Repros Receives FDA Guidance For Proellex Low Dose Oral Uterine Fibroid Program

(RTTNews) - Repros Therapeutics Inc. (RPRX) said Monday it has received guidance from the FDA regarding its clinical program for low dose oral Proellex in the treatment of uterine fibroids.

The company currently has three open Investigational New Drug Applications, or INDs, for Proellex:

•70,535 - oral treatment of fibroids STATUS: Full Clinical Hold •76,631 -- oral treatment for endometriosis STATUS: Partial Clinical Hold and in Phase 2 •112,576 -- vaginal treatment for fibroids STATUS: Initiating Phase 2b

In October, the company held a meeting with the FDA to discuss "going forward" plans for low dose oral Proellex in the treatment of uterine fibroids and to lift the clinical hold. In 2007, data had been discussed with the FDA based on the efficacy of a 12mg dose. The earlier study showed highly statistically significant results in achieving clinically relevant improvements in menstrual bleeding as well as symptoms associated with tumor bulk via a previously validated quality of life instrument.

During the meeting with the FDA, the Agency provided guidance to the company for endpoints it believed to be acceptable for the treatment of uterine fibroids. The Agency instructed the company to submit a request for lifting of the full clinical hold at the same time it submits a new protocol.

The company said it will follow FDA's recommendations and submit the protocol and full hold lift in a timely fashion.

The company will use the same design for the vaginal Phase 2b study and expects to start the two studies in early 2014. The company said it has accounted for the costs of these studies in its current budget and these studies will not change the projected cash burn rate for 2014.