Issue 01 - june 2013 BERENICE is an acronym for: “Benznidazol and Triazol REsearch group for Nanomedicine and Innovation on Chagas diseasE”. BERENICE is a Collaborative Project which is funded under the European Community’s 7th Framework Programme. Grant agreement number: HEALTH-30593 Contents • What is BERENICE? ......................... 1 • The European Commission commitment with neglected diseases............................................ 1 • News ................................................. 2 • Social burden of Chagas disease. 2 • Promising novel treatments for chagas disease based on nano drug delivery systems ..................... 3 • Facing Chagas by the pharma industry: the need for open innovation ........................................ 4 The European Commission commitment with neglected diseases BERENICE Project is supported by the European Commission, under the 7th Framework Program. The EC commission uses this instrument through several calls to promote and support R&D efforts to develop and transfer novel technological achievements to fight neglected diseases, covering the existing innovation gap. In this case, the Topic puts special interest in the development of “Low-cost interventions for disease control in resource poor settings”, as it is necessary to give solutions which are not only good from a technological point of view but also feasible to be applied in scarcity of resources context. www.berenice-project.eu What is BERENICE? B ERENICE (BEnznidazol and triazol REsearch group for Nanomedicine and Innovation on Chagas disease) is a European research network (Collaborative Project) coordinated by Vall d’ Hebron University Hospital and its Research Institute (ICS-HUVH, Barcelona, Spain). Starting in September 2012, this 5-year project is supported by the European Commission under the Health Innovation Work Programme of the 7th Framework Programme. The main objective of BERENICE project is to obtain a more effective, better tolerated and low-cost formulation of a drug with trypanocidal activity to cure Chagas disease in endemic and non endemic countries. Chagas disease is an important health problem in Latin America and a challenge in non endemic countries. Its prevalence is estimated between 8 and 10 million people infected and approximately 14,000 deaths/year. It represents the second highest burden of disease among Tropical Diseases in the Americas. Although Chagas disease has been identified and described for more than 100 years, the therapeutic alternatives are limited and merits exploration: benznidazole and nifurtimox are the only 2 drugs available for treatment. Both benznidazole and nifurtimox have frequent side effects, especially in adults, requiring discontinuation in up to 10% of patients. The encapsulation of benznidazole using nanotechnology will generate a new drug delivery system. A better toxic profile will be obtained because of the reduced amount of benznidazole used, which will consequently lower the side effects as wells as the cost. BERENICE brings together 8 European and Latin American partners: Nanomol Group of the Materials Science Institute of Barcelona-Spanish Scientific Research Council (ICMAB-CSIC), NanoBioCel Group of the University of Basque Country (UPV/EHU), Instituto de Higiene e Medicina Tropica de Lisboa, Parasitology Laboratory of the Faculty of Pharmacy at the University of Barcelona, Fundação Oswaldo Cruz, National Institute of Parasotology Argentina Dr. Mario Fatala Chaben, and two pharmaceutical companies, ELEA and PRAXIS. Berenice Project - Newsletter 1 NEWS GENERAL ASSEMBLY On June 26th 2013 the Second General Assembly of the BERENICE project will be held in Barcelona. This meeting will congregate all Berenice partners from 3 European Member States (Spain, France & Portugal) and 2 countries in South America (Argentina & Brasil), under the coordination of the Hospital Universitari Vall Hebron, Barcelona, Spain. The purpose of the meeting will be the discussion of the project progress, especially the work packages WP2, WP3 and WP4 and the presentation of the next deliverable scheduled for August 2013 (month 12 of the project). CONGRESS From 20 to 23 April 2013 took place in Lisbon the 2nd Tropical Medicine National Congress organized by the Institute of Hygiene and Tropical Medicine (IHMT). A round table in Chagas disease was organized with the participation of the Coordinator and some of the partners. Within the Congress it also was held the 3rd working meeting of Berenice project in which the consortium had the opportunity to exchange key information at at this stage of the project. Social burden of Chagas disease hagas disease is a parasitic infection caused by the protozoa Trypanosoma cruzi which affects about 10 million people worldwide. About 80% of infections occur through the main vector, the kissing bug, which