I. Key clinical steps for the NanoXray pipeline II. Strengthening management and corporate governance III. Increasing international reputation IV. Outlook and conclusion V. Financial calendar summary for 2014
I. Key clinical steps for the NanoXray pipeline
The NanoXray pipeline progressed significantly over the past 12 months. Lead product NBTXR3 achieved clinical proof-of-concept and NBTX-IV and NBTX-TOPO reached major preclinical milestones.
NBTXR3 nanoparticles are designed to absorb X-rays in order to significantly enhance the radiation dose within cancer cells.
The French National Agency for Medicines and Health Products (ANSM) gave its approval to Nanobiotix to launch a phase I clinical trial of NBTXR3 in patients with Soft Tissue Sarcoma (STS) to assess the feasibility of the concept and the patients tolerance to the product.
In June 2013, Nanobiotix published positive interim results from the phase I trial establishing the proof-of-concept of NBTXR3 by demonstrating adequate distribution of the nanoparticles within the tumors for over five weeks of radiation therapy along with patient tolerance to the product.
Achieving the proof-of-concept is a key step in the clinical development of NBTXR3, the first product from the NanoXray pipeline, and represents the first stage of Nanobiotixs transition as a novel therapeutic in humans.
Following the positive interim results of NBTXR3 in patients with advanced Soft Tissue Sarcoma, the ANSM gave its approval to start a new clinical trial for the product in patients with locally advanced head and neck cancers (cancers of the oral cavity or of the oropharynx).
These types of cancer are a major challenge to treat as the current standard of care, combining chemotherapy and radiotherapy, has a very high relapse rate.
This indication is of a high strategic interest as it embodies a new method of treatment that could mean the avoidance of highly disabling surgery for patients.
Originally posted here:
Nanobiotix 2013 Review: Significant Corporate and Clinical Progress