On January 29, 2014 OctreoPharm Sciences reported that the company has received approval of "Orphan Drug Designation" by the European Medicines Agency (EMA) for OPS202 as a diagnostic agent for the management of patients with gastro-entero-pancreatic-neuroendocrine tumors (GEP-NETs) (Press release, OctreoPharm Sciences, JAN 29, 2014, View Source [SID:1234504856]). This will significantly expedite and facilitate the access for NET patients to the 68Ga PET technology. Preliminary results on OPS202 in humans are highly promising and have shown superior results compared to other currently available modalities. The whole diagnostic procedure can be completed in 1 hour and provides quantification capability that might be improved compared to other radio-labeled compounds. "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", said Dr. Hakim Bouterfa, Managing Director of OctreoPharm Sciences GmbH. Udo Blaseg, Founder and Senior Advisor added: "The Orphan Drug status entitles us 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."
About OPS202 (future trade name: SOMscan)
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OPS202 is a new 68Gallium-labeled radiopharmaceutical in clinical development for positron emission tomography (PET, PET/CT) with the potential to detect even smallest lesions of NETs. It binds to the somatostatin receptor subtype 2 on the surface of neuroendocrine tumors. OPS developed a technology using a specific chelator and buffer system that allows labeling at room temperature in just a couple of minutes.
OPS202 is member of a family of next-generation antagonistic peptides, unlike the currently used agonists DOTATOC, DOTATATE or DOTANOC. Agonists as first-generation peptides have exclusively been used as radio ligands in the past decade without regulatory approval for the implementation of peptide receptor targeting of tumors in vivo. However, the new class of antagonistic peptides is independent of the sst2 receptor activation state (G protein phosporylation) and therefore can target many more receptors expressed on the tumor cell surface. OctreoPharm Sciences GmbH aims to develop these antagonists in an approach referred to as Theranostics. Depending on the labeled radionuclide OPS202 can be used for diagnosis (68Ga) as well as for therapy (90Y) – the later is currently in preclinical development as OPS201 (SOMther). This might provide a unique pathway for personalized medicine to diagnose and treat neuroendocrine tumors based on the same compound. Start of a clinical phase I study for OPS202 will be later this year.