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news.Janssen Products is supplying DOXIL (doxorubicin HCl liposome injection) to support Endocyte's ongoing Phase 3 PROCEED trial.
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The randomized, double-blind clinical trial is designed for evaluating Endocyte’s vintafolide drug in combination with DOXIL compared to DOXIL plus placebo for the treatment of folate-receptor positive platinum-resistant ovarian cancer.
Progression-free survival as measured by Response Evaluation Criteria in Solid Tumor (RECIST ) in criteria patients with folate-receptor positive tumors assessed by etarfolatide imaging is the primary endpoint of the trial.
Overall survival is a secondary endpoint.
Endocyte president and CEO Ron Ellis said the supply of DOXIL is meeting the ongoing needs of the PROCEED trial to continue to enroll patients without interruption.
"We will continue to work closely with Janssen to ensure that DOXIL supply allows the PROCEED trial to remain on schedule," Ellis added.
"Current estimates call for new supply of DOXIL to be available by the end of the year."