Repros Therapeutics receives FDA guidance for lifting clinical hold status of Proellex

Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that a teleconference was held with the FDA to review the clinical hold status of Proellex^®. Previously clinical studies were stopped due to findings of changes in liver enzymes at higher doses of the oral drug resulting in serious adverse events. Proellex is being studied as a treatment for uterine fibroids and endometriosis.

In a press release issued by the Company on April 5, 2010, Repros noted that it had requested the FDA lift the clinical hold to allow the Company to conduct a single parallel design study that would determine whether lower doses would be safe and effective. In the course of that submission the Company attempted to respond to all of the Agency's concerns. During the teleconference the FDA noted that it felt that not all of their concerns were fully answered but opined that if the Company was willing to modify the trial from a parallel design to an escalating dose design the FDA would consider lifting the full clinical hold and place Proellex on partial clinical hold to allow the low dose trial to be conducted. The Company agreed to modify the protocol and submit the new design to the Agency as soon as possible. There can be no assurances however that the FDA will find the new design acceptable or that they will lift the full clinical hold.