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) September 20, 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 September 20, 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 September 20, 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) |
||
| September 20, 2011
(Date) |
/s/ JOSEPH S. PODOLSKI
Joseph S. Podolski President and Chief Executive Officer |
| Exhibit Index | ||
| 99.1 | Press release dated September 20, 2011 | |
EXHIBIT 99.1
THE WOODLANDS, Texas, Sept. 20, 2011 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced it has commenced the dosing of the final cohort in its Phase 2 low-dose trial of oral Proellex. The current group will receive 12mg per day, the highest dose level in the trial. Following expected completion of the study this year, Repros plans to request an end of Phase 2 meeting with the FDA during the first half of 2012 in order to discuss the commencement of limited Phase 3 studies for the use of oral Proellex in the treatment of endometriosis. To date, there have been no signals of adverse effects on the liver for oral doses of Proellex seen in patients who have received the drug in the trial. The study is designed to provide rigorous assessment of the impact of the drug on menstrual events, as well as liver function.
Based on results of clinical studies to date, Repros believes a 6mg dose will provide for robust efficacy in the treatment of endometriosis and a significant margin of safety compared to the highest dose tested in previous studies, 50mg.
In a previous study of oral Proellex in the treatment of women with severe endometriosis as determined by the Biberoglu Bermann Symptom Survey, significant improvement compared to placebo was seen in all three elements of pain typically associated with the disorder; dysmenorrhea (menstrual pain), non menstrual pelvic pain, and dyspareunia (pain during sex). Doses of 25 and 50 mg were tested and good correlation between induction of amenorrhea (cessation of menses) and clinical outcome was demonstrated. In the current trial, doses as low as 3mg of oral Proellex consistently induce amenorrhea.
The previously completed study used FDA suggested endpoints evaluated with real time computer assisted reporting of daily outcomes. In addition to the patient reported outcomes, a dramatic reduction in the use of analgesics was recorded for the blinded active groups versus the placebo group. At baseline, between 55% and 65% of the women required narcotics at some point during their menstrual cycle to control the pelvic abdominal pain associated with endometriosis. This need remained unchanged in the placebo group. In the active dosing group the percent of women still requiring narcotic relief at the end of the four month study was less than 20%. In addition, at the beginning of the study, over 90% of women in the trial required some form of analgesic relief. In the placebo group this percentage was reduced slightly, while both of the active groups reduced the need for any analgesic usage to roughly 35% of the women in the 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.
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 its operations, 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