Sophiris Bio Announces 12 Month Follow-Up Data From Phase 2b TRIUMPH Clinical Trial Of PRX302 In Patients With Benign Prostatic Hyperplasia
Single administration of PRX302 as a short outpatient procedure provided sustained benefit over 12 months
SAN DIEGO, CA and VANCOUVER, Oct. 9, 2012 /PRNewswire/ - Sophiris Bio Inc. (TSX: SHS) today released top line data from the 12 month follow up of patients receiving PRX302 for the treatment of benign prostatic hyperplasia (BPH, or enlarged prostate) in a Phase 2b study (TRIUMPH). PRX302 produced a clinically significant improvement in the subjective symptom score (International Prostate Symptom Score, or IPSS) and the objective measure of mean peak urinary flow rate (Qmax) sustained over 12 months. As previously reported, the trial met the primary clinical endpoint of the study, which was to demonstrate the efficacy of PRX302 at 90 days post-treatment by a statistically significant improvement from baseline in IPSS when compared to placebo (vehicle only injection). Consistent with the results previously reported for this study, PRX302 continued to be well tolerated with no erectile function side effects during the 12 months following treatment.
PRX302 treatment resulted in approximately 8 to 9-point average reduction of IPSS that was sustained over 12 months. The IPSS is a patient self-administered questionnaire of lower urinary tract symptoms with a possible range of 0 to 35 points, with 0 being no symptoms and 35 being the high end of severe symptoms. This average improvement in IPSS was a clinically meaningful 2.8 to 4.1 point reduction over and above the IPSS improvement observed in the placebo group. In addition, PRX302 treatment resulted in a ~3 mL/sec average increase in Qmax, which was sustained over 12 months. Both IPSS and Qmax are validated clinical endpoints used for BPH product regulatory approvals.
PRX302 was well tolerated in this study with patients who had moderate to severe lower urinary tract symptoms due to BPH, about half of whom had previously taken oral medication for BPH. The side effect profile was favorable with most of the side effects attributed to the injection procedure itself and not related to drug toxicity.
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