Corporate | 27 February 2012 07:17

WILEX AG: FDA approves protocol amendment needed to conduct the final analysis of the pivotal RENCAREX(R) Phase III trial

WILEX AG / Key word(s): Miscellaneous

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 ( A djuvant R ENCAREX I mmunotherapy trial to S tudy E fficacy in non-metastasised R enal 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 100 ^th 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@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.

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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@wilex.com
Internet:	www.wilex.com
ISIN:	DE0006614720
WKN:	661472
Listed:	Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart

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