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.
Elsa Borghi, Chief Medical Officer of Nanobiotix, commented: “The Phase I interim results exemplify our first clinical validation of NBTXR3 and represent our successful transition of the NanoXray platform from preclinical models to a clinical stage. They have confirmed that NBTXR3 has the potential to become a safe and localized treatment to STS patients. In addition, the NBTXR3 results have demonstrated in all treated patients adequate distribution within the tumor, absence of leakage, optimal bioavailability over time and successful surgery. Encouraged by these results, we are looking forward to expanding clinical development of NBTXR3 in a variety of additional cancer indications.”
STS are cancers arising from different types of tissues such as fat cells, muscles, joint structures, small vessels, etc. Patients with high risk STS have poor prognoses: They need surgery to remove the tumor and their only therapeutic option before surgery is radiotherapy. However, there is an important unmet medical need for these patients. Treatment with NBTXR3 nanoparticles and radiotherapy aims at destroying tumor more efficiently, to allow surgery and to enable complete malignant tissue extraction during surgery.
The results have been presented to oncologists, patients association and industry representatives during a focus group meeting in Chicago on Saturday 1st June 2013.
For further information, the presentation can be downloaded following this link: