Diffusion Pharmaceuticals Receives FDA Orphan Designation for TSC, a First-in-Class Drug for the Treatment of Metastatic Brain Cancer

CHARLOTTESVILLE, Va.--(BUSINESS WIRE)--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 metastatic brain cancer. Metastatic brain cancer is one of the most deadly forms of cancer, with most of its victims dying within a year of diagnosis. The FDA has previously granted Diffusion Pharmaceuticals an Orphan Drug designation for the use of TSC in the treatment of the primary brain cancer known as glioblastoma multiforme or GBM. A Phase II clinical trial testing TSC in newly diagnosed GBM patients is now enrolling patients at twenty major cancer centers around the US. A Phase II clinical study testing TSC in brain metastases is currently being planned in cooperation with these centers.

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