Protox announces positive long-term data from BPH study
Protox Therapeutics Inc. announced positive results from its Phase 1 study evaluating PRX302 in patients with benign prostatic hyperplasia (BPH), a common and bothersome urological condition among the aging male population. The results indicate that promising signs of therapeutic activity continue to be seen at 6-months and 9-months following a single treatment with PRX302.
"Patients treated with PRX302 continue to show a good response to treatment with stabilization of symptoms and maintenance of voiding pattern," commented Dr. Peter Pommerville, co-principal investigator at Can-Med Clinical Research Centre in Victoria, B.C. "The fact that symptom improvement has been maintained to 9 months indicates the lasting effect of PRX302 on prostate tissue."
Therapeutic activity of PRX302 was assessed using standardized symptom indices, namely, International Prostate Symptom Score (IPSS) and Quality of Life Scores (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.
At 6-months post-treatment the mean IPSS values improved by an average of 6.4 points from 19.1 +/- 4.3 at screening to 12.7 +/- 5.2 at day-180 post treatment (p= 0.0009), with 6 of 15 patients showing a 10 point or greater improvement in IPSS values. In the 6 men for whom 9-month data are available at this time, IPSS values improved by an average of 6.1 points. QoL scores improved by 2.0 points from an average of 4.5 +/- 1.1 at screening to 2.5 +/- 1.4 by day-180 (p= 0.0002). In the 6 men for whom 9-month data is available, QoL scores improved by an average of 2.3 points by day-270. The mean prostate volume decreased by over 22%, from 46.4 cc at screening to 35.8 cc at day-180 post-treatment and by 20% from 49.6 cc at screening to 39.7 cc at day-270 post-treatment.
As reported before, 2008, despite a 14-fold escalation in dose, no safety issues were identified and the maximum tolerated dose was not reached in this study.
Based on the encouraging data from this study, Protox has initiated a Phase 2 clinical trial in men with moderate to severe BPH. The intent of this Phase 2 study will be to optimize dosing in order to fully exploit the therapeutic potential of PRX302, while maintaining its excellent safety profile.
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