A Multi-center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Suspected Metastatic Renal Cell Carcinoma
The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted
diagnostic radiopharmaceutical designed to bind to the folate receptor. The folate receptor
is a glycoprotein that is over-expressed in many types of cancer cells but it is only
minimally distributed in normal tissues. Folate conjugates bind to the folate receptor with
high affinity and are brought into the cell via endocytosis. In contrast, folic acid itself
enters most normal cells via the reduced folate carrier, a pathway entirely inaccessible to
folate conjugates. Therefore, these folate conjugates are specific to cancer cells.
Endocyte's folate-targeted delivery system was applied towards the targeting of a diagnostic
imaging agent (111In-DTPA-Folate) to ovarian cancer tumors. This proof-of-principle study
was designed to demonstrate the ability of folate to target drugs to
folate-receptor-positive (FR+) cancer tissue.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
United States: Food and Drug Administration
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