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BioXell Announces Phase II Results for Elocalcitol in Overactive Bladder


Milan , Italy , 11 th May, 2006 – BioXell S.p.A. today reported clear efficacy of its lead compound, Elocalcitol (previously BXL628), in a Phase II study in Overactive Bladder (OAB). In the recently concluded trial, Elocalcitol demonstrated numerical superiority on its primary endpoint and statistically significant efficacy in several clinically relevant subgroups compared to placebo. The study, a placebo-controlled, double-blind, 3-month trial involving 114 patients with OAB, also showed that Elocalcitol continues to be extremely well tolerated, with an adverse event profile comparable to placebo.

The primary endpoint of the study was Mean Volume Voided per Micturition (MVV), an objective and commonly used parameter in OAB trials which is strongly correlated with symptoms. Patients receiving Elocalcitol showed a 21.5% increase in MVV, versus a 10.9% increase in patients on placebo. A subgroup analysis also showed a statistically significant difference versus placebo in the percentage of patients with an MVV greater than 60ml. An effect of Elocalcitol was also observed after 4 weeks of treatment.

Overactive bladder is a medical condition characterized by urinary urgency, frequency and nocturia, and often associated with urge incontinence. OAB can be detrimental to the quality of life of sufferers, resulting in increased healthcare costs and deteriorated social functioning. In 2005, approximately 68 million people were diagnosed with the disease in the 7 principal pharmaceutical markets, with over $1 billion spent on drug treatments. Currently, the main approach to treating the symptoms is with the anti-muscarinic class of agents. However, the side effect profile for these compounds tends to have a negative impact on patient compliance.

Elocalcitol’s novel mechanism of action may allow it to treat involuntary bladder contractions without causing any of the side effects commonly associated with currently available treatments.

“We are pleased with these results because the magnitude of the effect demonstrates that Elocalcitol may have efficacy comparable to what we have seen historically with anti-muscarinics, and may have a superior tolerability profile,” said Enrico Colli, Chief Medical Officer at BioXell.

This opinion was echoed by Walter Artibani, Director of the School of Urology at the University Hospital of Padua, Italy: “OAB is a widespread condition for which current treatments are unsatisfactory. This study demonstrates that Elocalcitol, already shown to be effective in another major urological indication, has the potential to become the treatment of choice for OAB.”

Francesco Sinigaglia , CEO of BioXell, added, “These promising results in an additional major urological indication confirm the value of our VD3 platform and validate the Company’s strategic focus on urology, which represents a large and growing market opportunity.”

In 2004, BioXell completed a Phase IIa study with Elocalcitol in patients with Benign Prostatic Hyperplasia (BPH) in which the compound was shown to arrest prostate growth. Last year the company began a 500+ patient Phase IIb BPH trial, scheduled to be completed in 2007. In 2005, BioXell also began a Phase II trial with Elocalcitol in patients with Non-Bacterial Chronic Prostatitis; these results are expected by the end of 2006. BioXell further plans to begin a Phase II clinical study of Elocalcitol in Interstitial Cystitis at the beginning of 2007.

About urology
Urology is the study of urinary tract and urogenital disorders, many of which are highly prevalent in both males and females and may dramatically impact quality of life. While these disorders are seen in people of all ages, longer life expectancies underscore an increasing demand for effective, well-tolerated treatments. Until about the mid-1990’s, mainly due to the unavailability of less invasive treatment options, urology was primarily a surgical discipline and patients commonly underwent surgery to relieve symptoms. Underserved by existing therapies or lacking any approved treatments at all, the urology market currently represents a major commercial opportunity. BioXell’s lead compound, Elocalcitol, is in clinical development for four distinct urological indications.

About BioXell
BioXell is a biopharmaceutical company focused on the discovery and development of drugs that exploit novel mechanisms of action to treat major urological, inflammatory, and related disorders with significant unmet medical needs. The Company’s strategy is to maximize the commercial potential of its lead compound, Elocalcitol, and to leverage existing platforms into profitable partnerships. With analogues based on its proprietary VD3 (Vitamin D3) technology platform, BioXell has three Phase II clinical programmes underway, specifically evaluating Elocalcitol in Benign Prostatic Hyperplasia, Overactive Bladder, and Non-Bacterial Chronic Prostatitis. Since May 2005, BioXell has a TREM-1 fusion protein in development for septic shock in an exclusive partnership with Merck & Co., Inc. Most recently, in an agreement with Lay Line Genomics S.p.A., BioXell has in-licensed MNAC13, a novel anti-TrkA monoclonal antibody that represents a potential new approach to the treatment of pain. To date, BioXell has raised a total of €76 million through world-class specialised healthcare investors including MPM Capital, Index Ventures, BB BIOTECH, AlpInvest Partners, Life Sciences Partners and TVM Capital. BioXell currently employs 58 people and has sites in Milan , Italy and Nutley , NJ , USA.


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