is generally found in adobe houses. It also could be transmitted from mother to child during pregnancy, blood transfusion, organ transplantation, and ingestion of contaminated food. C The barrier in the diagnosis and treatment Chagas disease is directly linked to the precarious conditions of life from sufferers and is one of the biggest health problems in Latin America. Due to immigration, the disease also affects people in the United States and Europe. Simplified diagnostic tools and better treatments adapted to different contexts are also needed. These have to be accessible to patients in their health centers and close from their community. In Latin America, the parasite T. cruzi is transmitted primarily through infected feces of triatomine bugs (known as kissing bugs) that feed on blood. Usually they live in cracks and holes of poorly constructed houses in rural and suburban areas. They remain hidden during the day and become active at night feeding on human blood and other mammals. Generally, they bite into an exposed area of the skin such as the face, and defecate near the bite. The parasites enter into the body when the person is bitten and push instinctively rubbed feces into the bite, eyes, mouth, or an open skin lesion. Not only new drugs are needed to go along with this process, but also health authorities must ensure that the necessary drugs are available in all concerned countries. The patient care must be accompanied by a monitoring and vector control effort, which would allow the eradication of insects that transmit the parasite of Chagas disease. This disease, in its chronic stage, may cause cardiac complications and / or digestive in 20-30% of cases. Because of cardiac complications (arrhythmias and heart failure) approximately 10,000 people die annually. Nowadays, the lack of human resources and strong health infrastructures are the main barriers to guarantee access to diagnosis and treatment for patients. These should go together with promotion and education programs for both the population and health professionals. Similar to many parasitic diseases, Chagas disease is related to population’s low economic and social development. Thus, triatomine insects and diseases they transmit will exist as long as depressed housing persists in Latin America. Improving these conditions of life would be the best weapon to combat this and many other endemic diseases. CONGRESS From 29-31 May 2013 it was held the XVII Congress of the Spanish Society of infectious diseases and clinical microbiology. www.berenice-project.eu 2 Berenice Project - Newsletter Chagas disease represents the second highest burden of disease among Tropical Diseases in the Americas. Issue 01 - june 2013 Simplified diagnostic tools and better treatment adapted to different needed to combat Chagas disease. Promising novel treatments for chagas disease based on nano drug delivery systems N anomedicine is the innovative application of nanotechnology to the diagnosis, prevention, and treatment of disease in the human body. Usually, this kind of deep innovation has being fully applied only for diseases affecting developed countries. But this technology can be applied to fight several neglected parasitic diseases, like Chagas, that affect hundreds of millions of people and result in high morbidity and mortality worldwide. Efforts to reach that goal are being made, with projects like BERENICE being an example. Efficient Nano-Drug Delivery Systems (DDSs) are of great interest for neglected diseases treatment. This approach allows tuning up existent, low efficient and no safe treatments, as a way to obtain novel treatments but avoiding the extremely high costs related to novel compounds discovery , which is a critical aspect in the scarcity of novel therapeutics for neglected diseases like Chagas. These advantages derived from the use of nanocarriers are especially interesting in the treatment of Chagas disease, as the only current existent treatment (Benznidazol©) presents significant side effects and low efficacy for treatment of the chronic phase of the disease. 1. Small Unillamelar Vesicles (SUVs), which constitute one of the most promising drug nanocarriers in the field of drug delivery and Nanomedicine, will be conjugated to Benznidazole. The use of compressed fluids like CO2 has shown to provide very effective methodologies for the robust and environmental respectful preparation of this kind of nanoparticulated conjugates. SUVs obtained using this methodology present finely tuned size distributions, highly homogeneous supramolecular structure and morphology and an acute response to external stimuli, factors which improve their pharmacological properties. 