MILAN, Italy, July 28, 2006 (PRIMEZONE) -- BioXell S.p.A. (SWX:BXLN) today announced its plans to proceed with a Phase IIb clinical trial of its lead compound Elocalcitol in Overactive Bladder (OAB). Enrollment in the pan-European study is scheduled to begin in early 2007. Details of the study design are currently being finalised.
The new study follows the successful completion of a Phase IIa trial of Elocalcitol in 114 patients with OAB, announced in May, in which Elocalcitol demonstrated numerical superiority on its primary endpoint and statistically significant efficacy in several clinically relevant subgroups compared to placebo. Evidence was also obtained for efficacy of Elocalcitol in nocturia and incontinence, symptoms commonly associated with OAB. The Phase IIb trial is intended to confirm key findings from the previous study in a larger patient group.
"We are pleased with the promising results we have seen with Elocalcitol in symptoms where it is generally difficult to show efficacy," remarked Enrico Colli, Chief Medical Officer and Head of R&D at BioXell. "It is a logical next step for us to proceed with a robust Phase IIb study to confirm all these positive signals in a large scale study which could potentially be used as one of our pivotal trials."
"BioXell has been successful because of our world-class team and our rigorous approach to drug development, which as a public company we are as committed as ever to maintaining," stated Francesco Sinigaglia, BioXell's CEO. "We are delighted about the enthusiasm that Elocalcitol has created among the scientific community and the encouraging data we have collected until now."
The new Phase IIb trial will be the second for Elocalcitol in a urological indication. A Phase IIb trial in Benign Prostatic Hyperplasia (BPH) is currently underway, with a total enrollment of over 500 patients. The results are expected in 2007.
About OAB
OAB is a medical condition characterized by urinary urgency, frequency and nocturia, and often associated with urge incontinence. 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.
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 the treatment of three distinct urological indications, Benign Prostatic Hyperplasia (BPH), Overactive Bladder (OAB) and Non-bacterial Chronic Prostatitis (CP), and is expected to enter a fourth Phase II clinical trial in Interstitial Cystitis (IC) in the first half of 2007.
Since May 2005, BioXell has a TREM-1 fusion protein in development for the treatment of 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.
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.
More information on BioXell can be found at: http://www.bioxell.com
BioXell Plans Phase IIb European Trial for Elocalcitol in Overactive Bladder: http://hugin.info/133681/R/1066076/179876.pdf
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