Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.4.2-1 | Award Amount: 7.19M | Year: 2013
Chronic pain is estimated to affect 15-20% of children with varying disabilities. Due to the paucity of clinical information and appropriate medicinal products, in clinical practice paediatric patients are often under-treated causing profound impact on their QoL. To date, opioids, non-steroid anti-inflammatory drugs (NSAIDs), antidepressants and anticonvulsants are used to treat pain, but only few of these include a paediatric authorisation. In addition, the few available paediatric drugs have a very different authorisation profile across Europe and, when not approved in paediatrics, they are used off-label to cover the high therapeutic need, thus exposing children to unnecessary risks of dosing errors and increasing ADRs. The GAPP Project is focused on the development of gabapentin for the treatment of paediatric chronic pain, a condition where gabapentin, as demonstrated in adults, is expected to bring great benefit to children. To this end, a large international scientific Consortium is set up, with experienced professionals in the field of pain that will work together with a Pharmaceutical Company committed to apply for a PUMA using the project results. Within GAPP, age-appropriate formulation will be developed and two randomised, comparator-controlled clinical trials and a bridging study will be conducted in compliance to a submitted Paediatric Investigation Plan (PIP, Summary Report Day 90 - EMEA-001310-PIP01-12) in order to investigate appropriate dosages, efficacy and safety of gabapentin in the paediatric population. Further to this, in order to ensure the safety of gabapentin in very young children, a non clinical study will be conducted to evaluate the neurotoxic potentil of the drug. At the end of the project, gabapentin can be proposed for treatment of chronic pain in children both as monotherapy and as adjuvant therapy.
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: NMP-2008-1.1-1 | Award Amount: 4.86M | Year: 2009
The aim of this project is the assembly and the fabrication of a new generation of multifunctional nanostructures for performing combined hyperthermia and controlled drug release, specifically targeted to cancer cells. The magnetic nanocontainers we intend to develop can perform at the same time cell recognition, hyperthermia treatment, and, as a consequence of the heat and /or cell environment stimuli, the release of drug with high selectivity for ovarian carcinoma. These multifunctional tasks are made possible due to the inclusion of three main components: a) the magnetic nanoparticles, allowing detection by MRI, cancer treatment by hyperthermia and providing stimuli for drug release; b) the nanocontainers, which allow for drug encapsulation and protection from degradation, facilitate the release of the drug upon application of an external stimulus, such as heat, or an internal one, such as the acidic pH of the tumour cells; c) the antibody fragments attached to the surface of the magnetic nanocontainers to deliver them selectively to the ovarian cancer cells. The individual building blocks and their assemblies will be characterized with respect to physical, chemical, and biological features, followed by dissemination of the newly acquired knowledge. Cell culture experiments will allow to understand the performance of such nano-tools in vitro. Directed towards application in patients, in vivo animal studies will be carried out on the most successful magnetic nanocontainers. The objectives of this proposal cover a wide range of scientific fields, hence a truly interdisciplinary collaboration between chemists, physicists, and biologists is required. To this end, we propose a european network collaboration between academic partners, who will take care of the development of new solutions for nanofabrication, and industrial partners implied in the field of the proposed application who will evaluate/develop the materials and act as advisors for risks arising during the project.
Dompe S.P.A. | Date: 1997-05-06
Dompe S.P.A. | Date: 1994-11-18
Dompe S.P.A. | Date: 2005-03-15
Non-steriodal anti-inflammatory products, namely creams, ointments and lotions for topical application and pills or tablets for oral application.