The medicine agency of France, AFSSAPS has approved the commencement of the first clinical trial of NBTXR3, the lead compound in the NanoXray pipeline of Nanabiotix.
Under the first phase of the study the company will test the safety levels and ease of administering the compound by performing trials on 27 patients who have soft tissue sarcoma. This will be a non-randomized, single arm, prospective, open-label and dose escalation trial.
Under this trial patients will be given the NBTXR3 compound through a single injection into the tumour before the surgery. This will be subsequently followed up with radiotherapy. After all the standard treatment procedures are completed, the soft tissue sarcoma will be removed through surgery and will be evaluated for its response rate.
Once the NBTXR3 nanoparticle is injected to the sarcoma tumour, it populates the cancer cells and the hafnium oxide crystals in the compound enable the particles to emit a large number of electrons during radiation. The radicals which are formed due to these electrons damage and destroy the cancer cells. The cancer destroying capability of regular radiation therapy can be further enhanced since the particles in the NBTXR3 compound are non-reactive and disperse electrons only during radiation.
Preliminary results of these tests are expected to be available by 2012. The NBTXR3 has been categorised as a class III medical device in the EU and as a drug by the FDA in the US. The US and Europe are in the process of preparing for more clinical trials for this compound.
NanoXray portfolio of Nanobiotix includes a range of treatments based on nanoparticles that are created to enter tumor cells and destroy cancerous tissue.
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