Repros Therapeutics Inc. announced that it has received guidance from the FDA for its clinical trial on Proellex, a drug candidate for the treatment of uterine fibroids. The agency recommended endpoints that are believed to be acceptable for the treatment and instructed Repros to submit a request for lifting of the full clinical hold when it submits a new protocol. The company has responded by saying that it will follow the FDA’s new recommendations.
Currently, the company has three open Investigational New Drug Applications (INDs) for Proellex : (1) 70,535 – oral treatment of fibroids / Full Clinical Hold, (2) 76,631 – oral treatment for endometriosis /Partial Clinical Hold and in Phase 2, (3) 112,576 – vaginal treatment for fibroids /Initiating Phase 2b.
The company held a meeting with the FDA in October 2013 to discuss plans for low dose oral Proellex and to lift the clinical hold. In the previous meeting in 2007, they discussed the efficacy of Proellex based on data from 12mg dose test. The earlier study showed statistically significant results in achieving clinically relevant improvements in menstrual bleeding and symptoms associated with tumor bulk.
The company will apply the same design for Phase 2b study and expects to start the two studies in early 2014.