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Innlegg av: Titleist (19.05.17 17:14 ), lest 7291 ganger
Ticker: NANO

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Oslo, Norway, 19 May 2017

Nordic Nanovector ASA (OSE: NANO) announces that the Safety Review Committee
(SRC) for the ongoing LYMRIT 37-01 clinical trial of Betalutin in non-Hodgkins
Lymphoma (NHL) has reviewed safety data from the study and approved continued
clinical evaluation of 20 MBq/kg Betalutin administered after pre-dosing with
100 mg/m2 lilotomab.
Following the SRCs recommendation, new patients will be enrolled into a Phase 2
expansion cohort of Arm 4 in Betalutins Phase 1/2 study LYMRIT 37-01, to
continue the collection of safety and efficacy data of 20 MBq/kg Betalutin
after pre-dosing with 100 mg/m2 lilotomab. This will enable the company to build
a robust database of clinical data to confirm the optimal dosing regimen for the
pivotal Phase 2 PARADIGME study, which is on track to start in the second half
of 2017.

Luigi Costa, Nordic Nanovector CEO, said: This recommendation from the SRC
represents another important milestone for the development of Betalutin, in
line with our strategy and established timelines. It supports the hypothesis
that a higher pre-dosing regimen may enable the use of a higher dose of
Betalutin. The enrolment of new patients in Phase 2 provides the opportunity to
collect additional safety and preliminary efficacy data to support the selection
of the dosing regimen we will use in PARADIGME later this year.

About LYMRIT 37-01

The LYMRIT 37-01 study is an ongoing Phase 1/2 open label, dose-escalation study
with four treatment arms in patients with relapsed NHL to establish the
recommended dosing regimen of single-dose Betalutin for Phase 2. The study is
investigating three doses of Betalutin and different pre-dosing regimens with
the aim of identifying an optimal dose regimen to take into a pivotal Phase 2
PARADIGME trial.

The most recent results were presented at the American Society of Hematology
(ASH) annual meeting in December 2016 and showed:

. Significant anti-tumour activity observed: ORR of 62%, CR 38% in Arm 1
patients receiving 15MBq/kg