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news.Protox Therapeutics has announced today that the first two cohorts of patients in its phase I clinical trial for prostate cancer using PRX302 have been treated safely and that dose escalation to the third cohort will commence shortly.
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Protox also reported that the University of Vermont will participate in the clinical trial, joining Scott & White Memorial Hospital, the lead center in the trial, which began treating patients in May. The company believes this addition will ensure that patient recruitment is completed by the end of 2006.
The phase I trial is intended to examine the safety, tolerability and therapeutic activity of PRX302 in patients with localized recurrent prostate cancer. PRX302 is injected into the prostate under sonographic guidance. Each new cohort receives a higher dose of PRX302 once safety of the drug is established in the previous cohort. Changes in PSA levels are measured and prostate biopsies are performed after 30 days to monitor therapeutic activity.
The company anticipates being able to report interim results from this trial in the fourth quarter of 2006.
Protox also announced the completion of a preclinical trial application (CTA) meeting with Health Canada regarding a planned phase I clinical trial using PRX302 for the treatment of benign prostatic hyperplasia, or enlarged prostate.
Based on feedback from the Canadian regulator, Protox intends to submit a CTA for this indication in the third quarter of 2006.