Endocyte presents new biomarkers and fourth quarter loss
West Lafayette, Ind.-based biopharmaceutical company Endocyte announced Feb. 24 that the company's folate-receptor biomarkers vintafolide and etarfolatide had orphan drug status and were moving closer to approval with a review by the European Committee for Medicinal Products for Human Use (CHMP). In the company’s financial news, a net loss of $2.9 million was reported for fourth quarter 2013, compared to the loss of $0.8 million noted this time last year.
Vintafolide is a therapeutic molecular agent, whereas etarfolatide is used in diagnostic molecular imaging. A number of clinical trials, both underway and expected to move forward in 2014 are in the process of validating vintafolide for ovarian cancer, non-small cell lung cancer (NSCLC) and triple negative breast cancer.
"We made significant progress during 2013 with our lead program, vintafolide, across multiple indications and advancing our proprietary pipeline of [small molecule drug conjugates (SMDC)] into the clinic, setting the stage for several major milestones in the first half of 2014," said Endocyte president Ron Ellis in a release. "On the regulatory front, we were pleased to provide a recent oral explanation to the CHMP of the European Medicines Agency for our conditional marketing authorization applications for vintafolide and companion imaging agent, etarfolatide and anticipate receiving an opinion at the CHMP's next meeting in March.”
The U.S. Food and Drug Administration (FDA) has already designated vintafolide as an orphan drug for the treatment of ovarian cancer. Results of the phase II clinical trial (TARGET) for vintafolide and etarfolatide for non-small cell lung cancer (NSCLC) is expected in March. Enrollment for a phase I clinical trial for EC1456, a folate-tubulysin imaging agent for advanced solid tumors, is also moving forward.
The company is set to file for an investigational new drug application for a proprietary PSMA-targeted tubulysin agent for prostate cancer in March. The triple negative breast cancer trial is scheduled to begin for vintafolide in the second quarter of 2014.