WHO åpner opp for BGBIO godkjenning ?
Global helseambassadør i Utenriksdepartementet Jon-Arne Røttingen under gårsdagens innslag i Dagsrevyen 16.10.2020 bekreftet at vaksiner mot COVID-19 ikke viser seg å være så effektive som man tidligere håpet på.
En langt mer spennende kommentar fra Jon-Arne Røttingen i innslaget er at han for første gang langt på vei antyder at «anti-virale medisiner« fra mindre forsknings miljø ( typisk eksempel er BGBIO) kan vise seg å være mer effektive mot COVID-19 enn vaksiner.
Hittil har ikke WHO benyttet seg av medisiner som ikke er godkjente legemidler i sine SOLIDARITY studier (https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments).
Jeg føler og håper at denne praksisen nå er i ferd med å endre seg.
Se innslaget i Dagsrevyen fra 16.10.2020
Nå er WHO Solidarity snart klar for medisiner fra Accord studiene og jeg tror at Bemcentinib en av de «heteste» kandidatene av medisiner som inneholder såkalte «monoklonale antistoffer» som egner seg best til pasienter i tidlig fase som har fått påvist COVID-19.
«Dette hindrer viruset til å kunne utvikle seg», iflg Jon-Arne Røttingen. Dette bekreftes på generell basis av Jon-Arne Røttingen på innslaget i Dagsrevyen 16.10.2020
https://tv.nrk.no/se?v=NNFA19101620&t=404s
(Ca 6min 20 sek ut i sendingen.)
Dette kan åpne opp for at Bemcentinib fra BerGenBio blir tatt opp i WHO SOLIDARITY programmet og forhåpentligvis godkjent som medisin betydelig raskere enn tidligere antatt - ikke bare mot COVID-19, men da også mot ulike kreft former og antibiotika resistente bakterier....
Løp og Kjøp
En langt mer spennende kommentar fra Jon-Arne Røttingen i innslaget er at han for første gang langt på vei antyder at «anti-virale medisiner« fra mindre forsknings miljø ( typisk eksempel er BGBIO) kan vise seg å være mer effektive mot COVID-19 enn vaksiner.
Hittil har ikke WHO benyttet seg av medisiner som ikke er godkjente legemidler i sine SOLIDARITY studier (https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments).
Jeg føler og håper at denne praksisen nå er i ferd med å endre seg.
Se innslaget i Dagsrevyen fra 16.10.2020
Nå er WHO Solidarity snart klar for medisiner fra Accord studiene og jeg tror at Bemcentinib en av de «heteste» kandidatene av medisiner som inneholder såkalte «monoklonale antistoffer» som egner seg best til pasienter i tidlig fase som har fått påvist COVID-19.
«Dette hindrer viruset til å kunne utvikle seg», iflg Jon-Arne Røttingen. Dette bekreftes på generell basis av Jon-Arne Røttingen på innslaget i Dagsrevyen 16.10.2020
https://tv.nrk.no/se?v=NNFA19101620&t=404s
(Ca 6min 20 sek ut i sendingen.)
Dette kan åpne opp for at Bemcentinib fra BerGenBio blir tatt opp i WHO SOLIDARITY programmet og forhåpentligvis godkjent som medisin betydelig raskere enn tidligere antatt - ikke bare mot COVID-19, men da også mot ulike kreft former og antibiotika resistente bakterier....
Løp og Kjøp
Redigert 21.01.2021 kl 08:40
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Agurknytt
18.10.2020 kl 22:32
3873
Så dosering av bem kan allerede ha startet igjen i UK?
Redigert 21.01.2021 kl 08:40
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Yngling ØH
18.10.2020 kl 22:39
3827
Ikke bare kan ha startet igjen. Den skal ha startet igjen. Dersom BGBIO ikke har dosert noen pasienter siden siste oppdatering fra UK og Sør-Afrika, så burde det komme en melding snart om forsinkelser. Så lenge det ikke er meldt forsinkelser, så kan du regne med at pasienter doserer fortløpende nå.
