ROME: NANOBIOTIX, a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces the dynamic expansion of its pivotal phase II/III trial for NBTXR3 in Soft Tissue Sarcoma (“act.in.sarc” study) in 29 sites in 7 countries. The patient recruitment rate is increasing in line with the Company’s expectations.
The international multi-center pivotal study (phase II/III) began end of 2014 in France. By June 2015, the trial was running in 12 European clinical centers of reference in France, Belgium, Spain and Hungary.
Three additional countries (Poland, Romania and South-Africa) and 17 additional clinical centers are now involved. Clinical authorization requests are ongoing in Canada and other Asia-Pacific and European countries.
This study is expected to be the final step before CE mark which is anticipated towards the end of 2016.
Elsa Borghi, CMO of Nanobiotix, commented: “We are delighted with the growing dynamism of the study and the enthusiasm of our clinicians and other partners. NBTXR3 has the potential to significantly improve the efficiency of radiotherapy treatments across oncology indications, and the “Act.in.sarc” study could be the first step towards the generalization of the technology.”
