The Independent Data Monitoring Committee today informed WILEX that the Phase III interim analysis for futility was positive
MUNICH, Germany | December 13, 2007 | The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) announced that the Independent Data Monitoring Committee (IDMC) recommended on the basis of the interim analysis for futility for the Phase III ARISER trial to continue the study as planned. The analysis, which was performed after 100 patients relapsed, showed that the trial will probably deliver a significant result. Moreover the safety and tolerance of RENCAREX® had again been confirmed in a safety review by the IDMC in October 2007.
The IDMC evaluated the data with respect to the time between randomisation and relapse of 100 patients in comparision to time between randomisation and last computer tomography of all other patients randomised in the study at the time of analysis and which had not relapsed. No-one outside the independent Committee has had access to the data.
Dr. Paul Bevan, Head of Research and Development and member of the executive management board of WILEX, commented: “The positive result of the interim analysis for futility further supports our assumptions of the positive progress of the ARISER trial. Therefore, as well as continuing clinical development we will now accelerate the commercialisation of the product. “
About the ARISER study
The international, multicentre, randomised trial, called ARISER (Adjuvant Rencarex Immunotherapy trial to Study Efficacy in non-metastasized Renal cell carcinoma), examines the efficacy of the antibody RENCAREX® in comparison to placebo for the treatment of clear cell renal cell cancer patients after complete or partial surgical removal of the affected kidney in patients with no detectable metastases. This cancer belongs to one of the particularly aggressive indications. RENCAREX® aims to inhibit these malignant kidney tumours from further growth and recurrence and to help to destroy cancer cells and thereby prolong the disease-free survival of patients.
About the IDMC
The Independent Data Monitoring Committee (IDMC) consists of independent oncologists, urologists and a statistician and has the responsibility to check the data of the ARISER trial at regular intervals and recommends to WILEX, to modify, to discontinue or to continue the trial as planned. The members of the IDMC do not participate in the trial.
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 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 medicinal product candidates as well as research candidates. 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 has been listed in the Official Market Segment (Amtlicher Markt) / Prime Standard of the Frankfurt Stock Exchange
SOURCE: WILEX AG
