HASBROUCK HEIGHTS, N.J., April 1, 2015 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) 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.
For more information please contact info@nymox.com or 800-936-9669.
This press release contains certain "forward-looking statements" as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management's current expectations. Development of drug products involves substantial risks and actual results may differ materially from expectations. Factors that could cause actual results or events to differ materially from those projected in forward-looking statements are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.