20 Dec, 2018

Spago Nanomedical submitted application for initiation of the phase I clinical trial SPAGOPIX01

Spago Nanomedical AB (publ) applied today with the Swedish Medical and Pharmaceutical Agency for initiation of a phase I clinical trial of the contrast agent SpagoPix (SN132D) in patients with breast cancer. The study is planned to be conducted in Sweden at Uppsala University Hospital. The intention is to start patient recruitment as soon as possible following regulatory approval.

The primary aim of the clinical trial is to document safety in patients with breast cancer. Another key aim is to investigate the contrast enhancement in MRI of primary and secondary tumors.

”The SpagoPix project is running according to plan and we have taken another step towards the target to offer a cancer selective and gadolinium free contrast agent for MRI of solid tumors”, says CEO Mats Hansen.

The clinical study is named SPAGOPIX01. Study information and updates will be posted at www.clinicaltrials.gov.

For further information, contact Mats Hansen, VD Spago Nanomedical AB, +46 46 81188, mats.hansen@spagonanomedical.se.

Spago Nanomedical (Spotlight Stock Market, 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 20 December, 2018.

Spago Nanomedical submitted application for initiation of the phase I clinical trial SPAGOPIX01