Patient recruitment started in clinical Phase II trial with WX-671 in pancreatic cancer

WILEX AG has randomized the first patient in its clinical Phase II pancreatic cancer trial with the oral drug candidate WX-671 in combination with the chemotherapeutic agent Gemcitabine

MUNICH, Germany | June 26, 2007 |
The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) has randomized the first patient in its clinical Phase II pancreatic cancer trial with the oral drug candidate WX-671 in combination with the chemotherapeutic agent Gemcitabine (Gemzar®, Eli Lilly and Company, Indianapolis, USA).

The study with 90 patients is being conducted in six countries. WILEX AG had previously published details of the study design, having received the clinical trial authorisation from the German authorities. This information, the participating centres and the inclusion criteria will be available for review on the company’s website or First data from the trial is expected to be released in H1 2008.

Dr. Paul Bevan, Head of R&D and Member of the Executive Management at WILEX AG remarked: “We have commenced patient recruitment within the planned time line und expect the trial to progress as scheduled. WX-671 is the first substance of its kind worldwide to go into a clinical Phase II trial. This is a major milestone in the development of anti-metastatic uPA-inhibitors.”

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. The compounds were found to be safe and well tolerated. WX-671 can be administered orally and is converted into WX-UK1 in the body. This facilitates the long-term treatment of patients. Therefore, the Company decided to investigate the efficacy of WX-671 in two Phase II trials. In addition to the trial starting now the Company intends to conduct a Phase II trial in which patients with metastatic breast cancer are to be treated with WX-671 in combination with the chemotherapeutic agent Capecitabine (Xeloda®, Hoffmann La Roche AG, Basle, Switzerland). The Company intends to file for approval of this trial in 2007. After a positive outcome from these Phase II trials, the Company intends to test WX-671 in different types of cancer.

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 antibodies and small molecules. The therapeutic approach of WILEX targets the prevention of growth, spread and the metastasis of malignant tumours and the destruction of malignant tumours in the body. The late stage multi-product portfolio includes both drug and medical product candidates ranging from research to late stage clinical development. Currently the following compounds are in clinical development: WX-G250 (development name: RENCAREX®), WX-671, WX-UK1 and CA9-SCAN. The company’s strategy is to develop WILEX into a commercially successful biopharmaceutical company with a broad portfolio of new drugs and medical products for the treatment of cancer. WILEX AG is listed at the Frankfurt Stock Exchange on the Official Market Segment (Amtlicher Markt) / Prime Standard since November 13, 2006.


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