Jun 10 2015
NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces positive preliminary safety results for its lead NanoXray product NBTXR3, in its head and neck cancer Phase I/II clinical trial.
Figures: Patient treated with NBTXR3; MRI (visualization of the tumor) and CT Scan (visualization of the nanoparticles) taken both 24h after injection showing the presence of the product within the tumor (Photo: Business Wire)
- 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.
Expansion of the Head and Neck trial to address a larger population
The first part of this phase I/II clinical trial has targeted frail and elderly patients who cannot receive chemotherapy with radiotherapy and need new innovative treatments. These patients represent approximately 11% of the Head and Neck cancer population.
The positive safety results on the first levels and additional preclinical data that have been generated, allow to enlarge the scope of patients that could be targeted within the Head and Neck indication.
As a consequence, Nanobiotix plans to include in the continuation of this Phase I/II clinical trial, patients that are receiving Cisplatin in combination with radiotherapy, this combinaison is the reference treatment for Head and Neck cancers.
In this population, locoregional recurrence remains the dominant cause of treatment failure. There is a strong rationale for the use of NBTXR3 to improve locoregional control through radiotherapy enhancement for successful Head and Neck cancer treatment.
Studies in animals testing NBTXR3 with radiotherapy and Cisplatin have shown antitumor synergy with a very good tolerance. These data conjointly with the good safety profile observed in the treated patients have determined this more ambitious strategy.
Currently, the combinasion of Cisplatin with radiotherapy is given to 35-40% of patients with Head and Neck carcinomas. The inclusion of these patients would magnify the total potential treatable population for NBTXR3 in this indication.
One step further in the transferability of the NBTXR3 therapeutic approach
Soft Tissue Sarcoma is the most advanced indication for the NBTXR3 product. Currently, it is studied in a registration phase (II/III). CE mark is anticipated end 2016. The phase I/II of this trial showed successful feasibility and safety of the injection of NBTXR3 product with varying volumes and in different sarcoma subtypes.
The similarity of results so far in term of product behavior found in the Head and Neck study presents additional rationale for transferability of the product to many indications.