CureFAKtor Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for CFAK-C4, a potential pancreatic cancer treatment.

CureFAKtor is planning to initiate a Phase I clinical study of CFAK-C4 in combination with gemcitabine chemotherapy, the current standard of care for pancreatic cancer, in 2012.

Preclinical studies showed that CFAK-C4 demonstrated efficacy in a number of cancers, including pancreatic cancer, breast cancer, advanced melanoma and neuroblastoma.

The FDA grants orphan drug designation to those drugs that treat rare medical conditions affecting fewer than 200,000 people in the US.

Orphan drug designation gives the company a number of potential incentives associated with CFAK-C4, including a seven-year period of marketing exclusivity, reduced regulatory fees, certain tax credits, and additional regulatory support for research and development initiatives.