Jeg ser også for meg at det skal gå raskt å finne egnede kandidater til studien nå. Sykehusene er fulle i UK med covid-19 pasienter. Flere enn tidligere er mindre syke ved ankomst sykehuset nå enn de var under den første bølgen. Pasienter som kommer inn alvorlig syk faller utenfor kriteriene som er satt for deltagelse i studien på bemcentinib.
Jeg ser også for meg at det skal gå raskt å finne egnede kandidater til studien nå. Sykehusene er fulle i UK med covid-19 pasienter. Flere enn tidligere er mindre syke ved ankomst sykehuset nå enn de var under den første bølgen. Pasienter som kommer inn alvorlig syk faller utenfor kriteriene som er satt for deltagelse i studien på bemcentinib.
Redigert 21.01.2021 kl 08:40
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Yngling ØH
18.10.2020 kl 22:42
3808
Hva sier dere? Kan vi regne med å få resultater fra covid-19 studiene allerede ca rundt 20. november?
Redigert 21.01.2021 kl 08:40
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Får nok ikke resultater, men jeg er relativt sikker på 7-9 oktober ble det startet i UK og leser man meldingene til Bergenbio så fortsetter man der man avsluttet i uk
Og Sør Afrika skulle starte umiddelbart.
Jeg tipper at vi får melding om at rekruttering er avsluttet snarlig, så skal alle pasienter gå ut løpet sitt og data skal samles. I midten av november er nok data klare.
Leste feil, trodde du mente 20 oktober
Og Sør Afrika skulle starte umiddelbart.
Jeg tipper at vi får melding om at rekruttering er avsluttet snarlig, så skal alle pasienter gå ut løpet sitt og data skal samles. I midten av november er nok data klare.
Leste feil, trodde du mente 20 oktober
Redigert 21.01.2021 kl 08:40
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Agurknytt
18.10.2020 kl 23:08
3684
Håper du har rett i at medisinering med bem er i full gang, i alle fall i UK, og på at noe data kan foreligge ila november.
Hva tenker du om terskelen for bem til å gå videre til fase 3 slik situasjonen er nå contra tidligere, sett hen til at remdesivir ikke lengre er anbefalt av WHO?
Hva tenker du om terskelen for bem til å gå videre til fase 3 slik situasjonen er nå contra tidligere, sett hen til at remdesivir ikke lengre er anbefalt av WHO?
Redigert 21.01.2021 kl 08:40
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Yngling ØH
19.10.2020 kl 00:04
3556
De går videre :-)
Det er nok en del investorer som tviler. Det ser man på aksjekursen. Men jeg er ikke i tvil om at de rykker videre. Men for oss som har brukt muligheten til å øke posisjonen, så tenker jeg at dette blir storeslem.
Så tenker jeg også at Pfizer kommer med resultat fra sin fase III studie ca første uken i november. FDA har sagt at dersom vaksiner har mer enn 50% effekt, så får de godkjenning (mot vanligvis ca 70%). Oxford/AstraZeneca vaksinen er fortsatt på hold i USA. Jeg regner med at det kommer oppdatering denne uken, og at det er størst sannsynlighet for at de får fortsette.
Johnson & Johnson og Eli Lily kommer nok til å bli stoppet en stund til - eller helt.
Les denne:
"A vaccine with 50 per cent effectiveness against COVID-19
The AstraZeneca’s clinical blueprint or protocol states that its goal is to develop a vaccine with 50 per cent effectiveness against the SARS-CoV-2, the same threshold set by the US FDA in its guidelines outlining the approval process for future COVID-19 vaccines. The FDA had released a set of guidelines stating that any product will need to prevent or decrease the severity of the illness (COVID-19) by at least 50 per cent.
