NANOBIOTIX, a clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announced today that it has received approval from the French National Security Agency for Medicines and Health Products (ANSM) to start its Phase II/III registration trial of its lead product, NBTXR3, in patients with locally advanced Soft Tissue Sarcoma (STS).
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.
In parallel, Nanobiotix is establishing industrialization, market access and reimbursement strategies for NBTXR3 to prepare for a potential product launch at the end of 2016.
Laurent Levy, CEO of Nanobiotix commented: "Following the ASCO results, this approval is the second most important step we have accomplished this year as it launches the last clinical phase before potential market authorization. We believe our product, NBTXR3 will offer meaningful clinical benefit for patients with advanced sarcomas where there are serious unmet medical needs."