April 4, 2018 / 7:47 PM / 8 months ago

BRIEF-Nordic Nanovector's Paradigme faces delay, Humalutin indefinitely postponed

4 apr (Reuters) - Nordic Nanovector ASA:

* ‍NORDIC NANOVECTOR PROVIDES UPDATE ON PARADIGME CLINICAL TRIAL​

* ‍RESULTS FROM PARADIGME ARE TARGETED FOR 1H 2020 (PREVIOUSLY 2H 2019) AND FIRST REGULATORY FILING IN 2020

* ‍GUIDANCE IS UNCHANGED FOR PREVIOUSLY REPORTED MILESTONES FOR ARCHER-1 AND LYMRIT 37-05, BOTH ANTICIPATED IN 2H 2018​

* OUT FROM PARADIGME​

* ASSESSMENT OF EXPECTED RECRUITMENT RATES HAS LED COMPANY TO REVISE ITS TIMELINES FOR PIVOTAL PARADIGME PHASE 2B TRIAL WITH BETALUTIN IN THIRD LINE (3L) FOLLICULAR LYMPHOMA (FL) PATIENTS

* RESULTS FROM PARADIGME ARE TARGETED FOR 1H 2020 (PREVIOUSLY 2H 2019) AND FIRST REGULATORY FILING IN 2020. FIRST PATIENT IS EXPECTED TO BE DOSED IN 1H 2018

* WILL FOCUS ITS RESOURCES TOWARDS PARADIGME AND OTHER BETALUTIN CLINICAL PROGRAMMES

* TO POSTPONE START OF FIRST-IN-HUMAN CLINICAL TRIAL WITH HUMALUTIN FOR FORESEEABLE FUTURE

* 05, BOTH ANTICIPATED IN 2H 2018

* FINANCIAL RESOURCES ARE EXPECTED TO BE SUFFICIENT TO REACH DATA READ-OUT FROM PARADIGME

* RE-ANALYSIS OF PATIENT ENROLMENT RATE AND FACT THAT IT HAS TAKEN LONGER THAN EXPECTED TO ENROL FIRST PATIENT HAVE LED US TO ADJUST TIMELINES WE PREVIOUSLY COMMUNICATED

* TO DATE, PARADIGME IS OPEN FOR ENROLMENT AT 13 SITES AND IN SIX COUNTRIES

* IN NORWAY, PARADIGME IS PENDING APPROVAL AND COMPANY IS WORKING CLOSELY WITH NORWEGIAN REGULATORS TO ADDRESS ITS QUESTIONS

* IN USA, FOOD & DRUG ADMINISTRATION (FDA) HAS COMPLETED ITS REVIEW OF PARADIGME STUDY AND NORDIC NANOVECTOR EXPECTS US SITES TO BE OPEN FOR ENROLMENT DURING MID-2018

* OUT, NORDIC NANOVECTOR HAS DECIDED TO PUT HUMALUTIN STUDY ON HOLD FOR FORESEEABLE FUTURE

* PRESENTATION BY NORDIC NANOVECTOR’S MANAGEMENT TEAM WILL TAKE PLACE THURSDAY AT 1000 CET Further company coverage: (Reporting By Terje Solsvik)

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