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TheStreet Open House

Endocyte Granted Orphan Drug Status For Folic Acid By European Commission

WEST LAFAYETTE, Ind., Sept. 27, 2012 (GLOBE NEWSWIRE) -- Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, today announced that the Company was granted orphan drug status for folic acid solution for injection by the European Commission for the condition of ovarian cancer. Folic acid solution for injection is used as a pre-injection for the radiodiagnostic imaging agent, etarfolatide, to select patients for whom treatment with folate receptor targeted therapy, such as vintafolide, is being considered. Vintafolide is the therapeutic designed to target a potent drug to the folate receptors found on diseased cells.

The company plans to submit marketing authorization applications to EU health authorities in the fourth quarter of 2012 for vintafolide, etarfolatide and folic acid for the selection and treatment of women with folate receptor positive platinum-resistant ovarian cancer. All three agents have now been granted orphan drug status.

About Vintafolide (EC145)

Vintafolide is a conjugate of the vitamin folate and a potent vinca alkaloid. Folate is required for cell division and rapidly dividing cancer cells often over-express folate receptors in order to capture enough folate to support cell division. By attaching a chemotherapy drug to folate through proprietary chemistry, vintafolide targets cancer cells while avoiding most normal cells. This targeted approach is designed to provide treatment with potent drugs while lowering toxicity compared to standard chemotherapy. Endocyte and Merck, known as MSD outside the United States and Canada, (NYSE:MRK) entered into an agreement to develop and commercialize vintafolide. 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; both studies are also using Endocyte's investigational radiodiagnostic imaging agent, etarfolatide.

About Etarfolatide (EC20)

Etarfolatide is a folate-targeted molecular radiodiagnostic imaging agent that is being developed as a non-invasive method to identify tumors that over-express folate receptors. These tumors are the molecular target of Endocyte's folate-targeted therapeutic compounds such as vintafolide. Folic acid is used with etarfolatide to enhance image quality. To date, etarfolatide and folic acid have been administered safely to over 590 patients.

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