DGAP-News WILEX AG announces start of interim analysis for its Phase III ARISER registration trial with RENCAREX(R)
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DGAP-News: WILEX AG / Key word(s): Research Update
WILEX AG announces start of interim analysis for its Phase III ARISER
registration trial with RENCAREX(R)
24.01.2011 / 07:39
PRESS RELEASE
WILEX announces start of interim analysis for its Phase III ARISER
registration trial with RENCAREX(R)
Munich, Germany, 24 January 2011 - WILEX AG (ISIN DE0006614720 / WL6 /
Frankfurt Stock Exchange) today announced the achievement of a major
clinical milestone. Over 340 recurrences have now been reported to WILEX by
the local sites. Therefore the process for the interim analysis of efficacy
in the Phase III registration trial with the drug candidate RENCAREX(R) in
the indication renal cancer has now been started. The process involves the
central analysis of the data from all 864 patients by independent
radiologists. The interim analysis will be carried out by an Independent
Data Monitoring Committee (IDMC) and should provide definitive information
regarding the endpoint of the trial relevant for approval, namely
´disease-free survival´. The results of the interim analysis of efficacy
are expected to be available in about six months.
The drug candidate RENCAREX(R) is based on the antibody Girentuximab, which
binds to the tumour-specific antigen CA IX - an antigen that is
overexpressed in clear cell renal cell carcinomas. The therapeutic antibody
makes the tumour visible to the endogenous immune system, recruiting
natural killer cells which can destroy any existing cancer cells.
RENCAREX(R) should inhibit the further growth and recurrence of clear cell
renal cell carcinomas - a particularly aggressive type of cancer - and kill
cancer cells, thereby prolonging the disease-free survival of patients.
About the ARISER study
ARISER (Adjuvant RENCAREX Immunotherapy trial to Study Efficacy in
non-metastasised Renal cell carcinoma) is an international, multicentre,
randomised trial that examines the efficacy of the antibody RENCAREX(R) in
comparison to placebo in the treatment of clear cell renal cell cancer
patients following complete or partial surgical removal of the affected
kidney in patients with no detectable metastases. The Phase III ARISER
trial involves 864 patients, who received the study medication in
once-weekly infusions over a period of 24 weeks. The last patient completed
treatment in February 2009. Following the occurrence of the 100th relapse,
the first interim analysis for futility was carried out in late 2007. The
IDMC recommended that the trial be continued because it will probably
deliver a significant result. No drug has been approved to date by the FDA
or EMA for the adjuvant therapy of non-metastatic clear cell renal cell
carcinoma.
About WILEX
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused
on oncology, the company has a broad portfolio of near-to-market
therapeutic and diagnostic products for the targeted treatment and specific
detection of various types of cancer. The company´s therapeutic product
candidates are based on antibodies and small molecules. Through its US
subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a unique portfolio of
oncological biomarkers under the brand Oncogene Science. These biomarkers
can be used as companion diagnostics in clinical trials and for therapy
monitoring. The business model of WILEX covers the entire value chain in
the oncology market and comprises research, technology, development
collaboration as well as sales and marketing. WILEX´s customers and
partners include leading international pharmaceutical companies. Website:
http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6
Contact
WILEX AG
Corporate Communications
Katja Arnold (CIRO)
Grillparzerstr. 10
81675 Munich
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: 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..
End of Corporate News
24.01.2011 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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Media archive at www.dgap-medientreff.de and www.dgap.de
Language: English
Company: 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
109739 24.01.2011
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