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[title] => Stručnjaci komentiraju senzacionalnu vijest iz Bavarske: ‘Lijek protiv koronavirusa ćemo još pričekati i u najoptimističnijim scenarijima‘
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Na tržište u Europi još nije došlo ni cjepivo protiv koronavirusa, a Nijemci su se već pohvalili da su otkrili potencijalni lijek protiv COVID-a 19. Taj lijek je plod istraživanja njemačke tvrtke "Formycon".
No, da bi lijek uopće ugledao svjetlo dana i došao na tržište, potrebno je da dobije odobrenje njemačke regulatorne agencije. S obzirom na potrebu toga lijeka na tržištu, zasigurno će njegovo odobrenje biti dano puno ranije negoli bi to bilo u normalnim okolnostima.
Budući da je proteklih mjeseci u središtu zanimanja bilo pronalaženje cjepiva protiv koronavirusa, malo je tko u svijetu obraćao pozornost na one koji su krenuli u pronalaženje lijeka protiv bolesti koju taj virus izaziva. No, bez obzira na zaokupljenost cjepivom, neke su svjetske farmaceutske tvrtke krenule i u potragu za lijekom.
Farmaceutska tvrtka "Formycon", sa sjedištem u Bavarskoj, prije nekoliko dana iznenadila je informacijom da blokator virusa korone, koji je ta kompanija razvila pod nazivom FIB207, može u potpunosti spriječiti zarazu stanica.
Kao glavnu točku ulaska u ljudske stanice SARS-CoV-2 i drugi koronavirusi koriste ACE2 receptor na površini stanice. Upravo tu se aktiviraju "Formyconove" fuzijske bjelančevine za antitijela koje se efikasno vezuju za SARS koronaviruse.
"To znači da pacijenti koji su teško oboljeli od COVID-a 19 i koji su u bolnici imaju mogućnost liječenja", naglasio je šef "Formycona" Carsten Brockmeyer u intervjuu za njemački javni servis tagesschau.de.
"Za sada ne postoji lijek koji je dovoljno učinkovit za te pacijente", dodao je.
Kada bi ovaj lijek mogao biti odobren i na koji način on djeluje, upitali smo i prof. dr. sc. Andreja Trampuža, slovenskog infektologa koji je prvi čovjek odjela za kiruršku infektologiju bolnice Charite u Berlinu.
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---
– Lijek (antitijela protiv virusnih proteina) sprječava virus da uđe u ljudsku stanicu. To ga čini prvim lijekom koji je učinkovit protiv COVID-a 19. Međutim, mislim da on neće biti odobren za upotrebu prije 2022. godine – rekao nam je dr. Trampuž.
Zanimalo nas je zbog čega će na lijek trebati čekati toliko dugo.
– Zato jer još nisu provedena klinička ispitivanja, faza 1, 2, 3, a taj postupak traje oko godinu dana. Do sada su provedena samo predklinička (laboratorijska) ispitivanja, a klinička se tek planiraju. To je važno otkriće, ali u bliskoj budućnosti, za razliku od cjepiva, neće imati široku kliničku primjenu – rekao je dr. Trampuž.
Za sada se ne zna kako bi se lijek koristio, oralno (kroz usta) ili intravenozno (ubrizgavanjem u venu). No, pretpostavlja se da bi se mogao koristiti intravenozno, zbog potrebe njegova bržeg djelovanja na cijelo tijelo.
Za mišljenje o lijeku "koji obećava", zamolili smo i prof. dr. sc. Ivana Đikića, poznatoga hrvatskog molekularnog biologa koji živi i radi u Njemačkoj.
– Radi se o znanstvenom radu koji je postavljen na pre-print servis, što omogućuje znanstvenicima uvid u otkrića i prije same recenzije. U ovom znanstvenom radu, kolege iz Münchena napravili su fuzijski protein između FC ljudskih protutijela i ACE2 (taj protein na ljudskim stanicama služi kao ulazna "vrata" za virus). Poznato je da se šiljak S protein virusa mora vezati na ACE2 receptor i tek tada virus može ući u stanice. Ovo novo otkriće pokazuje da možemo blokirati virus prije nego što stupi u kontakt s ljudskom stanicom, te na taj način blokirati infekciju. No još uvijek je to u fazi predkliničkih ispitivanja – kazuje dr. Đikić.
Dok ovaj lijek ugleda svjetlo dana, proći će još podosta vremena.
– Tek sada se planiraju klinički pokusi koji bi mogli početi u 2021., a u najoptimističnijim scenarijima ovaj lijek bi mogao biti odobren za praktičnu upotrebu krajem 2022. ili početkom 2023. godine – kazuje dr. Đikić.
Zanimalo nas je hoće li se lijek uzimati oralno ili intravenozno.
– Za sada nije poznato na koji će se način davati taj mogući novi lijek. To će ovisiti o vrsti formulacija i mogućnosti djelovanja. Jako je važno da taj fuzijski protein bude lociran na mjestima ulaska virusa u ljudske stanice i širenja u tijelu – zaključuje prof. dr. sc. Ivan Đikić.
