Eight years for nothing
17.10.2012 - The dreams of Wilex CEO Olaf Wilhelm to bring a drug to the market are destroyed. The company's most advanced compound has failed in Phase III.
On Tuesday evening, the Munich-based antibody developer reported results of a comprehensive Phase III study testing an anti-CA-IX antibody in the adjuvant treatment of renal cancer after surgery. The analysis showed no improvement in median disease free survival (approximately 72 months) following treatment with Rencarex compared with placebo. The Independent Data Monitoring Committee has recommended to terminate the Phase III ARISER trial which was started as long ago as in June 2004.
Originally, the company planned to announce the results in 2008. However, the number of adverse events did not come in as planned. Professor Seppo Pyrhoenen, Chairman of the ARISER IDMC, said: "I have over 30 years experience in treating patients with kidney cancer and applaud this study for being well balanced, controlled and very well conducted. This is probably the most comprehensive study in the adjuvant setting conducted in the past 20 years."
Wilex is also conducting Phase II trials with Mesupron in pancreatic and breast cancer and developing a diagnostic based on a radioactively labelled version of Rencarex in Phase III. At the Frankfurt stock exchange, Wilex shares fell more than 60%. The biggest shareholder is SAP founder Dietmar Hopp.