Nordic Nanovector ASA (OSE: NANO), a company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology, announces that it has taken the decision to revise its clinical development plan for Betalutin®, its lead product candidate in development for the treatment of major types of non-Hodgkin's lymphoma (NHL), including Follicular Lymphoma.
A conference call to discuss the revised development plan will take place today at 9.30 a.m. CET / 8.30 a.m. BST – details below.
Luigi Costa, CEO of Nordic Nanovector, said: "We believe that our decision to revise the clinical development plan for Betalutin® makes good strategic sense. In light of newly available data and experts' advice with regard to pre-dosing, we have concluded that we now have a new opportunity to determine the best regimen to take into the pivotal Phase 2 PARADIGME trial. We are confident that by establishing the most appropriate regimen through an expanded Phase 1/2 study, rather than as part of PARADIGME, we will greatly improve the chances of successfully gaining regulatory approval for Betalutin® with a product profile that would make it a competitive new treatment for follicular lymphoma. I would like to thank all our advisors for their valuable input to this decision."
The revised clinical development plan sees the previous dose-finding element of the pivotal PARADIGME trial being expanded and integrated into the Phase 1/2 (Lymrit 37-01) trial that is currently underway. Previously, the dose-finding element was to be conducted in parallel as a 'run-in' phase to PARADIGME to potentially accelerate the time to approval. PARADIGME is now being planned as a single arm efficacy and safety trial.
The revised Phase 1/2 trial is projected to read out around the end of Q1 2017 and will allow the selection of the optimal dosing regimen to be used for the amended PARADIGME trial, which is now expected to start in 1H 2017. As a result, the first regulatory submission for Betalutin® is expected in the 1H 2019.
Based on the current plan, the Company expects that cash resources will be sufficient to reach the first regulatory submission despite the extended timelines. This is due to the overall reduction in patient numbers required for the PARADIGME study in the revised plan.
Conference call details
A conference call to discuss the revised development plan will take place today at 9.30 a.m. CET / 8.30 a.m. BST.
Please make sure to dial in 5-10 minutes prior to scheduled conference call start time using the number and confirmation code below:
Local - Norway +47 2350 0486
Local - UK +44 (0)20 3427 1912
Local – USA and International ++1 646 254 3366
Confirmation Code: 4608153
The presentation for the conference call will be publicly available at www.nordicnanovector.com in the section; Investor relations/Reports and Presentation/Presentation/2015.