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Prenumeration

Kalender

Est. tid*
2025-11-05 08:00 Kvartalsrapport 2025-Q3
2025-08-20 08:00 Kvartalsrapport 2025-Q2
2025-05-15 N/A X-dag ordinarie utdelning SPAGO 0.00 SEK
2025-05-14 N/A Årsstämma
2025-05-07 08:00 Kvartalsrapport 2025-Q1
2025-02-06 - Bokslutskommuniké 2024
2024-11-06 - Kvartalsrapport 2024-Q3
2024-08-21 - Kvartalsrapport 2024-Q2
2024-06-11 - X-dag ordinarie utdelning SPAGO 0.00 SEK
2024-06-10 - Årsstämma
2024-05-02 - Kvartalsrapport 2024-Q1
2024-02-07 - Bokslutskommuniké 2023
2023-11-03 - Kvartalsrapport 2023-Q3
2023-10-31 - Extra Bolagsstämma 2023
2023-07-31 - Kvartalsrapport 2023-Q2
2023-05-11 - X-dag ordinarie utdelning SPAGO 0.00 SEK
2023-05-10 - Årsstämma
2023-05-09 - Kvartalsrapport 2023-Q1
2023-02-02 - Bokslutskommuniké 2022
2022-11-08 - Kvartalsrapport 2022-Q3
2022-08-24 - Kvartalsrapport 2022-Q2
2022-05-19 - X-dag ordinarie utdelning SPAGO 0.00 SEK
2022-05-18 - Årsstämma
2022-04-27 - Kvartalsrapport 2022-Q1
2022-02-02 - Bokslutskommuniké 2021
2021-11-10 - Kvartalsrapport 2021-Q3
2021-08-24 - Kvartalsrapport 2021-Q2
2021-05-06 - X-dag ordinarie utdelning SPAGO 0.00 SEK
2021-05-05 - Årsstämma
2021-04-28 - Kvartalsrapport 2021-Q1
2021-02-02 - Bokslutskommuniké 2020
2021-01-15 - Extra Bolagsstämma 2021
2020-11-10 - Kvartalsrapport 2020-Q3
2020-08-24 - Kvartalsrapport 2020-Q2
2020-05-29 - X-dag ordinarie utdelning SPAGO 0.00 SEK
2020-05-28 - Årsstämma
2020-04-29 - Kvartalsrapport 2020-Q1
2020-01-30 - Bokslutskommuniké 2019
2019-11-13 - Extra Bolagsstämma 2019
2019-11-13 - Kvartalsrapport 2019-Q3
2019-05-09 - X-dag ordinarie utdelning SPAGO 0.00 SEK
2019-05-08 - Årsstämma
2019-04-25 - Kvartalsrapport 2019-Q1
2019-01-30 - Bokslutskommuniké 2018
2018-11-08 - Kvartalsrapport 2018-Q3
2018-08-27 - Kvartalsrapport 2018-Q2
2018-05-17 - X-dag ordinarie utdelning SPAGO 0.00 SEK
2018-05-16 - Årsstämma
2018-04-25 - Kvartalsrapport 2018-Q1
2018-02-14 - Bokslutskommuniké 2017
2017-11-08 - Kvartalsrapport 2017-Q3
2017-09-22 - Extra Bolagsstämma 2017
2017-08-25 - Kvartalsrapport 2017-Q2
2017-05-18 - X-dag ordinarie utdelning SPAGO 0.00 SEK
2017-05-17 - Årsstämma
2017-04-26 - Kvartalsrapport 2017-Q1
2017-02-14 - Bokslutskommuniké 2016
2016-11-08 - Kvartalsrapport 2016-Q3
2016-08-26 - Kvartalsrapport 2016-Q2
2016-05-12 - X-dag ordinarie utdelning SPAGO 0.00 SEK
2016-05-11 - Årsstämma
2016-04-27 - Kvartalsrapport 2016-Q1
2016-02-12 - Bokslutskommuniké 2015
2015-11-12 - Extra Bolagsstämma 2015
2015-11-06 - Kvartalsrapport 2015-Q3
2015-08-27 - Kvartalsrapport 2015-Q2
2015-05-06 - X-dag ordinarie utdelning SPAGO 0.00 SEK
2015-05-05 - Årsstämma
2015-04-29 - Kvartalsrapport 2015-Q1
2015-02-20 - Bokslutskommuniké 2014
2014-11-14 - Kvartalsrapport 2014-Q3
2014-08-27 - Kvartalsrapport 2014-Q2
2014-04-30 - X-dag ordinarie utdelning SPAGO 0.00 SEK
2014-04-29 - Årsstämma
2014-04-29 - Extra Bolagsstämma 2014
2014-04-29 - Kvartalsrapport 2014-Q1
2014-02-21 - Bokslutskommuniké 2013
2013-10-29 - Kvartalsrapport 2013-Q3
2013-08-29 - Kvartalsrapport 2013-Q2
2013-05-24 - Kvartalsrapport 2013-Q1
2013-04-25 - Årsstämma
2013-02-22 - Bokslutskommuniké 2012

