Repros Therapeutics' Proellex program to remain on partial clinical hold
Repros Therapeutics announced that it received preliminary feedback from the FDA on the Company's clinical development program for Proellex, its oral delivery mechanism for telapristone acetate. The Proellex program will remain on partial clinical hold, and based upon the FDA's review of all the existing liver function safety data, the FDA has indicated that the Company will be required to compile a large pre-approval safety data base to support future development. In light of the FDA guidance, the Company is assessing increasing its focus on its uterine fibroid and endometriosis development program utilizing a vaginal drug delivery program for telapristone acetate, a selective progesterone modulator. Additionally, Repros has received notice that on August 2 it will be granted a European patent relating to the use of SPRMs, in particular Telapristone Acetate or Ulipristal Acetate, with an Off Drug Interval for the treatment of estrogen-dependent hyperproliferative uterine conditions, such as uterine fibroids and endometriosis.