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BioXell Completes Recruitment for Phase IIb Trial of Elocalcitol in Benign Prostatic Hyperplasia


Milan, Italy, December 15th, 2006 - BioXell S.p.A. (SWX: BXLN) today announced that it has completed recruitment on schedule for its Phase IIb trial of lead compound Elocalcitol in Benign Prostatic Hyperplasia (BPH). With 532 randomized patients, the trial exceeds by 20 the planned sample size and represents the largest trial run by BioXell until now. Last patient visits are planned for June 2007, with results to be announced in the second half of 2007.
The double-blind, randomised, placebo-controlled, parallel group design trial is being carried out at 37 centres in Italy and 8 in Germany. The primary objective is to confirm the ability of Elocalcitol monotherapy to reduce prostate volume after 24 weeks of treatment. Secondary endpoints being measured are severity of symptoms, urinary flow rate, sexual function and quality of life. The study is also evaluating the effectiveness of a fixed combination of Elocalcitol and tamsulosin, currently the “gold standard” alpha-blocker therapy for BPH.
This is one of the largest studies ever performed to measure prostate volume using MRI (magnetic resonance imaging), a sophisticated technology that provides a high level of precision and reproducibility and can be carried out non-invasively.
Enrico Colli, Chief Medical Officer and Head of R&D at BioXell, commented, “We are pleased to be on schedule in the execution of this trial, which is of pivotal importance for confirming earlier results and providing valuable new data on the optimum medical treatment of BPH, a common, progressive condition that negatively affects quality of life.”
This trial follows a successful Phase IIa trial completed in September 2004, in which Elocalcitol led to significantly reduced prostate volume without affecting androgen levels, avoiding the negative sexual side effects associated with current therapies. The drug was also shown to be extremely well tolerated and accepted by patients. These results were published in European Urology 49 (2006) 82-86.
About Benign Prostatic Hyperplasia (BPH)
Benign Prostatic Hyperplasia (BPH) is a benign enlargement of the prostate which can cause troublesome lower urinary tract symptoms including both storage symptoms (frequency, urgency, and nocturia or night-time urination) and obstructive symptoms (hesitancy and decreased urine flow). BPH is a common disorder, affecting approximately 55 million men, and is progressive: according to the National Institute of Health, more than 50% of men over the age of 60 and approximately 90% of men over the age of 70 have some symptoms of BPH.
If untreated, BPH can lead to acute urinary retention and can often require surgery, with a potentially profound negative impact on quality of life. Current pharmacological options are unsatisfactory, as they are either ineffective in reducing prostate size or associated with unpleasant sexual side effects that negatively affect patient compliance. Despite these issues, sales of the existing drugs are currently $2.8 billion.
About BioXell
BioXell (SWX: BXLN) is a biopharmaceutical company focused on the discovery and development of drugs that exploit novel mechanisms of action to treat urological, inflammatory, and related disorders with significant unmet medical needs and representing large markets. 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.
BioXell’s lead compound, Elocalcitol, derived from its proprietary VD3 (Vitamin D3) technology platform, is in Phase II clinical trials for Benign Prostatic Hyperplasia (BPH) and Overactive Bladder (OAB). In addition, the Company has several follow-on programs based on both VD3 and other technological platforms. Since 2005 BioXell has a TREM-1 fusion protein in development for the treatment of septic shock in an exclusive partnership with Merck & Co., Inc. Furthermore, in 2006 BioXell in-licensed from Lay Line Genomics S.p.A. a novel anti-TrkA monoclonal antibody, MNAC13, which represents a potential new approach to the treatment of pain.
In June 2006, BioXell listed its shares on the main segment of the SWX Swiss Exchange. BioXell currently employs 58 people and has sites in Milan, Italy and Nutley, NJ, USA.
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