CE Mark filing based on current level of scientific and clinical evidence
Phase II/III clinical trial in Soft Tissue Sarcoma progressing well towards interim data readout with almost 2/3 of the patients randomized
Paris, France and Cambridge, Massachusetts, USA September 13, 2016 - NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, has filed for market approval (CE Marking) in Europe for its lead product, a first-in-class radio-enhancer, NBTXR3.
The CE Marking submission package is in particular based on current level of evidence generated in the Act.In.Sarc registration trial for treatment of locally-advanced soft tissue sarcoma (STS) and other NBTXR3 clinical trials. The submission has been made in parallel with the continuation of the Act.In.Sarc study and the wider clinical development of NBTXR3 in different cancer indications.
The company filed for CE mark on August 23, and received the confirmation from Gmed (the french notified body), that the evaluation will start this month. The latest guidance given by the notified body for review up to potential CE marking is at least 9 months.
Laurent Levy, CEO of Nanobiotix, commented, "This first market approval of NBTXR3 in Europe, is a major step for Nanobiotix, the fruit of more than 10 years of research and development. Recruitment has been a little slower than expected in STS clinical trial but overall we are progressing well in our global plan. With this filing we are closer to helping patients every day in hospitals."
Interim analysis readout of the Act.In.Sarc study
The Act.In.Sarc study is a global, randomized Phase II/III multi-center pivotal trial evaluating NBTXR3 in combination with radiotherapy before surgery in comparison to the current standard of care, radiotherapy alone, prior to surgery. 156 patients are expected to be included in the study. To date, 116 patients have been recruited and 92 patients randomized across 39 sites in 13 countries.
Nanobiotix plans to release the conclusion of the interim analysis conducted by an independent committee of experts in the coming months. The independent committee of experts will review (i) the data related to the primary endpoint (Complete Pathological Response Rate), ensure (ii) the safety of all patients enrolled in the study, (iii) the quality of the data collected, and (iv) the continued scientific validity of the study design once two third of the patients (104 patients) have been treated. This analysis will be performed four months after the 104th patient has been randomized (time to complete treatment plus readout).
The Company expects to complete patient enrollment of the Act.In.Sarc study in the 2nd quarter 2017.Editor's Details
Last updated on: 14/09/2016
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.