Perspective Therapeutics Selected by FDA to Participate in the CDRP Program to Expedite Chemistry, Manufacturing, and Controls Development Readiness for VMT-α-NET in NETs - Seite 2

About [²¹²Pb]VMT-α-NET

VMT-α-NET is a clinical-stage, targeted alpha particle therapy (TAT) radiopharmaceutical being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, which are a rare and difficult-to-treat type of cancer. VMT-α-NET incorporates Perspective Therapeutics' proprietary lead-specific chelator (PSC) to bind ²⁰³Pb for SPECT imaging, and ²¹²Pb for alpha particle therapy.  

About the Phase 1/2a Study of [²¹²Pb]VMT-α-NET

This is a multi-center open-label study (clinicaltrials.gov identifier NCT05636618) of [²¹²Pb]VMT-α-NET, PRRT-naïve patients with SSTR2-positive unresectable or metastatic NETs (including GEP-NETs, bronchial NETs and pheochromocytomas, and paragangliomas) who have experienced tumor progression on, lack of symptom relief on, or intolerance to, approved therapies. . The first part of the study involves dose-escalation designed to determine the maximum tolerated dose (“MTD”) or maximum feasible dose (“MFD”) based on observed dose-limiting toxicities (DLTs) and adverse events (AEs) following a single administration of [²¹²Pb]VMT-α-NET. The first patient cohort received 111 MBq (3mCi) per dose. The second cohort will receive administered activities of 185 MBq (5mCi), with cohorts 3 and 4 receiving 370 MBq (10 mCi) and 555 MBq (15 mCi), respectively. According to the modified toxicity probability interval 2 (mTPI-2) study design, intermediate de-escalation doses are also possible to allow selection of the optimal activity dose to take forward into the dose expansion part of the study.

The second part of the study is a dose-expansion phase based on the identified MTD/MFD.

About Perspective Therapeutics, Inc.

Perspective Therapeutics, Inc., is a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. The Company has proprietary technology that utilizes the alpha emitting isotope ²¹²Pb to deliver powerful radiation specifically to cancer cells via specialized targeting peptides. The Company is also developing complementary imaging diagnostics that incorporate the same targeting peptides, which provide the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity.