Elocalcitol trial unsuccessful

dshoskes · Post by **dshoskes** » Thu Sep 28, 2006 8:58 am

Too bad. This is actually the first treatment I have seen that lowers inflammation in the prostate that didn't help with pain in CPPS.

BioXell Reports Preliminary Phase IIa Results in Non-Bacterial Chronic Prostatitis
27 Sep 2006

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

MILAN, Italy | Sep 27, 2006 | BioXell S.p.A. (SWX: BXLN) today 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.

Francesco Sinigaglia, CEO of BioXell, commented: "CP remains a disabling condition for which no approved treatment exists. While we are disappointed that Elocalcitol has no effect on chronic pelvic pain and will therefore not be developed further in indications where pain is a central component, we are very pleased to see clinical evidence that the compound reduces IL-8 levels, a marker for inflammation, as these correlate with BPH progression. This finding also opens up additional development opportunities for the compound, and the new data on LUTS are also very encouraging for both OAB and BPH, since they confirm the effect of Elocalcitol on the bladder."

LightningTree · Post by **LightningTree** » Thu Sep 28, 2006 5:29 pm

That's too bad. But the silver lining is that every time they do one of these studies they help carve away at what could be causing the pain. They are small steps forward, but they are concrete, well tested steps none-the-less.

Post by **webslave** » Mon Oct 02, 2006 10:51 pm

Francesco Sinigaglia, CEO of BioXell, commented: "CP remains a disabling condition for which no approved treatment exists. While we are disappointed that Elocalcitol has no effect on chronic pelvic pain and will therefore not be developed further in indications where pain is a central component, we are very pleased to see clinical evidence that the compound reduces IL-8 levels, a marker for inflammation, as these correlate with BPH progression. This finding also opens up additional development opportunities for the compound, and the new data on LUTS are also very encouraging for both OAB and BPH, since they confirm the effect of Elocalcitol on the bladder.