BioXell announces start of Phase IIa trial of Elocalcitol in Male
Infertility
Milan, Italy, November 19, 2007 - BioXell S.p.A. (SWX: BXLN) today
announced the enrollment of the first patient in its Phase IIa trial
of Elocalcitol in male infertility, a widespread condition currently
with no effective treatment. The trial is designed to test the
ability of Elocalcitol to improve sperm quality in infertile male
patients. Results are expected for the end of 2008.
The randomized, double-blind, placebo-controlled, parallel group
study is being conducted at 8 Italian centers that are highly
specialized in infertility, under the coordination of Professor
Andrea Lenzi of the University of Rome. The trial will involve a
total of 234 infertile male patients with poor sperm quality and no
known specific causes of infertility, and will test Elocalcitol at
doses of 75 mcg and 150 mcg versus placebo for an effect on various
sperm parameters. Treatment duration is 4 months, preceded by 3
months of pre-screening/washout and one week of medication-free
run-in, and with a one month follow-up after treatment. The primary
endpoint is total sperm motility (percentage), with secondary
endpoints including forward motility (percentage), total and forward
motility (absolute value), morphology (atypical cells), conception
rate, IL-8 seminal plasma levels, leukocytes in the semen, and safety
and tolerability.
Infertile men with leukospermia (increased number of seminal
leukocytes) have previously been found to have significantly elevated
levels of the chemokine IL-8 in their seminal plasma. Seminal plasma
IL-8 levels have, in turn, been shown to be inversely correlated,
with high significance, with several measures of semen quality. In a
separate clinical trial completed last year, BioXell found that
Elocalcitol treatment induced a significant decrease in IL-8 levels
in the seminal plasma of patients suffering from chronic prostatitis,
a disease which is often associated with infertility. These elements
provide a strong rationale for carrying out the newly initiated
clinical study, in view of a possible use of Elocalcitol to treat
male infertility.
Enrico Colli, Chief Medical Officer and Head of R&D at BioXell,
commented, "Elocalcitol is emerging, through accumulated evidence
from clinical and preclinical studies, as a potential treatment of
choice for urological disorders with an inflammatory component. There
are strong reasons to believe that male infertility, for which there
is a large unmet medical need, may also be one of these indications,
broadening the potential therapeutic range of our lead compound."
About Male Infertility
Infertility is defined by the WHO as the inability of a sexually
active, non-contracepting couple to achieve pregnancy in one year.
The condition affects about 20% of couples, with male factors at the
origin of 50% of cases. Over a third of cases of male infertility are
idiopathic, with abnormal semen analysis but no known etiologic
factors. There are no FDA/EMEA-approved treatments for idiopathic
male infertility, and most proposed treatments are ineffective or of
unproven efficacy. A successful treatment would improve spontaneous
pregnancy rates and/or improve the results of reproductive
techniques.
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 IIa 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 IIa trials for post-surgical adhesions in 2008; MNAC13, an
innovative new 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 58 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. Rochat & Partners
Alvise Sagramoso or Angela Evans Christophe Lamps or Jonathan
Tel: +39 (0)2 210 49 51 Leighton
Fax: +39 (0)2 210 49 529 Tel: +41 22 718 37 46
alvise.sagramoso@bioxell.com Fax: +41 22 786 54 58
angela.evans@bioxell.com clamps@rochat-pr.ch
jleighton@rochat-pr.ch
Disclaimer
This press release does not constitute or form part, or all, of any
offer to sell or invitation to subscribe, or any solicitation of any
offer to purchase or subscribe for, any securities, nor shall part,
or all, of this press release and any attached and/or referred
material, if any, 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;
