Nordic Nanovector to Conduct a Comprehensive Review and Independent Data Evaluation of PARADIGME, its Phase 2b Trial with Betalutin® in R/R FL as a Result of Continuing Slow Recruitment
Oslo, Norway, 2 June 2022
Nordic Nanovector ASA (OSE: NANOV) today provides an update on PARADIGME, its ongoing Phase 2b trial of Betalutin® (177Lu lilotomab satetraxetan) in 3rd-line relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL).
As highlighted at the recent Q1 results, reported on 13 May 2022, recruitment into PARADIGME has been slower than anticipated, and despite ongoing efforts by the company this has continued into Q2 with no additional patients enrolled in May.
As a result, the Board of Nordic Nanovector has decided to conduct a comprehensive review of all aspects of the PARADIGME study. In order to fully protect the integrity of the study an independent evaluation of the data collected to date has been commissioned and will be analysed by an Independent Expert Panel. This information will then be used to determine the best path forward for the study. PARADIGME will continue to enrol patients while the independent evaluation is ongoing.
The current guidance for delivery of initial top line data from PARADIGME in the second half of this year will be reviewed concurrently.
The Board expects to report on the findings of the review of PARADIGME no later than the Q2 results to be released on 20 July 2022 and will not be commenting further until the review is complete.
The Board believes that this review of PARADIGME is in the best interests of all shareholders and the patients who Nordic Nanovector is targeting in this study to determine the optimal path forward for Betalutin® within a timeframe that is financially and commercially viable.
For further information, please contact:
IR enquiries
Malene Brondberg, CFO
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com
Media Enquiries
Mark Swallow/Frazer Hall (MEDiSTRAVA Consulting)
Tel: +44 203 928 6900
Email: nordicnanovector@medistrava.com
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.
Further information can be found at www.nordicnanovector.com.
Forward-looking statements
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 Section 5-12 of the Norwegian Securities Trading Act.
Source: Nordic Nanovector
