Repros Therapeutics Inc. Initiates a Comparative Phase 2b Study of Oral Androxal(R)...

Mon Jun 30, 2008 6:00am EDT

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Repros Therapeutics Inc. Initiates a Comparative Phase 2b Study of Oral Androxal(R) as Compared to Topical Testim(R) Examining Effects on Male Fertility and Testicular Function

     Provides Guidance on Proellex Endometriosis Phase 2 Data and
      Initiation of Androxal Phase 2b Study for the Treatment of
THE WOODLANDS, Texas--(Business Wire)--
Repros Therapeutics Inc. (NasdaqGM:RPRX) reported today that the
clinical sites have been initiated for its Phase 2b clinical study
monitoring the effects of Repros' oral drug Androxal(R) on male
fertility and testicular function in patients being treated for low
testosterone as compared to Testim(R), a popular marketed topical
testosterone medication. Enrollment of the 24 patients will commence
at two sites in the New York City area shortly. The study is being
conducted by Dr. Jed Kaminetsky in New York City and Dr. Michael
Werner in Purchase, NY.

   All subjects will have been previously diagnosed with secondary
hypogonadism and treated with topical testosterone for at least 6
months but not more than 2 years. Patients will be instructed to
discontinue their topical testosterone use and return to the clinic
within 7 to 21 days. If their morning testosterone is less than 300
ng/dl, they will be randomized to either Androxal or Testim. Patients
will be treated for 6 months with results assessed at both the 3 and 6
month time points.

   The primary endpoints for the study will be the change in semen
volume, sperm count and motility from baseline comparing the Androxal
and Testim groups. Secondary endpoints will consist of changes in
pituitary hormones as well as testosterone.

   In a previous 6 month study, Androxal has been shown to normalize
testicular function and be non-inferior to the leading prescribed
topical testosterone medication Androgel(R). In that study, a
once-daily oral dosage of 25 mg Androxal yielded a statistically
significant improvement in morning testosterone as compared to
Androgel (p=0.0009). In that same study Androxal showed statistically
significant differences in pituitary hormones that are drivers of
testicular function as well as testicular size, a surrogate of

   Joseph S. Podolski commented, "In our previously completed
Androxal study, over 30% of our men were less than 50 years of age.
There were as many men in their 40's as there were in their 60's and
the youngest man was 18. It was illuminating that in this clinical
trial less than 5% of the 600 patients screened were characterized as
having primary testicular failure as determined by elevated LH, the
pituitary hormone responsible for driving the testicular production of
testosterone. Men with secondary hypogonadism respond to the
administration of exogenous testosterone with suppression of the
pituitary hormones responsible for the production of testosterone and
spermatogenesis, thus impairing fertility further. We believe that
Androxal can provide an effective option for men with low testosterone
who wish to preserve their fertility." He further commented, "Our goal
is to request an end of Phase II meeting with the FDA once this study
is completed before moving into Phase III studies."

   Proellex and Androxal Guidance


   The data base to review the initial interim data for our current
Phase 2 clinical study with Proellex for the treatment of
endometriosis is scheduled to be locked during the first week of July.
This data will then be disseminated as soon as possible and is
expected to be available in mid July. The interim analysis will be
done using the modified Biberoglu and Behrman Symptom Severity Scale.
This modification was requested by the FDA and is being utilized in
the study as the Mean Endometriosis Symptom Severity Scale.


   Repros submitted a White Paper to the Division of Reproductive and
Urology Products in April 2008 which demonstrated that there was a
statistically significant reduction in fasting plasma glucose and a
higher response rate in subjects with a plasma glucose of greater than
or equal to 105mg/dL who were treated on Androxal as compared with the
placebo or Androgel-treated subjects. Repros requested a Type C
meeting with the FDA which would involve both the reviewing division
and the Division of Metabolic and Endocrine Products. The White Paper
is still under review by the FDA and a meeting date is to be
determined. The purpose of the submission was to request an additional
indication for Androxal in the management of subjects who have
secondary hypogonadism associated with hyperglycemia. Repros is
proceeding with a study at an academic endocrinology center to
prospectively confirm the observation of glucose reduction in men with
secondary hypogonadism who have associated hyperglycemia. This study
is expected to begin following the FDA meeting.

   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.

   Our lead drug, Proellex(R), is a selective blocker of the
progesterone receptor and is being developed for the treatment of
symptoms associated with uterine fibroids and endometriosis. We are
also developing Proellex as a short course pre-surgical treatment for
anemia associated with excessive menstrual bleeding related to uterine
fibroids. There is no currently-approved effective long-term orally
administered drug treatment for uterine fibroids or endometriosis. In
the United States alone, 300,000 women per year undergo a hysterectomy
as a result of severe uterine fibroids.

   Our second product candidate, Androxal(R), is a single isomer of
clomiphene citrate and is an orally active proprietary small molecule
compound. We are developing Androxal for men with low testosterone and
adult-onset idiopathic hypogonadotrophic hypogonadism ("AIHH") with
concomitant plasma glucose and lipid elevations, all of which are
components of Metabolic Syndrome. We are also developing Androxal for
men of reproductive age with low testosterone levels who want to
improve or maintain their fertility and/or sperm function while being
treated for low testosterone.

   Any statements that are not historical facts contained in this
release are forward-looking statements that involve risks and
uncertainties, including Repros' ability to raise additional capital
in a timely manner and on acceptable terms or at all, Repros' ability
to have success in the clinical development of its technologies, the
timing of enrollment and release of data in such clinical studies and
the accuracy of such studies, limited patient populations of clinical
studies to date and the possibility that final data may not be
consistent with interim data 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
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

Repros Therapeutics Inc., The Woodlands
Joseph S. Podolski, 281-719-3447
President & CEO

Copyright Business Wire 2008
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