Repros® Therapeutics Begins Randomization of Subjects in Androxal® Type II Diabetes Phase II Trial
26 October 2010 - 1:36AM
Business Wire
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.
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