Repros Initiates Two Head to Head Studies of Androxal(R) Versus the Leading
Topical Testosterone Gel
*Studies designed to compare performance of Androxal to testosterone (T)
replacement in restoring and maintaining normal testicular function
*Anticipated to expand Androxal label and thereby increase commercial
*Identical studies to be conducted at 23 US clinical sites
*Topline results expected by October 2014
*Study completion not expected to affect filing date for the NDA in Q4 2014
THE WOODLANDS, Texas, Jan. 8, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics
Inc.^® (Nasdaq:RPRX) today announced it has initiated two clinical studies
comparing Androxal to the leading US testosterone replacement therapy.
Investigational Review Board approval has already been obtained for several of
the study sites and an investigator meeting and shipment of drug is scheduled
for next week. Several sites have begun pre-screening subjects. The FDA has
previously indicated that head to head studies could be conducted against
approved testosterone products to establish claims for labeling purposes with
the proviso that Androxal must show superiority to the testosterone product
for any specific claims to be made.
The Company has decided to conduct two identical studies. Each study will
enroll 120 men, 40 each into three parallel arms: Androxal, approved topical
gel and placebo. All three arms will be blinded and "double dummied", meaning
men will receive both an active dose and a placebo mimicking the other active.
Men on placebo will receive two placebos, one for each active. The studies
will be of 17 week duration, consisting of 16 weeks of dosing and 1 week of
Men (≤60 years of age) enrolled in the study must exhibit sperm counts in the
normal range at baseline ( > 15 million/mL) on two separate days separated by
at least two days. Men also must exhibit morning testosterones of < 300 ng/dL
on two separate days to be eligible to enter the study.
The primary endpoint of the study is the comparison of Androxal to the topical
gel from the perspective of normalizing testicular function. As such, men must
exhibit 24 hour average testosterone levels in the normal range (300-1040
ng/dL), and an average of two sperm counts at the end of the study must remain
above the lower bound of the 95% confidence interval for normal male fertility
(15 million/mL). Based on results from previous Repros studies, the Company
believes the two trials are suitably powered (90% power, alpha=0.05) to
demonstrate the key difference between restoration of normal testicular
function with Androxal versus the T replacement-induced suppression of male
reproductive organ activity.
Additional efficacy and safety comparisons will also be made. These include
excursions of testosterone outside of the normal range as well as regression
of testosterone levels after the administration of the study drug is stopped.
Safety assessments will include impact on hematocrit, an important
cardiovascular safety marker.
The 23 clinical sites are located in the following states and cities:
Alabama: Birmingham, Mobile
Louisiana: New Orleans
New York: Albany, Garden City, NYC-Manhattan, Rochester
North Carolina: Raleigh
Rhode Island: Warwick
Texas: Houston, Hurst, Webster
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 within the meaning of the Private
Securities Litigation Reform Act of 1995 and are subject to various risks,
uncertainties and other factors that could cause the Company's actual results,
performance or achievements to differ materially from those expressed or
implied by such forward-looking statements. These statements often include
words such as "may," "will," "expect," "anticipate," "continue," "estimate,"
"project," "intend," "believe," "plan," "seek," "could," "can," "should" or
similar expressions. These statements are based on assumptions that the
Company has made in light of the Company's experience in the industry, as well
as the Company's perceptions of historical trends, current conditions,
expected future developments and other factors the Company believes are
appropriate in these circumstances. Forward-looking statements include, but
are not limited to, those relating to planned clinical studies and the timing
and nature of the results thereof, the impact of the studies on the Androxal
label and the commercial potential of Androxal and the timing of the Company's
expected filing of an NDA for Androxal.Such statements are based on current
expectations that involve a number of known and unknown risks, uncertainties
and other factors that may cause actual events to be materially different from
those expressed or implied by such forward-looking statements, including the
ability to have success in the clinical development of the Company's
technologies, the reliability of interim results to predict final study
outcomes, the ability to protect the Company's intellectual property rights
and such other risks as 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: Investor Relations:
The Trout Group
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