Corporate | 13 December 2007 16:34
WILEX AG / Miscellaneous
Release of a Corporate News, transmitted by DGAP - a company of EquityStory
AG.
The issuer / publisher is solely responsible for the content of this announcement.
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PRESS INFORMATION
WILEX announces positive result of the interim analysis for futility of its
Phase III ARISER trial with RENCAREX®
- The Independent Data Monitoring Committee today informed WILEX that the
Phase III interim analysis for futility was positive.
- Therefore, the study will probably deliver a significant result regarding
the study endpoint 'disease free survival', a requirement for approval.
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
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.
13.12.2007 Financial News transmitted by DGAP
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Language: English
Issuer: WILEX AG
Grillparzerstr. 10
81675 München
Deutschland
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info@wilex.com
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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