Nanobiotix (Euronext: NANO), a French nanomedicine company focused on cancer therapy, has announced today its development plan for the CE marking of NBTXR3, the first product from the NanoXray pipeline.
The positive results from the pilot phase of NBTXR3 in patients with advanced soft tissue sarcoma (STS), allow Nanobiotix to finalize and to announce its development plan for the launch of NBTXR3 on the market. It is with this first indication, advanced STS, that NBTXR3 could be CE marked as early as 2016, brought forward from the company's initial estimate of 2017. To achieve this, the product registration phase (pivotal) will begin in late 2014.
On February 10, 2014, the Independent Data Monitoring Committee (IDMC) met and gave a positive assessment of the recent pilot STS data which showed that NBTXR3 had a good safety profile, which is infrequent in oncology. Expert opinions, combined with encouraging signs of efficacy, have led to further product development in this indication.
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