Earnings Release • Oct 16, 2012
Earnings Release
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Ad-hoc | 16 October 2012 16:48
WILEX AG announces results of Phase III ARISER study with RENCAREX(R) in clear cell renal cell carcinoma
WILEX AG / Key word(s): Research Update
16.10.2012 16:48
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
Ad hoc release pursuant to § 15 Wertpapierhandelsgesetz
(German Securities Trading Act)
WILEX AG announces results of Phase III ARISER study with RENCAREX(R) in
clear cell renal cell carcinoma
Munich, Germany, 16 October 2012 - WILEX AG (ISIN DE0006614720 / WL6 / FSE)
today announced results of the Phase III ARISER trial with RENCAREX(R),
(INN: Girentuximab) to treat clear cell renal cell carcinoma (ccRCC). The
trial did not meet its primary endpoint. The analysis showed no improvement
in median DFS (approximately 72 months) following RENCAREX(R) treatment
compared with placebo. RENCAREX(R) was safe and well tolerated. The
Independent Data Monitoring Committee (IDMC) has recommended terminating
the Phase III ARISER trial.
Information and Explaination of the Issuer to this News:
Invitation to the conference call:
On 17 October 2012, WILEX will hold a public conference call for media,
analysts and investors at 3:00 p.m. CET in English. Please dial in ten
minutes before the conference call using the following dial-in numbers:
You will be welcomed by an operator taking your name and company. The
presentation slides for the conference will be available for download at
www.wilex.de on 17 October 2012 at 2:00 p.m. CET.
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 CAIX - an antigen that is
overexpressed in clear cell renal cell carcinomas (ccRCC).
ARISER (Adjuvant RENCAREX(R) 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 but at high risk
of recurrence. The study enrolled 864 patients that had had prior
nephrectomy of primary RCC no later than 12 weeks before study entry with
documented clear cell histology, an ECOG score of 0 or 1 and no evidence of
macroscopic or microscopic residual disease. Under the treatment schedule
patients received a once-weekly infusion of RENCAREX(R) or placebo (50:50)
for 24 weeks. Patients receiving RENCAREX(R) were dosed at 50 mg in the
first week followed by weekly doses of 20 mg during weeks 2-24.
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. In November, 2011 the IDMC recommended to cancel
an intended interim analysis and progress directly to the final Phase III
trial analysis.
RENCAREX(R) has Fast Track designation for ccRCC in the USA and Orphan Drug
designation for RCC in the USA and EU. WILEX has partnered RENCAREX(R) with
Prometheus Laboratories Inc, which has exclusive rights to commercialise
the treatment in the USA, and Laboratories Esteve S.A. in certain European
countries.
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. WILEX's US
subsidiary WILEX Inc. in Cambridge, MA, markets a portfolio of research use
only tests and in vitro diagnostic agents under the brand Oncogene Science.
The subsidiary Heidelberg Pharma GmbH offers an attractive and highly
promising antibody drug conjugate technology platform and preclinical
contract research services. The business model of WILEX comprises research,
technology, product development and commercialisation. 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: [email protected]
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.
16.10.2012 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: [email protected]
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart
End of Announcement DGAP News-Service
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