On March 23, 2020 SpagoPix reported that Data from the first dose group in the phase I study show that SN132D is well tolerated and provides valuable information for optimizing MR images in the next step (Press release, Spago Nanomedical, MAR 23, 2020, View Source [SID1234555755]). As the study thus continues to the next dose level, Spago has taken steps to increase patient recruitment, including by engaging in another breast cancer center.
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The internal safety committee of the SPAGOPIX-01 clinical trial, after analyzing data from the first six patients, has determined that the initial dose of SN132D is safe. The Committee also notes that the dose should be increased to optimize contrast enhancement in the tumors. The study thus continues with the next group of six patients, after which a new interim analysis will be done.
The fact that the first dose group was completed and proved to be safe is expected to facilitate continued patient recruitment. To further increase the recruitment rate, Spago Nanomedical has decided to extend the study to another breast cancer center, Sahlgrenska Hospital, to increase the patient base.
"The results are fully in line with our expectations and we are now looking forward to the results from the next dose level. We also intend to expand with another center to create even better conditions for including patients and being able to run the study at a higher rate, "says CEO Mats Hansen.
The dose that patients have received in the study so far has a very broad safety margin to the levels that have resulted in preclinical studies. The initial dose was intended to document initial safety and provide a basis for optimizing the possibilities of showing effect on subsequent dose levels.
SpagoPix (SN132D) is a contrast agent with the potential to significantly improve cancer diagnostics with magnetic resonance imaging (MRI). Initially, Spago Nanomedical has chosen to focus on breast cancer, a disease that affects approximately 2.1 million people annually, where MRI is already routinely used today for screening, diagnostics, or follow-up in 15-30 percent of all patients and the need for better precision in diagnoses. is big.
The primary goal of the SPAGOPIX-01 study is to document safety at different dose levels, but another important goal is to initially investigate the MR contrast effect in clinical use in patients with confirmed breast cancer. Study details and updates are published at www.clinicaltrials.gov .