Repros Reports Favorable Phase 2 Data for Proellex

Repros Therapeutics says new Phase 2 clinical data show that vaginal administration of Proellex at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, a key symptom of uterine fibroids. “When a sufficient concentration of Proellex is achieved in circulation, amenorrhea (cessation of menses) is achieved,” the company explains. “Just over half, 52%, of Proellex-treated subjects became amenorrheic with no evidence of a dose effect.” Along with changes in menstrual patterns, fibroids measured by MRI were reduced in volume in the drug-treated arms by 18% while the placebo group showed continued increase in size.

Repros believes Proellex represents a significant advantage over GnRH agonists and antagonists in treating uterine fibroids. It will soon request an end of Phase 2 meeting with FDA to discuss plans for Phase 3 studies.