Repros completes randomization of Phase 2b study of Vaginal Proellex in women with symptomatic uterine fibroids

The primary endpoint for the study is the incidence of amenorrhea induced by four months of treatment with two dose levels of Proellex compared to placebo.

In addition, subsequent to discussion with the FDA, Repros is collecting an assessment of blood loss by a validated alkaline hematin method at baseline and during off-drug intervals. At baseline menses women were required to exhibit > 80 ml of blood loss by that method to be enrolled.

In addition to blood loss, bulk symptoms associated with fibroids and treatment effects on uterine and fibroid size, determined by MRI, will also be assessed.

The Company expects to have topline results from the study of the subjects’ first four-month course of treatment during the second quarter of 2016.

A sister study using low doses of oral Proellex® in similar women has completed screening and should be fully randomized before the end of January 2016. Correspondingly, the topline data from that study will be available later than the vaginal data.

In a publication in BMC Women’s Health 2012; 12: 6, in a study of women age 15 – 49, across eight countries including the U.S., the self-reported incidence of uterine fibroids was 7% and 14.1% for women in their 30’s and 40’s, respectively.

A US study published in the American Journal of Obstetrics and Gynecology 2003 Jan; 188(1): 100-7, noted that by age 50, 70% of Caucasian and 80% of African American women have developed uterine fibroids before menopause. In the BMC article it was noted that in the U.S., a diagnosis of uterine fibroids is the leading indication resulting in hysterectomy. An effective therapeutic option for the treatment of fibroids is still a significant unmet medical need.