Drugs / SN132D
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05664828 | Nov 2022 → Jun 2023 | endometriosis | Spago Nanomedical AB | Completed | Met primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2025-01-15 | Spago Nanomedical AB | Results Spago Nanomedicals artikel med kliniska resultat från SPAGOPIX-01 accepterad för publicering i Investigative Radiology spagonanomedical.se ↗
Artikeln fokuserar på resultaten från den kliniska studien SPAGOPIX-01 ( NCT04080024 ) där produktkandidaten pegfosimer manganese (tidigare SN132D) visade acceptabel säkerhet och kliniskt relevant kontrastförstärkning i bilder från magnetresonanstomografi (MRT) av primärtumörer hos patienter med bröstcancer. |
| 2025-01-15 | Spago Nanomedical AB | Results Spago Nanomedical article on SPAGOPIX-01 clinical results accepted for publication in Investigative Radiology spagonanomedical.se ↗
Initial clinical results show that pegfosimer manganese provides clinically relevant contrast in malignant breast tumors while maintaining good safety. |
| 2023-12-15 | Spago Nanomedical AB | Results Spago Nanomedical reports positive top line data from clinical phase IIa study SPAGOPIX-02 in patients with endometriosis spagonanomedical.se ↗
The analysis of MR-images from the SPAGOPIX-02 clinical study shows that the primary endpoint of measuring the MRI enhancing effect in endometriotic lesions that was identified by the treating gynaecologist was met. |
| 2023-12-15 | Spago Nanomedical AB | Results Spago Nanomedical rapporterar positiva topline-data från den kliniska fas 2a studien SPAGOPIX-02 i patienter med endometrios spagonanomedical.se ↗
Analysen av MRT-bilder från den kliniska studien SPAGOPIX-02 visar att det primära effektmålet avseende mätningar av MRT förstärkande effekt i endometrioslesioner identifierade av behandlande gynekolog har uppnåtts. |
| 2023-07-31 | Spago Nanomedical AB | Results Spago Nanomedical interim report January-June 2023 spagonanomedical.se ↗
A preliminary analysis of data from the phase IIa clinical study SPAGOPIX-02 shows that SN132D has a good safety profile in patients with endometriosis. |
| 2023-07-31 | Spago Nanomedical AB | Results Spago Nanomedical delårsrapport januari-juni 2023 spagonanomedical.se ↗
En preliminär analys av bolagets kliniska fas IIa-studie SPAGOPIX-02 visar att kontrastmedlet SN132D har en god säkerhetsprofil i patienter med endometrios. |
| 2023-06-28 | Spago Nanomedical AB | Results Spago Nanomedical uppdaterar om den kliniska fas IIa-studien SPAGOPIX-02 spagonanomedical.se ↗
De första preliminära resultaten har sammanställts och analyserats av studiens Data Monitoring Committee som konstaterar att kontrastmedlet tolereras väl samt att ytterligare analysarbete krävs för att dra slutsatser om dess effekt. |
| 2023-06-28 | Spago Nanomedical AB | Results Spago Nanomedical updates on the clinical phase IIa study SPAGOPIX-02 spagonanomedical.se ↗
It was concluded SN132D is well tolerated in patients with endometriosis and that further analysis is needed before conclusions about efficacy can be made. |
| 2023-05-04 | Spago Nanomedical AB | Results Presentation of Spago Nanomedical’s clinical phase IIa study in endometriosis at the 15th World Congress of Endometriosis spagonanomedical.se ↗
Observations from patients examined so far may indicate contrast enhancement of deep lesions (deep endometriosis) and support further study recruitment. |
| 2023-05-04 | Spago Nanomedical AB | Results Presentation av Spago Nanomedicals kliniska fas IIa-studie i endometrios vid 15th World Congress of Endometriosis spagonanomedical.se ↗
Observationer från hittills undersökta patienter kan tyda på kontrastförstärkning av djupa lesioner (”deep endometriosis”) och stödjer vidare rekrytering till studien. |
| 2022-09-21 | Spago Nanomedical AB | Results Spago Nanomedical gets SpagoPix abstract accepted at breast cancer conference spagonanomedical.se ↗
The initial results from the open-label, non-randomized and non-placebo-controlled Phase I study SPAGOPIX-01, evaluating the drug candidate SN132D, demonstrate an acceptable safety profile and PoC for SN132D in breast cancer patients. |
| 2022-09-21 | Spago Nanomedical AB | Results Spago Nanomedical får SpagoPix-abstract accepterat på bröstcancerkonferens spagonanomedical.se ↗
De första resultaten från den öppna, icke-randomiserade och icke-placebokontrollerade fas I-studien SPAGOPIX-01, som utvärderar läkemedelskandidaten SN132D, visar en acceptabel säkerhetsprofil och konceptvalidering ( Proof of Concept ) för SN132D hos bröstcancerpatienter. |
| 2022-04-27 | Spago Nanomedical AB | Results Spago Nanomedical interim report January-March 2022 spagonanomedical.se ↗
Interim results from the second dose group in SPAGOPIX-01 show that SN132D is well tolerated and provides clear contrast enhancement in MRI images of solid tumors in the breast, as well as in the pancreas and liver. |
| 2022-03-22 | Spago Nanomedical AB | Results Spago Nanomedical presents its platform technology at ACS Spring today spagonanomedical.se ↗
Furthermore the poster presents results of patient imaging from the clinical study SPAGOPIX-01 with the company’s leading product candidate SN132D for precision MR imaging, as well as preclinical efficacy results of the leading candidate drug 177Lu-SN201 for targeted radionuclide therapy of solid tumors. |
| 2022-02-25 | Spago Nanomedical AB | Regulatory Spago Nanomedical receives go-ahead to include patients with pancreatic cancer in the clinical study SPAGOPIX-01 spagonanomedical.se ↗
The recruitment of patients with suspected or confirmed pancreatic cancer with spread to the liver begins immediately. |
| 2022-01-13 | Spago Nanomedical AB | Results Spago Nanomedicals phase 1 study with SpagoPix shows clear contrast enhancement and is expanded into new indications spagonanomedical.se ↗
The MRI images from the 6 patients in the second dose group show that SN132D provides clear contrast enhancement in breast tumors as well as in the pancreas and liver. |
| 2022-01-13 | Spago Nanomedical AB | Results Spago Nanomedicals fas 1-studie med SpagoPix visar tydlig kontrast och utökas till nya indikationer spagonanomedical.se ↗
MRT-bilderna från de 6 patienterna i den andra dosgruppen visar att SN132D ger tydlig kontrast i brösttumörer samt i bukspottskörteln (pankreas) och levern. |
All press releases naming this drug 17 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SN132D | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05664828 ↗ |