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BioXell to commence phase IIa trial of its lead compound, BXL628, in Overactive Bladder


Milan, Italy, 29 November, 2004 – BioXell SpA, today announced the enrolment of the
first patients into its phase IIa program investigating the efficacy of BXL628 in Overactive
Bladder (OAB). The study will be randomized, double-blind, placebo controlled and will
involve 120 patients in 13 urology and gynaecology centres across Italy. The trial will be
coordinated by the Division of Urology at the San Raffaele Hospital in Milan.

The primary end point will be the increase of the mean volume voided per micturition
(urination), an objective parameter to measure bladder capacity. Secondary end points will
be the number of frequency, urgency and urge incontinence episodes and general
improvement in Quality of Life, as measured by the Kings’ Health Questionnaire.* The
results are expected towards the end of 2005.
OAB affects both men and women and is characterized by urinary urgency with or without
urge incontinence generally associated with frequency and nocturia (night-time urination).
These symptoms are associated with the presence of spontaneous non-voiding bladder
contractions during the filling phase and a decreased bladder capacity. In 2003, 68 million
people worldwide suffered from overactive bladder, however, only 50% of sufferers seek
medical treatment due to the embarrassment associated with their symptoms.
“BXL628 has been shown in different validated preclinical models to increase bladder
capacity and to significantly decrease frequency and amplitude of spontaneous nonvoiding
contractions without affecting the residual volume. Consequently the drug should
be effective in restoring a normal micturition pattern without the side effects associated
with the current therapeutic agents (antimuscarinic drugs), in particular dry mouth,
constipation, palpitations, drowsiness and risk of urinary retention,” remarked Karl-Erik
Andersson, Professor and Head of Clinical Pharmacology at the University of Lund,
Sweden.
“Based on the highly encouraging results we have seen both preclinically and in the phase
IIa study in Benign Prostatic Hyperplasia (BPH), our plan is to move this compound
forward in development across a range of urological indications thus maximising its
potential commercial return. BXL628’s novel mechanism of action may be greatly
beneficial to patients in these indications where there is limited benefit in current
treatments,” commented Enrico Colli MD, Bioxell’s Chief Medical Officer.
BioXell recently announced successful phase IIa results for BXL628 in BPH, now due to
commence a Phase IIb trial in the first half of 2005. The Company also plans to begin two
additional Phase IIa trials with BXL628 in Interstitial Cystitis and Chronic Prostatitis next
year. The combined markets for these indications in the developed world are currently in
excess of $5 billion.
*The King's Health Questionnaire is a validated questionnaire to measure the quality of life
in patients with urinary incontinence and is recommended by the International Guidelines.
About BioXell
Spun-out from Roche in January 2002, BioXell is a private biopharmaceutical company
focusing on the discovery and development of new treatments for urological and chronic
inflammatory disorders. Through its proprietary technology platform based on Vitamin D3
analogues, BioXell has identified a number of promising lead development programmes.
Its pipeline includes BXL628 for benign prostatic hyperplasia and overactive bladder, as
well as compounds to treat other major urological indications. In order to further exploit its
Vitamin D3 platform, BioXell is collaborating with ProStrakan to develop drug candidates to
cure osteoporosis and secondary hyperparathyroidism. Furthermore, based on its unique
understanding of the inflammatory process and knowledge of GPCRs and TREM receptor
biology, BioXell is also committed to a number of cutting-edge research projects to
develop new drugs for chronic inflammatory diseases in coll


Publisher Contact Information:

Bioxell S.p.A.
+39 02-2104951
angela.evans@bioxell.com

Company profile of Bioxell S.p.A.
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