Nordic Nanovector announces that its Investigational New Drug (IND) application for a new Phase 1 clinical study of Betalutin in a second non-Hodgkin lymphoma (NHL) indication is now open with the US Food & Drug Administration (FDA).
The Company plans to investigate Betalutin in relapsed diffuse large B-cell lymphoma (DLBCL) patients who are ineligible for stem cell transplant. This represents the most prevalent relapsed DLBCL patient population and the one with the greatest unmet medical need.
The Phase 1 dose-finding study (Lymrit 37-05) has a classical 3+3 dose-escalation design and is expected to enrol up to 24 patients in the US and Europe. The study is designed to identify an optimal dose regimen of Betalutin in patients pre-dosed with unconjugated “cold” HH1 anti-CD37 antibody to take into Phase 2.
In approving the IND, FDA requested that an additional 3+3 cohort be included at the start of the study to investigate a regimen involving an intermediate pre-dose of cold HH1 prior to Betalutin injection in the DLBCL population.
The study protocol without the latest adjustments made to meet FDA’s requests has already been approved by the appropriate EU regulatory authorities, via the Voluntary Harmonisation Procedure.
Nordic Nanovector intends to adopt the FDA requested amendment also in Europe and plans to initiate the application process for the amended design with the relevant EU regulators as soon as possible. Pending approval of the amended design, the Company now expects the first DLBCL patient to be enrolled and treated in 2H 2016 compared to 1H 2016 as previously communicated.
Luigi Costa, Nordic Nanovector CEO, commented: “We are encouraged by FDA’s response to our IND, and intend to make the recommended amendment that will allow us to conduct our first study in DLBCL patients in both the US and Europe. We will work with EU regulators to expedite approval of the revised study design in Europe so that we can prepare and start patient recruitment in the second half of 2016. This is an important further step forward in the development of Betalutin®, data for which continue to highlight its potential to become a relevant new treatment of B-cell malignancies.”