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RNS - WILEX AG announces start of interim analysis for its Phase III ARISER registration trial with RENCAREX(R)

Company: Heidelberg Pharma AG Date: 2011-01-24 Language: English Register to download

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 News Details

Corporate | 24 January 2011 07:39

#   

WILEX AG announces start of interim analysis for its Phase III ARISER registration trial with RENCAREX(R)

  

WILEX AG / Key word(s): Research Update  

  

24.01.2011 / 07:39  

**PRESS RELEASE**

**WILEX announces start of interim analysis for its Phase III ARISER registration trial with RENCAREX (R)**

**Munich, Germany, 24 January 2011 –** WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) today announced the achievement of a major clinical milestone. Over 340 recurrences have now been reported to WILEX by the local sites. Therefore the process for the interim analysis of efficacy in the Phase III registration trial with the drug candidate RENCAREX (R) in the indication renal cancer has now been started. The process involves the central analysis of the data from all 864 patients by independent radiologists. The interim analysis will be carried out by an Independent Data Monitoring Committee (IDMC) and should provide definitive information regarding the endpoint of the trial relevant for approval, namely 'disease-free survival'. The results of the interim analysis of efficacy are expected to be available in about six months.

The drug candidate RENCAREX (R) 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 (R) should inhibit the further growth and recurrence of clear cell renal cell carcinomas – a particularly aggressive type of cancer – and kill cancer cells, thereby prolonging the disease-free survival of patients.

**About the ARISER study**

ARISER (Adjuvant RENCAREX Immunotherapy trial to Study Efficacy in non-metastasised Renal cell carcinoma) is an international, multicentre, randomised trial that examines the efficacy of the antibody RENCAREX (R) 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 Phase III 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, the first 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. No drug has been approved to date by the FDA or EMA for the adjuvant therapy of non-metastatic clear cell renal cell carcinoma.

  

**About WILEX**

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 unique portfolio of oncological biomarkers under the brand Oncogene Science. These biomarkers can be used as companion diagnostics in clinical trials and for therapy monitoring. 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

**Contact**

WILEX AG  

Corporate Communications  

Katja Arnold (CIRO)  

Grillparzerstr. 10  

81675 Munich  

Tel.: +49 (0)89-41 31 38-126  

Fax: +49 (0)89-41 31 38-99  

Email: [investors@wilex.com](mailto:investors@wilex.com)

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..

  

  

End of Corporate News  

  

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24.01.2011 Dissemination of a Corporate News, transmitted by DGAP – a company of EquityStory AG.  

The issuer is solely responsible for the content of this announcement.  

  

DGAP’s Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.  

Media archive at www.dgap-medientreff.de and www.dgap.de  

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|     |     |
| --- | --- |
| Language: | English |
| Company: | WILEX AG |
|     | Grillparzerstr. 10 |
|     | 81675 München |
|     | Deutschland |
| Phone: | +49 (0)89 41 31 38 – 0 |
| Fax: | +49 (0)89 41 31 38 – 99 |
| E-mail: | info@wilex.com |
| Internet: | www.wilex.com |
| ISIN: | DE0006614720 |
| WKN: | 661472 |
| Listed: | Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart |
|     |     |     |

|     |     |
| --- | --- |
|     |     |
| End of News | DGAP News-Service |

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| 109739  24.01.2011 |