DGAP-News: WILEX AG: ARISER Independent Data Monitoring Committee (IDMC) recommends conducting the final analysis of the pivotal Phase III trial with RENCAREX(R)
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Research Update
WILEX AG: ARISER Independent Data Monitoring Committee (IDMC)
recommends conducting the final analysis of the pivotal Phase III
trial with RENCAREX(R)
21.11.2011 / 19:23
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WILEX AG: ARISER Independent Data Monitoring Committee (IDMC) recommends
conducting the final analysis of the pivotal Phase III trial with
RENCAREX(R)
- Review of study status led the IDMC to recommend proceeding to the
final analysis for disease-free survival (DFS) now
- Recommendation supported by regulatory authorities and Medical Advisory
Board
- Full study results may be expected in Q4 2012
Munich, Germany, 21 November 2011. WILEX AG (ISIN DE0006614720 / WL6 /
Frankfurt Stock Exchange) today announced that the IDMC has recommended
cancelling the interim analysis and performing the final DFS analysis of
the Phase III ARISER trial with RENCAREX(R) in clear cell renal cell
carcinoma (ccRCC) now. This decision follows discussions with the Medical
Advisory Board, the Food and Drug Administration (FDA) in the USA and the
Swedish regulatory authority as well as WILEX's EU and US commercialisation
partners Esteve, S.A., Barcelona, and Prometheus Laboratories Inc., San
Diego, CA, USA.
Over the last year the recurrence rate has further declined leading the
advisors to conclude that the trial has matured such that the final
analysis can be conducted now instead of after 512 events as originally
planned. WILEX therefore plans to complete the final analysis immediately
following the necessary approvals from the regulatory authorities. In the
meantime the trial remains blinded.
Professor Seppo Pyrhönen, Chairman of the ARISER IDMC and Professor in
Oncology at Turku University Hospital in Turku, Finland, Department of
Oncology and Radiotherapy, commented: 'This strategy has the advantage of
eliminating the statistical penalty intrinsically associated with the
interim efficacy analysis and therefore increases the possibility of a
positive outcome.'
The process of formal protocol amendment will start immediately. Upon
approval by the regulatory authorities the final analysis will take place
and full results may be expected in Q4 2012.
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. 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 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.
Invitation to the conference call
WILEX will hold a conference call for media, analysts and investors on 22
November 2011 at 10:00 a.m. CET in German and at 4:00 p.m. CET in English.
Please dial in ten minutes before the conference call using the following
dial-in numbers:
1. Germany: +49 69 71044 5598
2. UK: +44 20 3003 2666
3. USA: +1 212 999 6659
4. USA Freephone: +1 866 966 5335
You will be welcomed by an operator taking your name and company. The
presentation for the conference will be available for download at
www.wilex.de at 9:00 a.m. CET on 22 November 2011. A replay of the
conference will be available from 23 November on the website
http://www.wilex.de/press-investors/presentations/
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 AG 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
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Language: EnglishCompany: 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
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