Shares of Endocyte ($ECYT) shot up 25 percent on Tuesday after the Indiana biotech announced that it plans to push ahead with an application for conditional European approval of its lead drug for advanced ovarian cancer and a companion diagnostic on the basis of Phase II data.
Endocyte's strategy is to use an imaging agent, EC20, to identify patients whose tumors express folate receptors. Those patients who test positive are treated with EC145, which combines a chemotherapy with a conjugate that includes vitamin folate, targeting specific cancer cells. That approach has produced promising results in mid-stage studies. But seeking an approval for a cancer drug with mid-stage data is far from easy, as Roche found out after the FDA handed back its application for T-DM1. But Endocyte says that its talks with European regulators indicated that it may have a solid shot.
"We've been in consultation with the EMA regarding our PRECEDENT results and the design of our Phase III trial, PROCEED," said Ron Ellis, president and CEO of Endocyte. "As part of this consultation, we explored the possibility of seeking conditional marketing authorization in the EU based on Phase II results. As a result of our interaction with the EMA, including a meeting with the Scientific Advice Working Party and written advice from the Committee for Medicinal Products for Human Use, we will prepare marketing applications for both EC145 and EC20. The CHMP welcomed the use of EC20 to select patients with the targeted receptor, so we plan to seek conditional marketing authorization in patients with platinum-resistant ovarian cancer who are EC20 positive. We will discuss these developments during our first quarter conference call scheduled for May 5, 2011."
Endocyte has also gained some support for its chances at the FDA.
"It is likely, in our view, that FDA could approve EC145 based on a robust, statistically significant progression-free survival advantage, which is later supported by either a strong trend or statistically significant overall survival advantage," noted Jason Kantor, an analyst at RBC Capital Markets.
- check out the Endocyte release
- here's the story from the International Business Times