Malignant Mesothelioma is a rare, aggressive and highly resistant tumour arising in the mesothelium, a thin tissue layer which covers important organs like the lungs, the peritoneal cavity organs, the heart and the testis. Despite being a rare cancer, its burden is increasing worldwide being recognized by the World Health Organization (WHO) as one of the top ten worldwide occupational cancers. This is due to the fact that mesothelioma is strongly associated with exposure to asbestos. The highest incidence rates are reported from the European Union countries where asbestos was definitively banned in January 2005. Knowing the long latency period for the disease, that takes 30-40 years to appear after asbestos exposure, an incidence peak is expected well beyond 2020. More alarming is the fact that there are still 190 countries mining and consuming asbestos. According to WHO, over 125 million persons remain daily exposed, of which 4-10% will develop eventually mesothelioma.
Current mesothelioma treatment includes the combination of surgery, chemotherapy and radiation. Unfortunately, most of the patients are diagnosed at advanced stage of the disease where chemotherapy remains the only option. The cisplatin and pemetrexed combination is considered the standard of care treatment although its efficacy is low: almost half of the patients are primary resistant and all finally develop resistance in less than 5 months. When therapy fails, there is no standard second-line chemotherapy treatment. Despite new targeted drugs and immunotherapy combinations are currently being evaluated in clinical trials, so far none has substantially improved the standard of care response rate or has been able to overcome the resistance phenotype.
Aware of the need, AROMICS develops a new class of antitumor agents (protected under granted patents) based on a pioneering mechanism of action: silencing an aberrantly expressed protein involved in the tumour progression and drug resistance. NAX035, is the first lead selected to advance up to clinics due to its great potency and appropriate pharmacology, toxicology and safety profile.
Activities inside BERMES has accomplished its main goals: the completion of the non-clinical regulatory package (proving its efficacy, pharmacology, toxicology and safety in relevant animal species) and the drug substance manufacture under GMP rules 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 human clinical trials (outlined in the project) right after the end of the project.
