TORONTO, April 25, 2016 /PRNewswire/ - Transition
Therapeutics Inc. ("Transition" or the "Company") (NASDAQ:
TTHI, TSX: TTH) today announced the dosing of the first patient of
a Phase 2 study of selective androgen receptor modulator (SARM)
drug candidate TT701. The Phase 2 study will evaluate the
efficacy and safety of TT701 in improving the symptoms of androgen
deficiency (sexual symptoms, fatigue/low vitality, and physical
dysfunction) in men with prostate cancer who have undergone radical
prostatectomy for organ-localized prostate cancer. Brigham and Women's Hospital (BWH) is
conducting the investigator-led Phase 2 clinical study which is
expected to enroll up to 125 subjects at selected specialized
clinical sites including BWH. The principal investigator for the
Phase 2 study is 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.
"Sexual dysfunction, fatigue and other distressing symptoms of
testosterone deficiency can greatly reduce the quality of life for
men who have undergone radical prostatectomy for organ localized
disease," said Dr. Bhasin, the trial's Principal Investigator,
"Therefore, the ability to treat these symptoms safely is an
important unmet need."
"Working closely with BWH and Dr. Bhasin has been instrumental
in advancing TT701 as a therapeutic to address these challenging
symptoms associated with radical prostatectomy procedures. The
properties of TT701 may provide these men an improved quality of
life," said Dr. Tony Cruz, Chairman
and Chief Executive Officer of Transition.
Transition's wholly-owned subsidiary, Transition Therapeutics
Ireland Limited exclusively licensed worldwide rights to the TT701
drug candidate from Eli Lilly and Company ("Lilly"). The
dosing of the first patient in this study will trigger a
US$500,000 milestone payment to
Lilly.
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 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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factors beyond Transition's control and the risk factors and other
cautionary statements discussed in Transition's quarterly and
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SOURCE Transition Therapeutics Inc.