Attached files
file | filename |
---|---|
8-K - REPROS THERAPEUTICS INC. | v206477_8k.htm |
Exhibit
99.1
Contact:
|
Repros
Therapeutics Inc.
|
Joseph
Podolski (281) 719-3447
President
and Chief Executive Officer
REPROS®
THERAPEUTICS SUBMITS DATA TO THE FDA SUPPORTING
MORNING
ASSESSMENT OF TESTOSTERONE FOR MEN TREATED WITH
ANDROXAL® AS
INDICATIVE OF AVERAGE AND MAXIMUM LEVELS ATTAINED
Typically
24 hour assessment is required in studies of testosterone replacement
therapies
THE
WOODLANDS, Texas – December 23, 2010 – Repros Therapeutics Inc.®
(NasdaqCM:RPRX) today announced it has submitted to the FDA data
collected from three different studies which the Company believes demonstrates
that the assessment of testosterone levels between 8 and 10 in the morning is
indicative of the maximum and average levels of the male hormone achieved during
a particular day following the administration of Androxal®. In
the Type B meeting held on November 8, 2010, and reported in the Company’s press
release of November 9, 2010, the FDA stated the preferred method to determine
testosterone levels in treatments designed to replace the hormone is a 24 hour
assessment.
Repros
used the services of an outside statistician, Dr. Richard Trout, Professor
Emeritus, Rutgers University, in arriving at the conclusions it has
reached.
The
Company has conducted three trials in which serial testosterone measurements
were made over a 24 hour period. Two of the studies assessed 14
(ZA-002) and 11 (ZA-003 subset) time points over the 24 hour period in a total
of 28 subjects. A third study (ZN-018) obtained measurements at six
points in a total of 20 subjects.
Using the
data from the 002 and 003 studies the sponsor has determined that a single total
testosterone assessment made between 8 and 10 in the morning correlates to the
average of the values of the testosterone measurements for a given subject on a
given day (correlation coefficient roughly 0.9 for the times 8, 9 and 10, p
value < 0.001).
Performing
the same assessment for the maximum value of total testosterone recorded in a 24
hour period, the same single total testosterone assessment made between 8 and 10
in the morning correlates to the maximum value of testosterone for a given
subject on a given day (correlation coefficient roughly 0.9 for the times 8, 9
and 10, p value < 0.001).
From the
018 study that assessed men at baseline and after 14 days of treatment, the
Company observed that Androxal raises each time point testosterone level by an
average of 200 ng/dl at 12.5 mg and 260 ng/dl at a 25 mg dose.
Unlike
topical testosterone preparations, Androxal maintains the normal daily rhythm of
testicular testosterone production with peak levels generally occurring in the
morning and trough levels exhibited in the evening. The testosterone
levels achieved by the administration of topical preparations are a function of
a variety of factors none of which relate to the normal daily rhythm. In some
instances, subject to subject variability can lead to supernormal levels of
testosterone several hours after administration of the topical preparations. The
Company has committed to conduct one additional 24 hour study to show that
Androxal’s action in maintaining the normal rhythm is both predictable and dose
dependent.
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 ongoing clinical trials, 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.