Nymox Announces Phase 3 BPH Studies

Nymox Pharmaceutical Corporation

announced today that the Company is undertaking further analyses of its pivotal U.S. Phase 3 studies of NX-1207 for prostate enlargement (BPH). This will include new long-term data from Studies NX02-0017 and NX02-0018. The Company expects to provide these new pivotal Phase 3 study results in Q2 or early Q3 this year. The pivotal U.S. studies NX02-0017 and NX02-0018 were initiated in 2009. Enrollment of NX02-0017 (499 patients randomized) was completed in 2012; enrollment of NX02-0018 (498 patients randomized) was completed in 2013. 973 patients were injected with either NX-1207 2.5 mg (n=582) or saline vehicle alone as control (n=391). At 12 months post-treatment there was no overall top-line statistical significance for the efficacy of treatment in terms of BPH Symptom Score improvement vs controls. The safety profile of NX-1207 was excellent. Dr. Paul Averback, CEO of Nymox said, "Despite the setback of top-line results not initially beating controls statistically at 12 months post-treatment in these large studies, we continue to believe that NX-1207 has enormous potential for long-term management of BPH. Additional new blinded protocol data from the same pivotal studies is being prospectively captured in order to assess long-term results in patients up to 5 years after a single injection of NX-1207 2.5 mg vs placebo." NX-1207 is also in late-stage development for low grade localized prostate cancer. In 2014 the Company reported 8 month efficacy results showing statistically significant reduced cancer progression in patients who received NX-1207 compared to standard of care.