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

Nanobiotix Presents Successful Phase I Results for NBTXR3 at ASCO

Published: Tuesday, June 03, 2014
Last Updated: Tuesday, June 03, 2014
Bookmark and Share
Final results demonstrate a very good safety, treatment feasibility and promising signs of efficacy in patients with advanced Soft Tissue Sarcomas.

NANOBIOTIX has announced the successful completion of the first in human study of its lead NanoXray product, NBTXR3, which will be presented at the American Society of Clinical Oncology (ASCO) annual meeting.

The Phase I clinical study established that intratumoral injection of NBTXR3 followed by radiotherapy has a good safety profile in patients with locally advanced soft tissue sarcoma (STS), who have an important risk of relapse and few treatment options.

These results allow Nanobiotix to proceed to the pivotal phase, which is the final step leading to registration (CE mark).

The study showed that promising signs of antitumor activity for different sarcoma subtypes were observed. Interestingly, tumor shrinkage and pathological response were observed in well-known refractory tumors. All patients underwent a wide surgical resection. This optimal surgery impacts the local recurrence rate, improving patient prognosis since local disease control prolongs progression free survival and overall survival in high grade sarcomas.

Elsa Borghi, CMO of Nanobiotix said: “These results are really encouraging, the feasibility of injecting different sarcoma subtypes with varying volumes of NBTXR3 nanoparticles was tested in this phase I study and a very good tolerance was observed. We are pleased to announce that each patient has been successfully operated on. This has reinforced the fact that radiotherapy with NBTXR3 has the potential to be an effective pre-operative treatment and offer meaningful clinical benefit to patients with advanced Soft Tissue Sarcoma (STS). Now, further development of NBTXR3 is warranted and a pivotal trial is planned to start in Q4 2014.”

The study enrolled 20 patients who received a single intratumoral injection of NBTXR3, at escalating volumes, followed by standard radiotherapy (50Gy RTx), as indicated in this clinical setting.

Primary endpoints included feasibility of the intratumoral implantation and safety. Secondary endpoints focused on the efficacy such as pathological response and RECIST (Response Evaluation Criteria In Solid Tumors) response, including tumor volume evaluation. Moreover, IntraTumoral permanence of NBTXR3 and operability were assessed.

Key findings:

Feasibility of the NBTXR3 injection within the tumor mass across different tumor types and volumes (from 55.06ml to 3682.56ml) was demonstrated.
No leakage of NBTXR3 to the surrounding healthy tissues was confirmed.
• Persistence of NBTXR3 during all sessions of radiotherapy: optimal bioavailability over time.
• Appropriate dispersion of the product within the tumor: diffusion in 3 dimensions.
Very good tolerance and local safety of the product at volume 2.5%, 5%, 10% and 20% was observed.
Promising signs of antitumor activity were observed in different sarcoma subtypes, such as undifferentiated sarcoma, rhabdomyosarcoma, and synovial sarcoma.
The recommended volume for the pivotal study is 10%.

Laurent Levy, CEO of Nanobiotix commented: “The completion of this Phase I study is a very important milestone for Nanobiotix. The next step for us is to initiate a pivotal study for NBTXR3 in patients with advanced soft tissue sarcomas. We expect to start enrolling patients by the end of 2014. This successful feasibility of our NBTXR3 approach in cancer patients also encourages us to expand the use of NBTXR3 in other indications like head and neck cancer, liver cancer, glioblastoma, rectal cancer and prostate cancer, and to think about developments of our other products, NBTX-IV and NBTX-TOPO.”


Further Information

Join For Free

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 3,000+ scientific posters on ePosters
  • More than 4,400+ 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.


Scientific News
Cell Transplant Treats Parkinson’s in Mice
A University of Wisconsin—Madison neuroscientist has inserted a genetic switch into nerve cells so a patient can alter their activity by taking designer drugs that would not affect any other cell.
Understanding Female HIV Transmission
Glowing virus maps points of entry through entire female reproductive tract for first time.
Experimental Drug Cancels Effect from Key Intellectual Disability Gene
A University of Wisconsin—Madison researcher who studies the most common genetic intellectual disability has used an experimental drug to reverse — in mice — damage from the mutation that causes the syndrome.
Common Class of Cancer Drugs May Not Lead to Cognitive Decline
UCLA study refutes 2015 research suggesting anthracyclines could cause memory loss, other impairments.
Designing Better Drugs
A rational drug engineering approach could breathe new life into drug development.
Genetic Approach May Lead to New Treatments for Digestive Diseases
Researchers at UMass Medical School have identified a new molecular pathway critical for maintaining the smooth muscle tone that allows the passage of materials through the digestive system.
Potential Target for Revolutionary Antibiotics
An international team of including the Lomonosov Moscow State University researchers discovered which enzyme enables Escherichia coli bacterium (E. coli) to breathe.
Unique Model for Studying ALS
Unique mouse model will allow researchers to better study the genetic origins and potential treatments of ALS.
Factors Influencing Influenza Vaccine Effectiveness Uncovered
The long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited, new research suggests.
New Model to Enhance Zika Virus Research
The model will allow researchers to better understand how the virus causes disease and aid in the development of antiviral compounds and vaccines.
SELECTBIO

SELECTBIO Market Reports
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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,400+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!