Biopharmaceutical company Wilex has received a special protocol assessment (SPA) from the FDA for a Phase III registration trial with its diagnostic product candidate CA9-SCAN.
The SPA confirms that the design and planned analysis of the clinical trial adequately address the requirements for a regulatory submission for CA9-SCAN, according to the Munich, Germany-based company.
CA9-SCAN is a radioactively labeled form of the antibody WX-G250, targets clear cell renal cell carcinoma and accumulates in the tumor tissue. This accumulation can be visualized by means of PET/CT, Wilex said.
Wilex will begin patient recruitment in the second quarter of 2008 for 166 patients suspected of having kidney cancer in more than 15 centers in the United States.
Patients will be imaged with CT and PET/CT (CA9-SCAN) prior to surgery to examine whether they have clear cell renal cell carcinoma. Patients included will be scheduled for complete or partial surgical removal of the affected kidney.
The company said the trial will evaluate whether imaging with CA9-SCAN can improve the diagnosis in comparison with CT alone.
CA9-SCAN could improve the planning of treatment and the post-operative monitoring of renal tumor patients, Wilex said.