Nanobiotix reports positive preliminary results in Head and Neck cancer Phase I/II clinical trial with NBTXR3

11-Jun-2015 - France

Nanobiotix announced positive preliminary safety results for its lead NanoXray product NBTXR3, in its head and neck cancer Phase I/II clinical trial.

Intermediate results show the feasibility of the injection of NBTXR3 and a good safety profile of the product for this indication
Good safety results allowing the enlargement of the targeted population to patients treated in combination with radiotherapy plus chemotherapy
One step further for use and transferability of NBTXR3 therapeutic approach in different types of tumors

A significant proportion of Head and Neck carcinomas in the western world are found in the oral cavity. The oropharynx is the posterior continuation of the oral cavity and connects with the nasopharynx (above) and laryngopharynx (below). It is also a frequent site of primary Head and Neck cancers. These structures play a crucial role in swallowing, breath and speech. Locally advanced oropharyngeal cancers can obstruct the air flow or infiltrate muscles or nerves, which significantly disturb local functions.

This trial is an open-label non-randomized, dose escalation study. The primary objectives are the evaluation of NBTXR3 safety and tolerability. The secondary objectives of this trial include: assessment of the tumor Response Rate and complete Response Rate by MRI; evaluation of local and general Progression Free Survival of NBTXR3 and the assessment of the feasibility of local administration.

Positive preliminary results

An independent safety committee of experts just gave a positive assessment of the safety profile of NBTXR3 injection, based on the 2 first dose levels preliminary results of the phase I/II of Head and Neck clinical trial.

The intermediate results show the feasibility of NBTXR3 injection at the 2 first dose levels evaluated. Volumes equivalent to 5% and 10% of the tumor size have been tested by intra tumoral injection. For the record, 10% is the recommended volume in the Soft Tissue Sarcoma indication, currently evaluated in a study for registration (phase II/III).

These results also confirm NBTXR3 good safety profile, as no Serious Adverse Events related to the product have been observed and as the product appears to stay within the tumor with no leakage in the surrounding healthy tissues.

In this trial, patients are being assessed particularly on their tolerance to the product. Exploratory efficacy endpoints will be evaluated and shown at the end of this clinical trial.

https://www.bionity.com/en/news/153220/nanobiotix-reports-positive-preliminary-results-in-head-and-neck-cancer-phase-i-ii-clinical-trial-with-nbtxr3.html