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CT21911-CR03-25
Catania, 18th November 2013

Etna Biotech is proud to announce the initiation of an EU supported research project aimed at developing a vaccine to prevent Leishmaniasis.

Leishmaniasis, among the parasitic diseases, is second only to malaria in terms of impact. While mainly prevalent in India, Bangladesh, Sudan, Ethiopia and Latin America, the incidence of this disease is also on the rise in Europe, particularly in Italy, Albania, Greece and Spain. 

The funding by the European Commission's Framework Programme 7 has enabled eight partners from across Europe to come together to form the consortium behind MuLeVaClin, being coordinated by Etna Biotech. 

Dr. C.P Thakur, Member of the Indian Parliament, Former Union Health Minister, Govt. of India, Chairman of the group's advisory committee said "I am very happy to see this ambitious proposal become a reality. A vaccine against Leishmaniasis would make a significant difference in preventing this devastating and neglected disease". 

The research project, called MuLeVaClin, has received approval for funding by the European Commission and is the recipient of the only European grant for Leishmania vaccine research this year. MuLeVaClin aims to establish two lines of protection against natural infection simulating a natural infection cycle of Leishmania in order to efficiently block vector transmission and infection of the human host. For this purpose MuLeVaClin will introduce a recombinant protein from saliva of the sandfly vector, together with recombinant target antigens from Leishmania infantum in combination with a strong TH1 adjuvant formulated in a Virus Like Particle structure. 

Dr. Reinhard Glueck, Chief Scientific Officer of Zydus Cadila and Board chairman of Etna Biotech, said "This project brings together many of the finest scientists from across Europe and the US. Our goal is to have a Leishmaniasis vaccine ready for clinical trials within two years, and within five years to achieve the proof of principle in humans". 

About Leishmaniasis 
Leishmaniasis is one of the most neglected tropical diseases, in relation to the few tools available for control and the lack of clear criteria for methods of control. In May 2007, the 60th World Health Assembly adopted resolution 60.13 on control of Leishmaniasis. The disease affects the poorest people in the world and in the last ten years has spread considerably. An estimated 1.3 million new cases and estimated 20,000 to 30,000 deaths occur annually. Existing treatments for this neglected disease have severe drawbacks: debilitating side effects, increasing drug resistance, high costs and long-term treatment. There are three forms of Leishmaniasis: visceral, cutaneous and mucocutaneous. The Visceral Leishmaniasis is the most severe form of the disease. The devastating effects of this disease affect largely the poorest of the poor, mainly in developing countries with a disease burden calculated at 2,090,000 disability adjusted life years. Each year, there are approximately 300,000 cases of visceral leishmaniasis (90% in Bangladesh, Brazil, India, Nepal and Sudan), with an estimate of more than 50,000 deaths. 

About the MuLeVaClin consortium 
The MuLeVaClin consortium has been constructed around an integrated assembly of eminent scientific groups with acknowledged complimentary expertise in the fields of molecular biology, immunology, vaccinology, and clinical evaluation. The consortium includes eight partners, located in Spain, Portugal, Italy, Switzerland and the Czech Republic. The partners have been selected for their capability to cover all the aspects for this specific vaccine development: The consortium includes most renowned experts in the field of Leishmaniasis, with two National Health Centers for the surveillance of the disease: ISTITUTO SUPERIORE DI SANITA‘ (Italy) and the INSTITUTE OF HEALTH CARLOS III (Spain); two prestigious research centers such as: the CENTRO DE BIOLOGIA MOLECULAR “SEVERO OCHOA” of the UNIVERSITY AUTONOMA DE MADRID (Spain) and the INSTITUTO DE BIOLOGIA MOLECULAR E CELULAR of UNIVERSITY of PORTO (Portugal); a renowned center with an extensive experience in clinical trials for tropical disease: the SWISS TROPICAL AND PUBLIC HEATH INSTITUTE (Switzerland), and three industrial partners: ETNA BIOTECH (Italy) a fully private research company owned by Indian Zydus Cadila Healthcare and part of Zydus' Vaccine Technology Center, with a strong expertise in R&D in vaccinology, from bench to the market; AMVAC AG (Switzerland) an ambitious SME focusing on the development of highly innovative vaccines for therapeutic and prophylactic purposes with GMP-grade vaccine manufacturing expertise; and the SME BIOTEST S.R.O. a well-known preclinical organisation specialised in toxicology. To enhance the likelihood of success the network includes collaborations with two leading organisations in the US: the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, the U.S.’s medical research agency, and the Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research and product development organization focused on infectious diseases of global importance.
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