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(SRC) for the ongoing LYMRIT 37-05 clinical trial of single-administration
Betalutin® (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory
diffuse large B-cell lymphoma (DLBCL) not eligible for stem cell transplantation
(SCT) has now reviewed safety data from the first three cohorts of patients.
Based on the data, the SRC approved advancing the trial to the next and final
cohort with the dose regimen 20 MBq/kg Betalutin and a lilotomab pre-dose of 100
mg/m2.
The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation
study designed to assess the safety, tolerability, pharmacokinetic profile and
preliminary anti-tumour activity of Betalutin®. Up to 24 patients are planned to
be enrolled in the US and Europe in total. More information on this study can be
found at www.clinicaltrials.gov (NCT02658968). Preliminary results are expected
in the second half of 2019.
Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: “We are
pleased to be moving ahead with the final cohort of patients in the study, which
will enable the selection of a recommended dose for further evaluation of safety
and preliminary efficacy in additional patients.”
DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for up
to 43% of all NHL cases, making it the most common form of the disease.
Approximately 40% of DLBCL patients relapse after first-line combination
treatment with rituximab and chemotherapy and only 30-40% of relapsed patients
respond with subsequent high-dose chemotherapy followed by SCT (ref. 1). There
are currently very few therapeutic options for patients not eligible for SCT,
which makes relapsed DLBCL a serious unmet medical need. The number of diagnosed
cases of DLBCL in the US and Europe in 2016 was 26,500 and 17,200, respectively.
These numbers are expected to reach 31,500 (US) and 19,000 (Europe) by 2024
(ref. 2).
References
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L.S. Raut and P. P. Chakrabarti: Management of relapsed-refractory diffuse
large B cell lymphoma (2014) South Asian J. Cancer 3(1): 66-70
-
Non-Hodgkin’s Lymphoma (2015) Decision Resources
For further information, please contact:
IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
Email: [email protected]
International Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
Email: [email protected]
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 intends to retain marketing rights and to actively
participate in the commercialisation of Betalutin® in core 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 Securities Trading Act.
http://www.netfonds.no/quotes/release.php?id=20190410.OBI.20190410S6
