Repros Therapeutics has provided a clarification on the occurrence of increased liver enzymes in patients treated with the 50mg dose of Proellex.
Repros’ recent decision to discontinue the use of the Proellex 50mg dose in its ongoing clinical trials, was based on observations of dose-related, clinically significant changes in liver enzymes in a low percentage of women. Following the decision, Repros notified all clinical sites involved in the study, and all patients on the 50mg dose have been switched to a 25mg dose.
The company said that all subjects with liver enzyme elevations = 3xULN had their treatment stopped and have been referred to an appropriate specialist for further evaluation. Of the nine subjects identified in the press release of July 7, 2009, with liver enzymes = 3xULN on the 50mg dose, the majority have had a reduction of their serum liver enzymes to within the normal range. Four of these subjects have not yet resolved and they are being followed closely.
The company believes that the decision to move forward with the 25mg and 12.5mg doses will improve the benefit/risk profile of Proellex.