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Scandinavian Biopharma announces first patient vaccinated in the age-descending study in Bangladesh
On October 20, we began enrollment of a placebo-controlled Phase I/II trial where our enterotoxigenic Escherichia coli (ETEC) vaccine candidate will be tested for safety and immunogenicity in different age groups, including infants as young as six months of age. The study is being conducted under a US Investigational New Drug Application and will enroll about 450 children.
Vaccines to prevent diarrheal diseases are an essential and lifesaving part of diarrhea-control strategies, and may even reduce malnutrition and developmental delays associated with severe diarrhea in children. That is why Scandinavian Biopharma, University of Gothenburg, and the international nonprofit PATH are working together on a new vaccine against one of the leading causes of this serious disease—ETEC. Nearly 600,000 children under the age of five years die every year from diarrheal diseases—many of them due to ETEC.
Travelers’ diarrhea caused by ETEC is also the leading cause of illness among international travelers to developing countries. About 80 million people travel from industrialized countries to high-risk areas in the developing world. Of these 30 to 50 percent may suffer from travelers’ diarrhea during their journey.
“Our vision is to successfully develop a vaccine that could save hundreds of thousands of lives in the developing world, and one that also can save a holiday for millions of travelers,” says Björn Sjöstrand, CEO of Scandinavian Biopharma.
The study is being conducted at the world-renowned icddr,b, a Bangladesh-based international nonprofit public health research institution. icddr,b conducts research, training, and extension activities, as well as program-based activities, in collaboration with academic and research institutions throughout the world, to develop and share knowledge for global lifesaving solutions.
We are pleased to have received US Food and Drug Administration acceptance for our clinical trial protocol, which indicates the high international standards we are meeting with our preclinical/clinical data package and development plan. Data from the trial will provide additional evidence of the vaccine’s safety and immunogenicity in infants and establish the appropriate dose for this population. This clinical trial is the first important step toward showing that our vaccine can improve children's chances of winning the fight against diarrheal disease.
For more information, please contact: Björn Sjöstrand, CEO: +46 727-125 120, bjorn.sjostrand@scandinavianbiopharma.se
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Scandinavian Biopharma
Scandinavian Biopharma is a Swedish research-based biotech company. The company is also a leading distributor of vaccines and immunoglobulins to the Nordic market. We are developing, together with PATH and researchers at the University of Gothenburg, a new oral travelers’ diarrhea vaccine candidate against ETEC. In several clinical trials, the vaccine has been proven safe and has shown a strong ability to activate the immune system. We believe that PATH’s support of this work to develop a new vaccine for diarrheal disease confirms that we are on the right track, that our vaccine meets very high standards, and that it has the potential to save lives in the developing world.
