(By Balaseshan) Endocyte Inc. (NASDAQ: ECYT) said it has received orphan drug status for a folic acid solution used for injection from 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. 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.
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.
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 & Co. Inc. (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.
ECYT is trading up 2.50 percent at $10.24 on Thursday. The stock has been trading between $3.02 and $11.63 for the past 52 weeks.