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) May 13, 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 7.01. Regulation FD Disclosure.
On May 13, 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 May 13, 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) |
||
| May 13, 2014
(Date) |
/s/ KATHI ANDERSON
Kathi Anderson CFO |
| Exhibit Index | ||
| 99.1 | Press release dated May 13, 2014 | |
EXHIBIT 99.1
THE WOODLANDS, Texas, May 13, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc® (Nasdaq:RPRX) today announced it has reached the enrollment goal of 120 subjects in the second of two previously announced head-to-head studies, ZA-304, comparing Androxal® to the leading U.S. testosterone replacement therapy. The two identical pivotal studies, ZA-304 and the previously enrolled ZA-305, were initiated in January 2014.
Each study is designed to enroll 120 men, 40 each into three parallel arms: Androxal®, approved topical gel and placebo. All three arms are blinded and "double dummied," meaning men will receive both an active dose and a placebo mimicking the other active. Men on placebo will receive two placebos, one for each active. The studies are of 17 week duration, 16 weeks dosing and 1 week follow-up.
Men (≤60 years of age) enrolled in the studies must exhibit sperm counts in the normal range at baseline (>15 million/mL) on two separate days separated by at least two days. Men also must exhibit morning testosterone of <300 ng/dL on two separate assessments to be eligible to enter each study.
The co-primary endpoints of the studies compare the semen concentration outcome of subjects treated with Androxal® to those treated with the topical gel. One endpoint compares the proportion of subjects whose semen concentrations are below 10 million/mL after 16 weeks of treatment and the second compares the percentage change from baseline in semen concentration after 16 weeks of treatment. Based on results from previous Repros studies, the Company believes both studies are suitably powered (greater than 80% power, alpha=0.05) to meet these two endpoints.
A variety of different efficacy and safety comparisons are also being made. These include excursions of testosterone outside of the normal range as well as impact on testosterone levels after the study drug is stopped. Safety assessments will include impact on hematocrit, an important cardiovascular safety marker.
The first fully enrolled study, ZA-305, was recruited at 10 clinical sites and randomized 127 subjects. This second study, ZA-304, has randomized 120 subjects at 16 clinical sites and may ultimately include as many as 128 subjects.
Joseph Podolski, President and CEO of Repros Therapeutics, commented, "The completion of enrollment represents an outstanding effort by our clinical development team. The rapid recruitment should enable us to meet our NDA timeline goals and demonstrates that the secondary hypogonadal population of men with normal sperm concentration is highly prevalent."
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, the impact of the studies on the Androxal® label and the commercial potential of Androxal® and the timing of the Company's expected filing of an NDA for Androxal®. 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