Nordic Nanovector Provides update on PARADIGME, its Phase 2b Pivotal Trial with Betalutin® in R/R Follicular Lymphoma

On January 7, 2022 Nordic Nanovector ASA (OSE: NANOV) reported that provides an update on the timeline for PARADIGME, its ongoing pivotal Phase 2b trial of Betalutin (177Lu lilotomab satetraxetan) in 3rd-line relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL) (Press release, Nordic Nanovector, JAN 7, 2022, View Source [SID1234598427]). The Company reports that 106 patients have been enrolled into PARADIGME as of 6 January 2022.

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Given the ongoing impact from the SARS-CoV-2 omicron variant on patient recruitment, the Company now anticipates the preliminary three-month data readout from PARADIGME to be reported during the second half of 2022 (previously first half of 2022).

As communicated on 3 August 2021, the changes to the PARADIGME protocol and other initiatives implemented by the Company have positively impacted execution of the PARADIGME trial. However, the ongoing COVID pandemic, exacerbated by the rapid spread of the new omicron variant of SARS-COV-2, has continued to affect the Company’s ability to screen, enrol and treat new patients whose physical condition means they are at the greatest risk from COVID-19 infection.

Despite this challenging situation, Nordic Nanovector continues to work diligently towards the completion of PARADIGME, which remains the Company’s key strategic priority for 2022.

Erik Skullerud, Chief Executive Officer of Nordic Nanovector, commented: "We are experiencing an unexpected significant impact of the new SARS-CoV-2 omicron variant on the enrolment rate of our clinical trial. However, we now have the end in sight, and I am confident that we can deliver the important preliminary data from this study during the second half of 2022."