Beskrivning

LandSverige
ListaFirst North Stockholm
SektorHälsovård
IndustriBioteknik
Spago Nanomedical är verksamt inom bioteknik. Bolaget utvecklar nanomedicin för diagnostik och behandling av livshotande sjukdomar. Bolagets huvudsakliga verksamhet är inriktad mot att utveckla ett cancerselektivt kontrastmedel för magnetisk resonanstomografi (MR), samt en produkt för radionuklidbehandling av cancer. Båda dessa projekt är baserade på egenutvecklade nanomaterial. Störst verksamhet återfinns inom den nordiska marknaden.
2025-03-04 08:00:00

Spago Nanomedical AB (publ) announced today that the independent Data Monitoring Committee (DMC) recommends a dose increase in the ongoing phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201. The recommendation is based on analysis of data from two patient groups, consisting of six patients with five different cancer types. Both groups show similar acceptable safety profile.

“We are very pleased with the decision from the DMC and the study is now proceeding to the next dose level. The recruitment of patients with multiple tumor types is accelerating while we continuously strengthen the understanding of how 177Lu-SN201 works in different cancer types. This knowledge will be of great importance for the next step. Our goal to complete the phase I part of the study in 2025 remains unchanged,” says CEO Mats Hansen.

The clinical phase I/IIa study Tumorad-01 is a first-in-human study with the purpose of evaluating the safety, tolerability, dosimetry and initial efficacy of 177Lu-SN201 in cancer patients. The phase I part of the study aims to identify a possible therapeutic dose for further testing in selected patient groups in the phase IIa part of the study. The second patient group in the study, consisting of three patients, two women with lung and throat cancer, respectively, and one man with rectal cancer, has now been treated with at least one dose-cycle of 177Lu-SN201. The DMC has conducted an analysis based on all available data for the two first patient groups and assesses that the safety profile in the patient groups is satisfactory and recommends to increase the dose in the study and continue the patient recruitment as planned.

A total of six patients with five different tumor types have been dosed in the study to date. In addition to the phase I primary objective of evaluating safety, an important secondary objective is to evaluate and develop imaging and dosimetry. Preliminary evaluation of the images that have been collected so far indicate biodistribution in line with preclinical results. Methods for optimal imaging and dosimetric calculations specifically adapted for 177Lu-SN201 are being continuously developed as the study progresses.

In August 2024, the company announced that the first patient group in the phase I part of the study, consisting of three patients, had been successfully treated with at least one dose of 177Lu-SN201, and that the DMC recommended that the study continue based on an evaluation of all data available at that time. The company has also received ethics approval to also include patients on a lower dose of 177Lu-SN201 in parallel. As such the study includes three dose levels so far and active recruitment to the higher and lower of these is now underway at two hospitals, Cancer Research SA in Adelaide and St Vincent's Hospital in Melbourne.

More information about the study is available at https://clinicaltrials.gov/study/NCT06184035