Descrizione del progetto
Nuovo approccio per il trattamento dei gliomi di alto grado
I gliomi di alto grado sono i tumori cerebrali più aggressivi. La prognosi dei pazienti affetti da gliomi di alto grado è infausta e il trattamento più efficace, la radioterapia, aumenta la sopravvivenza mediana solo di pochi mesi. La PMI italiana Lisapharma intende sviluppare un nuovo trattamento per i gliomi di alto grado, compreso il glioblastoma multiforme, partendo da una piattaforma nanotecnologica. Il farmaco comprende una dispersione iniettabile contenente nanoparticelle brevettate caricate con acido zoledronico come principio attivo. Rispetto agli attuali trattamenti contro il tumore cerebrale, questo prodotto ha dimostrato miglioramenti significativi in termini di maggiore efficacia e minore tossicità nei modelli animali. L’obiettivo del progetto EDROMA, finanziato dall’UE, è quello di finalizzare il prodotto e sviluppare un piano commerciale per la sua introduzione sul mercato.
Obiettivo
Lisapharma, an Italian pharmaceutical SME, aims to bring on the market Edroma: a new product based on a nanotechnology platform to treat malignant high-grade gliomas (HGG), for which there are no satisfactory curative methods. High-grade gliomas are the most aggressive type of brain cancer. Despite recent advances in treatment, the prognosis for patients with HGG is dismal: so far the most effective treatment, radiotherapy, brings an increase in median survival from 3-4 months to around 9-10. The Edroma medicinal product is a dispersion for injection made of nanoparticles encapsulating the active ingredient zoledronic acid, resulting by a self-assembling procedure made possible by Lisapharma’s patented platform. Compared to the current brain-cancer therapy solutions, Edroma innovation brings significant improvements in terms of higher efficacy and lower toxicity. Pre-clinical tests on mice demonstrated tumour reduction, increased life-expectancy and even, in one case out of 6, complete cure. Lisapharma has obtained the orphan designation from both EMA and FDA. This represents a unique business opportunity, as Lisapharma will be the only authorised provider of the new product for 10 year (7 in USA). It is estimated that the number of treatable cases in EU and USA could reach 20,000 subjects for which there are no alternative curative therapy. Considering 15,000 € per treatment cycle, the values of this potential market approximate 135 M€, and Lisapharma intends to reach 30% of this market in 5 years. The project has the potential to boost growth of Lisapharma by increasing significantly the company turnover. The total investment required is about 4.5 M€ over 3 years, for clinical studies, equipment and industrialisation, marketing and business development, with a foreseen ROI (internal return rate) of 122%.
Campo scientifico
- medical and health sciencesbasic medicinepharmacology and pharmacydrug discovery
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
- medical and health sciencesmedical biotechnologynanomedicine
- medical and health sciencesclinical medicineoncology
- engineering and technologynanotechnologynano-materials
Programma(i)
- H2020-EU.2.1.2. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies Main Programme
- H2020-EU.2.1.5. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced manufacturing and processing
- H2020-EU.2.1.3. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials
- H2020-EU.2.3.1. - Mainstreaming SME support, especially through a dedicated instrument
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SMEINST-1-2016-2017
Meccanismo di finanziamento
SME-1 - SME instrument phase 1Coordinatore
22036 ERBA
Italia
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.