OSLO, Norway, April 1, 2020 /PRNewswire/ -- Nordic Nanovector
ASA (OSE: NANO) today announces a number of initiatives to speed up
recruitment into its pivotal Phase 2b
PARADIGME trial with Betalutin® in advanced follicular lymphoma
(FL) as well as to extend its cash runway into 2021. A webcast will
take place on Thursday 2 April at 10:00 am
CET. Details below.
At the time of the Q4 results in February, the company noted
that it would, under its new management, critically assess the
current strategy and clinical trial operations.
Following this assessment several key development decisions have
been made:
- Streamlined strategy with all resources focused on PARADIGME -
all other clinical trials to be suspended following completion of
the current cohorts and all investments in pre-clinical assets to
be halted
- Request type C meeting with FDA to amend the current PARADIGME
protocol
- Intend to broaden PARADIGME's inclusion criteria to increase
rate of recruitment.
We have recently seen a slowdown in recruitment into the
PARADIGME study due to measures taken by many governments in
respons to contain the COVID-19 pandemic, as well as the need for
hospitals to prioritise resources on treating infected
patients.
In parallel, several cost savings initiatives are being
implemented to extend the Company's cash runway into 2021:
- Reduction in staffing levels by approximately 20% to be
completed by end April
- Consolidating several staff functions and closing offices
- Resources focused on core clinical operations and CMC
(Chemistry, Manufacturing and Controls)
- Phased investment in CMC and pre-commercialisation activities
with some spending moved into 2021
The company will provide a further update on PARADIGME when it
has received and reviewed the feedback from its discussions with
the FDA. Nordic Nanovector still plans a rolling submission for
Betalutin® with FDA once it has the top line data from the
PARADIGME trial.
Commenting on today's announcement, Lars Nieba, Interim CEO of
Nordic Nanovector, said: "The actions that we have announced today
are designed to significantly improve patient recruitment into our
pivotal Phase 2b PARADIGME trial with
Betalutin® and to extend our cash runway into 2021. We are
confident that the changes we are making will enable us to deliver
the key clinical data needed to support a planned US filing with
Betalutin® in a timely manner. I look forward to keeping you
updated on our progress."
Webcast
A webcast to discuss the restructuring plans and clinical trials
will take place on Thursday 2 April at 10:00
am CET. A link to the webcast and a presentation will be
uploaded to the company's frontpage website at 9:00 am CET on Thursday 2 April.
For further information, please contact:
IR enquiries
Malene Brondberg, VP Investor Relations and Corporate
Communications
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 antibody-radionuclide-conjugate 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 Sections 4-2 and 5-12 of the Securities Trading Act.
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