Nanotechnology Now

Our NanoNews Digest Sponsors

Heifer International

Wikipedia Affiliate Button

Home > Press > Nanobiotix: The Independent Data Monitoring Committee Recommends the Continuation of the Ongoing Phase II/III Trial of NBTXR3 in Soft Tissue Sarcoma

Abstract:
NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the local treatment of cancer, today announced that the Independent Data Monitoring Committee (IDMC) has completed the interim evaluation of the Phase II/III trial results (Act.In.Sarc) of NBTXR3 in soft tissue sarcoma.

Nanobiotix: The Independent Data Monitoring Committee Recommends the Continuation of the Ongoing Phase II/III Trial of NBTXR3 in Soft Tissue Sarcoma

Paris, France and Cambridge, MA | Posted on March 23rd, 2017

The interim evaluation was based on an analysis of the results of two-thirds of the patients included in the Phase II/III study – 104 patients were analyzed out of a total of 156. Based on the safety and available efficacy data, the IDMC has recommended the continuation of the Phase II/III trial of NBTXR3 in soft tissue sarcoma.

“The IDMC’s recommendation to continue the ongoing phase II/III trial of NBTXR3 is very positive news for soft tissue sarcoma patients, and an important milestone in NBTXR3’s clinical development.” said Elsa Borghi, Nanobiotix’s Chief Medical Officer “Now, we look forward to seeing the full data analysis” she added.

The pivotal international Phase II/III study in soft tissue sarcoma was launched in Europe and Asia in October 2014 and aims to evaluate the safety and the efficacy of NBTXR3, a first in-class radio enhancer that could potentially target most solid tumors. The Phase II/III study is a prospective, randomized, multi-center, open label and active controlled two-armed study of 156 patients with locally advanced soft tissue sarcoma. The primary endpoint is the complete pathological response rate. The secondary endpoints are the objective response rate (ORR) by imaging (MRI); the evaluation of the safety profile in term of clinical and laboratory adverse events; the tumor volume changes; the resection margins and the limb amputation rate.

The IDMC is an international independent body of experts made up of scientists, statisticians and practicing physicians. Specifically, it was chartered to review and ensure: i) the data related to the primary endpoint, ii) the safety of all patients enrolled in the study, (iii) the quality of the data collected, and (iv) the continued scientific validity of the study design on two thirds of the patients treated.

The completion of recruitment for the Act.in.Sarc trial is planned by the end of Q2 2017. The full data analysis, except for long-term follow-up, is expected to be available at the end of 2017.
Based on the positive recommendation from the IDMC, the Company will communicate, over the coming weeks, its overall plan to move forward.
For more information about the study: Clinical trial.gov and http://www.actinsarc.com/ .

####

About Nanobiotix
Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer. The Company’s first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy with a view to providing a new, more efficient treatment for cancer patients.
NanoXray products are compatible with current radiotherapy treatments and are meant to treat potentially a wide variety of solid tumors including soft tissue sarcoma, head and neck cancers, liver cancers, prostate cancer, breast cancer, glioblastoma, etc., via multiple routes of administration.

NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers (primary and metastases). Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix’s Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region. The Company filed in August 2016 for market approval (CE Marking) in Europe for its lead product NBTXR3.

The Company started in 2016 a new preclinical research program in Immuno-oncology with its lead product NBTXR3, which could have the potential to bring a new dimension to cancer immunotherapies.

Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company Headquarters are based in Paris, France, with an affiliate in Cambridge, Massachusetts.

Disclaimer
This press release contains certain forward-looking statements concerning Nanobiotix and its business. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the update of the reference document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) under number D.16-0732-A01 on December 27, 2016 (a copy of which is available onwww.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements.

This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Nanobiotix shares in any country. At the moment NBTXR3 does not bear a CE mark and is not permitted to be placed on the market or put into service until NBTXR3 has obtained a CE mark.
Violet Tran
RooneyPartners LLC

For more information, please click here

Contacts:
Sarah Gaubert
Director, Communications & Public Affairs
+33 (0)1 40 26 07 55





Noël Kurdi
Director, Investor Relations
+1 (646) 241-4400
/
Media relations

France - Springbok Consultants
Marina Rosoff
+33 (0)6 71 58 00 34



United States – RooneyPartners
Marion Janic
+1 (212) 223-4017

Copyright © Nanobiotix

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

The relationship between charge density waves and superconductivity? It's complicated July 19th, 2018

Sirrus's Issued Patent Portfolio Continues To Accelerate July 18th, 2018

FEFU scientists reported on toxicity of carbon and silicon nanotubes and carbon nanofibers: Nanoparticles with a wide range of applying, including medicine, damage cells of microalgae Heterosigma akashivo badly. July 18th, 2018

In borophene, boundaries are no barrier: Rice U., Northwestern researchers make and test atom-thick boron's unique domains July 17th, 2018

Cancer

Camouflaged nanoparticles used to deliver killer protein to cancer June 17th, 2018

Tiny particles could help fight brain cancer: Nanoparticles carrying two drugs can cross the blood-brain barrier and shrink glioblastoma tumors May 30th, 2018

New blood test rapidly detects signs of pancreatic cancer May 17th, 2018

Elastic microspheres expand understanding of embryonic development and cancer cells May 15th, 2018

Govt.-Legislation/Regulation/Funding/Policy

The relationship between charge density waves and superconductivity? It's complicated July 19th, 2018

FEFU scientists reported on toxicity of carbon and silicon nanotubes and carbon nanofibers: Nanoparticles with a wide range of applying, including medicine, damage cells of microalgae Heterosigma akashivo badly. July 18th, 2018

In borophene, boundaries are no barrier: Rice U., Northwestern researchers make and test atom-thick boron's unique domains July 17th, 2018

Tuning into quantum: Scientists unlock signal frequency control of precision atom qubits July 16th, 2018

Nanomedicine

Nano-kirigami: 'Paper-cut' provides model for 3D intelligent nanofabrication July 13th, 2018

UMBC researchers develop nanoparticles to reduce internal bleeding caused by blast trauma July 13th, 2018

Researchers identify cost-cutting option in treating nail fungus with nanotechnology: GW researcher Adam Friedman, M.D., studied the potential use of nitric oxide-releasing nanoparticles to improve onychomycosis treatment July 11th, 2018

New sensor technology enables super-sensitive live monitoring of human biomolecules July 3rd, 2018

Announcements

The relationship between charge density waves and superconductivity? It's complicated July 19th, 2018

Sirrus's Issued Patent Portfolio Continues To Accelerate July 18th, 2018

FEFU scientists reported on toxicity of carbon and silicon nanotubes and carbon nanofibers: Nanoparticles with a wide range of applying, including medicine, damage cells of microalgae Heterosigma akashivo badly. July 18th, 2018

In borophene, boundaries are no barrier: Rice U., Northwestern researchers make and test atom-thick boron's unique domains July 17th, 2018

Nanobiotechnology

UMBC researchers develop nanoparticles to reduce internal bleeding caused by blast trauma July 13th, 2018

Researchers identify cost-cutting option in treating nail fungus with nanotechnology: GW researcher Adam Friedman, M.D., studied the potential use of nitric oxide-releasing nanoparticles to improve onychomycosis treatment July 11th, 2018

New sensor technology enables super-sensitive live monitoring of human biomolecules July 3rd, 2018

Arrowhead Presents New Clinical Data on ARO-AAT at Alpha-1 National Education Conference July 1st, 2018

NanoNews-Digest
The latest news from around the world, FREE



  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project