fluorobenzyl polyethylene glycol mono-triazole tetraiodothyroacetic acid (fb-PMT) / NanoPharmaceuticals - LARVOL DELTA

Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: NanoPharmaceuticals LLC | Trial completion date: Oct 2027 ➔ Jun 2028 | Trial primary completion date: Oct 2026 ➔ Jun 2027 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

Phase I trial to evaluate the safety and tolerability of fb-PMT in patients with recurrent glioblastoma. (ASCO 2026) - P1 | "Funded by NanoPharmaceuticals LLC Clinical Trial Registration Number: NCT05226494 Background: Proliferative, pro-angiogenesis, and pro-inflammatory actions mediated by L-thyroxine in glioblastoma (GBM) are initiated at cell surface thyrointegrin αvβ3 receptors for thyroid hormone, located on the extracellular domain of αvβ3 integrin. This Phase 1 study demonstrated that treatment of recurrent glioblastoma with fb-PMT was safe and well tolerated, with a predictable pharmacokinetic profile. Two patients remain on therapy beyond 24 months. Future studies are planned."

Clinical • First-in-human • P1 data • Brain Cancer • Glioblastoma • Solid Tumor

Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=34 | Recruiting | Sponsor: NanoPharmaceuticals LLC | Trial completion date: Oct 2025 ➔ Oct 2027 | Trial primary completion date: Oct 2024 ➔ Oct 2026

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=34 | Recruiting | Sponsor: NanoPharmaceuticals LLC | Trial completion date: Aug 2024 ➔ Oct 2025 | Trial primary completion date: Aug 2023 ➔ Oct 2024

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Preclinical Assessment of Drug-drug interaction of fb-PMT, a novel anti-cancer thyrointegrin αvβ3 antagonist. (PubMed, Clin Transl Sci) - "However, fb-PMT inhibited the uptake of rosuvastatin by both OATP1B1 and OATP1B3 with IC s >3 and <10 μM. In summary, data suggest that the systemic administration of fb-PMT is unlikely to lead to DDIs through CYP enzymes or ABC and SLC transporters in humans."

Journal • Preclinical • Breast Cancer • Oncology • Solid Tumor • CYP2C19 • CYP3A4

Discovery of novel thyrointegrin αvβ3 antagonist fb-PMT (NP751) in the management of human glioblastoma multiforme. (PubMed, Neurooncol Adv) - "NP751-induced effects on gene expression support the model of molecular interference at multiple key pathways essential for GBM tumor progression and vascularization. fb-PMT is a potent thyrointegrin αvβ3 antagonist with potential impact on GBM tumor progression."

Journal • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Pharmacokinetics of fluorobenzyl polyethylene glycol conjugated tetraiodothyroacetic acid (NP751), a novel anticancer thyrointegrin αβ antagonist. (PubMed, Front Pharmacol) - "The peak plasma concentration (Cmax) and the area under the curve (AUC) results at different doses in mice, rats and monkeys suggest that pharmacokinetics of NP751 is dose-dependent within the dose ranges administered. Results indicate that NP751 has comparable PK parameters that provides enough exposure as a molecularly tumor targeted molecule in multiple species and is a promising anticancer therapeutic."

Journal • PK/PD data • Oncology