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BioXell Initiates Phase IIb Trial of BXL628 in Benign Prostatic Hyperplasia

BioXell S.p.A., an Italian biopharmaceutical company that is discovering and developing new treatments for urological disorders, today announced
initiation of a Phase IIb clinical trial evaluating the efficacy of its lead compound BXL628
in Benign Prostatic Hyperplasia (BPH).
Coordinated by the Division of Urology at the San Raffaele Hospital in Milan, the study
will enroll more than 500 patients in 60 urology centres across Italy. Using a double-blind,
randomised, placebo controlled, parallel group design, the trial’s primary objective is to
confirm the ability of BXL628 monotherapy to reduce prostate volume after 24 weeks of
treatment. Secondary endpoints are severity of symptoms, urinary flow rate, sexual
function and Quality of Life. In addition, the study will evaluate the effectiveness of a fixed
combination of BXL628 and tamsulosin, currently the “gold standard” alpha-blocker
therapy for BPH.
“By evaluating these clinically relevant objectives, we expect important new information
about the optimum medical treatment for BPH, as well as data that will be instrumental
for the further development of the drug” said Enrico Colli MD, Chief Medical Officer at
“We are extremely pleased with the rapid progress of our clinical development
programmes on BXL628, and we are highly committed to making our lead compound a
standard of care in the treatment of a number of urological diseases” commented
Francesco Sinigaglia MD, Bioxell’s Chief Executive Officer.
BioXell successfully completed a Phase IIa clinical trial in September 2004.
Comprehensive data from that study, reported at the March 2005 annual meeting of the
European Urology Association in Istanbul, demonstrated that the drug significantly
reduced prostate volume without affecting the androgen levels, thus avoiding the
negative sexual side effects associated with current therapies. In particular, the data
showed that after only three months of treatment, 29% of patients treated with BXL628
experienced a clinically significant reduction of prostate volume, vs. none of the patients
who had received placebo. The drug was also shown to be extremely well tolerated and
accepted by patients.
BPH is a common disorder in elderly men, occurring in approximately 50% of men aged
60 years and in 90% of those aged 85 years. The disease can often cause chronic lower
urinary tract symptoms such as urinary urgency, frequency and nocturia (night-time
urination). This affects the psychological and sexual life of patients leading to a
profoundly negative impact on their quality of life. Recent studies have shown that BPH is
a progressive disease with a risk of acute urinary retention, urinary tract infections and
need for surgery.
More than 54 million individuals suffer from BPH worldwide (2003), but only 5 million are
currently treated with drug therapy. Due to aging populations, the prevalence of the
disease is expected to increase. In the U.S. alone, social costs associated with BPH have
grown from $4 billion in 1993 to $26 billion in 2003.
BPH is commonly treated by orally administered 5 alpha reductase inhibitors and alpha 1
receptor antagonists, both of which are associated with tolerability issues, specifically
regarding sexual dysfunction. By contrast, due to its novel mechanism of action, BXL628
has the potential to overcome the limitations of currently prescribed therapies and if
successful, could represent a new approach to the treatment of BPH, a market worth
approximately €3 billion.
In addition to an ongoing Phase IIa trial in overactive bladder, BioXell also plans to
evaluate BXL628 in non-bacterial chronic prostatitis. The company expects to initiate an
additional proof of concept study in this indication by the end of 2005.

About BioXell
Spun-out from Roche in January of 2002, BioXell is a private biopharmaceutical company
focusing on the discovery and development of new treatments for urological disorders
that repres

Publisher Contact Information:

Bioxell S.p.A.
+39 02-21049520

Company profile of Bioxell S.p.A.
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