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WILEX
gives positive update of current pivotal Phase III trial of RENCAREX®
 |
Over
420 patients enrolled in the Phase III trial |
 |
Milestone
payment from Esteve received |
 |
Publication
of the results of the "futility analysis" expected for H2 / 2007 |
 |
Results
expected in H2 / 2008 |
Munich, April 3, 2007 - The Munich-based biopharmaceutical
company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime
Standard) announced today that, in its pivotal Phase III study of RENCAREX® (the
data of which are required for European and US filing for approval) over
420 of 856 patients planned have been enrolled. The international, multicentre,
randomised trial, called ARISER (Adjuvant RENCAREX Immunotherapy trial
to Study Efficacy in non-metastasized Renal cell carcinoma), examines
the efficacy of the antibody RENCAREX® in comparison to placebo for 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. RENCAREX® aims to inhibit these malignant kidney tumours
from further growth and recurrence and to help to kill cancer cells and
thereby prolong the disease-free survival of patients.
Dr. Paul Bevan, Head of Research and Development and member of the executive
management board of WILEX, commented: "Patient recruitment is outstanding with
the numbers increasing quarter on quarter. Furthermore, the drop-out rate,
at roughly 3%, is very low and suggests that the treatment regimen of weekly
injections is well tolerated. We are on track and can expect the results of
the trial in the second half of 2008".
The next important milestone of the ARISER study is the so-called "futility
analysis" as per the statistical analysis plan. An Independent Data Monitoring
Committee will analyse the data after 100 patients have relapsed. This is expected
in H2 2007. No-one outside the Committee will have access to the data. The
Committee will inform WILEX of the outcome and its expectation as to whether
the study is likely to deliver the result expected.
WILEX expects results of the study for European filing in the second half of
2008. The FDA requires a higher statistical significance which demands higher
number of relapses and, therefore, filing for approval at the FDA is planned
for 2009.
About WILEX
WILEX is a biopharmaceutical Company based in Munich,
which was founded in 1997 by a team of physicians and oncologists from
the Technical University of Munich. WILEX is focused on the development
of new cancer therapies based on antibodies and small molecules. The
therapeutic approach of WILEX targets the prevention of growth, spread
and the metastasis of malignant tumours and the destruction of malignant
tumours in the body. The portfolio includes both drug and medical product
candidates ranging from research to late stage clinical development.
Currently the following compounds are in clinical development: WX-G250
(development name: RENCAREX®), WX-671, WX-UK1 and CA9-SCAN.
WILEX has a license agreement with the Spanish pharmaceutical Company Laboratorios
del Dr. Esteve S.A. Barcelona (Spain) for the marketing of RENCAREX® in particular
countries in Southern Europe. Pursuant to the agreement, the Company has a
claim for payments upon attainment of particular development milestones.
The company's strategy is to develop WILEX into a commercially successful biopharmaceutical
company with a broad portfolio of new drugs and medical products for the treatment
of cancer. Since November 13, 2006 WILEX AG is listed at the Frankfurt Stock
Exchange on the Official Market Segment (Amtlicher Markt) / Prime Standard.
ISIN DE0006614720 / WKN 661472 / Stock market symbol WL6
Contact
Juliane Giese
Manager Public Relations
WILEX AG
Grillparzerstr. 10
81675 Munich
Germany
Tel.: +49 (0)89-41 31 38-29
Fax: +49 (0)89-41 31 38-99
Email: investors@wilex.com
Website: www.wilex.com
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