Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

Nanobiotix Receives Approval from ANSM to Start New Clinical Trial with NBTXR3

Published: Thursday, June 13, 2013
Last Updated: Thursday, June 13, 2013
Bookmark and Share
Second indication for NanoXray product in Head and Neck cancer patients.

NANOBIOTIX has announced that its lead compound NBTXR3 has received authorization from the French Medicine Agency, ANSM, to start a clinical trial in patients with locally advanced cancers of the oral cavity or oropharynx (head and neck cancer), at the Institut Curie, Paris, France, a French leading cancer treatment center.

This represents a second indication for NBTXR3 which is also in clinical trials for soft tissue sarcoma.

The phase I trial will be an open-label non-randomized, dose escalation study of safety and tolerability evaluation of NBTXR3.

The product will be implanted by intra-arterial (IA) or intra-tumor (IT) injection, and activated by high precision radiation therapy (Intensity-modulated radiation therapy - IMRT) delivered as per current medical practice.

Patients with locally advanced squamous cell carcinoma of the oral cavity or oropharynx constitute the targeted population which includes frail and elderly patients.

Two different administration schedules of NBTXR3 will be investigated simultaneously in 2 different groups of patients.

Allocation of patients to the intra-tumor injection or intra-arterial injection depends on the patient and tumor singularity.

Based on the observed safety, the recommended doses for further evaluation of NBTXR3 as intra-arterial or intra-tumor injection with radiotherapy will be selected.

The secondary objectives of the study include assessment of the tumor Response Rate and complete Response Rate by MRI, and the evaluation of local and general Progression Free Survival of NBTXR3.

Furthermore, the feasibility of local administration, either intra-tumor or intra-arterial injection of NBTXR3, then activated by radiotherapy will be evaluated.

Approximately, 24 patients are expected to be treated in any schedule (IT or IA) of the trial, with a total of maximum 48 patients.

“The approval from ANSM to start a second clinical trial with NBTXR3 in Head and Neck cancer patients is a major milestone for Nanobiotix,” said Laurent Levy, PhD, CEO of Nanobiotix.

Levy continued, “This follows the recent positive intermediate results from the clinical study of NBTXR3 in advanced Soft Tissue Sarcoma patients, which continues the regulatory pathway to market.”

Head and neck cancer represents a group of biologically similar cancers that appear in the mouth, the nose, the sinuses and at the top of the aerodigestive tract. This type of cancer could be cured if detected early.

With large tumours in this area, the most common method of treatment is some form of surgery or radiation therapy.

The issue with surgery is its detrimental effect on the patient’s function, in terms of swallowing, breathing or speech - and cosmetic appearance.

The aim of using the NanoXray product, NBTXR3 in radiation therapy is to improve tumor destruction and maintain the patients’ function and appearance.

“Head and neck cancers are a major concern of public health in some European countries and across Asia. There is an immediate need for innovative therapies in this type of cancer. NBTXR3 may significantly help to improve the quality of life in this patient population including frail and elderly patients,” said Alain Herrera, oncologist and non-executive board member of Nanobiotix.

Nanobiotix’s therapeutic aim is to help patients in the fight against cancer and enhancing the effect of radiotherapy treatment. Nanobiotix is committed to bringing science to healthcare and to improve patients' quality of life.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Nanobiotix Half Year Results for the Six Months Ended 30 June 2014
Significant operational and clinical progress made.
Tuesday, September 02, 2014
Nanobiotix Sees Clinical Advance in STS Pilot Trial with Lead Product, NBTXR3
Market development plan outlined for earlier potential launch in 2016.
Tuesday, February 11, 2014
NANOBIOTIX honored at the INVESTOR AWARDS 2013 in the “Young Talent” category
NANOBIOTIX announced it has been awarded the “Young Talent” Award at the INVESTOR AWARDS 2013, referring to a newly listed company.
Friday, November 08, 2013
Nanobiotix Announces €2.8 Million Grant to Develop NBTXR3
Through ETPN, Nanobiotix is driving nanomedicine in Europe and is now involved in the first nanomedicine consortium in France with the launch of NICE project.
Friday, July 05, 2013
Scientific News
New Class of RNA Tumor Suppressors Identified
Two short, “housekeeping” RNA molecules block cancer growth by binding to an important cancer-associated protein called KRAS. More than a quarter of all human cancers are missing these RNAs.
Biologists Induce Flatworms to Grow Heads and Brains of Other Species
Findings shed light on role of a new kind of epigenetic signaling in evolution, could yield clues for understanding birth defects and regeneration.
Turning up the Tap on Microbes Leads to Better Protein Patenting
Mining millions of proteins could become faster and easier with a new technique that may also transform the enzyme-catalyst industry, according to University of California, Davis, researchers.
Mathematical Model Forecasts the Path of Breast Cancer
Chances of survival depend on which organs breast cancer tumors colonize first.
Exploring the Causes of Cancer
Queen's research to understand the regulation of a cell surface protein involved in cancer.
Ancient Viral Molecules Essential for Human Development
Genetic material from ancient viral infections is critical to human development, according to researchers at the Stanford University School of Medicine.
Tardigrade's Are DNA Master Thieves
Tardigrades, nearly microscopic animals that can survive the harshest of environments, including outer space, hold the record for the animal that has the most foreign DNA.
The Secret Behind the Power of Bacterial Sex
Migration between different communities of bacteria is the key to the type of gene transfer that can lead to the spread of traits such as antibiotic resistance, according to researchers at Oxford University.
Farming’s in Their DNA
Ancient genomes reveal natural selection in action.
GMO Food Animals Should be Judged by Product, Not Process
In a world with a burgeoning demand for meat, milk and eggs, regulatory policies around the use of biotechnologies in agriculture need to be based on the safety and attributes of those foods rather than on the methods used to produce them, says a UC Davis animal scientist.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos