checkAd

    Nordic Nanovector  231  0 Kommentare Safety Review Committee Approves Advancing to Final Dosing Regimen in Phase 1 Trial of Betalutin in DLBCL

    OSLO, Norway, April 10, 2019 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANO) announces that the Safety Review Committee (SRC) for the ongoing LYMRIT 37-05 clinical trial of single-administration Betalutin (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for stem cell transplantation (SCT) has now reviewed safety data from the first three cohorts of patients. Based on the data, the SRC approved advancing the trial to the next and final cohort with the dose regimen 20 MBq/kg Betalutin and a lilotomab pre-dose of 100 mg/m2.

    The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study designed to assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of Betalutin. Up to 24 patients are planned to be enrolled in the US and Europe in total. More information on this study can be found at www.clinicaltrials.gov (NCT02658968). Preliminary results are expected in the second half of 2019.

    Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: "We are pleased to be moving ahead with the final cohort of patients in the study, which will enable the selection of a recommended dose for further evaluation of safety and preliminary efficacy in additional patients."

    DLBCL is an aggressive form of non-Hodgkin's Lymphoma (NHL) that accounts for up to 43% of all NHL cases, making it the most common form of the disease. Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy and only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by SCT (ref. 1). There are currently very few therapeutic options for patients not eligible for SCT, which makes relapsed DLBCL a serious unmet medical need. The number of diagnosed cases of DLBCL in the US and Europe in 2016 was 26,500 and 17,200, respectively. These numbers are expected to reach 31,500 (US) and 19,000 (Europe) by 2024 (ref. 2).

    References

    1. L.S. Raut and P. P. Chakrabarti: Management of relapsed-refractory diffuse large B cell lymphoma (2014) South Asian J. Cancer 3(1): 66–70

    2. Non-Hodgkin's Lymphoma (2015) Decision Resources

    For further information, please contact:

    IR enquiries

    Malene Brondberg, VP Investor Relations and Corporate Communications
    Cell: +44-7561-431-762

    Seite 1 von 3


    PR Newswire (engl.)
    0 Follower
    Autor folgen
    Verfasst von PR Newswire (engl.)
    Nordic Nanovector Safety Review Committee Approves Advancing to Final Dosing Regimen in Phase 1 Trial of Betalutin in DLBCL OSLO, Norway, April 10, 2019 /PRNewswire/ - Nordic Nanovector ASA (OSE: NANO) announces that the Safety Review Committee (SRC) for the ongoing LYMRIT 37-05 clinical trial of single-administration Betalutin (177Lu-satetraxetan-lilotomab) in patients …