LSO’s global Phase 3 trial of Aptocine in metastatic colorectal cancer (MCRC) has reached target enrollment of 450 patients at 52 sites. The controlled, randomised MCRC trial is being conducted to assess the progression free survival (PFS) and overall survival (OS) of patients with colorectal cancer with recurrent liver metastases treated with Aptocine plus chemotherapy versus chemotherapy alone.
LSO said that reaching target enrollment for the Phase 3 MCRC trial underscores LSO’s multi-front development of Aptocine. The company is also compiling data in its Phase 3 Aptocine trial in hepatocellular carcinoma (HCC), in which patient treatments were completed in May 2009.
Additionally, the company is preparing for worldwide regulatory filings, and anticipating further studies on Aptocine’s potential role as an immunotherapeutic. Additional studies have been completed or are being planned in a number of solid tumor indications, including glioma, nasopharyngeal, head and neck, lung, breast, pancreatic, and prostate.
The Phase 3 MCRC study is being conducted internationally under a Special Protocol Assessment (SPA) agreement with the FDA. Completion of patient treatment and final PFS data release is also expected in 2010, followed by regulatory filings worldwide.
Riccardo Lencioni, professor, in the department of liver transplantation of hepatology, and infectious diseases at Pisa University School of Medicine, said: “It is exciting to see recruitment completed in this important trial. As an investigator in Aptocine clinical studies, I see striking potential for patient benefit, particularly since Aptocine not only has been shown to destroy tumors much more safely than any other method, but also appears to cause a dramatic anti-tumor immune effect.”