The NoCanTher consortium planned to test in humans a new therapy for pancreatic cancer based on magnetic nanoparticles, which has a very bad prognosis, with a survival rate after 5 years (< 5%) unchanged over the last 30 years, despite tremendous efforts at the preclinical and clinical stage.
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.
Thus, to test this approach in humans, we needed to meet the following objectives:
SO1- Up-scaling under Certified Conditions.
The objective was to provide magnetic nanoparticles with the required properties for the therapeutic system exploited in this project, based on magnetic hyperthermia. These particles should be produced in a scalable manner and with the required certification for a clinical study.
SO2 - Preclinical assessment for the elaboration of the IMDD.
This objective aimed to collect information on the nanoparticles regarding their efficacy and safety. Thus, the particles were studied in different animal models, biodistribution and toxicity studies, including the required regulatory toxicity studies. All this information was used to prepare a Dossier for the clinical study.
SO3 - Clinical Study implementation.
With Clinical Study Authorisation, we started the clinical study using our therapeutic approach (nanoparticles and AMF producing device required to induce hyperthermia with the nanoparticles). The protocol for this study was designed based on the efficacy and toxicity results obtained in the preclinical assessment.
Conclusion:
The project has maintained its course of the final period on track for the impact envisioned at the beginning of the project. The progress towards the Specific Objectives has been clear with SO1 and SO2 have been met and the positive approval of the clinical study as part of SO3, the news of the first patient’s recruitment demonstrates the successful achievement of the project.
Although the clinical study is ongoing due to aforementioned reason our focus as a group is to maintain the momentum of the project outputs and complete the study. This will bring high visibility to the project outcomes and is already having a great impact in the society. In this regard, we want to highlight that during the development of the NTT System, we have had several meetings with Notified Bodies and the Spanish Drug Agency, to explain the approach, and we finally submitted the request for the study. Also at the hospitals we have met with the clinicians to discuss the technology and the ethical issues involved in the study. Similarly, we have had several activities with the Spanish Cancer Society, the Spanish Nanomedicine platform, politicians and the general public to explain the project and the advantages of using nanotechnology-based approaches to treat diseases.
We are convinced that these actions will ease the introduction of novel approaches based on nanotechnology. Therefore, besides the inherent impact of the NoCanTher project due to the development of a treatment of pancreatic cancer, our activities will have a multiplier effect on the society, which now understands better and supports more the development of novel therapeutic strategies, as this one funded by the EC. Besides the impact in the society in these terms, we believe that products/science developed (NTT agents, generators, magnetometer, synthetic and evaluation procedures, toxicity studies) is of utmost importance to European companies and scientific institutions to be competitive in the area of Health where new materials are involved.
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).
