OSLO, Norway, Nov. 8, 2017 /PRNewswire/ --
Nordic Nanovector ASA (OSE: NANO) notes that information relating to an application for a Protocol Amendment to the LYMRIT 37-01 study, for the planned pivotal Phase 2b clinical trial PARADIGME to evaluate Betalutin® (177Lu-lilotomab satetraxetan) in recurrent/relapsed follicular lymphoma has been published by MHRA (Medicines and Healthcare products Regulatory Agency).
The application for the Protocol Amendment is under-going review by the MHRA. The board of directors of Nordic Nanovector will decide on the final structure and initiation of the study upon response from regulatory authorities.
The application is based on a plan for PARADIGME to be a global Phase 2b clinical trial to compare the two dosing regimens from LYMRIT 37-01 in approximately 130 patients:
• 15 MBq/kg Betalutin® after 40 mg lilotomab pre-dosing;• 20 MBq/kg Betalutin® after 100 mg/m2 lilotomab pre-dosing
The objective of PARADIGME is to enable a robust dose selection process for future clinical use and to produce the best clinical data package to support the selected dosing regimen on which to base a Market Authorization Application for Betalutin®.
Further details of trial will be presented at the company's Capital Markets Day on 22 November in Oslo, as announced yesterday.
For further information, please contact:
IR enquiries Tone Kvåle, Chief Financial Officer Cell: +47-91-51-95-76 Email: [email protected]
Media Enquiries Mark Swallow/David Dible (Citigate Dewe Rogerson) Tel: +44 -07-282-2948/+44-207-282-2949 Email: [email protected] / [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 Antibody-Radionuclide-Conjugates (ARC) 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 20 billion by 2024.The Company aims to rapidly develop Betalutin®, alone and in combination with other therapies, for the treatment of major types of NHL, targeting first regulatory submission in relapsed/refractory follicular lymphoma in 1H 2019.Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.The Company is also advancing a pipeline of ARCs and other immunotherapies for multiple cancer indications.Further information about the Company can be found at www.nordicnanovector.com.
This information was brought to you by Cision http://news.cision.comhttp://news.cision.com/nordic-nanovector/r/nordic-nanovector--protocol-amendment-filed-in-the-uk-to-enable-initiation-of-phase-2-paradigme,c2385393
Nordic Nanovector ASA (OSE: NANO) notes that information relating to an application for a Protocol Amendment to the LYMRIT 37-01 study, for the planned pivotal Phase 2b clinical trial PARADIGME to evaluate Betalutin® (177Lu-lilotomab satetraxetan) in recurrent/relapsed follicular lymphoma has been published by MHRA (Medicines and Healthcare products Regulatory Agency).
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The application for the Protocol Amendment is under-going review by the MHRA. The board of directors of Nordic Nanovector will decide on the final structure and initiation of the study upon response from regulatory authorities.
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The application is based on a plan for PARADIGME to be a global Phase 2b clinical trial to compare the two dosing regimens from LYMRIT 37-01 in approximately 130 patients:
• 15 MBq/kg Betalutin® after 40 mg lilotomab pre-dosing;• 20 MBq/kg Betalutin® after 100 mg/m2 lilotomab pre-dosing
The objective of PARADIGME is to enable a robust dose selection process for future clinical use and to produce the best clinical data package to support the selected dosing regimen on which to base a Market Authorization Application for Betalutin®.
Further details of trial will be presented at the company's Capital Markets Day on 22 November in Oslo, as announced yesterday.
For further information, please contact:
IR enquiries Tone Kvåle, Chief Financial Officer Cell: +47-91-51-95-76 Email: [email protected]
Media Enquiries Mark Swallow/David Dible (Citigate Dewe Rogerson) Tel: +44 -07-282-2948/+44-207-282-2949 Email: [email protected] / [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 Antibody-Radionuclide-Conjugates (ARC) 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 20 billion by 2024.The Company aims to rapidly develop Betalutin®, alone and in combination with other therapies, for the treatment of major types of NHL, targeting first regulatory submission in relapsed/refractory follicular lymphoma in 1H 2019.Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.The Company is also advancing a pipeline of ARCs and other immunotherapies for multiple cancer indications.Further information about the Company can be found at www.nordicnanovector.com.
This information was brought to you by Cision http://news.cision.comhttp://news.cision.com/nordic-nanovector/r/nordic-nanovector--protocol-amendment-filed-in-the-uk-to-enable-initiation-of-phase-2-paradigme,c2385393
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SOURCE Nordic Nanovector
