Androxal® is an orally active small molecule under development that restores normal pituitary response in men resulting in normalization of testosterone and luteinizing hormone ("LH") levels. We intend to initiate two proof-of-concept Phase 2b clinical trials with Androxal in the second quarter of 2008.
One of these clinical trials will be in men with adult-onset idiopathic hypogonadotrophic hypogonadism, or AIHH, with concomitant plasma glucose and lipid elevations, all of which are components of Metabolic Syndrome. Recent published studies in older men show a link of low testosterone with higher incidences of insulin resistance, diabetes and consequently mortality rates. Based on a retrospective review of our recently completed six-month clinical trial with Androxal for the treatment of low testosterone due to secondary hypogonadism, our findings showed that Androxal therapy resulted in a significant reduction in mean glucose levels in men with a body mass index, or BMI, >26 and glucose levels >104 mg/dL, an outcome not seen in the placebo or AndroGel® arms of this study. AndroGel is the current leading therapy for testosterone replacement.
The second Phase 2b Androxal clinical trial will be in 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. We believe Androxal will be superior to the existing drugs used to normalize testosterone as only Androxal has the property of restoring both luteinizing hormone, or LH, and follicle stimulating hormone, or FSH, levels. LH and FSH are the pituitary hormones that stimulate testicular testosterone and sperm production, respectively.