BioXell starts Phase IIb European Trial of Elocalcitol in Overactive
Milan, Italy, July 23, 2007 - BioXell S.p.A. (SWX: BXLN) today announced the start of a large Phase IIb clinical trial of its lead compound Elocalcitol in Overactive Bladder (OAB), a widespread symptom syndrome characterized by urinary urgency, with or without urge incontinence, usually with frequency and nocturia. The objective of this study, which will include a urodynamic evaluation, is to confirm the positive clinical effects found in a previous Phase IIa study. Results are expected in the second half of 2008.
In May 2006 BioXell announced the results of the Phase IIa study of Elocalcitol in 114 patients with OAB. These results demonstrated clear efficacy signals on the primary endpoint (mean volume voided per micturition) and on symptoms, including frequency, nocturia and incontinence episodes. Elocalcitol was found to be extremely well tolerated, with an adverse event profile comparable to placebo.
"A large body of safety and efficacy data exists for Elocalcitol. A state-of-the-art urodynamic trial setting should allow us to further demonstrate its efficacy and also further characterize its mechanism of action," remarked Enrico Colli, Chief Medical Officer and Head of R&D at BioXell. "Our objective is to confirm Elocalcitol's potential as the treatment of choice for OAB."
"OAB is a highly prevalent symptom syndrome for which current treatments are suboptimal. As a consequence, it is necessary to identify drugs with novel mechanisms of actions if improvements are to be made in the management of this syndrome. As the existing anti-muscarinics on the market have already been subjected to urodynamic trials, the results with Elocalcitol can be directly compared with existing data," stated Professor Linda Cardozo of King's College in London, European coordinator of this study.
In addition to the new Phase IIb trial in OAB, Elocalcitol is currently in a Phase IIb study for another urological indication, Benign Prostatic Hyperplasia (BPH). Total enrolment in this trial encompasses 541 patients, with results expected by the end of September 2007.
Clinical trial design
The Phase IIb study will be a urodynamic, multi-center, double-blind, placebo-controlled study in which 234 patients will be randomized in three groups (placebo, 75mcg, 150mcg) and treated daily for 4 weeks. The primary endpoint will be the volume at which the first involuntary contraction occurs, with the objective being to increase this value through administration of Elocalcitol. The secondary outcomes to be evaluated include additional urodynamic parameters, symptom severity and patient perception of bladder condition. The trial will be performed in 26 centers located in Italy, the UK and the Netherlands. Should the trial be positive, a Phase III trial could be initiated in the first half of 2009.
Urodynamic studies measure the pressure/volume relationship of the bladder in order to provide objective and precise measurements of both storage and voiding phases. Additional advantages are that both the number of patients needed per arm and the trial duration can be substantially reduced. Performed in accordance with the International Continence Society (ICS) recommendations, this urodynamic trial will include centralized reading of the results.
OAB is a symptom syndrome characterized by urgency, with or without urge incontinence, usually with frequency and nocturia. 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.
BioXell (SWX: 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.
BioXell's lead compound, Elocalcitol, derived from its proprietary VD3 (Vitamin D3) technology platform, is in Phase IIb clinical trials for Benign Prostatic Hyperplasia (BPH) and Overactive Bladder (OAB), with a third Phase IIa trial for Male Infertility scheduled for the second half of 2007. In addition, the Company has several follow-on programs based on both VD3 and other technological platforms. These include BXL746, to enter Phase II trials for Post-Surgical Adhesions in 2008, as well as MNAC13, an innovative new approach to the treatment of pain, and the TREM platform, with TREM-1 in development for the treatment of septic shock.
In June 2006, BioXell listed its shares on the main segment of the SWX Swiss Exchange. BioXell currently employs 60 people and has sites in Milan, Italy and Nutley, NJ, USA.
More information on BioXell can be found at: http://www.bioxell.com
For further information, please contact:
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