BioXell plans phase 2b trial for Elocalcitol in overactive bladder

By E. Janene Geiss

Philadelphia, July 28 - BioXell SpA announced Friday its plans to proceed with a phase 2b clinical trial of its lead compound Elocalcitol in overactive bladder.

Enrollment in the pan-European study is scheduled to begin in early 2007, according to a company news release.

Details of the study design are being finalized.

The study follows the successful completion of a phase 2a trial of Elocalcitol in 114 patients with overactive bladder, announced in May, in which Elocalcitol demonstrated numerical superiority on its primary endpoint and statistically significant efficacy in several clinically relevant subgroups compared to a placebo.

Evidence also was obtained for efficacy of Elocalcitol in nocturia and incontinence, symptoms commonly associated with overactive bladder.

The phase 2b trial is intended to confirm key findings from the previous study in a larger patient group, officials said.

The phase 2b trial will be the second for Elocalcitol in a urological indication. A phase 2b trial in benign prostatic hyperplasia is underway with an enrollment of more than 500 patients. The results are expected in 2007.

Overactive bladder is a medical condition characterized by urinary urgency, frequency and nocturia, and often associated with urge incontinence.

BioXell is a Milan, Italy, biopharmaceutical company focused on treating urological, inflammatory and related disorders.

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