Published on November 13, 2012 at 11:59 PM
"The safety data from the first stage of the Phase I study met our expectations and confirms the positive safety data from our non-clinical studies results" said Dr. Elsa Borghi, Nanobiotix Medical Director. "A first milestone has been achieved in Nanobiotix' mission to address the medical need in patients with advanced tumors at high risk. We look forward to the next steps for NBTXR3 and remain confident in its potential to provide a new and important therapeutic option for patients with cancers."
The trial is a prospective, open-label, dose-escalation and single arm study. NBTXR3 is administered to the patients by a single intra-tumor injection, followed by standard radiotherapy as pre-operative treatment. This pre-surgical treatment aims at shrinking the tumor or rendering possible the extraction of the whole malignant tissue, i.e. all cancer cells are resected. After completion of the regular treatment procedure, the patients will undergo the soft tissue sarcoma surgery. The primary tumor tissue will then be available for the evaluation of the cancer cell killing.
Patients' candidates for this new modality of treatment are selected by the Sarcomas and Mesenchymal Tumors Committee of the Institut Gustave Roussy, which represents a highly specialized medical group for sarcoma care for more than 500 newly diagnosed patients per year.