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Na tržište u Europi još nije došlo ni cjepivo protiv koronavirusa, a Nijemci su se već pohvalili da su otkrili potencijalni lijek protiv COVID-a 19. Taj lijek je plod istraživanja njemačke tvrtke "Formycon".
No, da bi lijek uopće ugledao svjetlo dana i došao na tržište, potrebno je da dobije odobrenje njemačke regulatorne agencije. S obzirom na potrebu toga lijeka na tržištu, zasigurno će njegovo odobrenje biti dano puno ranije negoli bi to bilo u normalnim okolnostima.
Budući da je proteklih mjeseci u središtu zanimanja bilo pronalaženje cjepiva protiv koronavirusa, malo je tko u svijetu obraćao pozornost na one koji su krenuli u pronalaženje lijeka protiv bolesti koju taj virus izaziva. No, bez obzira na zaokupljenost cjepivom, neke su svjetske farmaceutske tvrtke krenule i u potragu za lijekom.
Farmaceutska tvrtka "Formycon", sa sjedištem u Bavarskoj, prije nekoliko dana iznenadila je informacijom da blokator virusa korone, koji je ta kompanija razvila pod nazivom FIB207, može u potpunosti spriječiti zarazu stanica.
Kao glavnu točku ulaska u ljudske stanice SARS-CoV-2 i drugi koronavirusi koriste ACE2 receptor na površini stanice. Upravo tu se aktiviraju "Formyconove" fuzijske bjelančevine za antitijela koje se efikasno vezuju za SARS koronaviruse.
"To znači da pacijenti koji su teško oboljeli od COVID-a 19 i koji su u bolnici imaju mogućnost liječenja", naglasio je šef "Formycona" Carsten Brockmeyer u intervjuu za njemački javni servis tagesschau.de.
"Za sada ne postoji lijek koji je dovoljno učinkovit za te pacijente", dodao je.
Kada bi ovaj lijek mogao biti odobren i na koji način on djeluje, upitali smo i prof. dr. sc. Andreja Trampuža, slovenskog infektologa koji je prvi čovjek odjela za kiruršku infektologiju bolnice Charite u Berlinu.
---
---
– Lijek (antitijela protiv virusnih proteina) sprječava virus da uđe u ljudsku stanicu. To ga čini prvim lijekom koji je učinkovit protiv COVID-a 19. Međutim, mislim da on neće biti odobren za upotrebu prije 2022. godine – rekao nam je dr. Trampuž.
Zanimalo nas je zbog čega će na lijek trebati čekati toliko dugo.
– Zato jer još nisu provedena klinička ispitivanja, faza 1, 2, 3, a taj postupak traje oko godinu dana. Do sada su provedena samo predklinička (laboratorijska) ispitivanja, a klinička se tek planiraju. To je važno otkriće, ali u bliskoj budućnosti, za razliku od cjepiva, neće imati široku kliničku primjenu – rekao je dr. Trampuž.
Za sada se ne zna kako bi se lijek koristio, oralno (kroz usta) ili intravenozno (ubrizgavanjem u venu). No, pretpostavlja se da bi se mogao koristiti intravenozno, zbog potrebe njegova bržeg djelovanja na cijelo tijelo.
Za mišljenje o lijeku "koji obećava", zamolili smo i prof. dr. sc. Ivana Đikića, poznatoga hrvatskog molekularnog biologa koji živi i radi u Njemačkoj.
– Radi se o znanstvenom radu koji je postavljen na pre-print servis, što omogućuje znanstvenicima uvid u otkrića i prije same recenzije. U ovom znanstvenom radu, kolege iz Münchena napravili su fuzijski protein između FC ljudskih protutijela i ACE2 (taj protein na ljudskim stanicama služi kao ulazna "vrata" za virus). Poznato je da se šiljak S protein virusa mora vezati na ACE2 receptor i tek tada virus može ući u stanice. Ovo novo otkriće pokazuje da možemo blokirati virus prije nego što stupi u kontakt s ljudskom stanicom, te na taj način blokirati infekciju. No još uvijek je to u fazi predkliničkih ispitivanja – kazuje dr. Đikić.
Dok ovaj lijek ugleda svjetlo dana, proći će još podosta vremena.
– Tek sada se planiraju klinički pokusi koji bi mogli početi u 2021., a u najoptimističnijim scenarijima ovaj lijek bi mogao biti odobren za praktičnu upotrebu krajem 2022. ili početkom 2023. godine – kazuje dr. Đikić.
Zanimalo nas je hoće li se lijek uzimati oralno ili intravenozno.
– Za sada nije poznato na koji će se način davati taj mogući novi lijek. To će ovisiti o vrsti formulacija i mogućnosti djelovanja. Jako je važno da taj fuzijski protein bude lociran na mjestima ulaska virusa u ljudske stanice i širenja u tijelu – zaključuje prof. dr. sc. Ivan Đikić.
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19. svibanj 2024 10:48
