WILEX starts clinical phase I trial with PI3K inhibitor WX-037

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Munich, 07 August 2013. WILEX AG (ISIN DE0006614720 / WL6 / FWB) today announced that the first patients were enrolled and dosed in a clinical phase I trial with the PI3K inhibitor WX-037. The open-label, dose-escalation study is being conducted in patients with solid tumours in three study centres in UK.

The purpose of the trial is to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of the PI3K inhibitor as monotherapy as well as in combination with the MEK inhibitor WX-554. In the first part patients with advanced solid tumours, for whom there is no effective standard therapy available, will be given WX-037. In the second part of the trial, patients with a deregulated PI3K pathway will be treated with WX-037 in combination with WX-554. According to the study design treatment cycles of three weeks until toxicity or tumour progression are planned.

More information can be found at www.ClinicalTrials.gov, Identifier: NCT01859351.

About WX-037
The phosphatidylinositol-3-kinase/protein-kinase signalling pathway – PI3K in short – sends a “growth” signal to the nucleus of a tumour cell. It has been shown that abnormal mutations of the PI3K signalling pathway are present in most types of cancer.

The PI3K inhibitor was acquired from UCB for further development in 2009 under the terms of a strategic alliance. Since then several preclinical trials concerning toxicology, pharmacology and pharmacokinetics have been conducted and the process for producing WX-037 in capsule form has been developed.

With the WX-037 project, WILEX AG is participating in the m4 Personalised Medicine and Targeted Therapies initiative of the Munich-based m4 Biotech Cluster, prize winners of the “Leading-Edge Cluster” competition run by the Federal Ministry of Education and Research (BMBF). WILEX receives total funding of up to € 2.6 million from the BMBF for the preclinical and clinical development of the PI3K inhibitor

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. WILEX’s therapeutic product candidates are based on antibodies (RENCAREX® in Phase III) and small molecules (MESUPRON® two Phase IIa trials completed, WX-554 in Phase Ib/II and WX-037 in preclinical development). In the field of diagnostics, REDECTANE® is an antibody-based, imaging diagnostic agent that is currently in a Phase III programme. 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

Katja Arnold (CIRO)
Grillparzerstrasse 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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