Protox’s phase I trial of prostate drug marches on
Mr. Anthony Boone reports
PROTOX ADVANCES PHASE I PROSTATE CANCER STUDY AND PLANNED BPH CLINICAL TRIAL
Protox Therapeutics Inc. has safely treated the first two cohorts of patients in its phase I clinical trial for prostate cancer using PRX302. Dose escalation to the third cohort will commence this month.
The University of Vermont will participate in the clinical trial, joining Scott & White Memorial hospital, the lead centre in the trial, which began treating patients in May, 2006.
“The participation of the University of Vermont and Dr. Mark Plante, the principal investigator, will ensure completion of patient recruitment for this trial by the end of the year,” said Dr. Fahar Merchant, president and chief executive officer of Protox Therapeutics. “We look forward to reporting interim results based on a larger number of patients in the fourth quarter.”
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 also completed a preclinical trial application meeting with Health Canada regarding a planned phase I clinical trial using PRX302 for the treatment of benign prostatic hyperplasia (BPH) or enlarged prostate. Based on feedback from Health Canada, Protox intends to submit a CTA in the third quarter of 2006.
Preclinical studies have shown that PRX302 can destroy prostate tissue in the presence of prostate specific antigen (PSA), an enzyme that is found at elevated levels in both BPH and prostate cancer. The purpose of the destruction is to reduce the size of the prostate and relieve the pressure exerted by the enlarged prostate on the urethra which causes a number of painful and bothersome urinary symptoms associated with the disease.
For further information contact:
Anthony Boone
Director, Investor Relations and Corporate Communications
Protox Therapeutics Inc.
604-688-0199
aboone@protoxtherapeutics.com
Michael Moore
Investor Relations
The Equicom Group
416-815-0700 x 241
mmoore@equicomgroup.com



