ARTICLE | Clinical News

REC 0482: Additional Phase II data

October 13, 2014 7:00 AM UTC

Nymox reported 8-month data from the open-label, U.S. Phase II NX03-0040 trial in 146 patients with low-grade localized prostate cancer showing that a single intraprostatic injection of 2.5 or 15 mg NX-1207 significantly reduced the proportion of patients who had upgraded blinded biopsy and laboratory results and went on to require and receive radiation therapy and/or surgery by >75% vs. the active surveillance control arm (p=0.002). Additionally, NX-1207-treated patients had 67% less progression to surgery and/or radiotherapy vs. active surveillance for all reasons, including elective surgery and/or radiotherapy with no biopsy or laboratory upgrades (p=0.008).

In April, Nymox reported top-line data from NX03-0040 showing that NX-1207 could not be evaluated on the primary endpoint of the proportion of patients with undetectable cancer at 45 days post-treatment in the region of the prostate where the baseline cancer was detected due to a high proportion of false negative repeat biopsies in the active surveillance control arm. Patients treated with NX-1207 did have less evidence of cancer progression in the treated area compared to active surveillance as determined by Gleason grade (see BioCentury, May 26). ...