NANOBIOTIX: the Independent Data Monitoring Committee recommends the continuation of the ongoing phase II/III trial of NBTXR3...
March 23 2017 - 1:16PM
NANOBIOTIX: THE INDEPENDENT DATA
MONITORING COMMITTEE RECOMMENDSTHE 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
Nanobiotix |
Sarah GaubertDirector, Communications & Public
Affairs+33 (0)1 40 26 07 55sarah.gaubert@nanobiotix.com
/contact@nanobiotix.com |
Noël Kurdi Director, Investor
Relations +1 (646) 241-4400 noel.kurdi@nanobiotix.com /
investors@nanobiotix.com |
Media relations |
France -
Springbok ConsultantsMarina Rosoff+33 (0)6 71 58 00
34marina@springbok.fr |
|
United States -
RooneyPartners Marion Janic +1 (212)
223-4017mjanic@rooneyco.com |
|
DisclaimerThis 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.
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