Spago Nanomedical receives approval to initiate the clinical trial SPAGOPIX-01

Spago Nanomedical AB (publ) has received approval from the Swedish Medical Products Agency to initiate the first clinical trial with the contrast agent SpagoPix (SN132D) in patients with breast cancer.

SpagoPix is a nanomedical contrast agent with potential to significantly improve cancer diagnostics with magnetic resonance imaging (MRI). Spago Nanomedical will initially focus on imaging of breast cancer, a disease that affects approximately 2.1 million people annually. MRI is used regularly for screening, diagnosis, or tumor staging in 15-30% of all breast cancer patients but the need for better precision is substantial.

”SN132D is a new and interesting contrast agent for MRI examination of solid tumors, a field in need of improvements”, says Associate Professor Fredrik Wärnberg, responsible investigator for the SPAGOPIX-01 trial and senior physician at Uppsala University Hospital.

The approval to start the Phase I trial SPAGOPIX-01 follows the application submitted by Spago Nanomedical on December 20, 2018. In the clinical trial, the product candidate SN132D, a tumor selective and gadolinium-free contrast agent for MRI, will be administered to patients with breast cancer.

The primary objective of the study is to document safety of SpagoPix, but another important objective is to investigate contrast effects with MRI in a clinical setting.

The trial, which is planned to include up to 20 patients, will be conducted at the Uppsala University Hospital in Sweden. The production of GMP material is ongoing, enrolment of patients will commence as soon as this is completed.

”The green light for the first clinical trial with SpagoPix means we have passed a very important milestone both in the project and the company. Spago Nanomedical is now in clinical development phase”, says CEO Mats Hansen.

Trial details and updates will be published on 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 19 February, 2019.

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