Yes that's correct. In my previous response to ghmm I noted that ECYT would be running a parallel trial to PROCEED using taxol but neglected to include what you just pointed out which is pretty important. There were some question marks as to whether the patient population would be FR++ so those details need to get ironed out.
Endocyte to Resume Patient Enrollment in PROCEED Phase 3 Trial in U.S. FDA Approves Importation of Doxil(R) From Europe for U.S. Enrollment
WEST LAFAYETTE, Ind., March 5, 2012 (GLOBE NEWSWIRE) -- Endocyte, Inc. (Nasdaq:ECYT - News), a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, today announced that the FDA has approved the importation of Endocyte's supply of Doxil(R) from Europe into the U.S. for use in the PROCEED Phase 3 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 chief executive officer. "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 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 final results observed in the PRECEDENT Phase 2 trial in this same patient population. 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.
Endocyte plans to provide additional updates on clinical development plans as part of the fourth quarter earnings announcement and conference call in mid-March.
About EC145
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 targets cancer cells while avoiding most normal cells. This targeted approach is designed to provide treatment with super-potent drugs while lowering toxicity compared to standard chemotherapy.
About EC20
EC20 is a folate-targeted molecular imaging agent that is being developed as a non-invasive method to identify tumors that over-express folate receptors. These tumors are the molecular target of Endocyte's folate-targeted therapeutic compounds such as EC145. To date, EC20 has been administered to over 500 patients.
About Endocyte
Endocyte is a biopharmaceutical company developing targeted therapies for the treatment of cancer and inflammatory diseases. Endocyte uses its proprietary technology to create novel SMDCs and companion imaging diagnostics for personalized targeted therapies. The company's SMDCs actively target receptors that are over-expressed on diseased cells, relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly active drugs at greater doses, delivered more frequently, and over longer periods of time than would be possible with the untargeted drug alone. The companion imaging diagnostics are designed to identify patients whose disease over-expresses the target of the therapy and who are therefore more likely to benefit from treatment.
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