Kurs & Likviditet
Beskrivning
Land | Norge |
---|---|
Lista | OB Match |
Sektor | Hälsovård |
Industri | Läkemedel & Handel |
2022-06-21 16:31:29
Oslo, Norway, 21 June 2022
Nordic Nanovector ASA (OSE: NANOV) today provides an update following its
comprehensive review and independent data evaluation of PARADIGME, its ongoing
Phase 2b trial of Betalutin[® ]([177]Lu lilotomab satetraxetan) in 3[rd]-line
relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL).
The independent expert panel reviewed the efficacy data collected to date.
Betalutin®, at the selected dose of 15 MBq/kg after a pre-dose of 40 mg
lilotomab (40/15), has continued to display an attractive safety profile. While
Betalutin® showed signs of efficacy in this frail, elderly and difficult-to
-treat patient population, the independent expert panel reported that the
efficacy data are less promising than the data reported from the Phase 2a LYMRIT
37-01 trial. The Company intends to seek further guidance from the competent
regulatory authorities, including the US Food and Drug Administration (FDA),
regarding the way forward for PARADIGME. Pending regulatory feedback, the study
will remain open for recruitment.
Following interaction with the regulatory authorities, the Company will provide
an additional update, which is expected in August. The Company will not be
commenting further until then. The Company's Q2 results will be rescheduled to
August and a new date will be confirmed in due course.
Given the continuing slow patient recruitment, Nordic Nanovector does now not
expect to deliver preliminary top line data from PARADIGME in H2 2022.
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 (MEDiSTRAVA Consulting)
Tel: +44 203 928 6900
Email: nordicnanovector@medistrava.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.
Forward-looking statements
This press release contains certain forward-looking statements. These statements
are based on management's current expectations and are subject to uncertainty
and changes in circumstances, since they relate to events and depend on
circumstances that will occur in the future and which, by their nature, will
have an impact on Nordic Nanovector's business, financial condition and results
of operations. The terms "anticipates", "assumes", "believes", "can", "could",
"estimates", "expects", "forecasts", "intends", "may", "might", "plans",
"should", "projects", "targets", "will", "would" or, in each case, their
negative, or other variations or comparable terminology are used to identify
forward-looking statements. These forward-looking statements are not historic
facts. There are a number of factors that could cause actual results and
developments to differ materially from those expressed or implied in the forward
-looking statements. Factors that could cause these differences include, but are
not limited to, risks associated with implementation of Nordic Nanovector's
strategy, risks and uncertainties associated with the development and/or
approval of Nordic Nanovector's product candidates, ongoing and future clinical
trials and expected trial results, the ability to commercialise Betalutin®,
technology changes and new products in Nordic Nanovector's potential market and
industry, Nordic Nanovector's freedom to operate (competitors patents) in
respect of the products it develops, the ability to develop new products and
enhance existing products, the impact of competition, changes in general economy
and industry conditions, and legislative, regulatory and political factors. No
assurance can be given that such expectations will prove to have been correct.
Nordic Nanovector disclaims any obligation to update or revise any forward
-looking statements, whether as a result of new information, future events or
otherwise.
This information is subject to a duty of disclosure pursuant to Section 5-12 of
the Norwegian Securities Trading Act.