Endocyte, Inc., a biopharmaceutical company developing targeted small molecule drug conjugates and companion imaging diagnostics for personalized therapy, has secured Doxil (doxorubicin HCl liposome injection) supply from Janssen Products, LP, to supplement existing supply already in place to support the ongoing phase III PROCEED trial in ovarian cancer.

The PROCEED trial compares vintafolide in combination with Doxil versus Doxil alone for the treatment of folate-receptor positive platinum resistant ovarian cancer.

“The supply of Doxil announced today adds to our flexibility in meeting the ongoing needs of the PROCEED trial so we may continue to enroll patients without interruption,” said Ron Ellis, president and CEO at Endocyte. Ellis further added, “We will continue to work closely with Janssen to ensure that DOXIL supply allows the PROCEED trial to remain on schedule. Current estimates call for new supply of Doxil to be available by the end of the year.”   

The PROCEED trial is a phase III randomized, double-blind clinical trial evaluating Endocyte’s drug candidate vintafolide in combination with Doxil compared to Doxil plus placebo for the treatment of folate-receptor positive platinum-resistant ovarian cancer. The primary endpoint of the trial is progression-free survival as measured by RECIST (Response Evaluation Criteria in Solid Tumour) criteria in patients with folate-receptor positive tumors assessed by etarfolatide imaging.

Overall survival is a secondary endpoint. The trial anticipates recruiting more than 400 patients at approximately 150 sites in the US, Canada, Europe, and Asia.