The presentation of the clinical results can be downloaded following this link:
Nanobiotix a clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces positive Phase I interim results of its lead nanoparticle-based product, NBTXR3, in patients with Soft Tissue Sarcoma (STS).
The open-label, single-arm Phase I clinical trial (NCT01433068) is designed to primarily assess the safety and feasibility of NBTXR3, administered by injection to 27 adult patients with STS with radiotherapy treatment according to established protocols.
Interim results from this on-going Phase I clinical trial in 12 patients have demonstrated that a single injection of NBTXR3 provides adequate distribution of nanoparticles within the tumor for over five weeks of radiation therapy, without leakage of nanoparticles to the adjoining healthy tissues and with marginal passage to systemic circulation, even for large tumors (up to 3,684 mL in size). These results were consistent to all patients tested, were independent of tumor histology, bone invasion and tumor size, and allowed subsequent surgical resection of the tumor, as planned.
The treatment was safe with no serious adverse events and allowed the patients to complete all their radiotherapy sessions. Few mild or moderate adverse events related to NBTXR3 were observed, with spontaneous resolution in the twelve treated patients. No grade 3 or 4 adverse event was observed.
Nanobiotix’s first-in-class, proprietary technology called NanoXray is at the forefront of a new era of nanomedicine, where nanoparticles are not just a vehicle for targeted drug delivery, but have become the principal active element. The NanoXray technology is based on the physical properties of hafnium-oxide nanoparticles and is used to enhance the efficacy of radiotherapy treatment for a variety of cancer indications.
Nanoparticles are designed to enter tumor cells and, upon activation by a standard dose of radiation, they emit large amounts of electrons resulting in the generation of free radicals that destroy cancer cells (the same mode of action than radiotherapy but largely amplified). Nanoparticle-enhanced radiotherapy therefore amplifies the lethal dose of energy locally within the tumor without changing the effect of the dose passing through surrounding healthy tissues.
By changing the coating of the nanoparticles, Nanobiotix is developing three different products that can be administered either by direct injection into the tumor (NBTXR3), intravenous injection (NBTX-IV) or topical application to fill tumor cavities after surgery (NBTX-TOPO). The product applied will depend on type of tumor and the patient’s specific clinical needs. NanoXray products are classified as a medical device in Europe and as a drug in the US. They are compatible with current radiotherapy methods with respect to equipment and protocols, as well as with older radiotherapy equipment or any radiation-based therapy.