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

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 2,500+ scientific posters on ePosters
  • More than 3,700+ 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 TechnologyNetworks.com 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
Liquid Biopsies: Utilization of Circulating Biomarkers for Minimally Invasive Diagnostics Development
Market Trends in Biofluid-based Liquid Biopsies: Deploying Circulating Biomarkers in the Clinic. Enal Razvi, Ph.D., Managing Director, Select Biosciences, Inc.
Watching a Tumour Grow in Real-Time
Researchers from the University of Freiburg have gained new insight into the phases of breast cancer growth.
Childhood Cancer Cells Drain Immune System’s Batteries
Cancer cells in neuroblastoma contain a molecule that breaks down a key energy source for the body’s immune cells, leaving them too physically drained to fight the disease.
Urine Proteins Point to Early-Stage Pancreatic Cancer
A combination of three proteins found at high levels in urine can accurately detect early-stage pancreatic cancer, researchers at the BCI have shown.
Researcher Discovers Trigger of Deadly Melanoma
New research sheds light on the precise trigger that causes melanoma cancer cells to transform from non-invasive cells to invasive killer agents, pinpointing the precise place in the process where "traveling" cancer turns lethal.
Self-Assembling, Biomimetic Membranes May Aid Water Filtration
A synthetic membrane that self assembles and is easily produced may lead to better gas separation, water purification, drug delivery and DNA recognition, according to an international team of researchers.
Error Correction Mechanism in Cell Division
Cell biologists have reported an advance in understanding the workings of an error correction mechanism that helps cells detect and correct mistakes in cell division early enough to prevent chromosome mis-segregation and aneuploidy, that is, having too many or too few chromosomes.
Researchers Resurrect Ancient Viruses
Researchers at Massachusetts Eye and Ear and Schepens Eye Research Institute have reconstructed an ancient virus that is highly effective at delivering gene therapies to the liver, muscle, and retina.
Cell Aging Slowed by Putting Brakes on Noisy Transcription
Experiments in yeast hint at ways to extend life of some human cells.
Crucial for Stem Cell Survival Protein Identified Using Editing Tool CRISPR
A team of University of Wisconsin-Madison engineers has identified a protein that is integral to the survival and self-renewal processes of human pluripotent stem cells (hPSC).
SELECTBIO

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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!