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2016-12-14

NANOBIOTIX: NANOBIOTIX reports positive Phase I/II preliminary data on feasibility and safety of NBTXR3 in liver cancers trial

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).

1 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.

1 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@nanobiotix.com |
| Media relations |
| France -Springbok Consultants EU Outside France -Instinctif Partners United States -The Ruth Group |
| |
|Marina Rosoff Melanie Toyne Sewell Kirsten Thomas / Chris Hippolyte |
| |
|+33 (0)6 71 58 00 34 +44 (0) 207 457 2020 +1 508-280-6592 / +1 646-536-7023 |
|marina@springbok.fr nanobiotix@instinctif.com Nanobiotix@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

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