Repros Therapeutics Inc. (NasdaqGM: RPRX) released positive results from its U.S. Phase 2 recently completed trial Proellex endometriosis. Oral Proellex is a progesterone receptor modulator. This analysis will form the basis for an application to the end of Phase II Meeting with FDA. The main conclusions of this doubleblind study were: br statistically significant reductions in symptoms of endometriosis for both doses of Proellex, evaluated with the average of endometriosis symptoms scale survey (MESSS) compared to placebo, br statistically significant reductions in the three patients reported earnings: Rules dysmenorrhea (painful), deep dyspareunia (painful intercourse) and nonmenstrual pelvic pain for Proellex compared with placebo; br The dropout rate for the placebo arm was more than twice the rate in any of the Proellex arms. br The data also show that pain, the most distressing symptom associated with endometriosis, is statistically significant and clinically significant reduction in one or two months of treatment and remains under control for the entire period of 4 months of treatment compared with placebo. These results clearly confirm and extend the positive results that were announced on 10 July 2008, when the result of two months of treatment was reported in a small group of subjects. The study results br The study of endometriosis SPA201 was designed to evaluate the efficacy of Proellex in women with moderately severe pain associated with severe endometriosis. A scale of symptoms of endometriosis adapted from Behrman and Biberoglu validated symptom severity scale was developed to collect pain scores per month. This instrument, the average level of severity of endometriosis symptoms (MESSS) is independent of the analgesic effect of concurrent use. The MESSS has 5 fields, three of which are: the severity of the patient reported dysmenorrhea, the patient reported the severity of deep dyspareunia and patient reported severity of nonmenstrual pelvic pain, the other two domains as your doctor reported the results of pelvic tenderness and induration at the pelvis examination. br Fortythree patients (placebo n = 15, Proellex 25 mg n = 14 and Proellex 50 mg n = 14) completed up to 4 months of doubleblind period provided qualified for this analysis. The MESSS baseline patient outcomes for patients randomized to placebo, 25 mg or 50 mg Proellex were 7.13, 6.86 and 7.0, respectively. These scores MESSS document that subjects experiencing clinically significant moderately severe to severe pain. There was no statistically significant difference in pain intensity between the treatment groups at baseline (p = 0.39 0.72). All the three patients reported MESSS scores for both doses of Proellex declined 6.93 at baseline to 2.07 (p = 0,007)), 1.21 (br p reduction in pain scores was accompanied by a reduction in the number of patients requiring analgesics in Proellex topics compared to placebo. In month four, 71.4% of the 50 mg group and 64.2% of the 25 mg group were analgesic free. In comparison, only 13.3% in the placebo group no longer required analgesics. This comparison gave significant P values of 0.0025 and 0.0078, respectively, for the 2 active doses. In addition, during the course the study of more than twice the number of patients who discontinued placebo group Proellex weapons. br Adverse events that occurred in this study were similar in nature to those observed in previous studies and were generally mild to moderate in severity and transient in nature. There is no new or unexpected events. br Andre van As, MD, PhD, Mr. Vice President Regulatory and Clinical Affairs for Repros said, the results of this study confirm our previously reported results of a rapid reduction of pain in the first month of treatment Proellex. These new results extend this finding to show that there is a sustained benefit for the entire period of 4 months of treatment. The large reduction in pain associated with a reduction in the use of narcotic analgesics and nonnarcotic. Issues of classification for this study had to have a level of pain intensity at or above percentile 66, the patient reported scale, which makes this significant reduction in pain for women living with severe discomfort . The current study, together with our previous phase 12 study suggests that the pain of all grades, due to endometriosis can be controlled by Proellex. The concomitant reduction in the use of analgesics is a unique observation suggests that Proellex may have a mode of action which results in controlling pain associated with endometriosis, and provides additional benefits to these women, allowing the reduction of concomitant medications. About br Repros Therapeutics Inc. Repros Therapeutics focuses on the development of small molecule oral drugs for major unmet medical needs that treatment of male and female reproductive disorders. br Our lead drug, Proellex, is a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. Proellex We are also developing a short course presurgical treatment for anemia associated with excessive menstrual bleeding related to uterine fibroids. There are currently no approved effective longterm oral drug treatment for uterine fibroids or endometriosis. In the United States, 300,000 women per year undergo a hysterectomy because of severe uterine fibroids. br Our second product candidate, Androxal, is a single isomer of clomiphene citrate and is an asset via Property oral small molecule compound. We are developing Androxal for men of reproductive age with low testosterone levels who want to improve or maintain their fertility and / or sperm function while being treated for low testosterone levels. In November 2008, we received guidance from the FDA suggests filing a new IND to the Division of Metabolic and Endocrine Products, or DMEPOS, Androxal for research as a potential treatment for type 2 diabetes. We intend to file a new IND for this indication to the DMEPOS as soon as possible. br Any statements that are not historical facts contained in this release are forward looking statements that involve risks and uncertainties, including Repros ability to raise additional capital in a timely manner and on terms acceptable to all, Repros ability to succeed in the clinical development of its technologies, the time of registration and publication of data in these trials and the accuracy of such studies, limited patient populations of clinical studies to date and the possibility that final data may not be consistent with interim data and other risks identified in the firms most recent Annual Report on Form 10K and subsequent quarterly reports on Form 10Q. 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 forwardlooking statement, whether as a result of new information, future events or otherwise. Repros Therapeutics Inc. br br
