Havana – HeberNasvac’, the new Cuban vaccine for the treatment of Chronic Hepatitis B created by scientists from the Centre of Genetic Engineering and Biotechnology (CIGB in Spanish), is going through the process of clinical evaluation in eight Asian countries in alliance with the French company Abivax.
For some time, researchers from the West Indies have been performing clinical trials to evaluate the security and efficiency of this new product.
Iris Lugo Carro, who is in charge of the CIGB Communication and Image group explained to The Havana Reporter that the clinical trial undertaken in alliance with Abivax under the code ABX 203, involves around 230 patients and 5 clinical locations.
Lugo said that to date the study has been approved by the regulatory authorities in Australia, New Zealand, Singapore, South Korea, Taiwan, Hong Kong, the Phillipines and Thailand.
The clinical protocol was designed by experts of the highest scientific level contracted by Abivax, in collaboration with Cuban specialists. The trial is in progress in the mentioned region of the world considered to be among the most affected by the virus.
The chronic hepatic illness provoked by the Hepatitis B virus is one of the principle causes of liver cancer, hepatic cirrhosis and other problems such as ascites, esophageal varices and splenomegaly, which all bring with them high health costs.
The World Organization of Health estimate that the annual number of deaths caused by the hepatitis B infection is close to one million. It is considered that approximately 300 to 500 million people are chronic carriers of the virus and around 400,000 people die every day because of it.
In the new therapeutic proposal, the surface antigen and the nucleocapsid of the hepatitis B virus are combined: two proteins recombined and produced by the CIGB. In preparation, it is administered nasally and subcutaneously, provoking fewer adverse reactions and a higher antiviral efficiency than the current existing treatments for this illness.
Meanwhile, a second clinical trial is being developed in Cuba with the participation of the Ministry of Public Health, with the objective of optimizing the scheme of treatment and the routes of administration of the product.
The investigation is being carried out in 13 clinical locations found troughout the country, and 160 Cuban patients will benefit from this same investigation. At present the trial is in the draft phase with a group of patients with chronic hepatitis B.
The Genetic Engineering and Biotechnology centre expect HeberNasvacÂ� to start being used in Cuba in 2016, after obtaining approval from the Health Register which gives consent to the State Control of Medicine and Medical devices centre (CECMED in Spanish).
The new therapeutic vaccine is endorsed by patents conceived in demanding markets and supported by more than 20 scientific publications of Cuban researchers in alliance with: the Japanese University Ehime, The Liver Foundation, the Society for Liver Studies in Bangladesh, the Pasteur Institute in France, the Scientific Investigations Institute in Venezuela and the University of Hanover in Germany.
Alongside the development of this future vaccine, the CIGB currently has more than 50 research and development projects in areas of biomedicine, agriculture and animal health which include human and veterinary vaccines, recombined proteins for therapeutic use, synthetic peptides and monoclonal antibodies.
In addition, the prestigious institution develops diagnostic systems that involve proteomics and bioinformatics, as well as the biotechnology of plants, concerning functional and aquacultural foodstuff.
Among their products, the HeberprotP stands out as being the only medicine which treats diabetic foot ulcers through intralesional infiltration directly from the wound, which lowers the risk of amputation of the extremities.