The findings to date indicate that PRX302 is well tolerated and shows encouraging signs of therapeutic activity following a single intra-prostatic injection.
This trial is intended to examine the safety, tolerability and therapeutic activity of PRX302 in patients with localized recurrent prostate cancer who show signs of disease progression.
Early assessment of potential therapeutic activity was determined by measuring PSA (prostate specific antigen) levels throughout the study and conducting prostate biopsies at 30 days post-treatment. Early results show that patients have observed decreases in cancer-positive biopsies and PSA levels. Of the 10 patients, eight for whom data are available had a decrease in cancer-positive biopsies.
“As the dose is escalated to levels found to produce substantial prostatic destruction in relevant preclinical models, we expect more of the patients will manifest absence of cancer on post-therapy biopsy with concomitant decrease in PSA levels,” said Dr Scott Coffield of Scott & White Memorial Hospital.
The company expects to complete the study by mid-year and begin planning for phase II to commence by year-end.