Project description DEENESFRITPL New approach for the treatment of high-grade gliomas High-grade gliomas (HGG) are the most aggressive brain cancer. The prognosis for patients with HGG is poor, and the most effective treatment, radiotherapy, increases median survival by only a few months. The Italian SME Lisapharma aims to develop a new treatment for HGG, including glioblastoma multiforme, based on a nanotechnology platform. The medicinal product comprises a dispersion for injection containing patented nanoparticles loaded with zoledronic acid as an active ingredient. Compared to current brain cancer treatments, this product demonstrated significant improvements with higher efficacy and lower toxicity in animal models. The objective of the EU-funded EDROMA project is to finalise the product and develop a business plan for its introduction to the market. Show the project objective Hide the project objective Objective 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%. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacydrug discoverymedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsmedical and health sciencesmedical biotechnologynanomedicinemedical and health sciencesclinical medicineoncologyengineering and technologynanotechnologynano-materials Programme(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 Topic(s) SMEInst-02-2016-2017 - Accelerating the uptake of nanotechnologies advanced materials or advanced manufacturing and processing technologies by SMEs Call for proposal H2020-SMEInst-2016-2017 See other projects for this call Sub call H2020-SMEINST-1-2016-2017 Funding Scheme SME-1 - SME instrument phase 1 Coordinator LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA SPA Net EU contribution € 50 000,00 Address VIA LICINIO 11 22036 ERBA Italy See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Nord-Ovest Lombardia Como Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 71 429,00
