Diffusion Pharmaceuticals LLC announced today that trans sodium crocetinate (TSC), the company's lead drug candidate, has been granted an Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of primary brain cancer, also known as glioblastoma multiforme or GBM. GBM is one of the most deadly forms of cancer, with over half of its victims dying within 18 months of diagnosis.
"This is an important development for Diffusion and TSC's clinical program, and potentially for patients suffering from GBM," said David Kalergis, the company's Chief Executive Officer. "We are currently initiating a phase I/II clinical trial of TSC to test the drug's safety and effectiveness in patients newly diagnosed with GBM."