WILEX starts first patient study with MEK inhibitor WX-554

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Munich, 11 April 2012. WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) announces today the start of a Phase Ib/II trial with the small-molecule MEK inhibitor WX-554. The open-label, dose-escalation study will investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of WX-554 in patients with solid tumours.

After a dose escalation part to confirm the biologically effective dose, a dose expansion part will follow, enriched for patients with MEK pathway relevant mutations, to investigate initial clinical activity.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved this Phase Ib/II trial with WX-554 in January 2012. The study is being conducted within the Experimental Cancer Medicine Centre (ECMC) network in the UK which is jointly supported by Cancer Research UK and the Departments of Health for England, Scotland, Wales and Northern Ireland. The goal of the ECMC Network initiative and the 19 involved cancer centres across the UK is to drive the development of new therapies to bring benefits to patients faster.

About WX-554
The small-molecule MEK inhibitor is one of five oncology preclinical programmes obtained under the strategic alliance agreed with UCB Pharma S.A. in January 2009 and is being clinically developed by WILEX. Mitogen activated protein kinase (MEK) has been shown to play a central role in signal transduction. The MEK signalling pathway is over expressed in more than 30% of cancers, resulting in uncontrolled cell growth and proliferation. The first two Phase I trials were successfully completed in 2010 and 2012. These healthy volunteer studies showed that both, intravenously and orally administered WX-554 were safe and well tolerated.

WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the company has a broad portfolio of diagnostic and therapeutic products for the specific detection and targeted treatment of various types of cancer. The company’s therapeutic product candidates are based on antibodies (RENCAREX® in Ph III) and small molecules (MESUPRON® in Ph II, WX-554 in Ph Ib/II and WX-037 early stage). In the diagnostic segment WILEX has REDECTANE®, an antibody based in vivo diagnostic imaging agent in a Phase III-programme. The 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. These diagnostic tests could be developed as companion diagnostics in clinical trials and for therapy monitoring. The subsidiary Heidelberg Pharma GmbH offers an attractive and highly promising antibody drug conjugate technology platform and a pre-clinical service business. The business model of WILEX comprises research, technology, product development 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 Press
Corporate Communications
Katja Arnold (CIRO)
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
E-Mail: 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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