BioXell Reports Preliminary Phase IIa Results in Non-Bacterial Chronic Prostatitis

Effect on pain comparable to placebo, effect observed on inflammation and lower urinary tract symptoms

29-Sep-2006

BioXell S.p.A. reported preliminary results from its proof of concept trial of Elocalcitol in patients with Non-bacterial Chronic Prostatitis. The effect of Elocalcitol was found to be no different from that of placebo on the primary endpoint, focused mainly on pelvic pain. In contrast, positive data for several secondary endpoints provide further support for the potential efficacy of the compound in both benign prostatic hyperplasia (BPH) and overactive bladder (OAB), indications for which Elocalcitol is also currently in clinical development.

The primary endpoint analysis of the 3 month trial in 129 patients showed that both Elocalcitol and placebo reduced the total NIH/Chronic Pelvic Pain Syndrome (CPPS) symptom score by 15 points out of a possible score of 43. One of the secondary endpoints of the trial was the level of IL-8 in the semen, a marker for inflammation in which Elocalcitol showed a clinically relevant reduction. A positive signal was also detected in lower urinary tract symptoms (LUTS) - frequency, urgency, and nocturia - as recorded in micturition diaries. In particular, among patients who began the trial with a frequency of urination greater than 10 times per day, 55% of patients on Elocalcitol saw their frequency decrease to less than 10 (versus only 14% on placebo). The trial again confirmed the excellent safety profile of the compound which was no different from placebo.

The data analysis is still ongoing and will be finalized (including sub-group analysis) in the following weeks.

https://www.bionity.com/en/news/58292/bioxell-reports-preliminary-phase-iia-results-in-non-bacterial-chronic-prostatitis.html