Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced today completion of a new long-term follow-up study of NX-1207 for benign prostatic hyperplasia (BPH). 114 subjects (representing 80% of eligible subjects) consented to participate in the blinded, placebo controlled study undertaken at clinical trial sites across the U.S. Individuals in the study were blindly assessed for symptomatic improvement, treatment outcomes, and durability of efficacy. Patients in the study were assessed 8 months to 19 months after NX-1207 or placebo treatment. The Company expects to complete statistical analysis of the data in the next 1-2 weeks and will be reporting the results once they are completed.
Paul Averback, CEO of Nymox, said, "We now have a large body of clinical data on treatment outcomes after up to 19 months on a significant cohort from a blinded, placebo controlled trial. We are optimistic about the outcome of this study.
NX-1207 has successfully completed three U.S. trials to date. The company's most recently reported trial, a Phase 2 double-blind, placebo controlled, randomized study, showed positive efficacy and safety results for NX-1207 after 3 months in patients with BPH. Overall, patients treated with NX-1207 showed after 3 months a mean improvement of 9.35 points in AUA Symptom Score values, the standard scale used to evaluate BPH drugs and treatments. This improvement compares favorably to the 3.5 to 5 point reported in published studies of currently approved drugs for BPH and reached statistical significance when compared to placebo. Subjects treated with NX-1207 also showed an overall significant reduction in mean prostate volume. The results of the trial demonstrated the excellent safety and side effect profile of NX-1207. Subjects treated with NX-1207 had no serious side effects. In particular, patients given NX-1207 had no (0%) significant sexual side effects.
BPH afflicts approximately half of men over age 50 and close to 90% of men by age 80. The disorder causes difficulties with urination associated with aging, such as urination at night, urge to void frequently, hesitancy, weak stream, and other problems.
More information about Nymox is available at www.nymox.com, email: 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. The conduct of clinical trials and the development of drug products involve substantial risks and uncertainties and actual results may differ materially from expectations. Promising early results do not ensure that later stage or larger scale clinical trials will be successful or will proceed as expected. Such factors are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.