–Nordic Nanovector ASA (OSE: NANOV) 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). The Company reports that 106 patients have been enrolled into PARADIGME as of 6 January 2022.
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.”
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 radioimmunotherapy 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 29 billion by 2026. Nordic Nanovector retains global marketing rights to Betalutin® and intends to actively participate in the commercialisation of Betalutin® in the US and other major markets.
This press release contains certain forward-looking statements. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Nordic Nanovector’s business, financial condition and results of operations. The terms “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “may”, “might”, “plans”, “should”, “projects”, “targets”, “will”, “would” or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. These forward-looking statements are not historic facts. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in the forward-looking statements. Factors that could cause these differences include, but are not limited to, risks associated with implementation of Nordic Nanovector’s strategy, risks and uncertainties associated with the development and/or approval of Nordic Nanovector’s product candidates, ongoing and future clinical trials and expected trial results, the ability to commercialise Betalutin®, technology changes and new products in Nordic Nanovector’s potential market and industry, Nordic Nanovector’s freedom to operate (competitors patents) in respect of the products it develops, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions, and legislative, regulatory and political factors. No assurance can be given that such expectations will prove to have been correct. Nordic Nanovector disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
This information is subject to a duty of disclosure pursuant to Sections 4-2 and 5-12 of the Securities Trading Act.
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