Protox(TM) Therapeutics Inc. (TSX-V: PRX), a 
 leader in advancing novel, targeted protein toxin therapeutics for the 
 treatment of cancer and other proliferative diseases, today announced positive 
 final results from its Phase 1 study evaluating PRX302 in patients with benign 
 prostatic hyperplasia (BPH), a common condition among the aging male 
 population. The trial results indicate that PRX302 is safe and well tolerated 
 and shows very promising signs of therapeutic activity for the treatment of 
     "The impact of PRX302 in the quality of life of most patients has been 
 dramatic," commented Dr. Peter Pommerville, co-principal investigator at 
 Can-Med Clinical Research Centre in Victoria, B.C. "In addition to the rapid 
 treatment response, the effect of PRX302 continued to improve with time and 
 showed that symptomatic relief was sustained over time. Furthermore, patient 
 satisfaction with the single ten minute office-based minimally invasive 
 treatment for BPH is high." 
     "We are very pleased with these data as PRX302 continues to deliver 
 impressive results in the clinic," said Dr. Fahar Merchant, President and 
 Chief Executive Officer of Protox. "In addition to the excellent safety and 
 tolerability profile, PRX302 has demonstrated substantial symptomatic benefit 
 in most patients who failed existing oral therapies." 
     Study Design: 
     This study was an open-label, multi-centre, dose escalation study where 
 the primary endpoint was safety and tolerability following a single 
 intra-prostatic administration of PRX302. The secondary endpoint was to 
 determine therapeutic activity as measured by the change in International 
 Prostate Symptom Score (IPSS) throughout the study, when compared to 
 screening. In addition, changes in Quality of Life (QoL) scores, prostate 
 volume and uroflow parameters were also monitored. A total of 15 patients with 
 moderate to severe BPH were treated in this trial. The dose was increased 
 14-fold between cohort 1 and cohort 4, keeping the dosing volume constant, 
 whereas one additional cohort received cohort 1 dose at a 4-fold higher 
 volume. Patient parameters at screening were as follows: age - 64.8 years 
 (range: 52-82); prostate size - 41.3 mL (range: 30.0-80.1); IPSS - 19.1 
 (range: 12-26); QoL - 4.3 (range: 3-6). Most patients treated in this study 
 were either refractory or intolerant to oral therapy. 
     Study Results: 
     Despite a 14-fold escalation in dose, no safety issues were identified 
 and the maximum tolerated dose was not reached in this study. Results indicate 
 that PRX302 was well tolerated with no serious adverse events observed. 
 Treatment related adverse events were generally reported as being mild, local 
 and transient in nature. 
     Therapeutic activity of PRX302 was evaluated at day-30 and day-90 
 post-treatment using standardized symptom indices, namely, IPSS and QoL. IPSS 
 assesses the severity of seven key symptoms of BPH, (incomplete emptying, 
 frequency, intermittency, urgency, weak stream, straining and nocturia). 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. 
     Treatment related symptomatic relief was rapid and substantial benefits 
 were noticed by day-30 post-treatment. Both symptom scores (IPSS and QoL) 
 continued to show further improvements in all cohorts at the end of the active 
 study period (day-90 post-treatment) indicating a potential for sustained 
 benefit following a single treatment with PRX302. 
     Across all treatment groups, IPSS scores showed a statistically 
 significant improvement from screening to Day 30 (p (less than) 0.01) and 
 continued to Day 90 post-treatment (p (less than) 0.001). The mean IPSS values 
 improved by an average of 5.8 points from 19.1 +/- 4.3 at screening to 14.3 
 +/- 5.7 at day-30 post treatment. By day-90, IPSS improved by an average of 
 8.5 points (10.6 - 5.9) with 8 of 15 patients showing a 10 point or greater 
 improvement in IPSS values. The improvements were observed across all seven 
 symptom sub-scores, each decreasing by at least 30%. Although early, these 
 results are compelling especially when a reduction in IPSS by greater than 
 four points is deemed to be highly clinically significant. 
     Improvement in QoL scores were observed in all five cohorts. Independent 
 of the treatment group, QoL scores improved from an average of 4.3 +/- 1.1 at 
 screening to 2.5 +/- 1.6 by day-30 (p (less than) 0.01) and continued to show 
 a 50% improvement by day-90 (QoL = 2.1 - 1.6; p (less than) 0.01)). 
 Furthermore, prostate volume decreased in all cohorts.
 Irrespective of cohort 
 assignment, the mean prostate volume decreased by over 26% from 41.6 cc at 
 screening to 30.5 cc at day-90 post-treatment (p (less than) 0.05). 
     Based on the encouraging data from this study, plans are currently 
 underway to commence a Phase 2 BPH clinical trial in the first quarter of