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WILEX announced today that it has successfully completed patient recruitment in the clinical Phase II trial with its oral drug candidate MESUPRON(R) (WX-671) in combination with the chemotherapeutic agent Gemcitabine (Gemzar(R), Eli Lilly and Company, USA) in pancreatic cancer patients
Munich, Germany | July 24, 2008 | Munich-based biopharmaceutical company 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(R) (WX-671) in combination with the chemotherapeutic agent Gemcitabine (Gemzar(R), Eli Lilly and Company, USA) in pancreatic cancer patients.
The trial is a randomised, open label three-arm Phase II-trial in patients with locally advanced, inoperable, non-metastatic pancreatic cancer and evaluates the anti-metastatic activity of the combination therapy. Patients will continue to be treated to follow several parameters, including progression free survival and time to first metastases. The study is conducted in more than 30 centres with 90 patients in six European countries
Dr. Paul Bevan, Head of R&D and Member of the Executive Management at WILEX AG remarked: “Patient recruitment proceeded according to plan. We will further monitor this study closely and we expect to have first preliminary results about the efficacy of our uPA inhibitor available in 2008”.
More information regarding WILEX’ uPA programme
WILEX has a late stage multi-product portfolio. In this portfolio MESUPRON(R) (WX-671) is being developed as part of the Company’s urokinase-type Plasminogen Activator programme (“uPA programme”).
The aim of MESUPRON(R) is to inhibit the uPA system, which plays a key role in the growth, spread and metastasis of various malignant tumours. In 2007, determining the uPA content 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 content 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 content in the tumour involving a total of 8,377 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.
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 MESUPRON(R). The compound was found to be safe and well tolerated. MESUPRON(R) can be administered orally. This facilitates the long-term treatment of patients. Therefore, the Company decided to investigate the efficacy of MESUPRON(R) in two Phase II trials. In addition to the pancreatic cancer trial the Company conducts a Phase II trial in which patients with breast cancer are treated with MESUPRON(R) in combination with the chemotherapeutic agent Capecitabine (Xeloda(R), Hoffmann La Roche AG, Suisse). After a positive outcome from these Phase II trials, the Company intends to test MESUPRON(R) in different types of cancer.
About WILEX
WILEX 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 and diagnostic agents with a low side effect profile and targeted treatment of different types of cancer as well as for early 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 substances RENCAREX(R) and REDECTANE(R) are currently undergoing a Phase III registration trial. The substance MESUPRON(R) is currently in a Phase II programme. Based on this pipeline, WILEX's aim is to achieve profitability within a few years through the consistent commercialisation of its products and in the long term to finance its research and development programmes from its operating business.
SOURCE: WILEX AG |
