Health
Visible Tumor Uptake and Recommended Dose Increase in Spago Nanomedicals's Phase I/IIa Study Tumorad-01
LUND, SE / ACCESS Newswire / October 14, 2025 / Spago Nanomedical AB (publ) (STO:SPAGO.ST)(FRA:7UX.F) announced today that the independent Data Monitoring Committee (DMC) recommends a dose increase in the ongoing Phase I/IIa clinical trial Tumorad-01 ...
About this update from Spago Nanomedical Ab
[{"type":"text","content":"LUND, SE / ACCESS Newswire / October 14, 2025 / Spago Nanomedical AB (publ) (STO:SPAGO.ST)(FRA:7UX.F) announced today that the independent Data Monitoring Committee (DMC) recommends a dose increase in the ongoing Phase I/IIa clinical trial Tumorad-01 with the radiopharmaceutical drug candidate 177Lu-SN201. In addition, significant visible tumor uptake of 177Lu-SN201 has been observed on SPECT images, which can be considered a proof-of-concept for Tumorad in humans according to the DMC. This provides strong support for continued development, as well as basis for exploring opportunities in indications with potential for orphan drug designation.","length":650,"tagName":"p"},{"type":"text","content":"Patient recruitment in the company's ongoing Phase I/IIa study Tumorad-01 has continued according to the current study protocol, and the third patient group is now fully recruited. A total of 12 patients with 10 different tumor types have been dosed, including three patients at the highest dose to date of 15 MBq/kg. An analysis of data from all patients treated to date confirms the previously demonstrated safety profile, i.e., that safety is acceptable and consistent. The independent Data Monitoring Committee (DMC) assesses that the maximum tolerable dose (MTD) has not yet been reached and recommends a further dose increase in the study.","length":649,"tagName":"p"},{"type":"text","content":""It is very gratifying that MTD has not yet been reached and that the DMC recommends a continued increase in dose, as this indicates that Tumorad has an acceptable safety profile so far. As with all cancer treatments, but perhaps even more so in radiotherapy, an acceptable safety profile is crucial. If we maintain the safety profile observed to date, this will be a significant advantage for Tumorad and a clear differentiating factor compared to other RNT drugs, both launched and in development, which often have more complex side effect profiles," says CEO Mats Hansen.","length":584,"tagName":"p"},{"type":"text","content":"Visible tumor uptake of 177Lu-SN201 has been observed with SPECT images in some participants. Significant levels of uptake have been observed in a patient with the rare cancer adenoid cystic carcinoma (ACC), who was treated with one cycle of 177Lu-SN201 at the current highest dose level. The observed tumor uptake supp...