Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced positive 12 month data from its open-label Phase 2 study of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH). The study results indicate that those patients who received an optimal dose of PRX302 continued to demonstrate significant symptomatic relief at 12 months following a single treatment.
"We are very excited to see a twelve point improvement in IPSS in this patient group even after twelve months following a single treatment," said Dr. Fahar Merchant, President and Chief Executive Officer of Protox. "This level of symptomatic improvement is almost double that seen with oral therapies and comparable to many surgical procedures, further strengthening our belief in the immense commercial opportunity of PRX302. We look forward to sharing these data as well as the upcoming results from our 92 patient double-blinded placebo controlled Phase 2b BPH study with our potential commercial partners."
"The results from this study are impressive and demonstrate the durable impact that this novel therapeutic has on potentially improving the quality of life of patients suffering with BPH," commented Dr. Peter Pommerville, co-principal investigator at Can-Med Clinical Research in Victoria, B.C. "PRX302 continues to demonstrate the ability to improve urinary tract symptoms while maintaining a good safety profile. Based on the results to date, I believe that PRX302 has definite potential to address a number of the inadequacies seen with existing BPH therapies, namely sexual dysfunction and other treatment related side effects."
Study Results:
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The International Prostate Symptom Score (IPSS) is a validated accepted clinical end-point used to assess the treatment benefit in BPH clinical studies. 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.
In this Phase 2 open-label volume optimization study, 13 of the 18 patients received the optimum PRX302 dosing of (greater than)-1mL per deposit. A total of 11 of the 13 patients were evaluable at 12-months and continued to show a statistically significant and sustained improvement in IPSS of 12.1 pointsUrologie to be held in Shanghai from November 1-5, 2009.
Study Design:
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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 deposits into each lobe of the prostate under ultrasound guidance. Therapeutic activity was measured by the change in IPSS when compared to screening. In addition, changes in QoL scores and prostate volume, Qmax 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).
Higher diet quality associated with reduced risk of prostate cancer grade reclassification