Patient recruitment in Phase II breast cancer trial with MESUPRON® successfully completed

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Munich, Germany, 05 May, 2011. WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) announced today that it has successfully completed patient recruitment in the clinical Phase II trial with its oral drug candidate MESUPRON® in first line treatment of patients with HER2-receptor negative1) metastatic breast cancer.

The uPA inhibitor MESUPRON® is given in combination with the chemotherapeutic agent Capecitabine (Xeloda®, Hoffmann La Roche AG, Switzerland). The double blind two arm randomised Phase II trial will evaluate the efficacy and safety of the combination therapy in comparison to capecitabine monotherapy. In the study 132 patients in 20 centres in five countries (Belgium, Brazil, Germany, Israel, US) were enrolled. Progression free survival is defined as the primary endpoint of the trial. The study will also evaluate the objective response rate, the overall survival and safety as well as pharmacokinetics.

Dr. Paul Bevan, Head of R&D and Member of the Executive Management at WILEX AG remarked: “We are pleased that we were able to complete patient recruitment in a competitive indication like breast cancer and we anticipate the data being available during 2012. After the impressive proof of concept data of MESUPRON® in pancreatic cancer, we eagerly await the results for efficacy of our uPA inhibitor in this second indication”.

This trial is supported by the US Department of Defense in their Breast Cancer Research Program.

More information regarding WILEX’ uPA programme
With MESUPRON®, WILEX has developed a drug candidate to inhibit the Urokinase Plasminogen Activator (uPA) system. The uPA system has been shown to play a key role in tumour cell invasion and metastasis, as well as in primary tumour growth, of various solid tumours including breast, ovarian, gastric, colon and pancreatic cancer. The uPA programme of WILEX can be considered as a promising new non-cytotoxic approach in cancer therapy to specifically block tumour metastasis in solid cancers.

In 2007, determining the uPA level in a patient’s primary tumour was incorporated into the treatment guidelines of the American Society of Clinical Oncology (ASCO). The guideline recommends that the uPA test is used in making the prognosis for patients who are newly diagnosed with breast cancer that has not affected lymph nodes in order to determine the appropriate treatment. The uPA level enables doctors to predict the statistical likelihood of a patient’s survival. This was established on the basis of a meta analysis of 18 different European studies on the length of survival in relation to the uPA level in the tumour involving a total of 8,377 patients. The tumour-associated proteolytic factor2) uPA and its inhibitor PAI-1 are the only tumour biological factors which have provided the highest level of evidence (LOE1) in terms of their prognostic and predictive significance.

WILEX has developed the orally available drug candidate MESUPRON®, as a pro-drug of WX-UK1. WX-UK1 and MESUPRON® are the first inhibitors of uPA in clinical oncology trials worldwide. Eight different clinical Phase I, Phase Ia and Ib trials with WX-UK1 and MESUPRON® in several indications with more than 150 patients were successfully conducted. Furthermore, MESUPRON® was tested very effective in a Phase II efficacy trial with 95 pancreatic cancer patients. MESUPRON® was found to be safe and well tolerated and can be administered orally. This facilitates the long-term treatment of patients.

1) Breast tumours that are HER2 receptor negative have a reduced risk of relapse and respond more positively to chemotherapy and anti-hormone therapy than HER2 receptor positive tumours.
2) Proteolytic factor: A factor which helps to degrade the surrounding tissue

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 oncological biomarker tests under the brand Oncogene Science. These biomarkers can be used as companion diagnostics in clinical trials and for therapy monitoring. Furthermore, the acquisition of Heidelberg Pharma AG is set to give 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
E-Mail: 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.

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