Nanobiotix receives approval from ANSM to start new Clinical Trial with Lead Product NBTXR3
(Thomson Reuters ONE) -
Second indication for NanoXray product in Head and Neck cancer patients
Paris, France, June 13, 2013 - NANOBIOTIX (Euronext: NANO), a clinical-stage
nanomedicine company pioneering novel approaches for the local treatment of
cancer, announces today that its lead compound NBTXR3 has received authorization
from the French Medicine Agency, ANSM[1], to start a clinical trial in patients
with locally advanced cancers of the oral cavity or oropharynx (head and neck
cancer), at the Institut Curie, Paris, France, a French leading cancer treatment
center. This represents a second indication for NBTXR3 which is also in clinical
trials for soft tissue sarcoma.
The phase I trial will be an open-label non-randomized, dose escalation study of
safety and tolerability evaluation of NBTXR3. The product will be implanted by
intra-arterial (IA) or intra-tumor (IT) injection, and activated by high
precision radiation therapy (Intensity-modulated radiation therapy - IMRT)
delivered as per current medical practice. Patients with locally advanced
squamous cell carcinoma of the oral cavity or oropharynx constitute the targeted
population which includes frail and elderly patients. Two different
administration schedules of NBTXR3 will be investigated simultaneously in 2
different groups of patients. Allocation of patients to the intra-tumor
injection or intra-arterial injection depends on the patient and tumor
singularity. Based on the observed safety, the recommended doses for further
evaluation of NBTXR3 as intra-arterial or intra-tumor injection with
radiotherapy will be selected.
The secondary objectives of the study include assessment of the tumor Response
Rate and complete Response Rate by MRI, and the evaluation of local and general
Progression Free Survival of NBTXR3. Furthermore, the feasibility of local
administration, either intra-tumor or intra-arterial injection of NBTXR3, then
activated by radiotherapy will be evaluated.
Approximately, 24 patients are expected to be treated in any schedule (IT or IA)
of the trial, with a total of maximum 48 patients.
"The approval from ANSM to start a second clinical trial with NBTXR3 in Head and
Neck cancer patients is a major milestone for Nanobiotix," said Laurent Levy,
PhD, CEO of Nanobiotix. "This follows the recent positive intermediate results
from the clinical study of NBTXR3 in advanced Soft Tissue Sarcoma patients,
which continues the regulatory pathway to market."
Head and neck cancer represents a group of biologically similar cancers that
appear in the mouth, the nose, the sinuses and at the top of the aerodigestive
tract. This type of cancer is could be cured if detected early. With large
tumours in this area, the most common method of treatment is some form of
surgery or radiation therapy. The issue with surgery is its detrimental effect
on the patient's function, in terms of swallowing, breathing or speech - and
cosmetic appearance.
The aim of using the NanoXray product, NBTXR3 in radiation therapy is to improve
tumor destruction and maintain the patients' function and appearance.
"Head and neck cancers are a major concern of public health in some European
countries and across Asia. There is an immediate need for innovative therapies
in this type of cancer. NBTXR3 may significantly help to improve the quality of
life in this patient population including frail and elderly patients," said
Alain Herrera, oncologist and non-executive board member of Nanobiotix.
Nanobiotix's therapeutic aim is to help patients in the fight against cancer and
enhancing the effect of radiotherapy treatment. Nanobiotix is committed to
bringing science to healthcare and to improve patients' quality of life.
[1] Agence Nationale de Sécurité du Médicament et des produits de santé
-- ENDS -
About NANOBIOTIX
Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a 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 to provide a new, more efficient treatment for cancer
patients. NanoXray products are compatible with current radiotherapy treatments
and are meant to treat a wide variety of cancers via multiple routes of
administration. Nanobiotix's lead product NBTXR3, based on NanoXray, is
currently under clinical development for soft tissue sarcoma. The Company has
partnered with PharmaEngine for clinical development and commercialization of
NBTXR3 in Asia. The Company is based in Paris, France.
For more information, please visit www.nanobiotix.com
About NANOXRAY
Nanobiotix's first-in-class, proprietary technology called NanoXray is at the
forefront of a new era of nanomedicine, where nanoparticles are not just a
vehicle for targeted drug delivery, but have become the principal active
element. The NanoXray technology is based on the physical properties of hafnium-
oxide nanoparticles and is used to enhance the efficacy of radiotherapy
treatment for a variety of cancer indications.
Nanoparticles are designed to enter tumor cells and, upon activation by a
standard dose of radiation, they emit large amounts of electrons resulting in
the generation of free radicals that destroy cancer cells (the same mode of
action than radiotherapy but largely amplified). Nanoparticle-enhanced
radiotherapy therefore amplifies the lethal dose of energy locally within the
tumor without changing the effect of the dose passing through surrounding
healthy tissues.
By changing the coating of the nanoparticles, Nanobiotix is developing three
different products that can be administered either by direct injection into the
tumor (NBTXR3), intravenous injection (NBTX-IV) or topical application to fill
tumor cavities after surgery (NBTX-TOPO). The product applied will depend on
type of tumor and the patient's specific clinical needs. NanoXray products are
classified as a medical device in Europe and as a drug in the US. They are
compatible with current radiotherapy methods with respect to equipment and
protocols, as well as with older radiotherapy equipment or any radiation based
therapy (brachytherapy, proton therapy...).
For more information, please contact:
Nanobiotix Yucatan
Laurent Levy Media relations (France)
CEO Annie-Florence Loyer/
+33 (0)1 40 26 07 55 Nadège Le Lezec
laurent.levy(at)nanobiotix.com +33 (0)1 53 63 27 27 / +33 (0)6 88 20 35 59
afloyer(at)yucatan.fr
NewCap. College Hill
Financial communication Media relations (Outside France)
and investors relations Melanie Toyne Sewell / Anastasios Koutsos /
Louis-Victor Delouvrier / Donia Al Saffar
Emmanuel Huynh +44 (0) 207 457 2020
+33 (0)1 44 71 98 53 nanobiotix(at)collegehill.com
lvdelouvrier(at)newcap.fr
Press Release (PDF):
http://hugin.info/157012/R/1709090/566374.pdf
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Source: NANOBIOTIX via Thomson Reuters ONE
[HUG#1709090]
Datum: 13.06.2013 - 08:00 Uhr
Sprache: Deutsch
News-ID 269290
Anzahl Zeichen: 8665
contact information:
Town:
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Kategorie:
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