The US Food and Drug Administration (FDA) has approved Nanobiotix’s Investigational New Drug (IND) application for the clinical study of NBTXR3 to treat prostate cancer
NBTXR3 is being developed for patients with intermediate and high-risk prostate cancer, with the aim of providing effective tumour destruction and disease control according to Nanobiotix.
The FDA approval will enable an open-label, two cohorts and non-randomised trial in prostate cancer patients with the first part of the trial involving departments of radiation oncology from three reference US oncology centers.
Efficient local control is key for treatment of the primary prostate tumour to prevent relapse and subsequent spreading of the disease according to Nanobiotix.
NBTXR3 is a nano-sized radio-enhancer that operates at the tumour level, bound and captured by cancer cells.
Using NBTXR3 in combination with radiotherapy could open the therapeutic window and improve efficacy by increasing the energy dose deposit within the malignant tissues, without adding toxicity to surrounding healthy tissues Nanobiotix said.
Laurent Levy, Nanobiotix CEO, said: "The FDA approval opens the regulatory pathway for our lead product NBTXR3 in the US, the largest market for cancer therapeutics.
“Expansion in new indications and global development of NBTXR3 are key to establish this technology as a new standard of care."