NANOBIOTIX reports positive Phase I/II preliminary data on feasibility and safety of NBTXR3 in liver cancers trial
(Thomson Reuters ONE) -
Nanobiotix reports positive Phase I/II preliminary data on feasibility and
safety of NBTXR3 in liver cancers trial
Good safety and feasibility of the treatment at 10% dose level
Third indication in global development confirming transferability across
different cancers
Paris, France and Cambridge, Massachusetts, USA, December 14, 2016 - NANOBIOTIX
(Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine
company pioneering novel approaches for the local treatment of cancer, today
announces a positive readout of initial data on the safety and feasibility from
the first patients treated in its Phase I/II trial evaluating NBTXR3 in liver
cancers, including primary (Hepatocellular, HCC) and metastatic tumors.
Patients with either HCC or liver metastases frequently cannot undergo surgery
and have very few or no therapeutic options available. Radiation therapy has
been shown to improve outcomes of these patients. Clinical trials have shown a
direct correlation between higher doses of radiation therapy and increased
survival, in both patient populations. The delivery of a high radiation dose is
complex and cannot be done in an optimal way in most situations due to toxicity.
NBTXR3 aims to amplify the energy dose within the tumor to offer better clinical
results and more therapeutic options to improve the poor prognosis of these
populations.
Nanobiotix's Phase I/II trial evaluates the safety and preliminary efficacy of
NBTXR3 nanoparticles administrated by intra-tumoral (IT) or intra-arterial (IA)
injection and activated by high precision radiation therapy, delivered as high
dose fractions (Stereotactic Body Radiation Therapy (SBRT)) for the treatment of
liver cancers.
Elsa Borghi, CMO of Nanobiotix: "At this stage, the safety and feasibility data
of NBTXR3 in liver cancers are excellent. Observations are similar to the
results of our more advanced trials: Soft Tissue Sarcoma and Head and Neck
cancers. This is significant because these trials cover very different patient
and disease profiles. Based on the information gathered to date, we anticipate
that by the end of this phase, we will have identified the appropriate
conditions to use NBTXR3 in these patients populations. Once again, all
transferability data show the potential of broad applicability of NBTXR3 for use
with radiotherapy in the treatment of solid tumors."
Preliminary data results:
1. Good safety profile with no serious adverse events recorded
Two sub-groups of patients have been treated at 10% dose of NBTXR3, with Intra
Tumoral injections (IT), using either 24 Gy or 45 Gy total radiation dose, based
on patients dosimetric constrains.
Intra-arterial injection has not been explored so far because the Intra Tumoral
(IT) injection has been shown to be feasible and successful.
Good safety has been demonstrated within these patients as well. To date, all
treated patients have completed their radiation therapy course, confirming good
local tolerability and no changes in liver hepatic functions (MELD Score
evaluation).
2. Treatment feasibility and appropriate distribution demonstrated
The data validate the feasibility of the injection with a volume level
equivalent to 10% of the baseline tumor volume in both patient populations:
primary cancer (HCC) and liver metastasis.
The product appears to stay within the tumors with no leakage in the surrounding
healthy tissues from the day of injection until end of radiotherapy treatment
(illustration 1 & 2). It confirms and supports the findings reported from the
clinical trials in Soft Tissue Sarcoma or Head and Neck cancers patients.
3. 10% volume level secured, further levels under evaluation
The 10% dose level was successfully evaluated in HCC and metastatic patients.
The 10% dose level is the recommended NBTXR3 volume for the treatment of soft
tissue sarcoma (STS) in the act.in.sarc study (www.actinsarc.com), the most
advanced indication developed by Nanobiotix (Phase II/III).
The trial is now recruiting next dose levels to evaluate safety and feasibility
at higher doses along with exploratory efficacy endpoints (complete Response
Rate, Progression Free Survival and Overall Survival).
-ends-
About liver cancers
According to WHO, liver cancers are the second most common cause of cancer death
in the world with 745,000 deaths each year, and 800,000 new liver cancer
patients per year.
Liver cancers are challenging diseases to address. Stereotactic Body Radiation
Therapy (SBRT) is the safest and most modern radiotherapy currently available
for the treatment of malignant liver tumors but SBRT has been shown to be
efficient only in specific subsets of population with small tumors. Complete
response is a rare event and local control is often compromised in big tumors,
metastases and HCC with portal vein tumor thrombosis and short progression Free
Survival and Overall survival.
About NBTXR3 trial protocol in liver cancer
NBTXR3 is a first-in-class radio-enhancer nanoparticle designed for direct
injection into malignant tumors. NBTXR3 has the potential to improve
radiotherapy efficacy by destroying locally advanced cancers more efficiently.
It has been engineered to increase the local absorption of the radiotherapy dose
and thereby increasing the efficacy of radiotherapy without increasing toxicity
or causing damage to surrounding healthy tissues.
The first phase of the ongoing, multicenter open-label, single-arm study is a
dose-escalation to evaluate the safety, feasibility and preliminary clinical
activity along with determining the right dose of NBTXR3 in this indication. The
second phase of the trial will be a dose-expansion phase, which will be a cohort
expansion at the recommended dose of NBTXR3.
Patients receive a single injection administration of NBTXR3 24 hours before the
beginning of the radiotherapy treatment. The total maximum radiotherapy dose is
45 Gy, delivered as three fractions of 15 Gy each, over 5 to 7 days.
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 provide 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 has filed in
August 2016 for market approval (CE Marking) in Europe for its lead product
NBTXR3.
Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN:
FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company
Headquarter is based in Paris, France. Affiliate in Cambridge, United States.
Contact
------------------------
Nanobiotix
------------------------
Sarah Gaubert
Head of Communication
and Public Affairs
+33 (0)1 40 26 07 55
contact(at)nanobiotix.com
------------------------ -----------------------------------------------------
Media relations
-------------------------------------------------------------------------------
France - Springbok EU Outside France - United States - The Ruth
Consultants Instinctif Partners Group
Marina Rosoff Melanie Toyne Sewell Kirsten Thomas / Chris
+33 (0)6 71 58 00 34 +44 (0) 207 457 2020 Hippolyte
marina(at)springbok.fr nanobiotix(at)instinctif.com +1 508-280-6592 /
+1 646-536-7023
Nanobiotix(at)theruthgroup.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 reference document of Nanobiotix filed with the French
Financial Markets Authority (Autorité des Marchés Financiers) under number D.16-
0732 on July 22, 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.
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: 14.12.2016 - 18:30 Uhr
Sprache: Deutsch
News-ID 512938
Anzahl Zeichen: 11350
contact information:
Town:
Paris
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 348 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"NANOBIOTIX reports positive Phase I/II preliminary data on feasibility and safety of NBTXR3 in liver cancers trial"
steht unter der journalistisch-redaktionellen Verantwortung von
NANOBIOTIX (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
