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Repros Therapeutics Inc.(R) (Nasdaq:RPRX) provided top line results for the end of dosing analysis on its Phase 2 clinical study of Androxal(R) in hypogonadal men with type 2 diabetes. Many men with secondary hypogonadism also have type 2 diabetes. A total of 108 men completed the three month dosing period and were the basis for this analysis. The study was conducted at 19 clinical sites in the US. A total of 119 men were enrolled in the study and satisfied the requirement of one visit in which efficacy measures could be assessed and are included in the intent to treat population. Outcomes for the "completer" and intent to treat populations were similar.

At baseline, mean morning testosterone levels for the three groups were; placebo (238 ng/dl), 12.5 mg Androxal (244 ng/dl) and 25 mg Androxal (246 ng/dl). There was no statistical difference between the groups in testosterone at baseline. At the end of the 3 month dosing period mean morning testosterone levels were placebo (231 ng/dl), 12.5 mg Androxal (445 ng/dl) and 25 mg Androxal (455 ng/dl). A comparison of either the 12.5 mg or 25 mg dose of Androxal to placebo showed them to be highly statistically different (p< 0.0001). There was no statistical difference between the two active arms. In previous Repros studies in men with low testosterone due to a variety of reasons, there was a dose dependent increase in testosterone levels.

Including all men that completed the 3 month dosing, there was a trend towards improved glycemic control in the men on the 25 mg dose. Men on the 25 mg dose saw a reduction of HbA1c (glycosylated hemoglobin) of 0.159% and a reduction of HOMA-IR (a measure of insulin resistance calculated by measuring fasting plasma glucose and insulin) of 2.89 units. Additionally, the change in HOMA-IR approached statistical significance (p=0.09) for men on the 25 mg dose. In the Intent-to-Treat population of men receiving 25 mg Androxal and who were younger than 65 years of age, the mean change in HbA1c was -0.385% which when compared to placebo men of the same age group (+0.145%) yielded a near statistically significant outcome, p=0.058.

To date, studies of testosterone replacement therapy in diabetic men conducted by others have shown no statistical difference comparing testosterone treatment to placebo when assessing impact on HbA1c levels after treatment. Trials completed by Repros have shown that unlike testosterone replacement therapy, Androxal stimulates normal production of the male hormone by the testes.

The drug was generally well tolerated at both doses compared to placebo. There were no drug related serious adverse events that led to discontinuation. The Company plans to hold a joint meeting with the Endocrine and Urologic Divisions of the FDA to discuss these and other findings.

Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.

More about RPRX at www.reprosrx.com.

Read the full article at: http://stock-pr.com/?p=20937



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