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8-K - REPROS THERAPEUTICS INC. | v205835_8k.htm |
Exhibit
99.1
Contact:
|
Repros
Therapeutics Inc.
Joseph
Podolski (281) 719-3447
President
and Chief Executive Officer
|
REPROS®
THERAPEUTICS PREPARES TO COMMENCE DOSING IN SECOND COHORT IN LOW DOSE
PROELLEX®
STUDY
No
signals of liver toxicity detected at one milligram dose of
Proellex
Low
levels of drug activity exhibited in first cohort
THE
WOODLANDS, Texas – December 16, 2010 – Repros Therapeutics Inc.®
(NasdaqCM:RPRX) today announced it has commenced preparation for dosing
the 3 mg cohort in the Company’s low dose study of Proellex®
following a safety review of data from women that have completed 8 weeks of
treatment at a 1 mg dose. No signals of liver toxicity were detected
to date in the 1 mg group. Unexpectedly, low levels of drug activity
were detected in this first cohort. The Company plans to commence
dosing of the second group, 3 mg Proellex, next week.
Proellex
is an oral therapy in development for the treatment of uterine fibroids and
endometriosis. Large Phase III clinical studies at doses of 25 and 50
mg exhibited severe liver toxicity in a small percentage of subjects that were
exposed to a 50 mg dose. As a result of these observations, the
program was placed on full clinical hold until the phenomenon could be better
understood. After an analysis of all the subjects that had been
exposed to Proellex, Repros petitioned the FDA to allow the Company to conduct a
low dose trial to assess impact on the liver and signals of
efficacy. In the summer of this year the FDA moved Proellex to
partial hold status to allow for the low dose study.
The trial
is enrolling up to 12 subjects per cohort. There are five cohorts; 1,
3, 6, 9 and 12 mg administered per day over the dosing period. The
next higher dose cohort is not allowed to commence until the Chairman of the
outside drug safety monitoring board, a hepatologist, reviews the liver safety
data from a minimum of 8 subjects from the current cohort that were dosed for a
minimum of 8 weeks.
One of
the first signals of efficacy for Proellex is induction of
amenorrhea. This has profound effects on symptoms of both uterine
fibroids and endometriosis. Though most women on the 1 mg dose
continued to menstruate, their menstrual patterns have begun to
change. In some, the time between menses has lengthened and in others
the intensity of daily bleeding has decreased. Though the Company
does not believe the observed effects would translate to an effective marketed
drug, it does believe that this first finding suggests doses lower than
previously tested may have sufficient efficacy to warrant further
development. Previously the Company tested a 12.5 mg dose and found
that dose to be effective in inducing amenorrhea in roughly 80% of patients
treated. This translates to no fibroid bleeding and no menstrual
pain.
The
Company plans to issue similar releases as each new cohort commences
dosing. Repros believes the study can be completed during the fourth
quarter of 2011.
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 the partial
hold on Proellex® lifted and to determine a safe and
effective dose for Proellex, 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.