According to a report in The New York Times, there will have to be at least 150 people ill with confirmed coronavirus among participants who were vaccinated or given placebo shots to determine the statistical confidence whether the company has met that set target. As per the protocol, a safety board will conduct an early analysis after there have been just 75 cases. And if the vaccine is found to be 50 per cent effective at that point, it might be possible for the firm to halt the trial early and apply for authorization from the government to release the vaccine for emergency use, added the report.
However, the benchmarks set by the World Health Organization (WHO) for approving a vaccine against COVID-19 are more stringent than the FDA’s - calling at the high end for 70 per cent efficacy and duration of protection of one year."
https://www.timesnownews.com/health/article/a-coronavirus-vaccine-with-50-per-cent-effectiveness-astrazeneca-shares-trial-blueprint-after-moderna-pfizer/655688
Det er nok en del investorer som tviler. Det ser man på aksjekursen. Men jeg er ikke i tvil om at de rykker videre. Men for oss som har brukt muligheten til å øke posisjonen, så tenker jeg at dette blir storeslem.
Så tenker jeg også at Pfizer kommer med resultat fra sin fase III studie ca første uken i november. FDA har sagt at dersom vaksiner har mer enn 50% effekt, så får de godkjenning (mot vanligvis ca 70%). Oxford/AstraZeneca vaksinen er fortsatt på hold i USA. Jeg regner med at det kommer oppdatering denne uken, og at det er størst sannsynlighet for at de får fortsette.
Johnson & Johnson og Eli Lily kommer nok til å bli stoppet en stund til - eller helt.
Les denne:
"A vaccine with 50 per cent effectiveness against COVID-19
The AstraZeneca’s clinical blueprint or protocol states that its goal is to develop a vaccine with 50 per cent effectiveness against the SARS-CoV-2, the same threshold set by the US FDA in its guidelines outlining the approval process for future COVID-19 vaccines. The FDA had released a set of guidelines stating that any product will need to prevent or decrease the severity of the illness (COVID-19) by at least 50 per cent.
According to a report in The New York Times, there will have to be at least 150 people ill with confirmed coronavirus among participants who were vaccinated or given placebo shots to determine the statistical confidence whether the company has met that set target. As per the protocol, a safety board will conduct an early analysis after there have been just 75 cases. And if the vaccine is found to be 50 per cent effective at that point, it might be possible for the firm to halt the trial early and apply for authorization from the government to release the vaccine for emergency use, added the report.
However, the benchmarks set by the World Health Organization (WHO) for approving a vaccine against COVID-19 are more stringent than the FDA’s - calling at the high end for 70 per cent efficacy and duration of protection of one year."
https://www.timesnownews.com/health/article/a-coronavirus-vaccine-with-50-per-cent-effectiveness-astrazeneca-shares-trial-blueprint-after-moderna-pfizer/655688
Redigert 21.01.2021 kl 08:40
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Yngling ØH
19.10.2020 kl 00:10
3535
Merk at både Pfizer og Moderna vaksinene har enorme distribusjonsutfordringer. De må ha kjølere i en skala som ikke finnes...
https://www.nytimes.com/2020/09/18/business/coronavirus-covid-vaccine-cold-frozen-logistics.html
Det kommer til å ta tid å produsere nok kjølere til distribusjon av nok vaksine til to doser til en stor andel av befolkningen på kloden.
Og tenk bare om vaksinene er ca 60% effektiv. Da vil 30 % likevel bli syke, og viruset kommer til å fortsette. Svært mange kommer ikke til å vaksinere seg.
Det vil bli nok syke i fortsettelsen til at det blir plass for bemcentinib
https://www.nytimes.com/2020/09/18/business/coronavirus-covid-vaccine-cold-frozen-logistics.html
Det kommer til å ta tid å produsere nok kjølere til distribusjon av nok vaksine til to doser til en stor andel av befolkningen på kloden.
