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
* 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
* 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)