Diffusion Pharmaceuticals LLC today announced completion of enrollment in a Phase II clinical trial of trans sodium crocetinate (TSC), its lead compound for the treatment of cancer. The study enrolled 56 patients with newly diagnosed primary brain cancer (glioblastoma multiforme or GBM) at 18 major U.S. cancer institutions. GBM is a particularly deadly form of cancer, with only about 61% of patients alive one year after diagnosis and about 26% at two years. The Diffusion study is designed to determine whether adding TSC to the current standard-of-care treatment for GBM can significantly improve these survival times.
“We expect most of it to be placed with our existing shareholders, although we may add several additional accredited investors from our network.”
Open enrollment in the Phase II study began in November 2012, following successful completion of an earlier Phase I safety lead-in study. An independent Safety Monitoring Committee determined that no dose-limiting toxicities had occurred in Phase I, that TSC had been well tolerated in all patients, and that open enrollment in Phase II should be authorized.