Repros Reports 6 Month Bone Mineral Density Data From Ongoing Study ZA-303
*No bone loss compared to placebo
*Early evidence of improving bone mineral density in Androxal^® subjects
THE WOODLANDS, Texas, Aug. 20, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics
Inc.^® (Nasdaq:RPRX) today reported interim 6 month results from the first 150
subjects enrolled into the ongoing one year placebo controlled study to assess
the impact of Androxal treatment of secondary hypogonadal men and its effect
on bone mineral density. There is no evidence of a deleterious effect of
Androxal on bone health and some evidence of improved bone mineral density.
Study ZA-303 is a single blind placebo controlled study with an Androxal to
placebo ratio of 2:1. Men assigned to Androxal were required to exhibit
morning testosterone levels of <300 ng/dL on two consecutive mornings. Men
assigned to placebo had to meet all the criteria of age (<60) and BMI (>25) of
those men assigned to Androxal with the exception that their testosterone
level could be in the normal range.
At the 6 month time point, there is no evidence that Androxal reduces bone
mineral density as assessed by DEXA scans.In addition, there is some evidence
that Androxal may be beneficial to bone health. Overall, there is a consistent
trend in many bone regions where an improvement of bone mineral density in
comparison to placebo is observed.Subjects treated with 25 mg of Androxal
exhibited a statistically significant increase in total hip bone mineral
density compared to placebo (p = 0.0339). However, although one should be
encouraged by these positive findings, clinically significant changes in bone
mineral density generally require exposures longer than 6 months and early
results do not always predict final results.
Study ZA-303 also indicates that testosterone may be more influential in
maintaining bone health than previously expected. Repros was surprised to find
that a relatively high percentage of subjects, 12%, screen failed due to low
bone mineral density in this relatively young population (mean age 48).
Topline results from the first 150 subjects completing 12 months of exposure
are expected in the second quarter of 2014. Based on the progress in this
study and others, the NDA remains on track for submission in mid-2014.
The Company has requested guidance from the FDA regarding what additional work
would be required to incorporate these positive findings on bone mineral
density into the Androxal label under a separate IND.
About Repros Therapeutics Inc.
Repros Therapeutics focuses on the development of small molecule drugs for
major unmet medical needs that treat male and female reproductive disorders.
Any statements made by the Company that are not historical facts contained in
this release are forward-looking statements that involve risks and
uncertainties, including the ability to have success in the clinical
development of its technologies, the reliability of interim results to predict
final study outcomes, the ability to protect its intellectual property rights
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
CONTACT: Repros Therapeutics Inc.
Joseph Podolski (281) 719-3447
President and Chief Executive Officer
The Trout Group
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