Start of Pivotal Phase III Trial for Lutathera® in Cancer Patients With Progressive Midgut Carcinoid
SAINT GENIS POUILLY, France, September 19, 2012 /PRNewswire/ --
- Lutathera® is the first theragnostic drug in Molecular Nuclear Medicine (MNM) to enter phase III clinical development
- First European patient enrolled on July 20,2012; first US patient expected to be enrolled in Q4 2012
- Phase II results in progressive midgut carcinoid showed Progression-Free Survival of more than 44 months compared to the reported 14.6 months of Novartis' Sandostatin® LAR
- Safety and efficacy evaluated at every treatment with a SPECT camera, without additional costs
- Lutathera® is approved, on a named patient basis, for pre-marketing sales in Greece, Portugal, Finland and Austria
Advanced Accelerator Applications (AAA), a fast growing international player in Molecular Nuclear Medicine (MNM), announces the initiation of an international Phase III clinical trial evaluating the effect of Lutathera®, an investigational peptide, in patients with inoperable progressive midgut carcinoid. The study will be conducted at multiple centres in Europe and North America. The first European patient was enrolled on July 20th 2012 in Madrid, Spain. The FDA approved the trial on September 10th and the first patient is expected to be enrolled in the US during the fourth quarter of 2012.
Stefano Buono, Chief Executive Officer of AAA, commented: "We believe Lutathera® represents a promising new treatment for patients with this disease and other Neuro Endocrine Tumours (NETs). Previous investigator sponsored studies in Europe, Asia and Australia have produced very encouraging data in thousands of patients and as result Lutathera® has been approved, on a named patient basis, for pre-marketing sales in selected European countries."
The study, known as NETTER-1, is a Phase III, international, multi-center, randomised, 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 is the assessment of Progression-Free Survival (PFS). Secondary endpoints include safety, Objective Response Rate (ORR), Time to Tumour Progression (TTP), Overall Survival (OS) and Quality of Life (QoL).
The trial, which is being managed in collaboration with Pierrel Research International, will be conducted at 28 centres across Europe and 14 centres in the USA.
Lutathera®, Lutetium-DOTA-Tyr-Octreotate, is a radiolabeled somatostatin analog that selectively targets somatostatin receptors which are over-expressed in some tumor types.
It acts like a Trojan horse, delivering Lu directly into the tumour cell. Lu is an instable particle that releases an electron which, as in radiotherapy, is capable of killing the tumors. 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® has been approved, on a patient name basis, for pre-marketing sales in Greece, Portugal, Finland and Austria and the Company expects other territories to follow in the coming months. The product 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 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 Tumours (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.
In progressive midgut carcinoid, the indication of the NETTER-1 study, the sub-population of 51 patients showed Progression Free Survival of more than 44 months that compares to the reported 14.6 months of Novartis' Sandostatin® LAR.
Theragnostic drugs in MNM are complex and challenging to produce, due to the short shelf lifes linked to the instability of the labeling tracer. Lutathera® is the first of this generation of therapies to enter Phase III clinical development. AAA has two unique GMP facilities in Italy, which have been authorised by AIFA (the Italian pharmaceutical agency), and are successfully producing and shipping Lutathera® within the 72 hours of its expiration time. AAA's experience as a leading European PET (Positron Emission Tomography) manufacturer has been essential to this success. PET products have a 10 hour expiration time and require even more stringent logistic and production reliability.
FTI Consulting (UK)
Twister Communications Group (Italy)
Advanced Accelerator Applications SA
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SOURCE Advanced Accelerator Applications