Project description
New promising treatment for malignant mesothelioma
Asbestos is a naturally occurring mineral that demonstrates resistance to heat and corrosion and has been employed as an insulator in many everyday materials. However, exposure to asbestos is highly toxic and can cause, among others, malignant mesothelioma in the linings of the lungs, abdomen or heart. Mesothelioma treatment entails the use of chemotherapy, which is characterised by limited efficacy, side effects and resistance. The EU-funded BERMES project has developed a novel drug with promising anti-tumour effects and safety profile. Project activities include completion of the preclinical package and the manufacture of the drug substance to achieve regulatory approval to proceed to clinical trials. The project also seeks the orphan drug designation for a novel mesothelioma treatment.
Objective
Malignant Mesothelioma (MM) is a rare, aggressive and highly treatment-resistant malignancy arising in the thin layer of tissue known as mesothelium, which covers many of the important internal organs like the lungs, the peritoneal cavity, the heart and the testis.
The World Health Organization has recognized that all forms of mesothelioma are strongly associated with asbestos exposure and that its burden is increasing worldwide. Asbestos was definitely banned in European Union in January 2005. However, since the disease has a long latency period (44.6 years from exposure to diagnosis), peak incidences are expected in EU beyond 2020.
The standard first line treatment is the combination of pemetrexed and cisplatin with limited efficacy and side-effects. Despite a great deal of research has been undertaken during the last 10 years, none of the current drugs under clinical trials has shown yet an improvement in overall survival over existing standard therapy or solved the emergence of chemoresistance.
NAX035, an innovative berberine derivative has exhibited efficacy as antitumour agent with a good preliminary pharmacokinetic, toxicity and safety data when administered as oral therapy for the treatment of malignant mesothelioma. Activities of BERMES (BERberine derivative for MESothelioma treatment are expected to close the translational gap (death valley) by pulling the product up to the clinical development: BERMES will focus on completion of the non-clinical package and the drug manufacture with the aim of obtaining the orphan drug designation as well as to accomplish all the regulatory requirements required by the European Medicine Agency to achieve the clinical trial authorization to proceed into clinical trial right after the end of the project.
Programme(s)
Funding Scheme
SME-2 - SME instrument phase 2Coordinator
08028 BARCELONA
Spain
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.