Rencarex
From Kidney Cancer Resource
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Overview
Anti cancer drug produced by Wilex AG WX-G250 (development name: RENCAREX®)
Articles
18-Dec-2007 - Wilex Updates the Status of the Rencarex Phase III-Ariser Study...
Wilex Updates the Status of the Rencarex Phase III-Ariser Study Following the Positive Interim Analysis for Futility
Over 760 patients enrolled in the study so far; drop out rate of approximately 3.9 % remains low
Patient recruitment in Europe should be successfully completed within the next 6 weeks
Next milestone is the interim analysis for efficacy after 343 relapses which is anticipated early 2009
The Munich-based biopharmaceutical company Wilex AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) announces updated details of the Phase III ARISER study with its drug candidate RENCAREX® after the positive interim analysis for futility. RENCAREX® is being developed for the adjuvant therapy of clear cell renal cell cancer, an indication for which there is currently no drug approved. So far over 760 of the 856 patients planned have been enrolled. The drop out rate at 3.9 % remains low. This again suggests that the treatment regimen of weekly injections is acceptable and well tolerated. The recruitment in Europe should be completed within the next six weeks. Recruitment in North America will continue for a few months to maintain the proportion of US patients planned.
To date a lower number of patients have relapsed than projected. After the positive interim analysis for futility a new estimate was calculated as to when the 343 relapses required for the next milestone would be reached. Currently, this is expected early in 2009. The study protocol specifies an interim analysis for efficacy of the antibody at this point which would be the basis for filing for approval in the European Union. This interim analysis will evaluate whether RENCAREX® shows a significant superiority over placebo in disease-free survival time. WILEX will continue to carefully monitor the relapse rate.
Dr. Paul Bevan, Head of Research and Development and member of the executive management board of WILEX, commented: "We are very pleased with the progress of the Phase III RENCAREX® trial with patient recruitment in Europe expected to be completed soon. The endpoints of the study are dependent on patients' relapse which we will continue to monitor carefully".
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
Website: http://www.wilex.com
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. The study is designed to detect a 35% improvement of disease-free survival time in patients treated with RENCAREX® compared to patients treated with placebo with a statistical significance of 1%.
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