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-Endocyte and Merck Expand Vintafolide Development -
-EMA Approval Decision for Vintafolide Expected by Year-End 2013 - -Conference call today at 4:30 p.m. EST -
WEST LAFAYETTE, Ind., Feb. 25, 2013 (GLOBE NEWSWIRE) -- Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy in cancer and other serious diseases, today announced financial results for the fourth quarter and year ending Dec. 31, 2012, and provided a business update.
"2012 was transformative for Endocyte, as we laid out a clear path toward commercialization and further development of the Company's pipeline and announced a landmark partnership with Merck for vintafolide," said Ron Ellis, Endocyte's president and chief executive officer. "Our marketing authorization application (MAA) filings for vintafolide and etarfolatide were accepted for review by the European Medicines Agency (EMA), and we continued enrollment for the Phase 3 PROCEED trial in platinum-resistant ovarian cancer and the Phase 2 TARGET trial in non-small cell lung cancer (NSCLC) while moving several other candidates toward the clinic."
Ron Ellis added, "In addition, today we announced Merck's and Endocyte's plans to initiate a Phase 2 randomized trial of vintafolide in folate receptor-positive triple negative breast cancer in the second half of this year. We have collaborated closely with Merck in the selection of this promising indication with a large patient population and significant unmet medical need. The randomized Phase 2 breast cancer trial underscores Merck's commitment to the development of vintafolide in multiple indications. This will be the fourth vintafolide clinical study, adding to the current studies in ovarian cancer, NSCLC, and the combination study with carboplatin and paclitaxel."
"We also announced our decision with Merck to amend the PROCEED trial design to provide the option to enroll an additional 100 patients to support the overall survival analysis. The decision to exercise the option and add the extra 100 patients will be made by the Data and Safety Monitoring Board, who could decide to stop the study at 250 patients (for futility, efficacy or safety reasons) or to enroll 100 additional patients to support the final overall survival analysis. If the 100 additional patients are enrolled, Merck will pay 75 percent of the incremental cost, and we would expect enrollment to take an additional nine - 10 months," Ron Ellis commented.