Nymox Pharmaceutical Corp. (NASDAQ: NYMX) shares jumped following positive results from its late-stage prostate cancer trial. The company announced successful new study results from the long-term repeated injection group from the U.S. Phase 3 trials for fexapotide, in late stage development for enlarged prostate (BPH) and for localized prostate cancer.
In the new study, long-term outcomes were determined in 344 patients who were given a single repeat fexapotide treatment after initial blinded treatment with fexapotide or placebo. Patients were followed for 2.0 to 6.5 years (mean 4.2 years) after initial treatment.
All treatment failures were included in the analysis. Results have now shown that there was long-term statistically significant symptomatic improvement compared to Phase 3 patients who received placebo alone. Repeat injection was found to be safe, with no significant drug-related toxicities or side effects found in the study.
In earlier reported Phase 3 studies, it was shown that fexapotide reduces the long-term need for surgery by up to 82% to 95% compared to approved conventional BPH treatments. Data indicate that fexapotide shows significant efficacy against prostate cancer as a therapeutic, and in addition has been shown in Phase 3 to reduce the risk of prostate cancer when fexapotide is used to treat BPH. This is in comparison to some conventional BPH treatments in routine clinical use today, which on the other hand increase prostate cancer risk and which have these many other well-known undesirable side effects.
Paul Averback M.D., CEO of Nymox, commented:
These prospective long-term study results in reinjected patients clearly demonstrate that fexapotide leads to clinically meaningful long-term symptomatic improvements in BPH patients with minimal treatment, and without the worrisome and bothersome toxicities of conventional BPH treatments such as retrograde ejaculation, and increased cancer risk.
Excluding Tuesday’s move, Nymox has underperformed the broad markets, with the stock down about 1% year to date. Over the past 52 weeks, the stock is down 11%.
Shares of Nymox were last seen up 17% at $3.81, with a consensus analyst price target of $10.25 and a 52-week trading range of $1.62 to $5.79.