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8-K - REPROS THERAPEUTICS INC. | v199833_8k.htm |
Exhibit
99.1
Contact:
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Repros
Therapeutics Inc.
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Joseph
Podolski (281) 719-3447
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President
and Chief Executive Officer
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REPROS®
THERAPEUTICS BEGINS RANDOMIZATION OF SUBJECTS IN
ANDROXAL® TYPE II
DIABETES PHASE II TRIAL
New
FDA ruling on potential for development of diabetes due to castrating effects of
GnRH
administration
reinforces Company strategy for Androxal
THE
WOODLANDS, Texas – October 25, 2010 – Repros Therapeutics Inc.®
(NasdaqCM:RPRXD) today announced it has commenced randomization of
subjects into its Phase II Androxal® study in
the treatment of type 2 diabetes (T2DM) in men with low
testosterone. Low testosterone and T2DM are co-morbid conditions in a
significant number of men. The study is being conducted at nine sites
across the US including both academic and private practices and will enroll up
to 150 patients. The five private practices are located in the
metropolitan New York area, San Antonio and Houston and were selected based on
their current data base of patients that meet the inclusion
criteria. These private practices have already begun to enroll and
randomize subjects. Four academic sites were selected based on the
same criteria, but were further assessed based on the expertise they bring to
the study. The academic sites will require individual institutional
review board approval, which can take a few months, before enrolling
subjects.
The five
private practice site locations and investigators are:
New York,
NY, Dr. Jed Kaminetsky MD, Clinical Assistant of Urology, New York University
School of Medicine
Purchase,
NY, Dr. Michael Werner, Urologist and Specialist in Sexual
Dysfunction
Houston,
TX, Dr. Rakesh Patel, Endocrinologist
Lake
Jackson, TX, Dr. Harvey Resnick, Family Practitioner, R/D Clinical Research,
Inc.
San
Antonio, TX, Dr. Sherwyn Schwartz, Endocrinologist, Medical Director of Cetero
Research – San Antonio
Given the
high level of interest in the study, Repros believes that the study will be
fully enrolled within four months after all sites have received IRB
approval. Since the private practice sites have begun randomization
and the dosing period is only three months in duration, the Company hopes to
have interim analysis of the key efficacy parameters, fasting plasma glucose
levels and HbA1c, when the first 60 subjects complete the study during the
second quarter of 2011 with complete results reported later that year when the
study is expected to conclude.
Joseph S.
Podolski, President and CEO of Repros, commented, “We are pleased to have an
enthusiastic clinical research team as part of our Androxal
program. We have a good mix of private practices and academic sites
that will not only allow us to obtain data quickly, but should the study outcome
duplicate previous results, provide for a strong voice of endorsement for a new
approach to the treatment of type 2 diabetes in the aging male.”
Previous
studies using exogenous testosterone have not shown any clinically relevant
impact on measures of glycemic control in type 2 diabetics. A study conducted by
Solvay (now Abbott) showed no positive effect on glycemic control in men with
diabetes. (Link: http://global.abbottgrowth.com/static/wma/pdf/1/3/4/4/2/S176.2.101.pdf). These findings are consistent
with those observed for men on AndroGel® in the
retrospective analysis from the 200 patient study completed by
Repros. Unlike AndroGel, Androxal exhibited clinically significant
reductions in fasting plasma glucose in the same population. These
reductions were similar to those reported by Glaxo for the 4 mg dose of
Avandia®. Unlike
Avandia, Androxal has exhibited no cardiovascular side effects to
date.
Dr.
Ronald Wiehle, Repros’ VP of Research, noted, “Very recently the FDA has
required companies that market GnRH agonists to add a warning to their label
indicating the potential for the induction of diabetes. These drugs
work centrally to suppress testicular synthesis of testosterone. We
believe that action by the agency, the Solvay study and the prior work of
Pitteloud et al. (JCEM 90:2636, 2005), who concluded that insulin resistance was
associated with a decrease in testicular testosterone, all strengthen our
hypothesis that Androxal can improve glycemic control.” He further remarked,
“Androxal does not work like either GnRH agonists or topical gels but does
restore testicular function and appears to modify metabolic processes that have
a positive impact on glycemic control.”
Repros
has an issued patent teaching the use of Androxal in restoration of testicular
function and has pending patent applications that deal specifically with the
drug’s ability to impact glycemic control.
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, maintain its listing on the NASDAQ Capital Market,
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.