Kurs & Likviditet
Beskrivning
Land | Norge |
---|---|
Lista | OB Match |
Sektor | Hälsovård |
Industri | Läkemedel & Handel |
2021-02-18 06:59:02
Oslo, Norway, 18 February 2021
Nordic Nanovector ASA (OSE: NANOV) provides an update on PARADIGME, its ongoing
pivotal Phase 2b trial of Betalutin® ([177]Lu lilotomab satetraxetan) in 3[rd]
-line relapsed/refractory follicular lymphoma (3L R/R FL).
Despite COVID has the company seen a significant improvement in the enrolment
rate from approximately two to approximately five patients per month. After the
expected lessening of COVID restrictions plus the ongoing operational
improvements, this rate could further increase to at least seven patients on
average per month by late spring.
14 patients were enrolled from November 2020 to 17 February 2021 (three patients
from August to November 2020), with visibility on increasing numbers of patients
in screening. 73 patients were enrolled as of 17 February 2021 (59 enrolled as
of 18 November 2020).
In addition, following discussions with the US Food and Drug Administration and
an internal review, the company believes that a robust clinical data set (safety
and efficacy) to support a filing at the designated dosing regimen of 40/15 can
be achieved with a reduction of the initially targeted population from 130 to
120 patients. On this basis, 47 more patients are required to complete PARADIGME
for regulatory submission of Betalutin®.
The trial protocol amendments that were submitted in Q3'2020 have now been
approved in all of the 24 participating countries including the US. In addition,
further initiatives have been implemented, especially in the US, to improve the
enrolment rate by entering agreements with organisations that specialise on
focused patient enrolment campaigns.
The recent improvement in the enrolment rate has been driven by these protocol
amendments and the initiatives being implemented to facilitate trial execution.
The company anticipates the enrolment rate to continue improving as the most
recent initiatives pay back fully and the impact of COVID-19 recedes with
restrictions lifting over time as the roll out of global vaccination programmes
takes effect.
As a result, the company is more confident that it can deliver preliminary three
-month top-line data from PARADIGME in H2'2021.
Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector,
commented: "We are beginning to see an encouraging improvement in the enrolment
rate for PARADIGME based on changes to the trial protocol and the initiatives we
are implementing to improve the execution of the trial. We now have clarity from
key regulators on the clinical data set that is expected as a basis for our
filing. This clarity, in conjunction with the improving enrolment rate and the
continuing recruitment initiatives, gives us confidence that we can meet our
goal of having preliminary three-month top-line data in H2' 2021."
For further information, please contact:
IR enquiries
Malene Brondberg, CFO
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com
Media Enquiries
Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)
Tel: +44 203 926 8535
Email: nordicnanovector@citigatedewerogerson.com
About Nordic Nanovector:
Nordic Nanovector is committed to develop and deliver innovative therapies to
patients to address major unmet medical needs and advance cancer care. The
Company aspires to become a leader in the development of targeted therapies for
haematological cancers. Nordic Nanovector's lead clinical-stage candidate is
Betalutin[®], a novel CD37-targeting radioimmunotherapy designed to advance the
treatment of non-Hodgkin's lymphoma (NHL). NHL is an indication with substantial
unmet medical need, representing a growing market forecast to be worth nearly
USD 29 billion by 2026. Nordic Nanovector retains global marketing rights to
Betalutin[®] and intends to actively participate in the commercialisation of
Betalutin[®] in the US and other major markets.
Further information can be found at www.nordicnanovector.com.
This information is subject to a duty of disclosure pursuant to Sections 4-2 and
5-12 of the Securities Trading Act.