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Marshall Edwards files IND application for oncology drug

Marshall Edwards, an oncology company, has filed an application with the FDA for an investigative new drug approval to undertake clinical studies with triphendiol as a chemosensitizing agent in combination with gemcitabine.

The investigative new drug (IND) application is to enable a Phase Ib study of triphendiol in combination with gemcitabine in patients with unresectable, locally advanced or metastatic pancreatic and bile duct cancers.

Triphendiol is an investigational drug in the Marshall Edwards oncology drug pipeline, currently being developed as an orally-delivered chemosensitizing agent, intended for use in conjunction with standard chemotoxic anticancer drugs for the treatment of late stage pancreatic cancer, cholangiocarcinoma, and melanoma.