Periodic Reporting for period 3 - NoCanTher (Nanomedicine upscaling for early clinical phases of multimodal cancer therapy)
Okres sprawozdawczy: 2019-04-01 do 2020-09-30
Worldwide in 2012 there were 338,000 new cases of pancreatic cancer and 331,000 associated deaths. Currently, surgery is the one curative treatment for PDAC (Pancreatic Ductal AdenoCarcinoma, a type of pancreatic cancer) but only a minority of patients present with potentially operable disease (10–20%). Therefore, there is an urgent need to develop effective treatments for this disease, and those based on nanotechnology might solve some of the problems faced with this disease.
Our approach is based on magnetic hyperthermia, where magnetic nanoparticles placed in the tumor are exposed to an alternating magnetic field (AMF) leading to an increase of the temperature of the particles and therefore the tumoral area. This process induces the death of the tumoral cells mainly.
Thus, to test this approach in humans, we need to meet the following objectives:
- Up-scaling under Certified Conditions.
The objective is to provide magnetic nanoparticles with the required properties for the therapeutic system exploited in this project, which is based on magnetic hyperthermia. These particles should be produced in a scalable manner and with the required certification to get the approval for a clinical study.
- Preclinical assessment for the elaboration of the IMDD.
This objective aims to collect information on the nanoparticles regarding their efficacy and safety. Thus, the particles are studied in different animal models, biodistribution and toxicity studies, including the required regulatory toxicity studies. All this information will be used to prepare a Dossier that will allow us to enter a clinical study.
- Clinical Study implementation.
Once we have Clinical Study Authorisation, we aim to run the clinical study using our therapeutic approach testing both the nanoparticles and a device developed in the Project that produces an alternating magnetic field (AMF), which is required to induce hyperthermia with the nanoparticles. The protocol for this study will be designed based on the efficacy and toxicity results obtained in the preclinical assessment.
The NoCanTher consortium counts on the involvement of 11 institutions from three different sectors (Academia, industrial, clinical) and five different countries (Spain, France, Germany, UK, and Ireland).
Meanwhile, the preclinical teams across 3 sites have been collecting information on the nanoparticles regarding their efficacy and safety. A preclinical version of the AMF generator has been used to assist the translation to the clinical setting. Thus, the efficacy of the approach (magnetic nanoparticles + AMF generator) have been studied in different animal models, including the biodistribution and toxicity studies of the nanoparticles. What is more, the required regulatory toxicity studies have been also carried out. The safety of the nanoparticles and device has also been thoroughly studied, with work towards the industrial sustainability of the process.
All of this information together with the certified production methods has allowed us to apply for the clinical trial authorisation, which has been recently granted.
To spread the word of what the consortium hopes to achieve NoCanTher has been represented at multiple events across Europe, communicating and disseminating the result and aims of the project, reaching out to the general public, researchers, clinicians and stakeholders.