Noxopharm’s pancreatic cancer candidate receives key US designation, sending shares higher

Noxopharm shares are up about 150 per cent after its pancreatic cancer drug candidate received orphan drug designation from the Food and Drug Administration in the US.

Noxopharm has hit a key milestone in the advancement of its pancreatic cancer drug candidate.

Noxopharm shares surged as much as 150 per cent on Wednesday after the US Food and Drug Administration granted orphan drug status to its pancreatic cancer drug candidate.

The company’s drug candidate, CRO-67, is still in the preclinical stage.

The orphan drug designation will grant it benefits including tax credits for qualified clinical trials, exemption from FDA application fees, and a potential seven years of market exclusivity after approval.

“CRO-67’s designation as an orphan drug supports the company’s development plan for the asset, and its future commercial value, as Noxopharm continues to build the data package that will be required for regulatory progression,’’ the company said.

“The designation comes shortly after further encouraging CRO-67 data was presented at the American Association of Cancer Research Special Conference on Pancreatic Cancer.

“The disease is set to become the second leading cause of cancer-related deaths in the US by 2040, and has a very poor five-year survival rate of about 9 per cent from the time of diagnosis.

Noxopharm chief executive Dr Gisela Mautner said it was a significant milestone in the development of the drug.

“In addition to financial benefits, the orphan drug designation will also strengthen our commercial position in a market that has seen very few new treatments over recent decades.

“Our pancreatic cancer program is a high priority, and we are committed to progressing its development as quickly as possible.

“Further studies are in the works, as are investigations into dosing and formulation.”

Noxopharm shares closed up 61.3 per cent at 10c each, after trading as high as 16.5c. The stock was trading at 3.8c a week ago.