Nymox Pharmaceutical Corp has suffered a massive setback with the news that its investigational treatment for experimental enlarged prostate drug has failed in two late-stage trials.

The US firm noted that two Phase III studies of NX-1207 failed to meet their primary efficacy endpoints. Full results will be reported at a later date and the company will hold a conference call on Monday at 4.30 pm Eastern time.

Nymox chief executive Paul Averback said drug safety was “acceptable”, and while “efficacy reached levels similar to earlier studies [it] was not statistically significant in comparison to the placebo control” due to a higher placebo response in men suffering from benign prostatic hyperplasia (BPH).

He added that the compound “remains promising for low-grade localised prostate cancer” where Phase II results showed evidence that NX-1207 had “a positive effect on biopsy results and clinical and biochemical progression”. The drug is partnered with Italy’s Recordati which holds European and other non-US rights to the drug in BPH.