Odds Favor Endocyte Receiving European Approval For Ovarian Cancer Drug

WEST LAFAYETTE, Ind. (TheStreet) -- The next significant catalyst for Endocyte (ECYT) is coming soon when European drug regulators will decide whether or not to recommend the approval of vintafolide for the treatment of platinum-resistant ovarian cancer. 

I learn towards a positive approval recommendation on vintafolide from Europe, but Endocyte's application is not without risks. The company has told investors its interactions with European drug reviewers to date have been generally supportive of vintafolide but we all know this doesn't insure a favorable outcome. With that said, I'm bullish about Endocyte and its ovarian cancer drug regardless of the European approval decision.

Vintafolide is a small molecule drug conjugate (SMDC) that targets the folate receptor on cancer cells to precisely deliver a potent cytotoxic payload.  Vintafolide's design is quite similar to antibody drug conjugates made by Seattle Genetics  (SGEN) and ImmunoGen  (IMGN) except vintafaolide uses ligands as opposed to the larger antibodies to target the cancer cells. Endocyte has also developed a companion diagnostic to properly identify the patients most likely to respond to treatment.

Women diagnosed with ovarian cancer that does not respond to platinum-based chemotherapy have few effective therapies available and a poorer prognosis than patients with platinum-sensitive ovarian cancer. (Median overall survival of 12.4 months compared to 24.3 months, according to published studies.) Ovarian cancer over-expressing the folate receptor is associated with even poorer outcomes for patients. Given the dire need of new treatments for these patients, Endocyte filed for conditional approval of vintafolide in Europe based on positive phase II data. 

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