Phase III ARISER study with RENCAREX®*: patient recruitment
successfully completed
Munich, July 3,
2008. Munich-based biopharmaceutical company WILEX AG
(ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard)
today announced that it has successfully completed patient recruitment
in the Phase III ARISER trial with its drug candidate RENCAREX®.
The international double-blind trial is testing RENCAREX® for
use as adjuvant therapy of clear cell renal cell carcinoma. The
trial is being carried out in more than 150 centres in North and
South America as well as Europe. The trial examines whether RENCAREX® could
prolong disease free survival and overall survival in comparison
to placebo. A total of 856 patients are taking part in the trial,
of which 583 were recruited in Europe and 273 in North and South
America. 203 patients were enrolled in the study centres in the
US, which represents 24% of the total. Patients who are at present
still undergoing the pre-enrolment screening process will also
be able to participate in the trial if they meet the inclusion
criteria. This means that the final number of patients in the
trial may still increase. The drop out rate at currently 4.2%
remains low. This again suggests that the treatment is well tolerated
and the regimen of weekly injections acceptable.
We reported on the positive outcome of the interim analysis for
futility in December 2007. The next milestone in the trial will
be when 343 relapses have occurred.
Dr. Paul Bevan, Head of Research and Development and Member
of the Executive Management Board at WILEX, said: "The number
of relapses we have recorded currently stands at over 180. This
is within the timeframe projected last December. We therefore
believe that we will reach the next milestone early in 2009. WILEX
will continue to closely monitor the relapse rate.”
When this next milestone is reached, the study protocol specifies
that all patient data will be analysed centrally to enable
the Independent Data Monitoring Committee to carry out an
interim
analysis for efficacy of RENCAREX®. This interim analysis
will evaluate whether RENCAREX® is significantly superior
to placebo with regard to disease-free survival. The data will
remain blinded to WILEX. If the result is positive, the analysis
may provide the basis for filing for approval in Europe.
About the ARISER study
The international, multicentre, randomised trial called ARISER (Adjuvant
RENCAREX Immunotherapy trial to Study Efficacy in non-metastasised
Renal cell carcinoma) examines the efficacy of the antibody RENCAREX® in
comparison to placebo in the treatment of clear cell renal cell
cancer patients after complete or partial surgical removal of
the affected kidney in patients with no detectable metastases.
This cancer belongs to one of the particularly aggressive indications,
for which no FDA or EMEA approved drug exists today. RENCAREX® aims
to inhibit these malignant kidney tumours from further growth
and recurrence and to help destroy cancer cells and thereby prolong
the disease-free survival of patients. Patients are given weekly
injections of RENCAREX® for a period of six months.
About WILEX
WILEX is a biopharmaceutical company based in Munich and is listed
at the Frankfurt Stock Exchange at the Regulated Market / Prime
Standard. WILEX’s mission is to develop drugs and diagnostic
agents with a low side effect profile and targeted treatment of
different types of cancer as well as for early detection of tumours.
The Company's product candidates are based on antibodies and small
molecules. WILEX has an attractive product pipeline which includes
both drug and diagnostic candidates: The substances RENCAREX® and
REDECTANE®* are currently undergoing a Phase III registration
trial. The substance WX-671 (developed under the name MESUPRON®)
is currently in a Phase II programme. Based on this pipeline,
WILEX's aim is to achieve profitability within a few years through
the consistent commercialisation of its products and in the long
term to finance its research and development programmes from its
operating business.
* temporary name while under development
Contact
WILEX AG
Grillparzerstr. 10
D-81675 Munich
Germany
Public Relations
Juliane Giese
Manager Public Relations
Tel.: +49 (0)89-41 31 38-29
Fax: +49 (0)89-41 31 38-99
E-mail: press@wilex.com
Investor Relations
Katja Arnold (CIRO)
Manager Investor Relations
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
E-mail: investors@wilex.com
This communication contains certain forward-looking statements
relating to the Company's business, which can be identified by the
use of forward-looking terminology such as "estimates", "believes", "expects", "may", "will" "should" "future", "potential" or
similar expressions or by a general discussion of the Company's
strategy, plans or intentions. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors, which
may cause our actual results of operations, financial position,
earnings, achievements, or industry results, to be materially different
from any future results, earnings or achievements expressed or implied
by such forward-looking statements.
Given these uncertainties, prospective
investors and partners are cautioned not to place undue reliance
on such forward-looking statements. We disclaim any obligation
to update any such forward-looking statements to reflect future
events
or developments.
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