Descripción del proyecto
Nuevo método para el tratamiento de los gliomas de gran malignidad
Los gliomas de gran malignidad (HGG, por sus siglas en inglés) son la neoplasia encefálica más agresiva. El pronóstico de los pacientes con HGG es malo, y el tratamiento más eficaz, la radioterapia, aumenta la supervivencia media en solo unos meses. La pyme italiana Lisapharma pretende desarrollar un nuevo tratamiento para el HGG, incluido el glioblastoma multiforme, basado en una plataforma nanotecnológica. El medicamento comprende una dispersión inyectable que contiene nanopartículas patentadas cargadas con ácido zoledrónico como principio activo. En comparación con los tratamientos actuales contra las neoplasias encefálicas, este producto demostró mejoras significativas con una mayor eficacia y una menor toxicidad en modelos animales. El objetivo del proyecto EDROMA, financiado con fondos europeos, es finalizar el producto y desarrollar un plan de negocio para su comercialización.
Objetivo
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%.
Ámbito científico
- 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
Programa(s)
- 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
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-SMEINST-1-2016-2017
Régimen de financiación
SME-1 - SME instrument phase 1Coordinador
22036 ERBA
Italia
Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.