UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) December 27, 2011
Repros Therapeutics Inc.
(Exact name of registrant as specified in its charter)
Delaware |
001-15281 |
76-0233274 |
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
2408 Timberloch Place, Suite B-7 The Woodlands, Texas |
77380 |
| (Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code: (281) 719-3400
________________________________________________________________________________
(Former name or former address, if changed since last report)
| 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: |
||
| [ ] | 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 December 27, 2011 the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
Exhibit 99.1. Press release dated December 27, 2011
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Repros Therapeutics Inc.
(Registrant) |
||
| December 27, 2011
(Date) |
/s/ JOSEPH PODOLSKI
Joseph Podolski President and CEO |
| Exhibit Index | ||
| 99.1 | Press release dated December 27, 2011 | |
EXHIBIT 99.1
THE WOODLANDS, Texas, Dec. 27, 2011 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today provided a status update for the one year open label extension of its Phase 2 clinical study ZA-203, of Androxal. At the end of the ZA-203 study, men were offered the opportunity to enroll in the extension study and given the choice to use either Androxal or Testim. Forty-five men chose to enroll in the one year extension study. The primary reason cited by men choosing not to enter the study was the need to provide additional sperm samples. If the men chose Testim, all of their drug supplies were provided at no expense to them.
The following table represents the distribution of the subjects and the group they came from in the ZA-203 study:
Distribution of Men in ZA-203 One Year Extension Study
| Original ZA-203 Arm | Chose Androxal | Chose Testim |
| Androxal (n=24) | 18 | 6 |
| Placebo (n=11) | 10 | 1 |
| Testim (n=10) | 7 | 3 |
Joseph Podolski, President and CEO of Repros Therapeutics, commented, "Given that men were allowed to freely choose which therapy to continue on, we believe this outcome demonstrates the potential preference of Androxal over the currently approved hormone replacements."
About Androxal
Androxal is an oral therapy that acts at the level of the hypothalamic-pituitary axis to restore the ability of the organ system to respond to low production of testosterone by the testes. Androxal blocks the negative feedback of estrogen and allows for increased production of important pituitary hormones that drive synthesis of testosterone by the testes. Testosterone replacement suppresses pituitary secretions resulting in shutdown of testicular function. This shutdown results in suppression of spermatogenesis as evidenced by the results from the ZA-203 study.
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.
The Repros Therapeutics Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7738
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including the ability to raise additional needed capital on a timely basis in order for it to continue to fund development of its Androxal program along with its other current and potential development programs including Proellex®, have success in the clinical development of its technologies, the reliability of interim results to predict final study outcomes, 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.
CONTACT: Repros Therapeutics Inc.
Joseph Podolski (281) 719-3447
President and Chief Executive Officer