In August 2005, LSO reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 trial of Aptocine in hepatocellular carcinoma (HCC). A Phase 3 trial of Aptocine in the treatment of HCC (OL005) completed enrollment in November 2008.
In January 2007, LSO reached an agreement with the FDA on a SPA for a Phase 3 clinical trial comparing use of Aptocine plus conventional chemotherapy for colorectal cancer metastatic to the liver (MCRC) versus chemotherapy alone. Patient enrollment has been completed in a Phase 3 trial of Aptocine in MCRC (OL006).
LSO is currently enrolling patients in a Phase 1 (OL008) and Phase 2 (OL012) trial in benign prostatic hyperplasia (BPH).
For additional information, contact info@lsoncology.com.