Og tenk bare om vaksinene er ca 60% effektiv. Da vil 30 % likevel bli syke, og viruset kommer til å fortsette. Svært mange kommer ikke til å vaksinere seg.
Det vil bli nok syke i fortsettelsen til at det blir plass for bemcentinib
Redigert 21.01.2021 kl 08:40
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Hayen
19.10.2020 kl 00:12
3527
Angående rekruttering:
28 september ,vedrørende restart accord skriver selskapet følgende :
"... det er ventet at opptil 25 steder i ACCORD-studien i Storbritannia vil rekruttere pasienter inn. Rekruttering av pasienter vil ta til igjen i løpet av noen uker."
->Det høres ut som det tar tid å komme igang. TTT i farmasi. UK brukte 5 uker på fpd i vår og er skeptisk til at de er igang igjen etter 1,5 uke, men tar gjerne feil.
30 september, India:
" Pasient dosering i India vil starte i løpet av de neste ukene og vi forventer å kunne oppdatere markedet i nær fremtid."
->Dette er ca 2,5 uke siden, og vi er vel fremdeles tidlig i 'de neste ukene' . Så kan man diskutere om 'oppdatering' er fpd eller en status på rekruttering når man har kommet godt igang
11 september, Sør-Afrika (og India) :
" Vi forventer å dosere de første pasientene i Sør-Afrika i nær
fremtid, og akselerere pasientrekrutteringen raskt med den planlagte utvidelse
til å inkludere pasienter i India og ser frem til å gi ytterligere oppdateringer
om vår fremdrift.""
28 september ,vedrørende restart accord skriver selskapet følgende :
"... det er ventet at opptil 25 steder i ACCORD-studien i Storbritannia vil rekruttere pasienter inn. Rekruttering av pasienter vil ta til igjen i løpet av noen uker."
->Det høres ut som det tar tid å komme igang. TTT i farmasi. UK brukte 5 uker på fpd i vår og er skeptisk til at de er igang igjen etter 1,5 uke, men tar gjerne feil.
30 september, India:
" Pasient dosering i India vil starte i løpet av de neste ukene og vi forventer å kunne oppdatere markedet i nær fremtid."
->Dette er ca 2,5 uke siden, og vi er vel fremdeles tidlig i 'de neste ukene' . Så kan man diskutere om 'oppdatering' er fpd eller en status på rekruttering når man har kommet godt igang
11 september, Sør-Afrika (og India) :
" Vi forventer å dosere de første pasientene i Sør-Afrika i nær
fremtid, og akselerere pasientrekrutteringen raskt med den planlagte utvidelse
til å inkludere pasienter i India og ser frem til å gi ytterligere oppdateringer
om vår fremdrift.""
Redigert 21.01.2021 kl 08:40
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Hayen
19.10.2020 kl 00:19
3503
"Og tenk bare om vaksinene er ca 60% effektiv. "
Det er så lavt at jeg tror det bør diskuteres om det er noe poeng å ta den i bruk.
Hvorfor? Fordi folk kommer til slappe av på tiltak med en gang de får høre at "nå kommer vaksinen". De viktigste tiltakene som håndhygiene og sosial distansering blir det mye slurv med og da er vi igang med R på 2,2 lenge før ineffektiv vaksine får en viss effekt
Det er så lavt at jeg tror det bør diskuteres om det er noe poeng å ta den i bruk.
Hvorfor? Fordi folk kommer til slappe av på tiltak med en gang de får høre at "nå kommer vaksinen". De viktigste tiltakene som håndhygiene og sosial distansering blir det mye slurv med og da er vi igang med R på 2,2 lenge før ineffektiv vaksine får en viss effekt
Redigert 21.01.2021 kl 08:40
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Yngling ØH
19.10.2020 kl 00:25
3484
SE FAQ her på ACCORD2 sin hjemmeside for ansatte:
"- How many arms are there on the trial?
