The FDA has approved the importation of Endocyte's supply of Doxil from Europe into the U.S. for use in the PROCEED Phase III trial.
"This supply is expected to support enrollment through the end of the year and will serve as a bridge to the availability of new supplies of Doxil," said Ron Ellis, president and CEO of Endocyte. "We also continue to explore alternatives for the resumption of enrollment outside the U.S."
The PROCEED trial was initiated in May 2011, but enrollment was stopped later in the year due to global shortages of Doxil. The PROCEED trial compares EC145, in combination with Doxil versus Doxil alone for the treatment of folate-receptor positive platinum resistant ovarian cancer and is designed to repeat the positive results observed in the PRECEDENT Phase II trial in this same patient population.
The company said that patients will be imaged with the companion imaging diagnostic, EC20, prior to treatment in order to identify patients whose cancer lesions over-express the folate receptor, the target of EC145.
West Lafayette, Ind.-based Endocyte plans to provide additional updates on clinical development plans as part of the fourth quarter earnings announcement and conference call in mid-March.
EC145 is a conjugate of the vitamin folate and a super-potent vinca alkaloid. Folate is required for cell division and rapidly dividing cancer cells often over-express folate receptors in order to capture enough folate to support cell division. By attaching a chemotherapy drug to folate through proprietary chemistry, EC145 seeks to target cancer cells.