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BioXell Completes Patient Enrollment in Elocalcitol Phase IIb Trial
in Overactive Bladder |
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Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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Milan, Italy, 17 December, 2008 - BioXell S.p.A. (SWX: BXLN)
announced today the completion of patient enrollment for the Phase
IIb clinical trial of its lead compound Elocalcitol in Overactive
Bladder (OAB), a common urological syndrome characterized by Lower
Urinary Tract Symptoms (LUTS). Preliminary results are expected in
early Q2 2009.
The trial is a urodynamic, multi-center, double-blind, placebo
controlled study in which 257 patients were randomized into three
groups (placebo, 75mcg, 150 mcg), and treated daily for 4 weeks. The
primary endpoint is to evaluate the effect of Elocalcitol on bladder
volume at the first involuntary detrusor contraction, following 4
weeks of treatment. Secondary endpoints include additional urodynamic
parameters, symptoms severity and patient's perception of bladder
condition. The trial is being performed in 47 centers in the United
Kingdom, the Netherlands, Italy and Eastern Europe (Ukraine, Latvia,
Estonia, Lithuania, and Romania).
"Compared to clinical trials based on subjective criteria only,
urodynamic studies allow the reduction of the usually high placebo
response shown in patients, with detrusor overactivity", commented
Francesco Sinigaglia, CEO of BioXell. "We are looking forward to the
results that will contribute to the full evaluation of Elocalcitol's
potential as the first line monotherapy in LUTS."
"We definitely need new drugs to treat the overactive bladder
syndrome", said Professor Linda Cardozo from King's College Hospital
London, international coordinating investigator of the trial.
"Currently available medications are either anti-muscarinics or drugs
with mixed action - predominantly anti-muscarinics - and not everyone
responds to this type of medication. In fact many experience the
side-effect of these drugs in an unacceptable manner and actually
worse than the condition itself."
Urodynamic studies objectively and precisely measure the
pressure/volume relationship of the bladder during both storage and
voiding phases. The trial is being performed in accordance with the
International Continence Society (ICS) recommendations and the Good
Urodynamic Practices (GUP), and includes centralized reading of the
results.
***
About Overactive Bladder
Today, more than 120 million people suffer from Overactive Bladder,
although only a small portion is diagnosed and treated. The term
"Overactive Bladder" (OAB) is used to describe a collection of
symptoms characterized by urgency, with or without urge
incontinence, usually with frequency and nocturia. It is commonly
encountered in both sexes and all ages. It might become extremely
bothersome, causing enormous disruption to the quality of life and
often leading to social isolation. The gold-standard treatment is
represented by a class of drugs called anti-muscarinics. These drugs
should be prescribed and taken for a long period of time. However,
the side effects are common thus limiting patient compliance.
Elocalcitol is a new drug with a novel mechanism of action. Its
excellent tolerability and safety profile may allow the treatment of
OAB without causing any of the side effects commonly associated with
currently available drugs. The global market for OAB-related
medications is expected to grow from the current $1.8 billion to
$3.5 billion by 2010, due to increased awareness of the disease and
aging population.
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 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, has successfully completed a
Phase IIb clinical trial for Benign Prostatic Hyperplasia (BPH).
Elocalcitol is currently in a Phase IIb clinical trial for Overactive
Bladder (OAB) and in a Phase II trial for male infertility. In
addition, the Company has several follow-on programs based on both
VD3 and other technological platforms. These include BXL746, to enter
Phase I trials for post-surgical adhesions in early 2009; BXL1H5, an
innovative approach to the treatment of pain; and the TREM platform,
with TREM-1 in development for the treatment of inflammatory
conditions.
In June 2006, BioXell listed its shares on the main segment of the
SWX Swiss Exchange. BioXell currently employs 50 people and has sites
in Milan, Italy and Nutley, NJ, USA.
More information on BioXell can be found at: www.bioxell.com
For further information, please contact:
BioXell S.p.A. Dynamics Group SA
Alvise Sagramoso Christophe Lamps
Tel: +39 (0)2 210 49 51 Tel: +41 (0)22 308 6222
Fax: +39 (0)2 210 49 Fax: +41 (0)22 308 6236
529
alvise.sagramoso@bioxell.com cla@dynamicsgroup.ch
This press release can be downloaded at www.bioxell.com.
Disclaimer
This press release does not constitute or form part, or all, of any
offer or invitation to sell or issue, or any solicitation of any
offer to purchase or subscribe for, any securities, nor shall part,
or all, of these materials or their distribution form the basis of,
or be relied on in connection with, any contract or investment
decision in relation to any securities. This press release contains
forward-looking statements based on the currently held beliefs and
assumptions of the management of BioXell, which are expressed in good
faith and, in their opinion, reasonable. Forward-looking statements
involve known and unknown risks, uncertainties and other factors,
which may cause the actual results, financial condition, performance,
or achievements of BioXell, or industry results, to differ materially
from the results, financial condition, performance or achievements
expressed or implied by such forward-looking statements. Given these
risks, uncertainties and other factors, recipients of this document
are cautioned not to place undue reliance on these forward-looking
statements. BioXell disclaims any obligation to update these
forward-looking statements to reflect future events or developments.
--- End of Message ---
bioXell S.p.A
via Olgettina 58 Milan Italy
WKN: A0J3MW; ISIN:
IT0004069933 ;
Listed: Main Market in SWX Swiss Exchange; Copyright © Hugin AS 2008. All rights reserved.
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