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Protox Announces Positive Clinical Data from Prostate Cancer Study

ncouraging signs of therapeutic activity were observed.

No significant safety issues relating to PRX302 treatment were encountered in this clinical trial. One patient in the study, who met inclusion criteria in spite of having borderline liver abnormalities, showed a transient rise in liver enzymes (Grade 3 on the National Cancer Institute's 5-stage grading scale) that quickly returned to screening levels. An expanded cohort was enrolled at this dose in order to collect additional safety data. No safety issues were observed in any patients within the expanded cohort or in further cohorts that received higher doses. In summary, no serious adverse events were reported relating to PRX302 and all other adverse events reported were mostly associated with the injection procedure, rating no higher than Grade 1 (mild).

Assessment of potential therapeutic activity was determined by measuring PSA levels throughout the study and conducting prostate biopsies at 30 days post-treatment. PSA is one of the most widely recognized disease markers in prostate cancer and levels of PSA in the blood are used in the diagnosis of prostate cancer, monitoring cancer progression and tracking patient responses to its treatment.

A comparison of prostate biopsies taken at baseline and at 30 days post-treatment shows that 18 of the 24 patients tested in this trial had a decrease in the percentage of cancer-positive biopsies. Three of the patients showed a complete absence of cancer in their day 30 biopsy.

Two specific measurement indicators, PSA doubling time (PSADT) and PSA velocity (PSAV), are key parameters in predicting clinical progression, metastasis and mortality in patients with prostate cancer. Of the 24 patients tested in this study, 90 day PSA data is available for 15 patients at this time. Comparison of PSA levels pre- and post-treatment shows a clear and desirable trend towards an incr
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