BioXell announces positive Phase IIb results for Elocalcitol in Benign Prostatic Hyperplasia

Primary endpoint met - Elocalcitol highly effective in arresting prostate growth


BioXell S.p.A. announced top-line results of its Phase IIb trial of Elocalcitol in Benign Prostatic Hyperplasia (BPH). The primary endpoint was met with a high degree of statistical significance, with Elocalcitol effectively arresting prostate growth. Elocalcitol also showed relevant effects on the symptomatic parameters urgency, frequency and nocturia, as well as on the urodynamic parameter maximum urinary flow rate (Qmax). Enrico Colli, Chief Medical Officer and Head of R&D at BioXell, commented, "We are very pleased that the study has demonstrated the effectiveness of Elocalcitol in the treatment of BPH by arresting prostate growth and improving symptoms. Elocalcitol continues to show excellent safety and tolerability, avoiding the side effects associated with the currently available treatment options. These data will enable us to move Elocalcitol into the next phase of development." The double-blind, randomised, placebo-controlled, parallel group design trial, carried out on a total of 514 patients with BPH at 46 centres in Italy and Germany, was intended to determine the effect of Elocalcitol monotherapy (75 or 150 mcg), as well as a combination of Elocalcitol (150 mcg) with tamsulosin (0.4 mg), on prostate volume, measured with high precision magnetic resonance imaging (MRI), as well as on symptoms.

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