DGAP-News: WILEX AG: FDA approves protocol amendment needed to conduct the final analysis of the pivotal RENCAREX(R) Phase III trial
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Miscellaneous
WILEX AG: FDA approves protocol amendment needed to conduct the final
analysis of the pivotal RENCAREX(R) Phase III trial
27.02.2012 / 07:17
---------------------------------------------------------------------
PRESS RELEASE
FDA approves protocol amendment needed to conduct the final analysis of the
pivotal RENCAREX(R) Phase III trial
Munich, Germany, 27 February 2012. WILEX AG (ISIN DE0006614720 / WL6 / FSE)
today announced that the US Food and Drug Administration (FDA) approved the
protocol amendment for the pivotal Phase III ARISER trial with RENCAREX(R)
needed to cancel the interim analysis and perform the final analysis of
disease free survival (DFS). Final DFS analysis and results are expected in
Q4 2012; the study will continue as planned in order to assess overall
survival
As announced in November 2011 the ARISER Independent Data Monitoring
Committee had recommended cancelling the interim DFS analysis and
performing the final DFS analysis instead. This recommendation was
consistent with advice from the FDA and European regulatory authorities.
About RENCAREX(R) and the ARISER study
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 (ccRCC). The therapeutic
antibody makes the tumour visible to the endogenous immune system and binds
natural killer cells, which can destroy existing cancer cells. RENCAREX(R)
should inhibit the further growth and recurrence of ccRCC - a particularly
aggressive type of cancer - and kill cancer cells, thereby prolonging the
disease-free survival of patients.
ARISER (Adjuvant RENCAREX Immunotherapy trial to Study Efficacy in
non-metastasised Renal cell carcinoma) is an international, multicentre,
randomised Phase III 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 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, an 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.
WILEX has granted commercialisation rights for RENCAREX(R) for certain
countries of Southern Europe to the Spanish pharmaceutical company Esteve
and US commercialisation rights to the US-based company Prometheus.
About WILEX AG
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 portfolio of
research use only and in vitro diagnostic tests under the brand Oncogene
Science(R). These diagnostic tests could be developed as companion
diagnostics in clinical trials and for therapy monitoring.The wholly owned
subsidiary Heidelberg Pharma GmbH gives WILEX access to an attractive and
highly promising antibody drug conjugate technology platform and a
pre-clinical service business. 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
Katja Arnold (CIRO)
Corporate Communications
WILEX AG
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: investors(at)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
---------------------------------------------------------------------
27.02.2012 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
Language: English
Company: WILEX AG
Grillparzerstr. 10
81675 München
Germany
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info(at)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
---------------------------------------------------------------------
158041 27.02.2012
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 27.02.2012 - 07:17 Uhr
Sprache: Deutsch
News-ID 118528
Anzahl Zeichen: 10369
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 341 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: WILEX AG: FDA approves protocol amendment needed to conduct the final analysis of the pivotal RENCAREX(R) Phase III trial"
steht unter der journalistisch-redaktionellen Verantwortung von
WILEX AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
