OSLO, Norway, June 30, 2020 /PRNewswire/ -- Nordic Nanovector
ASA (OSE: NANO) announces that it will amend the trial protocol for
its PARADIGME trial to broaden the inclusion criteria and expand
the pool of eligible patients with the aim of increasing the
present rate of enrolment. This decision has been made based on the
company's reviewed discussions with the US Food and Drug
Administration (FDA).
PARADIGME is the company's ongoing pivotal, global, randomised
Phase 2b trial investigating
Betalutin® (177Lu-lilotomab satetraxetan) as a single
administration in 3rd-line relapsed/refractory
follicular lymphoma (3L R/R FL) patients. The trial aims to enrol
130 patients into two arms to compare different dosing regimens; 51
patients were enrolled as of 25th May 2020 - Q1 report.
One of the measures to improve the recruitment rate into
PARADIGME is to allow for FL patients who have undergone stem cell
transplant (SCT) to be included in the trial. In some countries,
for example UK, Italy,
Turkey, Israel and Spain, SCT is frequently used for treating R/R
FL and patients who have had a SCT make up the majority of 3L FL
patients. This and other ways to broaden the inclusion criteria
will, when implemented, substantially expand the pool of patients
eligible for recruitment into PARADIGME.
As soon as practicable, Nordic Nanovector will seek approvals
for the protocol amendments from the regulators in each of the 25
countries in which PARADIGME is active. It is anticipated that it
will take 2-3 months to gain approval for these protocol amendments
in all countries. Until the amendments have been approved, the
company will continue to enrol patients under the existing
protocol.
A close collaboration with the company's Clinical Research
Organisation (CRO) will be prioritised to ensure smooth
implementation of the new protocol and maximise enrolment once the
new protocol is approved in each country.
The company expects that expanding the pool of eligible patients
will significantly improve the present enrolment rate. During
August, the company will provide updated timelines for PARADIGME
based on more clarity on the impact of COVID-19 and after the
completion of the interim analysis.
In the Phase 1/2 LYMRIT 37-01 study, a single administration of
Betalutin® demonstrated encouraging anti-tumour activity, with a
65%, overall response rate (ORR) and 28% complete responses (CR) in
the subset of FL patients (n=57). The median duration of response
(mDoR) was over one year (13.6 months) for all responders and
nearly three years (32.0 months) for complete responders.
The LYMRIT 37-01 study also showed that Betalutin® was safe and
well tolerated in these fragile patients with advanced stage
disease, who have few remaining options available.
Jean Pierre Bizzari, MD, Chair
of Nordic Nanovector's Clinical Committee, said: "We are
extremely encouraged by the preliminary data we are seeing both in
terms of efficacy and safety profile. This novel 'one-time`
treatment in this underserved resistant/refractory patient
population is especially important in these frail elderly patients
for whom other treatment options are too toxic. We are confident
that the protocol amendments the company is implementing to expand
the eligible pool of FL patients will significantly increase the
rate of enrolment into PARADIGME."
Dominic Smethurst, MD, interim
Chief Medical Officer, commented: "We are very happy that
we can now start to implement these important protocol amendments
to PARADIGME. As soon as the amendments are made, we will implement
a plan with our CRO to gain approval in all currently active
countries as soon as possible. We intend to provide an updated
timeline for PARADIGME once we have more clarity on the impact of
the easing of the COVID-19 restrictions and the completion of the
interim analysis."
"We are also very pleased to have received Fast Track
designation for Betalutin® in marginal zone lymphoma (MZL), another
form of non-Hodgkin's lymphoma for which new treatments are
urgently needed and against which Betalutin® has already
demonstrated encouraging data. We are evaluating this new
opportunity within the context of PARADIGME and will provide an
update when we have made a decision on our development plans in
this indication."
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 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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