OSLO, Norway, May 29, 2018 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANO) announces that its pivotal PARADIGME Phase 2b trial with Betalutin® (177Lu-satetraxetan-lilotomab) in third-line (3L) follicular lymphoma (FL) patients has been approved by the Regional Committees for Medical and Health Research Ethics (REK) in Norway. Nordic Nanovector has now received all necessary approvals to begin PARADIGME in Norway and will commence start-up activities with the selected clinical sites immediately with the intention of recruiting patients into the study as soon as possible.
PARADIGME is a global, randomised Phase 2b clinical trial comparing two promising Betalutin® dosing regimens in patients with third-line follicular lymphoma who are refractory to anti-CD20 immunotherapy (including rituximab), a population with a high unmet medical need. The trial will enrol 130 patients at 80-85 sites in approximately 20 countries. The first patient is expected to be dosed in the first half of 2018 and the data read-out is targeted to the first half of 2020.
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About Nordic Nanovector
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers.
Nordic Nanovector's lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin's lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 20 billion by 2024. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
Further information about the Company can be found at www.nordicnanovector.com
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SOURCE Nordic Nanovector