The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) announced today that it has recruited the first patients in its Phase III registration trial with the diagnostic product candidate CA9-SCAN. This marks the next important milestone in this project after the Investigational New Drug (IND) approval in October 2007 and a special protocol assessment (SPA) in February 2008.
WILEX will conduct the study in accordance with the approved protocol. The FDA confirms with the SPA that the design and planned analysis of the clinical trial adequately address the requirements for a regulatory submission for CA9-SCAN. The FDA considers itself bound by this protocol assessment as part of the approval process.
166 patients suspected of having kidney cancer will be enrolled in more than 15 centres in the USA. Patients included are scheduled for complete or partial surgical removal of the affected kidney. They will be imaged with computer tomography (CT) and CA9-SCAN (positron emission tomography (PET)-CT) prior to surgery to examine whether they have clear cell renal cell carcinoma. The trial will evaluate whether imaging with CA9-SCAN can improve the diagnosis in comparison to the current standard (CT alone). CA9-SCAN could improve the planning of treatment and the post-operative monitoring of renal tumour patients.
Patient recruitment and follow-up is expected to be completed by the end of 2008 with the data and report available three to six months later.
Dr. Paul Bevan, Head of R&D and Member of the Executive Management Board at WILEX AG remarked: “We are pleased to have commenced patient recruitment and expect the trial to progress as scheduled. CA9-SCAN represents the second product from WILEX developed in a Phase III registration trial.”

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