Nuvilex seeks orphan drug status for pancreatic cancer treatment in Australia

The pancreatic cancer treatment includes implanting living cells that have been encapsulated in pin-head sized, cellulose-based, protective cocoons through the use of the Cell-in-a-Box technology, followed by the administration of low doses of the anti-cancer prodrug ifosfamide.

In order to be effective, ifosfamide must be converted into its cancer-killing form, which will be performed by the encapsulated cells.

The anti-cancer effects of the drug are optimized by placing these encapsulated ifosfamide-activating cells in proximity to the pancreatic cancer.

Nuvilex president and CEO Kenneth Waggoner said: "In order for the Orphan Drug Designation to be granted to a particular drug or treatment, the target disease must be considered life-threatening and ‘rare’.

"Pancreatic cancer, no matter where it occurs in the world, is undoubtedly life-threatening and, in our opinion, its prevalence in Australia classifies it as a rare disease.

"It is expected that this application to the TGA will be reviewed relatively quickly, and we may have a decision on it before the end of the year."

The submission follows similar applications to the US Food and Drug Administration and the European Medicines Agency (EMA) in the European Union (EU).