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

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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, CA (July 25, 2023) 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). doi.org/10.1007/s00345-020-.... 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.

All subjects with 18 months or more follow-up were compared with the inclusion of follow-up data from up to 10 years or more after a single injection of NYMOZARFEX (TM). For the patients where investigational sites were closed or where patients for unrelated reasons were no longer available, the last known status reports were included if they were 18 months or longer. For any subject with a worsening (increase) in grade of prostate cancer on biopsy; or with prostate cancer surgery, or radiotherapy or chemotherapy, they were included regardless of time after study treatment, and were counted in the calculation as treatment failures. The data shows that the number of patients with one focal injection of NYMOZARFEX (TM) 15 mg directed at the tumor had significantly less progression to more advanced cancer or to major cancer treatments, than the randomized control subjects followed in the study.

PDF available here => nymox.com/files/download/c4...