Spago Nanomedical has Submitted Application to Start Tumorad(R) Clinical Phase I/IIa Study
BIOMARKER
1. Spago Nanomedical has submitted an application to begin the clinical phase I/IIa trial for Tumorad-01, a radionuclide therapy program, in Australia.
2. The application has been sent to the ethics committee, and patient enrollment is expected to start in summer 2023.
3. The clinical trial will evaluate the safety, tolerability, and early efficacy of the candidate drug 177Lu-SN201 in patients with advanced cancer.
4. The study will include up to 30 patients in the phase I part, with a focus on assessing the selective tumor accumulation of Spago Nanomedical's functional nanoparticles.
5. The radioisotope lutetium-177 (177Lu) will be combined with Spago Nanomedical's polymeric nanomaterial for targeted treatment of cancer.
6. The study will be conducted in Australia, benefiting from competent clinical sites, an expedited regulatory pathway, and financial support for research and development costs.
7. This milestone marks the transition of Spago Nanomedical's radionuclide therapy program into clinical development.
8. The company expects to include the first patient in the study during the summer.
9. Spago Nanomedical is a Swedish nanomedicines company focused on precise diagnosis and treatment of life-threatening diseases.
10. The company's shares are listed on Nasdaq First North Growth Market, and FNCA Sweden AB serves as its Certified Adviser.