FDA Approves Investigational New Drug (IND) for Neuroendocrine Tumors from Molecular Targeting Technologies, Inc.

On March 2, 2021 Molecular Targeting Technologies, Inc. (MTTI), a clinical stage radiopharmaceutical therapy company focused on therapies for rare diseases, reported the approval of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) (Press release, Molecular Targeting Technologies, MAR 2, 2021, View Source [SID1234575970]). It enables a Phase I clinical study of the Safety and Dosimetry of its lead product, EBTATE (177Lu-DOTA-EB-TATE), in patients with neuroendocrine tumors (NET).

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EBTATE is used in Precision Medicine for Targeted Radionuclide Therapy. The key feature of this technology is the appendage of Evans blue (EB) to the targeting radiopharmaceutical. EB binds reversibly to serum albumin to enhance the radiotherapeutic time window with longer circulation half-life and increase tumor uptake/retention to improve therapeutic outcome.

Dr. Chris Pak, President & CEO of MTTI commented: "The clearance of our IND is an important milestone for MTTI. Having solidified our clinical trial preparedness and manufacturing readiness, we are well-positioned to advance EBTATE. The upcoming trial is an open-label, dose-escalation study planned for patients with neuroendocrine tumors (NET)."