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) August 27, 2012
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 August 27, 2012 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 August 27, 2012
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Repros Therapeutics Inc.
(Registrant) |
||
| August 27, 2012
(Date) |
/s/ KATHI ANDERSON
Kathi Anderson CFO |
| Exhibit Index | ||
| 99.1 | Press release dated August 27, 2012 | |
EXHIBIT 99.1
THE WOODLANDS, Texas, Aug. 27, 2012 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced the FDA has provided guidance for a Phase 2 study of low dose oral Proellex® in the treatment of endometriosis. The following are the key elements of the guidance:
Repros plans to submit the revised protocol to the FDA as soon as practicable. Once received, the FDA agreed to review the design within 30 days, at which time, if the protocol is acceptable, Repros could commence the Phase 2 trial in the fourth quarter of this year. The Company intends to enroll up to 90 women into the study (30 per arm).
The Company believes prior experience with higher dose Proellex bodes well for the eventual outcome of the trial. In previous studies of oral Proellex in women with severe endometriosis at doses of 25 and 50 mg, Proellex in comparison to placebo statistically significantly reduced the three elements of endometriosis related pain. The three elements of pain are dysmenorrhea or painful menses, dyspareunia or painful sex and non menstrual pelvic pain. In addition to the statistically significant reduction (p < 0.05) in all three pain elements, there was also a statistically significant reduction in the need for over the counter or narcotic analgesics used to control the endometriosis related pain in the Proellex arm.
Notably, there was no difference in the response between the two active doses. The Company believes the primary driver in pain relief associated with the use of Proellex is the suppression of menses. Both the 25 and 50 mg dose of Proellex suppress menses to the same extent. Importantly, the two doses in the proposed Phase 2 study, 6 and 12 mg, have been shown to suppress menses equivalent to the two higher doses.
Joseph S. Podolski, President and CEO of Repros, commented, "We are pleased with the FDA's willingness to consider continued development of low dose oral Proellex. We believe Proellex will offer distinct advantages over approved therapies as well as those currently under development, for this significant and undertreated female health disorder."
It is estimated that nearly 5 million women of reproductive age in the US and Canada suffer from endometriosis. The disorder is characterized by severe pelvic abdominal pain that, in many cases, peaks during menses. In severe cases hysterectomies are the intervention of last resort.
About Repros Therapeutics Inc.
Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
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® and Proellex® programs, 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.
The Repros Therapeutics Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7738
CONTACT: Repros Therapeutics Inc.
Joseph Podolski (281) 719-3447
President and Chief Executive Officer
Investor Relations:
Thomas Hoffmann
The Trout Group
(646) 378-2931