100 patients recruited across US and Europe
SAINT-GENIS-POUILLY, France, Oct. 16, 2013 /CNW/ - Advanced Accelerator
Applications (AAA), a fast growing international player in Molecular
Nuclear Medicine (MNM), announced today that the 100-patient milestone
has been reached for the NETTER-1 study, an international Phase III
clinical trial evaluating the effect of Lutathera® in patients with inoperable progressive midgut carcinoid
tumors. Lutathera® is the first theragnostic drug in MNM to enter phase III clinical
development. Its efficacy can be imaged and evaluated at each of a
total of four treatments via a SPECT (Single Photon Emission Computed
Tomography) camera, with no additional cost.
Stefano Buono, Chief Executive Officer of AAA, commented: "Recruitment has really started to gain momentum as physicians increasingly recognize the potential of
Lutathera®to help patients with this fatal disease. We expect results from the study to be published in 2015 and hope to obtain marketing authorization in H1 2017."
NETTER-1 is a Phase III, international, multi-center, randomized,
comparator-controlled, parallel-group study evaluating the efficacy and
safety of Lutathera® compared to Novartis' Sandostatin® LAR, in patients with inoperable, progressive, somatostatin receptor
positive, midgut carcinoid tumors. The primary endpoint of the trial is
the assessment of Progression-Free Survival. Secondary endpoints
include Safety, Objective Response Rate, Time to Tumor Progression,
Overall Survival and Quality of Life.
The study will include 200 patients across 51 centers in nine different
countries (Austria, Belgium, France, Germany, Italy, Portugal, Spain,
UK and the US). The rate of recruitment has accelerated in both Europe
and the US, with 68 additional patients consenting to take part in the
study (26 in Europe and 42 in the US) in the past six months. As of
today, 43 sites have been initiated (31 in Europe, 12 in US), and 23 of
them are actively recruiting.
Phase II results of Lutathera® in patients with progressive midgut carcinoid showed Progression-Free
Survival of over 45 months compared to the reported 14.6 months of
Novartis' Sandostatin® LAR.
Lutathera® is currently used on a named patient basis or compassionate use for
pre-marketing sales in several European countries (Austria, Estonia,
Finland, Greece, Portugal, Spain, Switzerland and the UK) when no
alternative therapeutic option is available and under specific
About Advanced Accelerator Applications
Advanced Accelerator Applications (AAA) is a European pharmaceutical
company founded in 2002 to develop innovative diagnostic and
therapeutic products. AAA's main focus is in the field of Molecular
Imaging and targeted, individualized therapy for the management of
patients with serious conditions (Personalized Medicine). AAA currently
has 16 production and R&D facilities able to manufacture both
diagnostics and therapeutic MNM products and over 260 employees in 10
countries (France, Italy, Germany, Switzerland, Spain, Poland,
Portugal, Israel, U.S., Canada). In 2012 AAA reported revenues of €44.6
million (+22.5% vs. 2011) and an EBITDA of €9.4 million (+59% vs.
2011). For more information please visit: http://www.adacap.com
Lutathera®, 177Lutetium-DOTA0-Tyr3-Octreotate, is a radiolabeled somatostatin analog that selectively
targets somatostatin receptors which are over-expressed in some tumor
It acts like a Trojan horse, delivering 177Lu directly into the tumor cell. 177Lu is an instable particle that releases an electron, which, as in
radiotherapy, is capable of killing the tumors by breaking the DNA of
its cells. It also releases a gamma ray, which exits the body and
enables physicians to image and evaluate the progress of the treatment
via a SPECT (Single Photon Emission Computed Tomography) camera.
Lutathera® is a true example of a theragnostic drug, since its efficacy can be
evaluated and monitored using imaging at every therapeutic injection,
without additional costs.
Lutathera® was developed by AAA's wholly-owned subsidiary, BioSynthema Inc, based
in St Louis, Missouri, USA under a licence from Covidien. Lutathera® has orphan drug status in Europe, Switzerland and the USA.
A single Phase III protocol was submitted to both the FDA and EMA at the
same time using a Parallel Scientific Advice procedure. Phase I/II
results were based on an independent review of a large
investigator-sponsored clinical study in over 600 patients affected by
different Gastro Entero Pancreatic Neuro Endocrine Tumors (GEP-NETs)
subtypes performed at the Erasmus Medical Centre, Rotterdam. Lutathera® was shown to extend patients' lives by between 3.5 and 6 years in
comparison to current treatments, including chemotherapy. It was also
shown to significantly improve quality of life.
For more information on the NETTER-1 study please visit: http://www.netter-1.com
SOURCE: Advanced Accelerator Applications
For further information:
Advanced Accelerator Applications SA Laetitia Defaye, Head of Corporate Communications, firstname.lastname@example.org, Tel: +33 (0)6 86 65 73 52; Véronique Mermet, Communications Officer, email@example.com, Tel: +33 (0)4 50 99 30 70 ; Media enquiries: FTI Consulting (UK): Stephanie Cuthbert, Stephanie.Cuthbert@fticonsulting.com , Tel: +44 (0)20 3077 0458 ; Julia Phillips, Julia.firstname.lastname@example.org, Tel: +44 (0)20 7269 7187