WILEX AG: ARISER Independent Data Monitoring Committee (IDMC) recommends conducting the final analysis of the pivotal Phase III trial with RENCAREX®
- Review of study status led the IDMC to recommend proceeding to the final analysis for disease-free survival (DFS) now
- Recommendation supported by regulatory authorities and Medical Advisory Board
- Full study results may be expected in Q4 2012
Munich, Germany, 21 November 2011. WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) today announced that the IDMC has recommended cancelling the interim analysis and performing the final DFS analysis of the Phase III ARISER trial with RENCAREX® in clear cell renal cell carcinoma (ccRCC) now. This decision follows discussions with the Medical Advisory Board, the Food and Drug Administration (FDA) in the USA and the Swedish regulatory authority as well as WILEX’s EU and US commercialisation partners Esteve, S.A., Barcelona, and Prometheus Laboratories Inc., San Diego, CA, USA.
Over the last year the recurrence rate has further declined leading the advisors to conclude that the trial has matured such that the final analysis can be conducted now instead of after 512 events as originally planned. WILEX therefore plans to complete the final analysis immediately following the necessary approvals from the regulatory authorities. In the meantime the trial remains blinded.
Professor Seppo Pyrhönen, Chairman of the ARISER IDMC and Professor in Oncology at Turku University Hospital in Turku, Finland, Department of Oncology and Radiotherapy, commented: “This strategy has the advantage of eliminating the statistical penalty intrinsically associated with the interim efficacy analysis and therefore increases the possibility of a positive outcome.”
The process of formal protocol amendment will start immediately. Upon approval by the regulatory authorities the final analysis will take place and full results may be expected in Q4 2012.
About RENCAREX® and the ARISER study
The drug candidate RENCAREX® is based on the antibody Girentuximab, which binds to the tumour-specific antigen CA IX an antigen that is overexpressed in clear cell renal cell carcinomas. The therapeutic antibody makes the tumour visible to the endogenous immune system, recruiting natural killer cells, which can destroy any existing cancer cells. RENCAREX® should inhibit the further growth and recurrence of ccRCC a particularly aggressive type of cancer and kill cancer cells, thereby prolonging the disease-free survival of patients.
ARISER (Adjuvant RENCAREX Immunotherapy trial to Study Efficacy in non-metastasised Renal cell carcinoma) is an international, multicentre, randomised Phase III trial that examines the efficacy of the antibody RENCAREX® in comparison to placebo in the treatment of clear cell renal cell cancer patients following complete or partial surgical removal of the affected kidney in patients with no detectable metastases. The ARISER trial involves 864 patients, who received the study medication in once-weekly infusions over a period of 24 weeks. The last patient completed treatment in February 2009. Following the occurrence of the 100th relapse, an interim analysis for futility was carried out in late 2007. The IDMC recommended that the trial be continued because it will probably deliver a significant result.
WILEX has granted commercialisation rights for RENCAREX® for certain countries of Southern Europe to the Spanish pharmaceutical company Esteve and US commercialisation rights to the US-based company Prometheus.
Invitation to the conference call
WILEX will hold a conference call for media, analysts and investors on 22 November 2011 at 10:00 a.m. CET in German and at 4:00 p.m. CET in English. Please dial in ten minutes before the conference call using the following dial-in numbers:
1. Germany: +49 69 71044 5598
2. UK: +44 20 3003 2666
3. USA: +1 212 999 6659
4. USA Freephone: +1 866 966 5335
You will be welcomed by an operator taking your name and company. The presentation for the conference will be available for download at www.wilex.de at 9:00 a.m. CET on 22 November 2011. A replay of the conference will be available from 23 November on the website http://www.wilex.de/press-investors/presentations/
About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the company has a broad portfolio of near-to-market therapeutic and diagnostic products for the targeted treatment and specific detection of various types of cancer. The company’s therapeutic product candidates are based on antibodies and small molecules. Through its US subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a portfolio of research use only and in vitro diagnostic tests under the brand Oncogene Science®. These diagnostic tests could be developed as companion diagnostics in clinical trials and for therapy monitoring. The wholly owned subsidiary Heidelberg Pharma AG gives WILEX access to an attractive and highly promising antibody drug conjugate technology platform and a pre-clinical service business. The business model of WILEX covers the entire value chain in the oncology market and comprises research, technology, development collaboration as well as sales and marketing. WILEX’s customers and partners include leading international pharmaceutical companies.
Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6
Katja Arnold (CIRO)
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will” “should” “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial position, earnings, achievements, or industry results, to be materially different from any future results, earnings or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.