-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OW4ZmL/5cMouy1J7TIFXRVpzmGAamqf0kkp+5nHW5ZuDDTfwEaS3fo0S9CvNEW8o zHsVmQ5gKttUiTwTExG+1Q== 0001144204-10-055280.txt : 20101025 0001144204-10-055280.hdr.sgml : 20101025 20101025130520 ACCESSION NUMBER: 0001144204-10-055280 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20101025 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101025 DATE AS OF CHANGE: 20101025 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPROS THERAPEUTICS INC. CENTRAL INDEX KEY: 0000897075 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 760233274 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-15281 FILM NUMBER: 101139447 BUSINESS ADDRESS: STREET 1: 2408 TIMBERLOCH PL STREET 2: SUITE B-7 CITY: WOODLANDS STATE: TX ZIP: 77380 BUSINESS PHONE: 2817193400 MAIL ADDRESS: STREET 1: 2408 TIMBERLOCH PLACE B-7 CITY: THE WOODLANDS STATE: TX ZIP: 77380 FORMER COMPANY: FORMER CONFORMED NAME: REPROS THERAPEUTICS INC DATE OF NAME CHANGE: 20060503 FORMER COMPANY: FORMER CONFORMED NAME: ZONAGEN INC DATE OF NAME CHANGE: 19930208 8-K 1 v199833_8k.htm
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
 
FORM 8-K
 
Current Report Filed Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
 
Date of Report
(Date of earliest event reported): October 25, 2010
 
Repros Therapeutics Inc.
(Exact name of registrant as specified in its charter)

Delaware
001-15281
76-0233274
(State or other jurisdiction of incorporation or organization)
(Commission File Number)
(I.R.S. Employer Identification No.)
2408 Timberloch Place, Suite B-7
The Woodlands, Texas  77380
(Address of principal
executive offices
and zip code)
 
(281) 719-3400
(Registrant’s telephone
number, including area code)
 


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

[  ]           Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]           Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]           Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]           Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 

 
 
Item 8.01  Other Events.
 
On October 25, 2010, Repros Therapeutics Inc. (the “Company”) issued a press release titled “Repros® Therapeutics Begins Randomization of Subjects in Androxal® Type II Diabetes Phase II Trial.”  A copy of such press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01  Financial Statements and Exhibits.
 
(d)  Exhibits.
 
Exhibit
 
Number
Description
99.1
Press Release dated October 25, 2010


 
 

 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
  Repros Therapeutics Inc.
     
     
Date: October 25, 2010
   
By:
/s/ Joseph S. Podolski                            
   
Joseph S. Podolski
   
President and Chief Executive Officer

 
 
 

 
 
 
EXHIBIT INDEX
 
Exhibit
 
Number
Description
   
99.1
Press Release dated October 25, 2010


 
 

 
EX-99.1 2 v199833_ex99-1.htm

Exhibit 99.1
 
Contact:
Repros Therapeutics Inc.
 
Joseph Podolski (281) 719-3447
 
President and Chief Executive Officer



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.
 
 
 
 

 
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