US FDA grants Orphan Drug Designation for Noxopharm's CRO-67

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The US FDA has granted Orphan Drug Designation status to Noxopharm's (ASX:NOX) CRO-67 preclinical drug candidate for the treatment of pancreatic cancer.

The status, for drugs aimed at preventing, diagnosing or treating rare diseases or conditions, includes benefits such as tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval.

Noxopharm said CRO-67’s designation supports its development plan for the asset and its potential future commercial value.

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

Noxopharm CEO Dr Gisela Mautner said, “For CRO-67 to achieve an ODD is a significant milestone in the development of the drug. In addition to financial benefits, the ODD 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.”