NANOBIOTIX: the Independent Data Monitoring Committee recommends the continuation of the ongoing phase II/III trial of NBTXR3 in Soft Tissue Sarcoma
(Thomson Reuters ONE) -
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, Massachusetts, USA, March 23, 2017 - 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.
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: www.nanobiotix.com
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.
Contact
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Nanobiotix
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Sarah Gaubert Noël Kurdi
Director, Communications & Public Director, Investor Relations
Affairs +1 (646) 241-4400
+33 (0)1 40 26 07 55 noel.kurdi(at)nanobiotix.com /
sarah.gaubert(at)nanobiotix.com / investors(at)nanobiotix.com
contact(at)nanobiotix.com
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Media relations
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France - Springbok Consultants United States -
Marina Rosoff RooneyPartners
+33 (0)6 71 58 00 34 Marion Janic
marina(at)springbok.fr +1 (212) 223-4017
mjanic(at)rooneyco.com
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 on
www.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.
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: NANOBIOTIX via GlobeNewswire
Datum: 23.03.2017 - 18:15 Uhr
Sprache: Deutsch
News-ID 532156
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