Currently there are 4 arms being recruited to; 002 – Bencentinib, 003 – MEDI3506, 004 – Acalabrutinib and 006 – Zilucoplan.
Arm 005 has had some start-up work completed by sites but is not being pursued at this time and there is a committee that reviews other drugs that may be of interest to the ACCORD platform."
"Do sites only have the option to take part in one arm?
No, sites can open two arms at the moment. IQVIA colleagues have worked hard with new and existing sites to open arm 003 and arm 006 at as many hospitals as possible due to a re-focus on enrolment for the study."
Altså: Det er fire "arms" som det rekrutteres til. Arm 5 rekrutteres det ikke til.
Sykehusene kan åpne 2 arms. IQVIA har jobbet hardt med nye og eksisterende sykehus for å åpne amr 003 og arm 006 på så mange sykehus som mulig på grunn av re-fokus på rekrutering for studien.
Jeg vet ikke hvordan man skal tolke det i forhold til bemcentinib... om det betyr at at bemcentinib allerede har nok fokus, og at det er åpent for at også arm 003 og arm 006 kan startes på alle sykehus?... eller om det betyr at arm 003 og arm 006 skal prioriteres på flere sykehus, selv om bemcentinib er førstevalget til ACCORD2?
Det ville vert litt rart. Hvorfor ha bemcentinib som førstevalg både før midlertidig stopp - og etter midlertidig stopp, om de skal gi andre medikament forrang?
Jeg tolker derfor dette som at bemcentinib har fått prioritet, uten at dette nevnes spesifikt.
https://www.accord-trial.org/for-site-staff
4 pasienter ble dosert med bemcentinib før studien ble stoppet midlertidig i sommer:
https://6ad9fcf8-fbac-43e4-a470-d2b695c1a9af.filesusr.com/ugd/178f68_390fb2c3d1e44bcf970361766432675a.pdf
"- How many arms are there on the trial?
Currently there are 4 arms being recruited to; 002 – Bencentinib, 003 – MEDI3506, 004 – Acalabrutinib and 006 – Zilucoplan.
Arm 005 has had some start-up work completed by sites but is not being pursued at this time and there is a committee that reviews other drugs that may be of interest to the ACCORD platform."
"Do sites only have the option to take part in one arm?
No, sites can open two arms at the moment. IQVIA colleagues have worked hard with new and existing sites to open arm 003 and arm 006 at as many hospitals as possible due to a re-focus on enrolment for the study."
Altså: Det er fire "arms" som det rekrutteres til. Arm 5 rekrutteres det ikke til.
Sykehusene kan åpne 2 arms. IQVIA har jobbet hardt med nye og eksisterende sykehus for å åpne amr 003 og arm 006 på så mange sykehus som mulig på grunn av re-fokus på rekrutering for studien.
Jeg vet ikke hvordan man skal tolke det i forhold til bemcentinib... om det betyr at at bemcentinib allerede har nok fokus, og at det er åpent for at også arm 003 og arm 006 kan startes på alle sykehus?... eller om det betyr at arm 003 og arm 006 skal prioriteres på flere sykehus, selv om bemcentinib er førstevalget til ACCORD2?
Det ville vert litt rart. Hvorfor ha bemcentinib som førstevalg både før midlertidig stopp - og etter midlertidig stopp, om de skal gi andre medikament forrang?
Jeg tolker derfor dette som at bemcentinib har fått prioritet, uten at dette nevnes spesifikt.
https://www.accord-trial.org/for-site-staff
4 pasienter ble dosert med bemcentinib før studien ble stoppet midlertidig i sommer:
https://6ad9fcf8-fbac-43e4-a470-d2b695c1a9af.filesusr.com/ugd/178f68_390fb2c3d1e44bcf970361766432675a.pdf
Redigert 21.01.2021 kl 08:40
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Yngling ØH
19.10.2020 kl 00:28
3474
Godt poeng Hayen! Det tar den tiden det tar. Det siste toget går ikke på en stund ennå.
