WILEX AG: Final Phase II data of Mesupron confirm impressive increase in overall survival of patients with pancreatic cancer

Munich, Germany, 3 May 2010. The biopharmaceutical company WILEX AG (ISIN DE0006614720 /Frankfurt Stock Exchange/Prime Standard) today announced that the clinical Phase II combination trial with the oral drug candidate MESUPRON® in pancreatic cancer patients has been completed successfully. Final analysis confirms preliminary data published in September 2009, for example with regard to improvement in tumour response and increase in overall survival.

The results will be published at the annual meeting of the American Society of Clinical Oncology (ASCO), which will take place from June 4 to 8, 2010 in Chicago, USA. ASCO is the most important worldwide clinical conference for oncology experts.

Prof Volker Heinemann, Medical Centre Grosshadern, University Munich, and Principal Investigator, said: “The results regarding tumour response and overall survival are impressive and signify important progress in the treatment of cancer patients with a urgently needed, innovative and well tolerated therapeutic approach. Doctors and patients eagerly await further developments with MESUPRON®.”

Information regarding MESUPRON® and the uPA programme

The aim of MESUPRON® is to inhibit the Urokinase Plasminogen Activator enzyme system (uPA), which plays a key role in the growth and spread of various malignant tumours. 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 content in the tumour involving a total of more than 8,300 patients. The tumour-associated proteolytic factor 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.


MESUPRON® is the first uPA inhibitor worldwide in clinical development and which has shown positive activity in cancer patients in a Phase II trial. MESUPRON® could have the potential to treat cancer like a chronic disease in a long-term therapy with low side effects.


Information on the trial

In the completed Phase II trial, patients with locally advanced, inoperable, non-metastatic pancreatic cancer were treated with MESUPRON® together with the chemotherapeutic Gemcitabine (Gemzar®, Eli Lilly and Company, USA). The study is a randomised, open label, three-arm trial. Patients were administered either Gemcitabine alone or in combination with a daily oral dose of 200 mg or 400 mg MESUPRON® respectively until progression. As previously demonstrated in the eight completed Phase I trials, MESUPRON® proved to be safe and well tolerated.


In addition to the pancreatic cancer trial the Company is conducting a Phase II trial in which HER2 receptor negative breast cancer patients are treated with MESUPRON® in combination with the chemotherapeutic agent Capecitabine (Xeloda®, Hoffmann La Roche AG, Switzerland).


About WILEX AG WILEX AG is a biopharmaceutical company based in Munich and is listed at the Frankfurt Stock Exchange at the Regulated Market / Prime Standard. WILEX’s mission is to develop drugs with a low side effect profile and targeted treatment of different types of cancer as well as diagnostic agents for specific detection of tumours. The Company's product candidates are based on antibodies and small molecules. WILEX has an attractive product pipeline which includes both drug and diagnostic candidates: The candidates REDECTANE® and RENCAREX® are undergoing Phase III registration trials. MESUPRON® is in Phase II trials in two indications. The MEK inhibitor WX-554 is in a Phase I trial, and the other four oncology projects (PI3K inhibitor WX-037 and three antibody programmes) are in preclinical development. WILEX aims within a few years to be able to finance its research and development programmes from its operating cash flow. Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6

Kind regards,

WILEX AG Katja Arnold (CIRO) Senior Manager Corporate Communications Grillparzerstr. 10 81675 Munich Germany Tel.: +49 89 41 31 38-126 Fax: +49 89 41 31 38-99 Mobile: +49 160 936 030 22 Email: katja.arnold@wilex.comkatja.arnold@wilex.com> Website: http://www.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.

WILEX AG | Grillparzerstrasse 10, 81675 München, Deutschland, Tel. +49 (0) 89 413138-0, Fax +49 (0) 89 413138-99, info@wilex.cominfo@wilex.com>, www.wilex.com | Vorstand: Prof. Dr. Olaf G. Wilhelm (Vorsitzender), Dr. Paul Bevan, Peter Llewellyn-Davies, Dr. Thomas Borcholte | Vorsitzender des Aufsichtsrates: Dr. David R. Ebsworth | Sitz der Aktiengesellschaft: München, Amtsgericht München, HRB 136670 | HypoVereinsbank München, BLZ 700 202 70, Kto. 5800225304 | Deutsche Bank München, BLZ 700 700 10, Kto. 1616150.
 

Posted: May 2010

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