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     295  0 Kommentare Nordic Nanovector ASA - Results for the Second Quarter and First Half 2019

    OSLO, Norway, Aug. 22, 2019 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANO) announces its results for the second quarter and first half 2019. A presentation by the company's senior management team will take place today in Oslo at 08:30 CEST, see details below. 

    Eduardo Bravo, CEO, commented: "We continue to progress our clinical development programmes with Betalutin in major NHL indications. In PARADIGME, we have reached our target range in terms of activated sites and while the recruitment rate has accelerated in recent months, this has not been at the rate we anticipated. This has led us to reassess the trial timelines and we now estimate to complete patient enrolment in 2H 2020 rather than 1H 2020 as previously guided. We would expect the data read-out from the trial a few months after the final patient has been dosed. As a one-off treatment, Betalutin has an exciting product profile, and we have been encouraged by the preliminary analysis of the extended median duration of response data that we have disclosed today. We remain focused on advancing PARADIGME and our other clinical programmes as quickly as possible given the clear benefits that Betalutin could deliver to NHL patients around the globe."

    Highlights

    • Preliminary analysis shows median duration of response (mDoR) of 13.5 months (formerly 9.0 months in December 2018) for Phase 1/2a LYMRIT 37-01 trial of Betalutin in R/R FL
    • Pivotal Phase 2b PARADIGME trial of Betalutin in advanced recurrent follicular lymphoma (FL) progressing with 81 sites in 23 countries open for enrolment as of August 21st, 2019
      • Patient recruitment has accelerated in recent months but not at the rate anticipated
      • Full enrolment now expected 2H 2020 compared with 1H 2020 as previously guided
    • Phase 1b Archer-1 trial of Betalutin plus rituximab (RTX) in patients with relapsed/refractory (R/R) 2nd line FL advanced into second cohort
    • Global patent portfolio strengthened with grant of European patent covering the use of Betalutin (and other anti-CD37 targeting agents) in combination with anti-CD20 antibodies   (including rituximab) for the treatment of non-Hodgkin's lymphoma (NHL)
    • Promising preclinical results from R&D collaboration to develop a novel CD37-targeting alpha therapy for B-cell tumours presented at international scientific congresses (TAT11 and TRP19)
    • Recruitment completed for dose escalation phase of LYMRIT 37-05 trial of Betalutin in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) – preliminary results expected in 2H 2019
    • Dr Lars Nieba appointed as Chief Technology Officer to drive the company's CMC strategy

    Financial Highlights Q2 and 1H'19

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    Nordic Nanovector ASA - Results for the Second Quarter and First Half 2019 OSLO, Norway, Aug. 22, 2019 /PRNewswire/ - Nordic Nanovector ASA (OSE: NANO) announces its results for the second quarter and first half 2019. A presentation by the company's senior management team will take place today in Oslo at 08:30 CEST, see …