The company has received feedback from the Regional Committees for Medical and Health Research Ethics (REK) in Norway with regard to the Clinical Trial Application (CTA) for the Archer-1 Phase 1b trial with Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab in second-line follicular lymphoma patients.
Feedback from REK has been received following a review of the CTA for Archer-1, which took place on 26 April. The company and the lead investigator for the trial, Dr Arne Kolstad, senior consultant in medical oncology and radiotherapy at Oslo University Hospital Radiumhospitalet, are continuing discussions with REK towards gaining approval to start the study as soon as possible. Nordic Nanovector is targeting dosing of the first patient in the second half of 2018.
The CTA for the PARADIGME Phase 2b trial was also reviewed by REK on 26 April and its decision is still pending.
Both CTAs have already been approved by the Norwegian Medicines Agency (NoMA).
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. As of 5 April 2018, PARADIGME was open for enrolment in 13 clinical sites in 6 countries.