Nanobiotix startar Fas II/III studie mjukdelssarkom

Patients with locally advanced STS have very limited therapeutic options. Today, a standard treatment of care before surgery is radiotherapy aiming to reduce the tumor volume. Thereafter surgery is still required to remove the tumor. But despite of radiotherapy, a considerable proportion of patients with advanced tumors that cannot be resected in their entirety. The remaining tumor mass promotes the further development of the disease resulting in a poor prognosis for the patient.

NBTXR3 has the potential to provide a significant clinical benefit by improving radiotherapy efficacy, destroying locally advanced tumors more efficiently and to improve the quality of surgery enabling a more complete removal of the tumor.

This international multi-center pivotal study will start in France and then be conducted in around 25-30 sites throughout Europe once further authorizations are received. This pivotal trial is expected to be the final step before registration in Europe (CE mark) and should be –completed towards the end of 2016. In the Asia-Pacific region, as announced recently, PharmaEngine intends to participate in this pivotal study by opening clinical sites in several countries.