Redigert 21.01.2021 kl 08:40
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Hayen
19.10.2020 kl 00:36
3446
https://www.accord-trial.org/for-site-staff er sist oppdatert 27 juli
Redigert 21.01.2021 kl 08:40
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Yngling ØH
19.10.2020 kl 00:39
3438
"What medication is being tested?
All participants taking part in this study will continue to receive the currently accepted medical standard-of-care for COVID-19.
In this study, bemcentinib will be tested as a potential treatment for COVID-19. Bemcentinib is being developed by BerGenBio ASA. It is taken as a capsule (a type of pill) by mouth.
Bemcentinib is currently being developed to treat different types of cancer, including leukaemia. However, studies have shown that bemcentinib may have an effect on various types of viruses, including SARS-CoV-2. Bemcentinib may block SARS-CoV-2 from making extra copies of itself. It does this by lowering the ability of the virus to infect the linings of lungs. It has also been shown that bemcentinib may help the way the lungs defend against the virus. It is hoped that bemcentinib will reduce lung damage caused by the virus, which may help to reduce the symptoms and shorten the time it takes for people with COVID-19 to start feeling well.
Bemcentinib comes as a 100 mg capsule (a type of pill). It is taken by mouth once a day.
If you take part in the study, you will be randomly assigned and have a chance to receive “bemcentinib with standard-of-care” or “standard-of-care only”, with more people receiving bemcentinib. About 90 - 120 people are expected to receive either the “bemcentinib with standard-of-care” or “standard-of-care only”. This is Stage 1. If it is deemed that the bemcentinib should continue to be tested, about 252 people are also expected to receive either “bemcentinib with standard-of-care” or “standard-of-care only”. This is Stage 2.
How long will I be in the study?
You will be in the study for approximately 90 days (3 months).
What will happen if I take part in the study and what will I have to do?
The study consists of three periods:
• Screening period – up to 2 days, to check that the study is right for you
• Treatment period – up to 15 days, to receive either bemcentinib with standard-of-care or standard-of-care only as randomly assigned (by chance)
• Follow-up period – up to 3 months, to check how you are doing and if you have had any side effects from bemcentinib
If you agree to participate, you will undergo some tests to check that the study is right for you. These include:
• Pregnancy testing if you are a woman who is able to become pregnant
• Physical exam and vital signs
• Electrocardiogram (ECG): A painless test to check the health and rhythm of your heart
• Chest x-ray or CT scan to look at your lungs
• Collection of blood, saliva (spit), throat/nose swab samples for testing
If the study is right for you and you are assigned to receive bemcentinib, you will take bemcentinib once per day for up to 15 days (about 2 weeks) or until you are discharged from the hospital if less than 15 days (whichever is first). It should be taken in the morning, on an empty stomach (2 hours before a light meal) or more than 2 hours after a light meal. After taking bemcentinib, you should not eat or drink anything besides water for at least 1 hour. If you are not able to take bemcentinib, you may need to stop taking part in the study.
• On the first 3 days, you will take 4 capsules (400 mg total) of bemcentinib by mouth with water once a day.
• Afterwards, for the next 12 days, you will take 2 capsules (200 mg total) of bemcentinib by mouth with water once a day.
You will have some tests and assessments, and be asked to provide samples, while in the hospital. These include:
• Checking your health, heart, and whether you need oxygen
• Taking blood, saliva (spit), and throat/nose samples to check your health
About 332 ml (about 22.5 tablespoons) of blood will be taken from you over the entire study.
Some of the tests and assessments being done in this study would also be done as part of your standard-of-care for COVID-19, even if you did not participate in this study.
There is preliminary evidence that some people may be more susceptible or have worse symptoms and outcomes because of their genetic makeup; therefore, one exploratory objective is whole genome sequencing of your DNA (the “instruction book” of your body). Analysis of your DNA will allow genetic factors to be further studied.
