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(EMAILWIRE.COM, November 25, 2008 ) Vancouver, British Columbia - Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced positive data from its Phase 2 study of PRX302 in patients with benign prostatic hyperplasia (BPH), a painful and bothersome urological condition that affects over 50 million men worldwide. The study results indicate that PRX302 provided significant symptomatic relief while maintaining an excellent safety profile in men with moderate to severe BPH.
"The results that we have seen in this study are very impressive," commented Dr. Peter Pommerville, co-principal investigator at Can-Med Clinical Research Centre in Victoria, B.C. "This simple 10 minute, office based procedure is safe and has demonstrated a marked reduction in symptoms and a profound improvement in patients' quality of life following a single treatment. The avoidance of surgery, sexual and other side effects caused by oral therapy, the rapid onset of improvement in obstructive symptoms without catheterization and the ability for patients to get back to their regular routine quickly are all features that make PRX302 an attractive therapeutic approach for the treatment of BPH."
"PRX302 is a breakthrough PSA activated targeted therapeutic capable of selective ablation of prostatic tissue," said Dr. Fahar Merchant, President and Chief Executive Officer of Protox. "These data show that PRX302 provides symptom relief which is much more profound than currently approved oral therapies and comparable to many office based surgical procedures without any of the side effects or complications associated with them."
Study Design:
This was a single-arm, open-label, multi-centre, Phase 2 study in which increasing volumes of PRX302, at a fixed concentration (3 mg/mL), was administered into the prostates of men with moderate to severe BPH. Three cohorts of six subjects each received PRX302 at volumes equivalent to 10%, 20% or 30% of prostate volume. The intended volume for each subject was administered via a single injection consisting of three equal deposits into each lobe of the prostate under ultrasound guidance. Therapeutic activity was measured by the change in International Prostate Symptom Score (IPSS) when compared to screening. In addition, changes in Quality of Life (QoL) scores and prostate volume were also monitored. A total of 18 patients who were refractory, intolerant or unwilling to use alpha-blockers were enrolled in this study. Patient parameters at screening were as follows: age – 66.1 years (range: 49-80); prostate size - 49.2 cc (range: 30.0-74.0 cc); IPSS – 20.2 (range: 13-30); QoL - 4.5 (range: 3-6).
Study Results:
Therapeutic activity of PRX302 was evaluated in this study using standardized symptom indices, namely IPSS and QoL. IPSS is the most well defined clinical end-point that is used to assess therapeutic activity in BPH clinical studies. This symptom index was developed and validated by the American Urological Association and consists of seven categories including weak urinary stream, straining, intermittence, nocturia (or how many times one gets up to urinate at night), incomplete emptying, urgency and frequency. This index is measured on a 0-35 scale with 0 defined as having no problems and 35 defined as the high end of severe symptoms. The mean pre-treatment IPSS of subjects in this study was 20.2 (severe symptoms). The QoL score is measured on a scale from 0-6 with 0 defined as "delighted" and 6 defined as "terrible" with respect to patient quality of life due to BPH.
IPSS results at 90 days post-treatment demonstrated symptomatic relief in all cohorts with an average improvement in IPSS of 2.8 points in Cohort 1 (15.6%), 10.9 points in Cohort 2 (54.0%) and 10.3 points in Cohort 3 (46.2%).
IPSS data appear to indicate a dose response, with Cohort 1 showing both a smaller point and a smaller percentage improvement than Cohorts 2 and 3 at the 90-day time point. Furthermore, this dose response is more evident when subjects are stratified by the volume of PRX302 administered per deposit. Subjects who received 1.0mL or greater volume per deposit (n=13) showed a statistically significant IPSS improvement of 11.2 points (p
Protox Therapeutics
James Beesley
604-484-0975
jbeesley@protoxtherapeutics.com 
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