and Women's Hospital
(BWH). TTIL will support a Phase 2 study to evaluate selective
androgen receptor modulator (SARM) drug candidate TT701 as a
therapy to improve the symptoms of androgen deficiency in men with
prostate cancer who have undergone a radical prostatectomy
procedure. The Phase 2 clinical study is expected to enroll up to
125 subjects and will be performed at selected specialized clinical
sites including BWH. The principal investigator for the Phase 2
study will be Dr. Shalender Bhasin,
Director of the Research Program in Men's Health: Aging and
Metabolism at BWH and an internationally recognized endocrinologist
with expertise in testosterone biology and men's
aging.
"Improved survival of men with prostate cancer has focused
attention on the high prevalence and adverse effects of the
distressing symptoms of androgen deficiency – sexual dysfunction,
fatigue, and physical dysfunction - on the quality of life of
prostate cancer survivors," said Dr. Bhasin, "This trial offers the
opportunity to potentially improve the lives of men with a history
of prostate cancer, who experience these bothersome symptoms of
androgen deficiency after prostate surgery."
"We are extremely pleased to work together with BWH and
Dr. Shalender Bhasin on the
development of the TT701 drug candidate. BWH is a world-class
center for clinical research with renowned physician-investigators,
biomedical scientists and faculty. Dr. Bhasin's expertise in the
field of androgen deficiency is well-known and his leadership of
the TT701 Phase 2 study underscores the importance to finding
therapies to aid these individuals and their challenging symptoms,"
said Dr. Tony Cruz, Chairman and
Chief Executive Officer of Transition.
The Phase 2 study is scheduled to commence in calendar Q4
2015.
About Androgen Deficiency After Radical Prostatectomy
Surgery
Prostate cancer is the most common malignancy in American men,
accounting for 29% of all diagnosed cancers and approximately 13%
of all cancer deaths; its incidence is on the rise, partly due to
increased screening with PSA. The majority of these men have
low-grade, organ-confined prostate cancer and excellent prospects
of long term survival. Substantial improvement in survival in men
with prostate cancer has focused attention on the high prevalence
of sexual dysfunction, physical dysfunction, and low vitality in
these men, which are important contributors to poor quality of life
among these patients. The pathophysiology of these symptoms -
sexual dysfunction, fatigue/low vitality, and depressed mood -
after radical prostatectomy is multifactorial, but androgen
deficiency is an important remediable contributor to these
symptoms.
About Transition
Transition is a biopharmaceutical
development company, advancing novel therapeutics for CNS and
metabolic disease indications. The Company's wholly-owned
subsidiary, Transition Therapeutics Ireland Limited ("TTIL") is
developing CNS drug candidate ELND005 for the treatment of
Alzheimer's disease and Down syndrome. Transition's lead metabolic
drug candidate is TT401 (LY2944876) for the treatment of type 2
diabetes and accompanying obesity. The Company's shares are listed
on the NASDAQ under the symbol "TTHI" and the Toronto Stock
Exchange under the symbol "TTH". For additional information about
the Company, please visit www.transitiontherapeutics.com.
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should be considered accurate only as of the date of the release
and may be superseded by more recent information we have disclosed
in later press releases, filings with the OSC, SEC or otherwise.
Except for historical information, this press release may contain
forward-looking statements, relating to expectations, plans or
prospects for Transition, including conducting clinical trials and
potential efficacy of its products. These statements are based upon
the current expectations and beliefs of Transition's management and
are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include
factors beyond Transition's control and the risk factors and other
cautionary statements discussed in Transition's quarterly and
annual filings with the Canadian commissions. For further
information on Transition, visit www.transitiontherapeutics.com
SOURCE Transition Therapeutics Inc.