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BioXell Reports Top-line OAB Phase IIb Results
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BioXell S.p.A. has announced top-line results of its Phase IIb trial of Elocalcitol in patients suffering from Overactive Bladder (OAB).
The urodynamic trial was conducted in 257 patients treated for 4 weeks in a multi-centre, double blind, placebo controlled study. A statistically significant effect on the primary endpoint, the 'change in volume at first involuntary contraction', was not achieved. A statistically significant improvement in 'bladder volume at first desire to void' was observed in the intention-to-treat population (ITT).
Numerical improvements in most other urodynamic parameters compared to placebo were observed but did not reach statistical significance. Numerical improvements were also seen for the key symptoms of OAB in all treatment groups.
A statistically significant improvement in incontinence episodes was observed in the modified-intention-to-treat (MITT) population. There was a strong dose related trend in the improvement in Patient's Perception Bladder Condition (PPBC) in the ITT population which reached statistical significance in the per protocol (PP) analysis.
"The results on the primary endpoint are disappointing," remarks Francesco Sinigaglia, CEO, "Data on the secondary endpoints are encouraging and we will be discussing the full data set with our experts and investigators in the coming weeks."
BioXell is currently performing further analyses on the data. A full analysis of the Elocalcitol OAB data will be presented in the course of the Annual General Meeting and the Analyst Presentation in Zurich on April 30, 2009.
The urodynamic trial was conducted in 257 patients treated for 4 weeks in a multi-centre, double blind, placebo controlled study. A statistically significant effect on the primary endpoint, the 'change in volume at first involuntary contraction', was not achieved. A statistically significant improvement in 'bladder volume at first desire to void' was observed in the intention-to-treat population (ITT).
Numerical improvements in most other urodynamic parameters compared to placebo were observed but did not reach statistical significance. Numerical improvements were also seen for the key symptoms of OAB in all treatment groups.
A statistically significant improvement in incontinence episodes was observed in the modified-intention-to-treat (MITT) population. There was a strong dose related trend in the improvement in Patient's Perception Bladder Condition (PPBC) in the ITT population which reached statistical significance in the per protocol (PP) analysis.
"The results on the primary endpoint are disappointing," remarks Francesco Sinigaglia, CEO, "Data on the secondary endpoints are encouraging and we will be discussing the full data set with our experts and investigators in the coming weeks."
BioXell is currently performing further analyses on the data. A full analysis of the Elocalcitol OAB data will be presented in the course of the Annual General Meeting and the Analyst Presentation in Zurich on April 30, 2009.
