Endocyte folic acid solution for injection wins orphan drug status

Folic acid solution for injection, which is used as a pre-injection for etarfolatide radiodiagnostic imaging agent, is intended for use in selecting patients for whom treatment with folate receptor targeted therapy, such as vintafolide is being considered.

Vintafolide, a drug conjugate of the vitamin folate and a potent vinca alkaloid, is designed to target a potent drug to the folate receptors found on diseased cells.

The company is planning to file a marketing authorization applications for vintafolide, etarfolatide and folic acid in the fourth quarter of 2012.

The company said Vintafolide is currently being evaluated in a Phase 3 clinical trial for platinum-resistant ovarian cancer, (PROCEED trial) and a Phase 2 trial for non-small cell lung cancer.

In addition, the company and Merck have entered into a collaboration agreement to develop and commercialize vintafolide.