Nobuko Hijiya, MD, Pediatric Hematology-Oncology at Columbia University Irving Medical Center and NewYork-Presbyterian Morgan Stanley Children’s Hospital speaks about A Phase 2 Study Of Nilotinib In Pediatric Patients With CML: Long-term Update On Growth Retardation And Safety.
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https://www.nordicnanovector.com/investors-and-media/press-releases?page=/press/perma/1936235
PRNewswire "“ OSLO, Norway, August 3, 2021 " PARADIGME, Nordic Nanovector ASA’s ongoing pivotal Phase 2b study of Betalutin® (177Lu lilotomab satetraxetan) in 3rd-line relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL), has received an update. The Company now expects the preliminary three-month data readout from PARADIGME within the first half of 2022, after reviewing the recent rate of patient enrollment with its clinical advisers and considering the ongoing impact of the COVID pandemic.
On Thursday, August 5, 2021, at 08.30 CEST, the Company will hold a live webcast and Q&A. On Wednesday, August 4th, in the afternoon, a link to the webcast will be accessible at www.nordicnanovector.com.
As of 3 August, 92 individuals had been registered in PARADIGME, compared to 83 patients on 25 May 2021 and 73 on 17 February 2021, according to the company.
While the Company’s ability to screen, enroll and treat new patients has improved as a result of changes to the PARADIGME protocol and initiatives implemented to improve trial execution, the ongoing COVID pandemic situation, exacerbated by the spread of the more infectious SARS-CoV-2 delta variant, continues to hamper the Company’s ability to screen, enroll, and treat new patients. This is because the patients in this research are at the highest risk of contracting COVID-19 because of their physical state. As a result, patient recruitment has progressed more slowly than expected.
Nordic Nanovector continues to prioritize PARADIGME and devote all necessary resources to its completion. Nordic Nanovector has opted to close clinical locations where recruitment has been especially difficult and spends resources on other efforts as part of this prioritization; the trial remains available for enrolment at 85 sites. The Company’s existing financial position will allow it to operate until the second half of 2022.
Furthermore, the company clarifies that it will not spend any additional funding in the Archer-1 Phase 1b study, which is looking at Betalutin® in conjunction with rituximab in 2nd-line FL. The results of this trial, which will be released on May 25, 2021, will be crucial in determining the future development plan for Betalutin® in 2L FL.