Phase III ARISER Study with Rencarex: Patient Recruitment Successfully Completed
MUNICH, Germany, July 3,2008- Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today announced that it has successfully completed patient recruitment in the Phase III ARISER trial with its drug candidate Rencarex®. The international double-blind trial is testing RENCAREX® for use as adjuvant therapy of clear cell renal cell carcinoma. The trial is being carried out in more than 150 centres in North and South America as well as Europe. The trial examines whether RENCAREX® could prolong disease free survival and overall survival in comparison to placebo. A total of 856 patients are taking part in the trial, of which 583 were recruited in Europe and 273 in North and South America. 203 patients were enrolled in the study centres in the US, which represents 24% of the total. Patients who are at present still undergoing the pre-enrolment screening process will also be able to participate in the trial if they meet the inclusion criteria. This means that the final number of patients in the trial may still increase. The drop out rate at currently 4.2% remains low. This again suggests that the treatment is well tolerated and the regimen of weekly injections acceptable.
We reported on the positive outcome of the interim analysis for futility in December 2007. The next milestone in the trial will be when 343 relapses have occurred.
Dr. Paul Bevan, Head of Research and Development and Member of the Executive Management Board at WILEX, said: "The number of relapses we have recorded currently stands at over 180. This is within the timeframe projected last December. We therefore believe that we will reach the next milestone early in 2009. WILEX will continue to closely monitor the relapse rate."
When this next milestone is reached, the study protocol specifies that all patient data will be analysed centrally to enable the Independent Data Monitoring Committee to carry out an interim analysis for efficacy of RENCAREX®. This interim analysis will evaluate whether RENCAREX® is significantly superior to placebo with regard to disease-free survival. The data will remain blinded to WILEX. If the result is positive, the analysis may provide the basis for filing for approval in Europe.
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About the ARISER study
The international, multicentre, randomised trial called ARISER (Adjuvant RENCAREX Immunotherapy trial to Study Efficacy in non-metastasised Renal cell carcinoma) examines the efficacy of the antibody RENCAREX® in comparison to placebo in 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, for which no FDA or EMEA approved drug exists today. RENCAREX® aims to inhibit these malignant kidney tumours from further growth and recurrence and to help destroy cancer cells and thereby prolong the disease-free survival of patients. Patients are given weekly injections of RENCAREX® for a period of six months.
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® and REDECTANE® are currently undergoing a Phase III registration trial. The substance WX-671 (developed under the name MESUPRON®) 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.
WILEX AG | Grillparzerstraße 10, 81675 München, Deutschland, Tel. +49 (0) 89 413138-0, Fax +49 (0) 89 413138-99, firstname.lastname@example.org, www.wilex.com <http://www.wilex.com/> | Vorstand: Prof. Dr. Olaf G. Wilhelm (Vorsitzender), Dr. Paul Bevan, Dr. Thomas Borcholte, Peter Llewellyn-Davies | Vorsitzender des Aufsichtsrates: Dr. David R. Ebsworth | Sitz der Aktiengesellschaft: München, Amtsgericht München, HRB 136670 | HypoVereinsbank München, BLZ 700 202 70, Kto. 5800225304 | Deutsche Bank München, BLZ 700 700 10, Kto. 1616150
Posted: July 2008