Attached files
| file | filename |
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| 8-K - REPROS THERAPEUTICS INC. | v207076_8k.htm |
Exhibit
99.1
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Contact:
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Repros
Therapeutics Inc.
|
Joseph
Podolski (281) 719-3447
President
and Chief Executive Officer
REPROS
THERAPEUTICS® RECEIVES
IRB APPROVAL TO COMMENCE PHASE IIb STUDY OF ANDROXAL® IN THE
TREATMENT OF SECONDARY HYPOGONADISM
Company
believes previously reported reanalysis of completed studies bodes well for new
trial
Company
plans to commence enrollment of subjects in January and hopes to complete the
study by year end 2011
THE
WOODLANDS, Texas – January 3, 2011 – Repros Therapeutics Inc.®
(NasdaqCM:RPRX) today reported it has received Institutional Review Board
(IRB) approval to commence the Phase IIb study of Androxal® in men
with secondary hypogonadism. The Company has submitted the protocol
for FDA comment and plans to begin enrolling subjects in
January. Depending on the rate of subject enrollment, Repros hopes to
have the study completed before the end of 2011.
The study
will be conducted at up to 20 US clinical sites. Two sites in Texas
have been initiated already and have commenced screening subjects. At
this time the Company is planning to have sites in Houston and San Antonio,
Texas; the metropolitan area of New York City; and San Diego, Los Angeles and
Sacramento, California. The Company is also considering sites in Las
Vegas, Nevada.
The study
will enroll up to 120 men with morning testosterone levels < 250
ng/dl. The men must be naïve to testosterone therapy or have not used
testosterone for at least six months. The men will be equally
randomized to four different groups, double blind Androxal 12.5 mg and 25 mg,
matching placebo and open label Testim used per manufacturer’s
recommendations. Men will be dosed for three months.
The
primary efficacy endpoint of the study is change in morning testosterone levels
comparing the baseline visit to the levels achieved after three months to those
achieved for placebo. Changes in pituitary hormones that control
testicular function will be assessed as secondary efficacy
measures.
Change in
reproductive status as determined by semen analyses will be a safety endpoint as
instructed by the FDA.
Analyses
of previously completed studies by independent statisticians suggest that this
study is well powered to achieve statistical significance for the primary and
secondary efficacy endpoints. Those completed studies comparing
Androxal to topical testosterone preparations showed statistically significant
suppression of pituitary hormones that regulate testicular function by the
replacement therapies. These findings suggest that the topical
preparations will be viewed negatively when assessed from the perspective of
reproductive status.
In the
Company’s submission that reanalyzed the data from previous studies of Androxal,
it also reviewed with the FDA the variability of morning testosterone levels
from day to day. Over a six-month period, men on placebo moved in and
out of the normal range for morning testosterone. In that submission
the Company noted, “The sponsor believes this finding raises one other
consideration. Given that a variety of factors can cause episodes of
low testosterone, we believe starting all men on exogenous testosterone is not
appropriate. Once exogenous testosterone therapy is initiated a
subject would be relegated to such therapy due to the suppressive effects on
pituitary responsiveness. A drug such as Androxal would allow men who
exhibit episodes of low T to be treated in a fashion that does not impair
pituitary responsiveness. This is particularly true for younger
men. As the male ages and the testes no longer are capable of
responding to pituitary stimulatory signals, exogenous preparations of
testosterone would be appropriate treatments.”
About
Repros Therapeutics Inc.
Repros
Therapeutics focuses on the development of oral small molecule drugs for major
unmet medical needs that treat male and female reproductive
disorders.
Any statements that are not
historical facts contained in this release are forward-looking statements that
involve risks and uncertainties, including Repros' ability to have success in
its clinical trial programs, raise needed additional capital on a timely basis
in order for it to continue to fund its operations and pursue its development
activities, and such other risks which are identified in the Company's most
recent Annual Report on Form 10-K and in any subsequent quarterly reports on
Form 10-Q. These
documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
For more
information, please visit the Company's website at http://www.reprosrx.com.