After you are discharged from the hospital, you may have up to 4 additional visits to the study centre. If you are not able to visit, a member of the study team may call or come to see you at home.
We will also ask you to allow the use of your leftover samples for future scientific research and provide optional blood samples for additional research. If you do not agree, you will still be able to take part in the main study and your medical care will not be affected.
Additional detailed information about the study tests and assessments is provided in the Main Participant Information Sheet.
What are the risks or benefits of taking part in the study?
Although there is no guarantee that you will benefit from taking part in this study, it may be possible that the treatment helps symptoms improve. However, your condition may stay the same or worsen, during your participation in this study. Bemcentinib may also involve risks to your future health that we currently don’t know about.
The following side effects have been reported for bemcentinib:
VERY COMMON (happening in at least 1 of every 5 people)
• Diarrhoea, liquid bowel motions
• Feeling sick, as though about to throw up
• Changes in blood tests which show how well your liver is working
• Small changes in the electrical activity of the heart, without any change to the heart rhythm, but which need to be monitored if they occur.
COMMON (happening to more than 1 in every 20 people):
• Fatigue (feeling tired)
• Vomiting (throwing up)
• Lower numbers of the red cells in your blood (anaemia)
• Poor appetite (not feeling hungry)
• Small changes in blood tests that show how well your kidneys produce urine
• Skin rash (particularly in combination with other drugs)
It is unknown whether bemcentinib causes damage or changes to the genetic information within the body’s cells, which may lead to cancer. However, in animal and clinical studies with bemcentinib that have been completed, there are no signs of any risk of cancer.
We will ask you about any side effects or other health issues occurring during the study and continue to check on these, if they do happen.
If you suffer any of these side effects (or any others not listed) or you think you are experiencing a side effect during this study, please tell your study doctor immediately.
In addition to the risks of taking the study drug, there are other risks that are associated with taking part in the study and some of the study procedures.
"
All participants taking part in this study will continue to receive the currently accepted medical standard-of-care for COVID-19.
In this study, bemcentinib will be tested as a potential treatment for COVID-19. Bemcentinib is being developed by BerGenBio ASA. It is taken as a capsule (a type of pill) by mouth.
Bemcentinib is currently being developed to treat different types of cancer, including leukaemia. However, studies have shown that bemcentinib may have an effect on various types of viruses, including SARS-CoV-2. Bemcentinib may block SARS-CoV-2 from making extra copies of itself. It does this by lowering the ability of the virus to infect the linings of lungs. It has also been shown that bemcentinib may help the way the lungs defend against the virus. It is hoped that bemcentinib will reduce lung damage caused by the virus, which may help to reduce the symptoms and shorten the time it takes for people with COVID-19 to start feeling well.
Bemcentinib comes as a 100 mg capsule (a type of pill). It is taken by mouth once a day.
If you take part in the study, you will be randomly assigned and have a chance to receive “bemcentinib with standard-of-care” or “standard-of-care only”, with more people receiving bemcentinib. About 90 - 120 people are expected to receive either the “bemcentinib with standard-of-care” or “standard-of-care only”. This is Stage 1. If it is deemed that the bemcentinib should continue to be tested, about 252 people are also expected to receive either “bemcentinib with standard-of-care” or “standard-of-care only”. This is Stage 2.
How long will I be in the study?
You will be in the study for approximately 90 days (3 months).
What will happen if I take part in the study and what will I have to do?
