The production of the first series of Polish drug for COVID-19 from plasma of convalescents has started – informed Biomed Lublin. The drug will undergo clinical trials, due to start in approximately two months.
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– Today we are starting production, we are starting fractionation – said Piotr Fic, member of the management board of Biomed, at the press conference. – From today until the moment of submitting anti-SARS-CoV-2 immunoglobulin for clinical trials, about two months will pass, we will probably be able to release the drug for clinical trials by the end of October – he added.
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Great expectations
Biomed is to produce about 3,000 in the first batch. ampoules of the drug that will be administered to patients in the Department of Infectious Diseases of the Independent Public Clinical Hospital No. 1 in Lublin, where clinical trials will be conducted. They will last about four months, after which the drug can be submitted for registration and then sold.
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The standard drug registration procedure takes about 210 days, while the regulations on combating the coronavirus pandemic allow it to be shortened to 150 days, Fic reported.
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The drug is to be given to patients by injection into a muscle. It will contain the same amount of antibodies as plasma, it will be standardized, purified from undesirable components. It will be able to be administered to all patients, not only those who are compatible with the donor blood, as is the case with plasma.
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Head of the Department of Infectious Diseases SPSK 1 in Lublin prof. Krzysztof Tomasiewicz emphasized that the coronavirus does not go away and will probably stay longer, so creating an effective form of therapy and prevention is extremely important. He noted that administering convalescent plasma to patients brings very good results, so a drug made from plasma should be effective.
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– Our expectations are really great, optimistic and supported by some experiences. There is a good chance that we will have a drug that will work in a very large proportion of patients – said Tomasiewicz.
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“We have no other alternative”
Tomasiewicz added that the drug could also be administered prophylactically in a situation where someone, after contact with an infected person, would like to avoid the disease. – It does not conflict with the vaccine concept. The vaccine will ensure safety in the long term, while the immunoglobulin is a preparation that will protect against immediate infection – he emphasized.
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Senator Grzegorz Czelej, one of the initiators of the project, said that 150 liters of plasma from healers were needed to start the production of the drug, most of them – over 100 liters – were given by miners. Czelej appealed to the bodies of the European Union and the authorities of individual countries to establish banks of plasma with antibodies so that it could be used to produce a medicine. – I am asking the European Union and national parliaments to increase resources for collecting and storing plasma with antibodies – he said.
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– We have no other alternative, we do not have any other medicine on the horizon – emphasized Czelej.
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Rector of the Medical University of Lublin, prof. Andrzej Drop emphasized that the development of a new drug is of great importance for the university. – It is a great matter related to the university and cooperation with business. This is very important and essential, said Drop.
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The research project on the new drug was co-financed by the Medical Research Agency with the amount of PLN 5 million. The leading institution is the Clinic of Infectious Diseases SPSK 1 in Lublin. The project partner is the Institute of Hematology and Transfusion Medicine in Warsaw.
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In June 2020, Biomed Lublin signed contracts with nine out of 21 Regional Blood Donation and Blood Treatment Centers, seven of which eventually provided the necessary amount of plasma for production. These were centers from Racibórz, Radom, Bydgoszcz, Kalisz, Lublin, Szczecin and Wrocław.
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photo-source">Main photo source: PAP / Wojtek Jargiło
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