SpagoPix shows good safety in regulatory preclinical studies
Spago Nanomedical AB (publ) has completed the in-life part of the regulatory preclinical program with SpagoPix. The product candidate SN132D displays a good safety margin to clinically relevant doses.
Data from the preclinical studies will be included in the regulatory application for the first clinical trial with SpagoPix. The aim is to submit the application in order to allow a study in humans to start during this year. The planned clinical study will be performed in cancer patients and is being designed to document safety and MR images of tumors.
”We are currently working with the detailed design of the first study with SpagoPix in humans. The aim is to commence the clinical trial at the end of this year”, says Mats Hansen, CEO of Spago Nanomedical.
”The results of the preclinical studies confirm the data previously seen in pilot studies and we are confident that SN132D is safe to use in clinically relevant doses. This is a major risk reduction in the SpagoPix project”, says Oskar Axelsson, CSO of Spago Nanomedical.
The regulatory preclinical program has been conducted in collaboration with Charles River Laboratories and included extensive toxicity- and safety studies.
För ytterligare information, kontakta Mats Hansen, VD Spago Nanomedical AB, +46 767 764294, mats.hansen@spagonanomedical.se.
Spago Nanomedical (AktieTorget Stockholm: SPAG) develops nanomaterials for cancer diagnostics and therapy. The company´s development activities are primarily focused on the cancer selective MRI-contrast agent SpagoPix, and the Tumorad®-project for cancer selective radionuclide therapy of cancer. The business concept of Spago Nanomedical is to develop projects from explorative to regulatory preclinical or early clinical phase, and then out-license or enter partnership for continued development of the projects to market launch. Spago Nanomedical collaborates with well-established and reputable patent consultants to continuously strengthen the intellectual property protection of the projects.
SpagoPix is a nanoparticle-based contrast agent with manganese with potential to improve cancer diagnosis using magnetic resonance tomography (MRI). By offering high precision and superior enhancement of tumors and metastases in MRI-images, the chances of correct diagnosis increase. Improved MRI diagnostics increase the chances of effective treatment for the patient. SpagoPix is also free from gadolinium, an element that may cause unwanted side effects and has caused regulatory agencies to issue warnings or withdraw products from the market.
For further information, see www.spagonanomedical.se.
The information in this press release is such that Spago Nanomedical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (EU, 596/2014). The information was submitted for publication, through the agency of the contact person set out above, on 24 May, 2018.
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