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15 December, 2006 Munich (Germany)– The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today received the clinical trial authorisation (CTA) from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) for a clinical Phase II trial with its drug candidate WX-671 in combination with the chemotherapeutic agent Gemcitabine (Gemzar®, Eli Lilly and Company, Indianapolis, USA) in pancreatic cancer patients. WILEX plans to conduct the study in approximately 30 centres with 90 patients in several European countries. The trial is a randomised, open label Phase II-trial in patients with locally advanced, inoperable, non-metastatic pancreatic cancer. Patients are to be treated with oral WX-671 once-a-day in combination with the standard treatment of Gemcitabine (intravenous once weekly). This three-arm trial is designed to assess the anti-metastatic activity of the combination therapy and will follow several parameters, including progression free survival and time to first metastases. Patient recruitment is expected to start in Q2 2007 with the first data expected to be available in H1 2008. Dr. Paul Bevan, Head of R&D at WILEX AG pointed out: “WX-671 was found to be a safe and well tolerated drug in various successful Phase I trials. The start of the first Phase II trial with our drug candidate WX-671 is a major milestone in the development of our anti-metastatic uPA-inhibitors.” WX-671 is an oral serine protease inhibitor targeting the Urokinase Plasminogen Activator system (uPA system) which has been shown to play a key role in metastasis and primary tumour growth of breast cancer and various other solid tumours. About the uPA programme Two drug candidates, WX-UK1 and WX-671, 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. About WILEX WILEX is a biopharmaceutical Company based in Munich, which was 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 malig-nant tumours in the body. The portfolio includes both drug and medical product candi-dates 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 de-velop WILEX into a commercially successful biopharmaceutical company with a broad portfolio of new drugs and medical products for the treatment of cancer. Since No-vember 13, 2006 WILEX AG is listed at the Frankfurt Stock Exchange on the Official Market Segment (Amtlicher Markt) / Prime Standard.
ISIN DE0006614720 Contact Juliane Giese | |
| © 2006 WILEX AG all rights reserved |
2007/2008
WILEX receives approval for clinical Phase II trial with oral WX-671 in pancreatic cancer