Attached files
| file | filename |
|---|---|
| 8-K - REPROS THERAPEUTICS INC. | v206703_8k.htm |
| EX-99.1 - REPROS THERAPEUTICS INC. | v206703_ex99-1.htm |
|
|
Exhibit
99.2
|
|
Contact:
|
Repros
Therapeutics Inc.
|
Joseph
Podolski (281) 719-3447
President
and Chief Executive Officer
REANALYSIS
BY OUTSIDE STATISTICIAN SHOWS ANDROXAL® PROVIDES
STATISTICALLY SIGNIFICANT IMPROVEMENT IN TESTOSTERONE LEVELS IN MEN WITH MALE
HORMONE LEVELS ≤ 250 ng/dL
FDA
recommends men with morning testosterone ≤ 250 ng/dl should
be
studied in Phase IIb trial
THE
WOODLANDS, Texas – December 28, 2010 – Repros Therapeutics Inc.®
(NasdaqCM:RPRX) today reported it has submitted to the FDA a reanalysis
of the previously completed 200 subject trial ZA-003 of Androxal® in the
treatment of secondary hypogonadism as noted by Repros in the Company’s press
release of November 9, 2010. The Company contracted an outside
statistician, Tony Orlando, Ph.D, V.P., Global Data Division, Pharm-Olam
International Ltd. to conduct the analysis.
Dr.
Orlando performed several different analyses. He first assessed the
subset of men in the 003 study that exhibited morning testosterone levels ≤ 250
ng/dl to mimic the upcoming Phase IIb study. He examined the data for
the men after three months of treatment and again for those that completed the
six month study. There were 11, 16, 20 and 21 men in the 12.5 mg
Androxal, 25 mg Androxal, Androgel and placebo groups, respectively, that met
the baseline testosterone criteria and completed three months of the study.
After three months of treatment the mean change from baseline in morning
testosterone levels for the four groups were 216.8, 260.5, 213.6 and 50.1 ng/dl
for the 12.5 mg Androxal, 25 mg Androxal, Androgel and placebo groups,
respectively. Even with the small number of men in this subset, both
doses of Androxal achieved statistically significant changes from baseline
results when compared to placebo (p=0.0001 @ 25 mg and 0.0021 @ 12.5
mg). For the men from this group that remained in the study for the
full six month period, changes from baseline levels as compared to placebo
remained significant (p<0.01).
Dr.
Orlando also performed a “completer” analysis for all the men in the
study. Now with roughly 33 to 37 men per group, he observed that mean
changes of morning testosterone for the four groups from baseline to after six
months of treatment were 139.4, 271.5, 132.3 and 12.5 ng/dl for the
12.5 mg Androxal, 25 mg Androxal, Androgel and placebo groups respectively. Both
of the Androxal groups exhibited p values < 0.0001 compared to
placebo. Mean testosterone levels after the six month study were
410.4 at 12.5 mg and 519.3 at 25 mg Androxal.
As part
of Dr. Orlando’s analyses he also looked at the impact of Androxal and Androgel
on luteinizing hormone (LH) and follicle stimulating hormone (FSH) in the men
with baseline morning testosterone ≤ 250 ng/dl. Androxal
significantly increased LH levels in a dose dependent manner. LH
stimulates the testes to produce testosterone. Androxal also
significantly increased FSH in a dose dependent manner. FSH
stimulates the testes to produce sperm. He further determined that
there was a statistically significant correlation between changes in LH and
changes in morning testosterone level (correlation = 0.6137, p value
<0.0001). This analysis underscores the mode of action of Androxal
which restores pituitary responsiveness to low circulating levels of
testosterone, in turn stimulating the testes to produce normal levels of
testosterone in a normal rhythmic pattern.
Conversely,
Androgel significantly reduced pituitary secretions of both LH and FSH which
further suppressed testicular function, and causes variability in testosterone
levels not corresponding to the normal rhythmic pattern observed in healthy
males.
One of
the safety assessments proposed by the FDA that will be made in the planned
Phase IIb study is to assess the impact of Androxal compared to placebo and
Testim (an approved topical testosterone preparation) upon the reproductive
status of men receiving three months of treatment with the study
drugs. Dr. Orlando also observed that over 62% of men on Androgel in
the analysis of the 003 study exhibited FSH levels below the lower limit of
normal (1.4 mIU/ml) after three months of Androgel treatment, and noted that
over 43% of those men had FSH levels below the lower limit of detection 0.3
mIU/ml. In a previous proof of principle study conducted by Repros it
was found that roughly 80% of men with FSH levels less than 2.0 exhibited sperm
parameters that would be considered sub fertile. After three months
of treatment all men on the 25 mg dose of Androxal had FSH levels above 1.4
mIU/ml (minimum observed 2.9).
Joseph S.
Podolski, President and CEO of Repros commented, “We believe Dr. Orlando’s
observations bode well for our upcoming Phase IIb study and further reinforce
the findings from our previous studies.” He further stated, “Unlike
testosterone replacement therapy, Androxal treats the underlying defect that is
the reason for low testosterone levels in the majority of men that experience
this condition. Androxal normalizes testicular function, improving
testosterone levels back into the normal range, and maintains a man’s
reproductive status.”
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.