US FDA Investigational New Drug approval for first-in-human trial of novel cancer-targeting nanoparticle

摘要

A collaboration between scientists at the Nanotechnology Center of Memorial Sloan-Kettering (MSK) Cancer Center, Cornell University and Hybrid Silica Technologies Inc., has resulted in an inorganic silica nanoparticle with the potential for the targeted molecular imaging of cancer. The researchers have received approval from the US FDA for an Investigational New Drug application and are about to launch a first-in-human trial of the particle in melanoma patients, a first-of-its-kind trial for an inorganic nanoparticle approved as a drug. Lead investigator Michelle Bradbury commented, "This is a very exciting and important first step for this new particle technology that we hope will ultimately lead to significant improvements in patient outcomes and prognoses for a number of different cancers". The purpose of the trial is to investigate the distribution, uptake and safety of the particles in humans by positron emission tomography (PET) imaging. This resulting data could serve as a guideline for future trials and oncologic clinical applications.