Milan, Italy, April 8, 2009 - BioXell S.p.A. (SIX: BXLN) today announces 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. To discuss the top-line OAB phase IIb results as well as the 2008 Financial Results (to be published on April 9, 2009), BioXell will hold a:
Conference call on Thursday, April 9, 2009 at 10.00am CET To participate in the conference call, please dial +41 (0) 22 592 7312 (Europe & CH), +39 (0) 06 452 108 001 (Italy), +44 207 153 2027 (UK), +1 480 629 1990 (USA)
About BioXell BioXell (SIX: BXLN) is a biopharmaceutical company focused on the discovery and development of drugs that exploit novel mechanisms of action to treat important urological, inflammatory, and related disorders with significant unmet medical needs. The Company was founded in 2002 as a spin-out from Roche. BioXell’s strategic goal is to become a fully integrated pharmaceutical Company by maximizing the commercial potential of its product portfolio and leveraging existing platforms into profitable partnerships.
In June 2006, BioXell listed its shares on the main segment of the SIX Swiss Exchange. BioXell approx. employs 40 people and has its sites in Milan, Italy.
About the OAB Phase IIb trial The OAB trial was a urodynamic, multi-centre, double-blind, placebo controlled study in which 257 patients were randomized into three groups (placebo, 75mcg, 150 mcg), and treated daily for 4 weeks. The primary endpoint was to evaluate the effect of Elocalcitol on bladder volume at the first involuntary detrusor contraction, following 4 weeks of treatment. Secondary endpoints included additional urodynamic parameters, symptoms severity and Patient’s Perception of Bladder Condition. The trial was performed in 47 centres in the United Kingdom, the Netherlands, Italy and Eastern Europe. More on BioXell can be found at: www.bioxell.com For further information, please contact:
BioXell S.p.A. Dynamics Group SA Alvise Sagramoso Christophe Lamps Tel: +39 (0)2 210 49 51 Tel: +41 (0)22 308 6222 Fax: +39 (0)2 210 49 529 Fax: +41 (0)22 308 6236 alvise.sagramoso@bioxell.com cla@dynamicsgroup.ch
This press release can be downloaded at www.bioxell.com. Disclaimer This press release does not constitute or form part, or all, of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any securities, nor shall part, or all, of these materials or their distribution form the basis of, or be relied on in connection with, any contract or investment decision in relation to any securities. This press release contains forward-looking statements based on the currently held beliefs and assumptions of the management of BioXell, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of BioXell, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. Given these risks, uncertainties and other factors, recipients of this document are cautioned not to place undue reliance on these forward-looking statements. BioXell disclaims any obligation to update these forward-looking statements to reflect future events or developments.
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