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Nanobiotix files for European approval of cancer treatment

Sufficient data to make the application even though a number of trials are still ongoing
picture of patient undergoing radiotherapy
NanoXRay makes radiotherapy treatment much more effective

Cancer treatment group Nanobiotix (EPA:NANO)  has filed for European market approval (CE Marking) for its lead product, radio-enhancer NBTXR3.

Nanobiotix said there was sufficient data to make the application even though a number of trials are still ongoing.

In particular, the CE submission is based on an Act.In.Sarc registration trial for treatment of locally-advanced soft tissue sarcoma (STS).

This study is a phase II/III trial to evaluate NBTXR3 in combination with radiotherapy compared to the current standard of care, which is radiotherapy alone.

In addition, there are earlier stage trials currently underway for head and neck cancer and safety and feasibility trials for its use in liver cancer.

The company filed for a CE mark on 23 August with the current guidance that it can take at least nine months to be granted.

Laurent Levy, Nanobiotix’s chief executive, said filing for market approval was a major step and marked the fruit of more than 10 years of research and development.

While patient recruitment for the STS trial had been a little slower than expected overall its plans were progressing well, he said.

So far, 116 patients out of a total of 156 had been selected with 92 or two- thirds of the patients randomised.

Nanobiotix said it expects to complete recruitment for the STS trial in the second quarter of 2017 though interim analysis will be released after 104 patients have been treated.

NBTXR3 works by directly injecting nanoparticles into cancerous tumours.

Once inside the tumour, the nanoparticles absorb the ionizing radiation delivered by radiotherapy and magnify its effect locally.

This amplifies the X-ray dose delivered to the tumour, while the dose delivered to healthy tissues remains unchanged.

The treatment shrinks the tumour making it easier to remove during surgery.

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