The FDA approved Argos Therapeutics' revised Special Protocol Assessment (SPA) for its Phase III clinical study of AGS-003 for the treatment of metastatic renal cell carcinoma, or kidney cancer. The study is expected to begin dosing patients in the second half of 2012 with a goal of overall survival.
The treatment has demonstrated a lack of toxicity, due to its specificity for the tumor. The immunotherapy homes in on mutated tumor antigens known to drive the progression of the disease. The body recognizes the mutated antigens as foreign T-cells, allowing AGS-003 to direct a potent and specific immune response against the tumor, according to Charles Nicolette, chief scientific officer and vice president of R&D at Argos.
"FDA acceptance of our revised SPA is an important step forward for our continued clinical development of AGS-003 in newly diagnosed mRCC patients," said Jeff Abbey, CEO of Argos Therapeutics. "Based on the highly encouraging long-term survival we observed in our Phase 2 combination study of AGS-003 plus sunitinib, we amended our Phase 3 protocol to focus on a primary endpoint of improving overall survival for patients randomized to receive AGS-003 plus sunitinib versus sunitinib alone. With our revised SPA, the FDA has agreed that the pivotal ADAPT study could support a future BLA submission if the study objectives are met."
Renal cell carcinoma can spread to the lymph nodes, lungs, liver, bones or brain. About 70% of people with kidney cancer develop metastases, according to a News-Medical article.
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