Cuba's HeberNasvac® vaccine, unique in the world for treating patients infected by the virus of chronic Hepatitis B, obtained the health registration by the Center for State Control of Drugs, Equipment Medical Devices.
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This was announced at the 2nd International Congress on Research, Development and Technological Innovation in the Pharmaceutical Industry, which concluded at Havana's Convention Center.
Developed by the Center for Genetic Engineering and Biotechnology (CIGB), the therapeutic vaccine is supported by patents granted in the most demanding markets, and has more than 20 scientific publications by Cuban researchers with foreign contributors.
Among them, from the Ehime University in Japan, the Liver Foundation and the Society for the Study of Liver of Bangladesh, the Pasteur Institute of France, the Venezuelan Institute for Scientific Research, and the University of Hanover, of Germany.
In Cuba, works related to the immunogen have received the Annual Award of the Academy of Sciences on several occasions, said Dayana Martinez, a specialist in Communication and Marketing.
In addition to the clinical study in Bangladesh, which demonstrated the validity of the vaccine and allowed the granting of registration, clinical research continues, for which a study on efficacy is performed in conjunction with the French counterpart, Abivax, that includes 280 patients from eight Asian countries and develops successfully in this region of the world, among the hardest hit by the virus.
The research has been approved by regulatory authorities of Australia, New Zealand, Singapore, South Korea, Taiwan, Hong Kong, Philippines and Thailand and the clinical protocol was designed by international experts of the highest scientific level, in cooperation with Cuban specialists.
Martínez announced that in Cuba a second clinical study is being conducted with the participation of the Ministry of Public Health, in order to optimize the treatment regimen and route of administration of the product.
Such project includes 160 Cubans in 13 clinical sites in the country, it's in the process of recruiting patients with chronic hepatitis B, and the use of HeberNasvac® is scheduled to start in Cuba in 2016.
The 2nd International Congress of Research, Development and Technological innovation in the Pharmaceutical Industry began on December 6, and included plenary lectures, round tables, oral presentations and poster works.
There were also symposia on pharmaceutical technologies for drug development, pharmacology, toxicology and analytical research, drug registration, integrated management of quality, environment, human capital, bioinformatics and scientific information. / ACN.