Nymox Reports Successful New NYMOZARFEX (TM) Long-Term Prostate Cancer Treatment Clinical Trial Results

NYMOZARFEX 15 mg Minimal Treatment of Low Grade Prostate Cancer Leads to Significant Long-Term Reduction in Incidence of Associated Prostate Cancer Surgery and Radiotherapy

IRVINE, Calif., July 25, 2023 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation [OTC: NYMXF] (the “Company”) is pleased to announce today important new long-term clinical trial results from the Company's 146 patient NX03-0040 NYMOZARFEX (TM) U.S. study for low grade localized prostate cancer. New long-term follow-up data from the prospective randomized clinical trial of NYMOZARFEX (TM) for low grade early prostate cancer has indicated that there is strong statistically significant benefit from the treatment compared to controls when all available patient outcomes were included from 18 months to as long as up to >10 years after treatment.

These additional 5 to 10-year data points add to the 5-year data that was published in the peer review World Journal of Urology in 2020 (World J Urol 38, 3101–3111 (2020). https://doi.org/10.1007/s00345-020-03127-w). All clinical trial sites that were still open were contacted for follow-up data on the prostate cancer status of all available patients. A full effort was made to reach all possible subjects. The outcome comparisons showed greatly reduced percentages of subjects treated with NYMOZARFEX (TM) who had progressed by either cancer grade worsening or by prostate cancer surgery, radiotherapy, or chemotherapy; and which remained overall strongly statistically significant compared to the study's randomized controls (p<.01).

This unique and successful study is the world's first and only long-term prospective randomized controlled study of an intraprostatic molecular injectable treatment for low-grade localized prostate cancer to have been accomplished. The new data represents the longest term data available from this major study.

Study NX03-0040 was undertaken starting in 2012 at investigational sites across the U.S. with 146 men with the biopsy confirmed diagnosis of Grade Group1 prostate cancer. NYMOZARFEX (TM) was administered by a single painless injection directly into the prostate in a relatively simple procedure requiring several minutes or less in an office setting without sedation or anesthesia, and guided by routine ultrasound. NYMOZARFEX (TM) was injected into the area of the prostate where the cancer was previously detected prior to enrollment in NX03-0040. The patients were then biopsied after 6 weeks and then every 18 months, along with serial PSA measurements and long-term follow-up.