The European Medicines Agency (EMA) has granted Orphan Drug Designation for OctreoPharm Sciences’ OPS202 as a diagnostic agent for the management of patients with gastro-entero-pancreatic-neuroendocrine tumours (GEP-NETs).
The orphan drug status will accelerate and facilitate the access for NET patients to the 68Ga PET technology.
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Compared with the currently available modalities, OPS202 demonstrated improved results in humans in the preliminary results.
The company said that the complete diagnostic procedure can be completed in one hour and provides quantification capability that might be improved compared with other radio-labelled compounds.
OctreoPharm Sciences managing director Hakim Bouterfa said: "This designation is an important step in the development of a new and potentially heavily improved diagnostic and staging tool for a seriously debilitating and potentially lethal disease."
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The company said that OPS202 is a new 68Gallium-labeled radiopharmaceutical being developed for positron emission tomography (PET, PET/CT) with the potential to detect even smallest lesions of NETs.
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By GlobalDataOPS202 binds to the somatostatin receptor subtype 2 on the surface of neuroendocrine tumours.
The company has developed a technology using a specific chelator and buffer system that allows labelling at room temperature in just a couple of minutes.
OctreoPharm Sciences founder and senior advisor Udo Blaseg said the orphan drug status entitles the company to ten year market exclusivity in Europe following marketing approval for OPS202.
"It also provides special benefits, including possible exemptions in certain regulatory fees during development, which will significantly help in an expedited and less expensive regulatory pathway for a final approval," Blaseg said.
Unlike the currently used agonists DOTATOC, DOTATATE or DOTANOC, OPS202 is member of a family of next-generation antagonistic peptides.
The company expects to start a clinical Phase I study for OPS202 later in 2014.
Image: Micrograph of a neuroendocrine tumour. Photo: courtesy of Nephron.
