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2008
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WILEX
announces positive result of the interim analysis for futility of its
Phase III ARISER trial with RENCAREX®
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The Independent Data
Monitoring Committee today informed WILEX that the Phase III
interim analysis for futility was positive.
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Therefore, the study will probably
deliver a significant result regarding the study endpoint “disease free
survival“, a requirement for approval.
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Munich, 13 December 2007. The Munich-based
biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock
Exchange / Prime Standard) announced that the Independent Data Monitoring
Committee (IDMC) recommended on the basis of the interim analysis for
futility for the Phase III ARISER trial to continue the study as planned.
The analysis, which was performed after 100 patients relapsed, showed
that the trial will probably deliver a significant result. Moreover
the safety and tolerance of RENCAREX® had
again been confirmed in a safety review by the IDMC in October 2007.
The IDMC evaluated the data with respect to the time between randomisation
and relapse of 100 patients in comparision to time between randomisation and
last computer tomography of all other patients randomised in the study at the
time of analysis and which had not relapsed. No-one outside the independent
Committee has had access to the data.
Dr. Paul Bevan, Head of Research and Development and member of the executive
management board of WILEX, commented: “The positive result of the interim
analysis for futility further supports our assumptions of the positive progress
of the ARISER trial. Therefore, as well as continuing clinical development
we will now accelerate the commercialisation of the product. “
Invitation to a conference call:
WILEX will hold a public conference call on 18
December 2007 at 15:00 CET.
Dial-in number for the Conference Call (listen-only):
Germany: +49 (0) 69 – 25 499 300
UK: +44 (0) 207 – 108 6206
Please dial in 10 minutes before the beginning of the
conference.
About the ARISER study
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 destroy cancer cells and thereby prolong
the disease-free survival of patients.
About the IDMC
The Independent Data Monitoring Committee (IDMC)
consists of independent oncologists, urologists and a statistician
and has the responsibility to check the data of the ARISER trial at
regular intervals and recommends to WILEX, to modify, to discontinue
or to continue the trial as planned. The members of the IDMC do not
participate in the trial.
About WILEX
WILEX is a biopharmaceutical Company based in
Munich 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 late stage multi-product portfolio includes
both drug and medicinal product candidates as well as research candidates.
Currently the following compounds are in clinical development: WX-G250
(development name: RENCAREX®),
WX-671, WX-UK1 and CA9-SCAN. 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. WILEX AG has been listed in the Official Market Segment
(Amtlicher Markt) / Prime Standard of the Frankfurt Stock Exchange
ISIN DE0006614720 / WKN 661472 / 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: http://www.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 general discussion of strategy, plans or intentions
of the Company. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors, which may cause our actual results
of operations, financial condition, performance, or achievements, or
industry results, to be materially different from any future results,
performance 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.
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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