Novogen subsidiary files IND

Novogen’s US subsidiary Marshall Edwards has filed an investigational new drug (IND) application with the US FDA for its chemo-sensitising agent triphendiol.

Triphendiol - to be used in conjunction with gemcitabine, a nucleoside analogue marketed by Eli Lilly as Gemzar – was granted orphan drug status in January for treatment of pancreatic cancer.

The IND application is to enable a Phase I study in patients with unresectable or metastatic pancreatic and bile duct cancers.

Marshall Edwards’ lead candidate, phenoxodiol, is in Phase III trials for recurrent ovarian cancer.

Novogen has licensed both triphendiol and phenoxodiol to Marshall Edwards, and is now looking at another compound, the mTOR inhibitor NV-128, to act against cancer stem cells.

The compound induces caspase-independent apoptosis via the AKT-mTOR pathway and is being investigated for its action against rapidly dividing cells in solid tumours.

A collaboration with a team from Yale University has found the compound has a high level of potency against cancer stem cells, the company said.