Clinical trials of BioBlock nasal spray with coronavirus antibodies will start today in two family doctor practices in Tallinn: in Telliskivi Family Health Center and Mustamäe and Nõmme Family Health Centers. Although BioBlock nasal spray is already on the market, and laboratory studies have shown that the antibodies in it have a blocking effect against at least four virus strains, the clinical trial provides even more comprehensive and reliable evidence of the product’s effectiveness.
“In a clinical trial, it is possible to find out how effective BioBlock is in protecting the human body against SARS-CoV-2 infection and how the use of BioBlock affects the course of the disease and the prevention of more serious manifestations of the disease. We hope that people who have been diagnosed with COVID-19 in Tallinn and Harju County will join the trial with their families. Their contribution is the most important in the success of this study promoting Estonian science,” said Anneli Uusküla, Head of the Clinical Study, Professor of the Institute of Family Medicine and Public Health, University of Tartu.
People who are currently ill and their family members can take part in the study. 342 volunteers will be included in the clinical trial. The research methodology was developed by researchers at the University of Tartu and has been approved by the Ethics Committee for Human Research of the University of Tartu.
Family physicians conducting the clinical trial shall invite patients on their list who are diagnosed with corona, together with their families. If possible, they are also ready to add patients from outside their list.
Corona positives living in Tallinn and its vicinity together with family members can send a wish to participate in the study to Telliskivi Family Health Center at firstname.lastname@example.org or by phone 5332 6622, Mustamäe and Nõmme Family Health Centers at email@example.com and in Mustamäe by phone 659 8043 and in Nõmme 677 0700.
“Together with Icosagen researchers, we want to thoroughly study the protection of nasal spray with SARS-CoV-2 antibodies. Laboratory studies and early tests have already shown that BioBlock works against the virus strain of Wuhan found in Brazil, Great Britain, and South Africa. Tests are underway on the Indian strain. BioBlock is a great example of science-based product development aimed at ending a pandemic. The interest in this product is very high both at home and abroad. We are investing in research to provide users of this product with more comprehensive information on the effectiveness of protection,” said Ruth Oltjer, President and CEO of Chemi-Pharm.
“There is no doubt that antibodies produced from colostrum from hyperimmunized cows inactivate the SARS-CoV-2 virus; we now want to know how effectively they can do this on the human nasal mucosa when using nasal sprays,” added Professor Mart Ustav, CEO of Icosagen.
The decision to allow the production and sale of BioBlock have been issued by the Health Board on the basis of the opinion of an expert group of borderline products consisting of specialists from the State Agency of Medicines, the Health Board, the Agriculture, and Food Board and the Consumer Protection and Technical Regulatory Authority. BioBlock is not legally a medicine or a medical device, but its product information and packaging information have been approved by both the State Agency of Medicines and the Health Board.
Bioblock is an innovative Estonian product, the concept, and antibody solution of which were developed by Icosagen researchers under the guidance of Professor Mart Ustav. The development and launch of the BioBlock product were led by Chemi-Farm specialists in cooperation with researchers from the University of Tartu and Icosagen. The product is patented by Icosagen Cell Factory OÜ, AS Chemi-Pharm, OÜ Teadus ja Tegu, Estonian University of Life Sciences, and the Inclusive Technology Consortium of the University of Tartu. BioBlock nasal spray is manufactured and marketed by Chemi-Pharm AS.