Cutaneous leishmaniasis (CL) is a poverty related, neglected tropical disease, which is without an effective and cheap systemic treatment. The aim of TT4CL is to develop a new orally available drug for treatment of CL aimed towards registration with stringent regulatory authorities. Oleylphosphocholine (OlPC), regarded as a new drug by the FDA, is structurally related to the anti-leishmanial miltefosine. It is being developed as an immediate-release tablet for the treatment of CL and, currently, is the only systemically delivered drug specifically being developed for this indication. OlPC is active in vitro and in vivo against different CL-causing Leishmania parasite species and shows curative advantage over miltefosine in rodent models of leishmaniasis. The primary objective of this study is to complete the pre-clinical package that is essential for the subsequent clinical development of OlPC. The project will aim to optimize the synthesis and formulation of OlPC, including stability testing that is appropriate for tropical climates. It will include in vitro drug sensitivity analyses in parasites causing CL (Leishmania tropica and L. major) in the Islamic Republic of Iran, with our endemic-country partner. Comparative studies in animal models with existing anti-leishmanial compounds will establish efficacy advantages and determine pharmacokinetic-pharmacodynamic relationships for OlPC. Phase 1 studies will confirm tolerability and pharmacokinetics of single doses and multiple dosing regimens. Results will be used to guide decisions by future partners on the clinical development of OlPC. This proposal directly addresses the priorities highlighted in this H2020 call. To our knowledge, we are the only consortium that is implementing this type of approach, and there is no other interest in the pharmaceutical sector to carry out a development programme for the oral treatment of CL.
As a consequence of the ageing of the society, osteoporosis (literally “porous bone”) and its complications is becoming more and more prevalent, making the bone disease a health priority in many parts of the world. Currently osteoporosis is commonly known as a “silent killer” disease. Usually osteoporosis manifests itself in a drastic manner, i.e. through fracture of the osteoporotic bone in the affected individual. Until now little or no measures for prevention or early detection of this disease are taken, because no simple, yet sufficiently precise or sensitive tools for early detection of individuals at risk of osteoporosis are available. The overall objective of the currently proposed PoCOsteo project therefore is the development, clinical validation and preparation for commercialisation of a Point-of-Care tool for bone disease (a.o. osteoporisis) prevention, detection and treatment. To realize this objective a balanced consortium of 5 research partners and 3 SME’s has been brought together, and a well considered workplan devised. Two TRL3 technologies for individual proteomic and genomic electrochemical sensors, available from 2 consortium partners will form the base of the developments. The sensors will be further optimised, combined in a single microfluidic cartridge and integrated in a complete and independent point-of-care bone health assessment tool. The tool will consequently be clinically validated in 2 hospitals (Graz and Tehran), and a business plan for a commercial start-up company wil be prepared for the intended valorisation of the technical and medical activities. The aim is to reach a TRL6 / TRL7 for the complete tool and for the combined microfluidci cartridges. The project will be supported and advised by the IOF, the International Osteoporosis Foundation, which is the main global alliance of patient societies, research organizations, healthcare professionals and international companies working to promote bone, muscle and joint health.
Worldwide, more than 550,000 new cases of head and neck cancer (HNC) occur each year, resulting in approximately 300,000 deaths annually. It is the 6th most common cancer in both Europe and South America. A major reason for the high mortality rate for this cancer is the late stage of diagnosis for many patients. Accurate assessment of the prognosis of HNC cases also allows for appropriate treatment decisions. HEADSpAcE will bring together a consortium of 18 partners with a long and successful record of collaboration in HNC. The impact of HEADSpAcE will be to understand reasons for late diagnosis and reduce the proportion of HNC that are diagnosed at a very late stage. It will identify the most appropriate fashion for diagnosis cancer caused by human papilloma virus, and also provide genomic evidence of strong predictors of prognosis that will have the potential to improve care and reduce treatment related morbidity. We will also develop guidelines for implementation into clinical care.