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UC cancer nanoparticle gets designation of “orphan drug”

A new generation lipid-based nanoparticle to fight cancer, PEGASEMP, developed at the University of Coimbra (UC), obtained the status of “orphan medicine” from the European Medicines Agency (EMA) and from the American regulatory authority Food and Drug Administration (FDA) for the treatment of malignant mesothelioma, a rare type of cancer that results from exposure to asbestos. This status is a facilitating factor for carrying out a clinical trial in patients.

“Orphan drugs” are drugs aimed at the diagnosis or treatment of serious rare diseases, identified as orphan diseases, which affect a small number of people compared to the general population.

The attribution of EMA and FDA is the result of several and complex studies carried out over several years at the Center for Neuroscience and Cell Biology (CNC) of the University of Coimbra (UC), in collaboration with national and foreign research centers, under the leadership of João Nuno Moreira, professor, and researcher at the CNC and the Faculty of Pharmacy, University of Coimbra (FFUC).

In the most recent work, whose results have just been published in the scientific journal Nano Today, which specializes in the dissemination of the most influential and innovative works in nanoscience and technology, João Nuno Moreira‘s team developed and tested a prototype of industrial production of PEGASEMP technology under conditions GMP (Good Manufacturing Practices), extensively characterized in terms of physical and chemical properties, demonstrating the safety and antitumor effectiveness of this drug delivery system.

Anticipating potential use in humans, very detailed experiments were carried out on different animal species. «The safety of the nanoparticle in mice, rats and dogs was evaluated according to the rules for the development of new drugs for cancer treatment. Their safety has been effectively demonstrated», reports the team leader.

Basically, the product PEGASEMP can be described as a blister of fat (of lipidic nature), containing in its interior an anti-cancer compound, which accesses solid tumors through a new entrance door, blocking the growth and the tumor invasion.

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