Actionable news
All posts from Actionable news
Actionable news in NANO: Nanometrics Incorporated,

Nordic Nanovector Announces First Patient Enrolled in Arm 3 of Expanded Phase 1/2 Study of Betalutin® in NHL Patients

OSLO, Norway, May 04, 2016 (BUSINESS WIRE) -- Nordic Nanovector ASA (ose:NANO), a biotechnology company focusing on the development of novel targeted therapeutics in haematology and oncology, announces that the first patient has been enrolled into one of the two new arms of its expanded Lymrit 37-01 clinical study with Betalutin®.

Betalutin® is a novel anti-CD37 targeting Antibody Radionuclide Conjugate in development for the treatment of major types of non-Hodgkin’s lymphoma (NHL), including Follicular Lymphoma (FL).

The new arm (Arm 3) is designed to investigate the safety and efficacy of Betalutin® in up to 12 patients with relapsed FL pre-dosed with standard anti-CD20 immunotherapy (rituximab) on Day 0, a few hours prior to the administration of Betalutin®.

Luigi Costa, Nordic Nanovector CEO, commented: “We are pleased to initiate the first of the two new cohorts in our ongoing clinical study, which represents a significant step forward in Betalutin’s development plan. Data we have seen to date suggest that we can achieve strong clinical efficacy with a regimen that controls haematological side effects. The two new arms are investigating if different pre-dosing regimens will allow the use of higher doses of Betalutin® to potentially achieve even higher efficacy than that so far observed, and therefore an even more compelling product profile.”

The Lymrit 37-01 study is a Phase 1/2 open label, single injection ascending dose study investigating three dose levels of Betalutin® and different dosing regimens in patients with relapsed NHL with the aim of identifying an optimal dose regimen to take into the Phase 2 PARADIGME study, which is expected to start in 2H 2017.

Patient recruitment into the Phase 2 part of Arm 1 (15Mbq/kg plus 50mg/ml unconjugated “cold” HH1 anti-CD37 antibody) is progressing as planned with dose-escalation expected to begin in 2H 2016. Patient screening is also underway for the final arm in the expanded Lymrit 37-01 study (Arm 4), in which escalating doses of Betalutin® plus pre-treatment with a higher dose of cold anti-CD37...