Wilex ag - press releases 2007

WILEX receives US FDA approval (IND) for clinical Phase II trial
with its uPA inhibitor WX-671 in metastatic breast cancer
Munich, 28 January 2008 The Munich-based biopharmaceutical company
WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard)
today announced that the U.S. Food and Drug Administration (FDA) approved
an Investigational New Drug application (IND) for a clinical Phase II trial with its
drug candidate WX-671. The study will evaluate the efficacy of WX-671 in
combination with the chemotherapeutic agent capecitabine (Xeloda®, Hoffmann
La Roche AG, Basel, Suisse) in patients with HER2-receptor negative
metastatic breast cancer. The trial is supported under the agreement number
DAMD17-03-1-0634 by the US Department of Defense Breast Cancer Research
Program.
The study will be conducted in 114 patients in approximately 40 centres in sixcountries. The Fox Chase Cancer Center (FCCC) in Philadelphia, a member ofthe Eastern Cooperative Oncology Group (ECOG), will be the lead centre in theUS (the FCCC also participated in the Phase I trial with WX-UK1 reportedrecently). The study is a randomised, double blind Phase II trial in patients withmetastatic breast cancer. It will evaluate the efficacy of combination therapy ofWX-671 and capecitabine in comparison to capecitabine monotherapy. Patientswill receive daily doses of WX-671 for three weeks in one of the two treatmentgroups, while the other treatment group will receive placebo. All patients willreceive daily capecitabine concomitantly for the first 2 weeks of every cycle. Thetreatment cycles will be continued until progression or unacceptable toxicity.
Progression free survival is defined as a primary endpoint of the trial. The studywill also evaluate the overall survival and the objective response rate. The startof patient recruitment is expected in Q2 2008.
WILEX recently published the results of a Phase I clinical trial with WX-UK1, theintravenously administered drug candidate, of which WX-671 is the orallyadministered pro-drug. In this difficult to treat patient population with advancedtumours and no standard efficacious treatment options, combination therapywith WX-UK1 showed encouraging effects in several patients including evidenceof prolonged stable disease and in 3 patients, 2 of whom with metastatic breastcancer showed a partial response. “The effects that we have seen in the Phase I trial have supported our decisionto further develop the combination with our uPA inhibitor and capecitabine”, PaulBevan, PhD, Head of R&D and Member of the Executive Management Board atWILEX AG remarked. “We will switch to the oral pro-drug WX-671, which isconverted into WX-UK1 in the body, because it is more convenient for thepatients getting oral therapy. This will facilitate the long-term treatment ofpatients.” About the uPA programme
WILEX’s late stage multi-product portfolio includes two drug candidates,
WX-UK1 and WX-671, which are being developed as part of the Company’s
urokinase-type Plasminogen Activator programme (“uPA programme”). In this
programme WILEX is developing various compounds that inhibit the uPA
system. The uPA system plays a key role in the growth, spread and metastasis
of various malignant tumours. The Company expects that drug candidates which
emerge from the uPA programme may be used for the treatment of patients with
tumours such as breast, pancreatic, ovarian, gastric and colon cancer.
WILEX successfully completed Phase I studies with WX-UK1 and WX-671. Thecompounds were found to be safe and well tolerated. WX-671 can beadministered orally and is converted into WX-UK1 in the body. This facilitatesthe long-term treatment of patients. Therefore, the Company decided toinvestigate the efficacy of WX-671 in two Phase II trials. In addition to the trialstarting now the Company conducts a Phase II trial in which patients withpancreatic cancer are treated with WX-671 in combination with thechemotherapeutic agent Gemcitabine (Gemzar®, Eli Lilly and Company,Indianapolis, USA). After a positive outcome from these Phase II trials, theCompany intends to test WX-671 in different types of cancer.
About WILEX
WILEX is a biopharmaceutical Company based in Munich founded in 1997 by a
team of physicians and oncologists from the Technical University of Munich.
WILEX is focused on the development of new cancer therapies based on
WILEX is focused on the development of new cancer therapies based onantibodies and small molecules. The therapeutic approach of WILEX targets theprevention of growth, spread and the metastasis of malignant tumours and thedestruction of malignant tumours in the body. The late stage multi-productportfolio includes both drug and medicinal product candidates as well asresearch candidates. Currently the following compounds are in clinicaldevelopment: WX-G250 (development name: RENCAREX®), WX-671,WX-UK1 and CA9-SCAN. The company’s strategy is to develop WILEX into acommercially successful biopharmaceutical company with a broad portfolio ofnew drugs and medical products for the treatment of cancer. WILEX AG hasbeen listed in the Regulated Market / Prime Standard of the Frankfurt StockExchange Contact
Juliane Giese
Manager Public Relations
WILEX AG
Grillparzerstr. 10
81675 Munich
Germany
Tel.: +49 (0)89-41 31 38-29
Fax: +49 (0)89-41 31 38-99
email: investors@wilex.com

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