In January 2007, LSO reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase III clinical trial comparing use of Litx plus standard treatment for colorectal cancer metastatic to the liver (MCRC) versus standard treatment alone. A Phase III trial of Litx in MCRC (OL006) began in June 2007.
The SPA for MCRC follows an August 2005 SPA for a Phase III trial of Litx in hepatocellular carcinoma (HCC). A Phase III trial of Litx in the treatment of HCC (OL005) began in August 2006.
In addition, a Phase II study of Litx in the treatment of glioma (OL007) began in February 2007 and completed enrollment in February 2008. LSO currently anticipates initiating a Phase III glioma study in 2008.
For additional information, contact Jay Winship, M.D. Chief Medical Officer, LSO, at info-at-lsoncology-dot-com.