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Repros Therapeutics Inc allowed to conduct phase 1 and 2 clinical studies of Low Dose Oral Proellex in treatment of Uterine Fibroids and Endometriosis


Monday, 17 Mar 2014 09:20am EDT 

Repros Therapeutics Inc:Receives guidance from FDA indicating that Repros may proceed to conduct Phase 1 and 2 studies of oral Proellex under two separate INDs for endometriosis and uterine fibroids, while remaining on partial clinical hold.FDA guidance provides that highest allowed dose will be 12 mg daily.Repros is conducting Phase 2 study for use of Proellex in severe endometriosis and plans to submit a Phase 2 protocol for the treatment of symptomatic fibroids.Regarding proposed uterine fibroid Phase 2 protocol, FDA provided guidance as to the appropriate inclusion and exclusion criteria for study subjects as well as the preferred efficacy endpoint.FDA preferred efficacy endpoint is reduction in excessive menstrual bleeding associated with uterine fibroids.FDA also noted preferred methodology to determine changes in bleeding.Repros will comply with FDA guidance as well as collecting additional efficacy outcomes such as tumor size and other symptomatic relief. 

Company Quote

21.92
0.34 +1.58%
29 Aug 2014