The Swedish clinical CRO CTC Clinical Trial Consultants will conduct Spago’s first clinical study with SpagoPix.
The aim of the clinical trial is to document safety and MR images in cancer patients. Compilation of clinical study protocol and material for the application for clinical trial with the Swedish Medical Products Agency is in progress. The study will include approximately 20 cancer patients and be conducted at a small number of centers.
”Following on the recently communicated positive preclinical results the agreement with CTC marks the next step into clinical development of SpagoPix. The study design is emerging and I look forward to initiation of our first clinical trial by the end of the year”, says Mats Hansen, CEO of Spago Nanomedical.
SpagoPix is a contrast agent based on nanoparticles and manganese aiming to improve cancer diagnostics using magnetic resonance imaging (MRI). The company recently reported good safety of the product candidate SN132D in the regulatory preclinical program including toxicity- and safety studies. Transfer and validation of the production process at the contract manufacturing organization ChemConnection is in progress. The GMP-production of material for the clinical trial is expected to commence during the summer. The aim is to initiate the clinical trial shortly after release of the GMP-material.
Photo of Mats Hansen: Spago Nanomedical