2. SLN´s (Solid Lipid Nanoparticles) is other possible nanoformulation of this triazols that could increase the activity and reduce the toxicity of Benznidazol by providing a sustained release formulation of the drug. SLNs are colloidal carrier systems made from solid lipids, introduced at the beginning of the nineties as drug delivery systems alternative to existing colloidal carriers. Excellent tolerability, increased drug stability, reduced citotoxicity and possibility of qualified industrial large scale production are clear advantages of SLN. New developments in innovation based on lipid nanoformulations would alleviate the limitations of current Chagas treatments. It is expected to improve the pharmacokinetics and pharmacodynamics of current Chagas disease therapies by decreasing the total dose of drug used, minimizing the toxicity profile, reducing the appearance of resistance and increasing the tissue concentration. In the framework of BERENICE project, two groups of CIBER-BBN, NANOMOL and NANOBIOCEL, will develop new methodologies for preparing formulations which are based on: Berenice Project - Newsletter 3 PARTNERS Spain Argentina Brasil France Portugal Project Coordinator Israel Molina P. de la Vall d’Hebron, 119-129 08035 Barcelona, SPAIN Phone: +34 93 274 62 51 Email: [email protected] Project Manager Esperanza Esteban P. de la Vall d’Hebron, 119-129 08035 Barcelona, SPAIN Phone: +34 93 274 60 00 (Ext. 64 73) Email: [email protected] For further information, please visit our website at: www.berenice-project.eu 4 Berenice Project - Newsletter Facing Chagas by the pharma industry: the need for open innovation Neglected diseases, like Chagas, mean a major health problem for a significant number of people, generally located in pour resource setting and endemic zones, mostly Central and South America, Africa and parts of Asia. There exist different definitions for neglected diseases, but the fact is that they afflict more than 1400 million people worldwide. Many of them live on less than $1.25 per day. Neglected diseases are linked to poverty, bad hygienic conditions, lack of access to clean water, extremely low quality buildings, and, in many cases, scarcity of access to adequate treatments for patients suffering this kind of diseases. This difficult of access to treatment is due to several conditions: scarcity of economic resources, difficulties for distribution due to lack of infrastructures and no existence of efficient, actualized treatments. The improvement of living conditions led to eradication of these diseases in places where people has access to good health services and a reasonable standard of living. Consequently, efforts for development of novel treatments has been discontinued for decades, as Pharmaceutical industry and capacity for innovation is established in the no affected countries. The described situation leads to an “innovation gap”, motivated by the lack of purchasing power which would drive the investment in novel medicines to treat neglected diseases. Chagas is a paradigmatic example of this situation, as only two treatments exist currently (Benznidazol and Nifurtimox), both of them discovered more than 40 years ago, when pharmaceutical development was conditioned by the existent technological level and clinical trials, side effects evaluation, etc, were less strict than nowadays. Connected to this innovation scarcity, market problems have also raised, leading to definitively stop the production and sale of Nifurtimox and causing that Benznidazol production was discontinued for some months, until laboratory Elea took the responsibility of re-start the production of this drug, which, even if it is not ideal, is the best currently existent weapon against the disease.” Fortunately, during the last decade this situation is changing. Efforts from private and public initiatives (DNDi, Bill and Melinda Gates Foundation, the European Commission, Mundo Sano, CyCA-Ciencia y Conocimiento en Acción Foundations, etc), together with a major compromise from the Pharma industry, is leading to the development of novel treatments for neglected diseases. The industry is conscious of the demands of the world of neglected diseases, and is getting more and more compromised with the problem, due to social responsibility convincement, personal compromise of the major shareholders (as happens with Praxis and Chagas disease) and opportunities to face projects prioritized by unmet medical needs and no commercial benefit. This new approach should be faced using open innovation paradigms, which means developing solutions through collaboration with different partners, sharing technology, intellectual property, knowledge, etc, allowing the obtaining of solutions with low cost and lower risk. BERENICE project is a clear example of this strategy, putting together clinicians, academics and industry in order to obtain a lower cost, more efficient and safer treatment for Chagas disease.
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