Nordic Nanovector: Protocol Amendment Filed in the UK to Enable Initiation of Phase II PARADIGME
OSLO, Norway, Nov. 8, 2017 /PRNewswire/ --
Nordic Nanovector (OSE: NANO) notes that information relating to an application for a Protocol Amendment to the LYMRIT 37-01 study, for the planned pivotal Phase 2b clinical trial PARADIGME to evaluate Betalutin® (177Lu-lilotomab satetraxetan) in recurrent/relapsed follicular lymphoma has been published by MHRA (Medicines and Healthcare products Regulatory Agency).
The application for the Protocol Amendment is under-going review by the MHRA. The board of directors of Nordic Nanovector will decide on the final structure and initiation of the study upon response from regulatory authorities.
The application is based on a plan for PARADIGME to be a global Phase 2b clinical trial to compare the two dosing regimens from LYMRIT 37-01 in approximately 130 patients:
• 15 MBq/kg Betalutin® after 40 mg lilotomab pre-dosing;
The objective of PARADIGME is to enable a robust dose selection process for future clinical use and to produce the best clinical data package to support the selected dosing regimen on which to base a Market Authorization Application for Betalutin®.
Further details of trial will be presented at the company's Capital Markets Day on 22 November in Oslo, as announced yesterday.
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SOURCE Nordic Nanovector
Company Codes: Bloomberg:NANO@NO, ISIN:NO0010597883, Oslo:NANO, RICS:NANO.OL