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) March 17, 2014
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 March 17, 2014 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 March 17, 2014
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) |
||
| March 17, 2014
(Date) |
/s/ KATHI ANDERSON
Kathi Anderson CFO |
| Exhibit Index | ||
| 99.1 | Press release dated March 17, 2014 | |
EXHIBIT 99.1
THE WOODLANDS, Texas, March 17, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported it has received guidance from the FDA indicating that Repros may proceed to conduct Phase 1 and 2 studies of oral Proellex® under two separate INDs for endometriosis and uterine fibroids, while remaining on partial clinical hold. The FDA guidance provides that the highest allowed dose will be 12 mg daily. Repros is currently conducting a Phase 2 study for the use of Proellex in severe endometriosis and plans to submit a Phase 2 protocol for the treatment of symptomatic fibroids.
Regarding the proposed uterine fibroid Phase 2 protocol, the FDA provided guidance as to the appropriate inclusion and exclusion criteria for study subjects as well as the preferred efficacy endpoint. The FDA preferred efficacy endpoint is reduction in excessive menstrual bleeding associated with uterine fibroids. The FDA also noted the preferred methodology to determine changes in bleeding. Repros will comply with FDA guidance as well as collecting additional efficacy outcomes such as tumor size and other symptomatic relief. Given the prior experience with Proellex at 6 and 12 mg daily dosages, Repros plans to enroll fewer than 75 women in a three arm, parallel design double blind trial. The study is sized to provide greater than 90% power in demonstrating efficacy associated with reducing subject bleeding.
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 within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as "may," "will," "expect," "anticipate," "continue," "estimate," "project," "intend," "believe," "plan," "seek," "could," "can," "should" or similar expressions. These statements are based on assumptions that the Company has made in light of the Company's experience in the industry, as well as the Company's perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to planned clinical studies and the timing and nature of the results thereof. Such statements are based on current expectations that involve a number of known and unknown risks, uncertainties and other factors that may cause actual events to be materially different from those expressed or implied by such forward-looking statements, including the ability to have success in the clinical development of the Company's technologies, the reliability of interim results to predict final study outcomes, the ability to protect the Company's intellectual property rights and such other risks as 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: Investor Relations:
Thomas Hoffmann
The Trout Group
(646) 378-2931
thoffmann@troutgroup.com