HASBROUCK HEIGHTS, NJ, USA I October 29, 2015 I Nymox Pharmaceutical Corporation (NYMX) reported today that long-term randomized cross-over data from the Company’s trial of fexapotide triflutate for low grade localized prostate cancer has shown statistical significance in efficacy compared to controls. The study results indicate that randomized control subjects who subsequently switched to fexapotide had long-term outcomes significantly superior to control patients who did not change (cross-over) to fexapotide treatment.
These results are the initial 18 month follow-up results for the fexapotide trial for prostate cancer to be reported. The cross-over study arm of NX03-0040 consisted of 35 subjects. Based on biopsy progression the proportion of patients who progressed on biopsy and required biopsy progression-related surgery or radiotherapy in the cross-over group (0%) at 18 months was significantly less than in the control group (p<.03).
The cross-over group patients received randomized fexapotide 15 mg or 2.5 mg in a single treatment targeted toward the positive baseline cancer focus identified in initial positive biopsies. There were no cases in either of the 2 fexapotide dosage level treatment groups with biopsy progression at 18 months (p<.03).
In addition to the positive clinical progression results, the primary endpoint of the study (re-biopsy absence of tumor in the initially positive biopsy baseline area of the prostate) also reached statistical significance (p<.03) in the cross-over study. At the 18 month assessments, the post-treatment biopsy taken from the treated area of the prostate which was initially positive at baseline, showed absence of tumor (tumor presence in re-biopsy of baseline positive focus n=0) in the cross-over treated patients, which was statistically significant compared to controls (p<.03).
The Company expects to report results from its long-term NX03-0040 low grade localized prostate cancer study in the fourth quarter.
One of the major problems with current prostate treatments for localized prostate cancer (radical prostatectomy, external beam radiation, or brachytherapy) is the relatively high incidence of reported sexual dysfunction post-treatment. In 9 studies, NX-1207 treatment has been shown to have no significant adverse effect post-treatment on sexual function or testosterone levels.
SOURCE: Nymox Pharmaceutical
Post Views: 83
HASBROUCK HEIGHTS, NJ, USA I October 29, 2015 I Nymox Pharmaceutical Corporation (NYMX) reported today that long-term randomized cross-over data from the Company’s trial of fexapotide triflutate for low grade localized prostate cancer has shown statistical significance in efficacy compared to controls. The study results indicate that randomized control subjects who subsequently switched to fexapotide had long-term outcomes significantly superior to control patients who did not change (cross-over) to fexapotide treatment.
These results are the initial 18 month follow-up results for the fexapotide trial for prostate cancer to be reported. The cross-over study arm of NX03-0040 consisted of 35 subjects. Based on biopsy progression the proportion of patients who progressed on biopsy and required biopsy progression-related surgery or radiotherapy in the cross-over group (0%) at 18 months was significantly less than in the control group (p<.03).
The cross-over group patients received randomized fexapotide 15 mg or 2.5 mg in a single treatment targeted toward the positive baseline cancer focus identified in initial positive biopsies. There were no cases in either of the 2 fexapotide dosage level treatment groups with biopsy progression at 18 months (p<.03).
In addition to the positive clinical progression results, the primary endpoint of the study (re-biopsy absence of tumor in the initially positive biopsy baseline area of the prostate) also reached statistical significance (p<.03) in the cross-over study. At the 18 month assessments, the post-treatment biopsy taken from the treated area of the prostate which was initially positive at baseline, showed absence of tumor (tumor presence in re-biopsy of baseline positive focus n=0) in the cross-over treated patients, which was statistically significant compared to controls (p<.03).
The Company expects to report results from its long-term NX03-0040 low grade localized prostate cancer study in the fourth quarter.
One of the major problems with current prostate treatments for localized prostate cancer (radical prostatectomy, external beam radiation, or brachytherapy) is the relatively high incidence of reported sexual dysfunction post-treatment. In 9 studies, NX-1207 treatment has been shown to have no significant adverse effect post-treatment on sexual function or testosterone levels.
SOURCE: Nymox Pharmaceutical
Post Views: 83
