Nordic Nanovector ASA - Results for the Third Quarter 2017

OSLO, Norway, Nov. 22, 2017 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANO) announces results for the third quarter 2017. A presentation by the company's senior management team will take place today following the company's Capital Markets Day in Oslo (see separate announcement today and details below).

Nordic Nanovector is ready to initiate the pivotal Phase 2b study, PARADIGME, with Betalutin® in patients with relapsed, anti-CD 20 Ab-refractory FL (R/R FL), a high unmet medical need group, pending approval of the proposed trial design from regulatory authorities. PARADIGME is designed to generate the clinical data needed to support the filing of the best Betalutin® dosage regimen for this patient population. The PARADIGME design is aligned with health authority and clinical expert feedback. The company is also enrolling patients into its Phase 1 study in DLBCL, and making final preparations to start a Phase 2 combination study of Betalutin® and rituximab in iNHL patients (ARCHER-1) in 2017. Preparations to initiate a Phase 1 study of Humalutin® are also progressing.

Luigi Costa, CEO of Nordic Nanovector, comments: "The company has made excellent progress during 2017. Clinical results with Betalutin® and in-depth market research confirm its potential to be an important treatment of patients with iNHL. We are on track to start the pivotal PARADIGME study, which aims to compare the two promising dosing regimens that have emerged from our ongoing clinical trial with Betalutin®. We are confident that the trial design will generate the robust data needed and improve the probability of a successful regulatory filing. We are also pleased with recruitment into our DLBCL study and with the preparations to start the ARCHER-1 study of Betalutin® in combination with rituximab, which is on track to begin soon."

Operational Highlights Q3'17

-  Steady progress towards planned start of the pivotal Phase 2b study PARADIGME in 2H 2017 to investigate Betalutin® in patients with 3rd line R/R FL

• PARADIGME expected to be a global, randomized Phase 2b trial comparing the two most promising dosing regimens identified from the LYMRIT-37-01 Phase 1/2 study in approximately 130 patients with R/R FL
• Objective to generate the clinical data needed to support the filing for market approval of the best Betalutin® dosage regimen
• Design builds on promising clinical results and is aligned with regulatory authority feedback
• Protocol amendment submitted and under review by multiple regulatory authorities with further submissions expected in the coming weeks; other preparations to initiate trial underway
• Patient screening anticipated to begin before end of 2017 (pending approval of the amendment)

-  Recruitment of DLBCL patients into Phase 1 dose-escalation study with Betalutin® ongoing