Spago Advances to Higher Dose in Tumorad-01 Trial

3 June 2024
A recent development in the medical field has brought a significant update to the clinical trial landscape. Spago Nanomedical, a Swedish clinical development company, has reported a key recommendation from an independent data monitoring committee (DMC) regarding their ongoing phase I/IIa study, Tumorad-01. The DMC has advised an escalation in dosage for the study's candidate drug, 177Lu-SN201, after reviewing initial safety data from the first patient.

The study, which is focused on advanced cancer patients, is designed to assess the safety, tolerability, dosimetry, and preliminary efficacy of 177Lu-SN201. The first participant received a starting dosage of 10 MBq/kg and demonstrated a safety profile that prompted the DMC's recommendation for an increase to 25 MBq/kg for subsequent patients.

The phase I component of the Tumorad-01 study is crucial as it seeks to establish a therapeutic dosage based on the safety and biodistribution of 177Lu-SN201. This information will guide further testing in specific patient groups during the phase IIa segment of the trial. Recruitment for the study is on track, and preliminary findings from phase I are anticipated to be released in the latter part of the first half of 2024.

Spago Nanomedical's innovative approach utilizes a unique platform of polymeric materials, which are integral to the development of more accurate treatments and diagnostics for cancer and other severe illnesses. The company's shares are publicly traded on the Nasdaq First North Growth Market under the ticker symbol SPAGO.

While the study progresses, the company continues to advance its mission to enhance patient outcomes through the development of novel therapies. The Tumorad-01 study is a testament to Spago Nanomedical's commitment to pioneering research and the potential for improving cancer treatment options.

It is important to note that the study's details, including its progress and any updates, can be found on the ClinicalTrials.gov registry, ensuring transparency and accessibility of information for interested parties. This approach aligns with Spago Nanomedical's dedication to ethical research practices and the pursuit of breakthroughs in medical science.

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