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Results In Line with Study ZA-301 FindingsAll Studies Fully Compliant with FDA Good Clinical Practice
THE WOODLANDS, Texas, Sept. 18, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.
® (Nasdaq:RPRX)today reported additional topline results for study ZA-302, the second pivotal efficacy study for Androxal
®. The results of both pivotal studies, ZA-301 and ZA-302, have met the SPA co-primary endpoints as defined by the FDA.
Study ZA-302 had no detected site anomalies. Additional data which may be of interest to investors are provided below for informational purposes. It should be noted that these results are topline and not fully audited. However, the Company does not believe any changes will occur that will affect the conclusions that can be drawn. The Company has conducted several placebo controlled trials of Androxal in the treatment of secondary hypogonadism. In every study Androxal achieved highly statistically significant and clinically relevant improvement in testicular function as evidenced by improved endogenous production of the male hormone. Importantly, Androxal improves pituitary secretions of important hormones necessary to maintain normal testicular function including both testosterone synthesis and spermatogenesis. This feature distinguishes Androxal from all of the testosterone replacement therapies which, via the negative feedback on the pituitary of exogenous testosterone, result in suppression of pituitary signaling and testicular function.
It should be of further interest that in all placebo controlled Androxal studies, it has been observed that at any given time approximately 20% of secondary hypogonadal men will be in the normal range. These men still have a functional hypothalamic-pituitary-testes axis, unfortunately it does not function consistently. In these men, hormone replacement therapy results in complete suppression of the axis in about 40% of subjects based on Repros studies.
Baseline Morning T Median (ng/dL)
Week 12 Morning T Median(ng/dL)
Subjects in Normal Range (%)
Baseline Median Sperm Conc.
Week 12 Median Sperm Conc.
Median Percentage Change from Baseline Sperm Conc. (%)
Percentage of Subjects with ≥50% Change from Baseline Sperm Conc. (%)
P value (Androxal vs. Placebo)
Non-inferior Confidence Interval on the Difference (-0.1832, 0.0053)
In previously reported results for study ZA-301, we reported 1 subject on placebo and 15 subjects on drug dropping below 50% of baseline sperm concentrations. In the final study analysis this changed to 1 and 16 in the final ITT but the conclusions of the analyses were no different than previously reported. The Company chose to include the subjects from site 30 where there were some reports of fabricated data as part of the overall ITT because much of the data had since been verified as accurate. It is imperative to note that the inclusion of site 30 data did not change the outcome of the study and only the fabricated data was excluded from the analyses. Specifically, with all site 30 subjects in the analysis, the lower bound of the confidence interval is 0.194 (1/38 vs. 16/113) and with all of the site 30 subjects removed it is 0.196 (1/36 vs. 15/109). The Company is convinced study ZA-301 meets all the criteria set forth by the FDA under the SPA.