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
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.
Enzyme Critical to Maintaining Telomere Length Discovered
New method expected to speed understanding of short telomere diseases and cancer.
Gene Drive Reversibility Introduces New Layer of Biosafety
Ability to introduce or reverse the spread of genetic traits through populations could one day improve pest management and disease control.
RNA-Based Drugs Give More Control Over Gene Editing
CRISPR/Cas9 gene editing technique can be transiently activated and inactivated using RNA-based drugs, giving researchers more precise control in correcting and inactivating genes.
University of Glasgow Researchers Make An Impact in 60 Seconds
Early-career researchers were invited to submit an engaging, dynamic and compelling 60 second video illuminating an aspect of their research.
Metabolic Profiles Distinguish Early Stage Ovarian Cancer with Unprecedented Accuracy
Studying blood serum compounds of different molecular weights has led scientists to a set of biomarkers that may enable development of a highly accurate screening test for early-stage ovarian cancer.
Dead Bacteria to Kill Colorectal Cancer
Scientists from Nanyang Technological University (NTU Singapore) have successfully used dead bacteria to kill colorectal cancer cells.
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