The study consists of three periods:
• Screening period – up to 2 days, to check that the study is right for you
• Treatment period – up to 15 days, to receive either bemcentinib with standard-of-care or standard-of-care only as randomly assigned (by chance)
• Follow-up period – up to 3 months, to check how you are doing and if you have had any side effects from bemcentinib
If you agree to participate, you will undergo some tests to check that the study is right for you. These include:
• Pregnancy testing if you are a woman who is able to become pregnant
• Physical exam and vital signs
• Electrocardiogram (ECG): A painless test to check the health and rhythm of your heart
• Chest x-ray or CT scan to look at your lungs
• Collection of blood, saliva (spit), throat/nose swab samples for testing
If the study is right for you and you are assigned to receive bemcentinib, you will take bemcentinib once per day for up to 15 days (about 2 weeks) or until you are discharged from the hospital if less than 15 days (whichever is first). It should be taken in the morning, on an empty stomach (2 hours before a light meal) or more than 2 hours after a light meal. After taking bemcentinib, you should not eat or drink anything besides water for at least 1 hour. If you are not able to take bemcentinib, you may need to stop taking part in the study.
• On the first 3 days, you will take 4 capsules (400 mg total) of bemcentinib by mouth with water once a day.
• Afterwards, for the next 12 days, you will take 2 capsules (200 mg total) of bemcentinib by mouth with water once a day.
You will have some tests and assessments, and be asked to provide samples, while in the hospital. These include:
• Checking your health, heart, and whether you need oxygen
• Taking blood, saliva (spit), and throat/nose samples to check your health
About 332 ml (about 22.5 tablespoons) of blood will be taken from you over the entire study.
Some of the tests and assessments being done in this study would also be done as part of your standard-of-care for COVID-19, even if you did not participate in this study.
There is preliminary evidence that some people may be more susceptible or have worse symptoms and outcomes because of their genetic makeup; therefore, one exploratory objective is whole genome sequencing of your DNA (the “instruction book” of your body). Analysis of your DNA will allow genetic factors to be further studied.
After you are discharged from the hospital, you may have up to 4 additional visits to the study centre. If you are not able to visit, a member of the study team may call or come to see you at home.
We will also ask you to allow the use of your leftover samples for future scientific research and provide optional blood samples for additional research. If you do not agree, you will still be able to take part in the main study and your medical care will not be affected.
Additional detailed information about the study tests and assessments is provided in the Main Participant Information Sheet.
What are the risks or benefits of taking part in the study?
Although there is no guarantee that you will benefit from taking part in this study, it may be possible that the treatment helps symptoms improve. However, your condition may stay the same or worsen, during your participation in this study. Bemcentinib may also involve risks to your future health that we currently don’t know about.
The following side effects have been reported for bemcentinib:
VERY COMMON (happening in at least 1 of every 5 people)
• Diarrhoea, liquid bowel motions
• Feeling sick, as though about to throw up
• Changes in blood tests which show how well your liver is working
• Small changes in the electrical activity of the heart, without any change to the heart rhythm, but which need to be monitored if they occur.
COMMON (happening to more than 1 in every 20 people):
• Fatigue (feeling tired)
• Vomiting (throwing up)
• Lower numbers of the red cells in your blood (anaemia)
• Poor appetite (not feeling hungry)
• Small changes in blood tests that show how well your kidneys produce urine
• Skin rash (particularly in combination with other drugs)
It is unknown whether bemcentinib causes damage or changes to the genetic information within the body’s cells, which may lead to cancer. However, in animal and clinical studies with bemcentinib that have been completed, there are no signs of any risk of cancer.
We will ask you about any side effects or other health issues occurring during the study and continue to check on these, if they do happen.
If you suffer any of these side effects (or any others not listed) or you think you are experiencing a side effect during this study, please tell your study doctor immediately.
In addition to the risks of taking the study drug, there are other risks that are associated with taking part in the study and some of the study procedures.
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Yngling ØH
19.10.2020 kl 00:43
3427
400mg er 4x så stor dose bemcentinib som mange kreftpasienter får.
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Yngling ØH
19.10.2020 kl 01:00
3398
Protocol Title: ACCORD-2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform
Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of
COVID-19 in Hospitalised Patients
Master Protocol Number: ACCORD-2-001
https://6ad9fcf8-fbac-43e4-a470-d2b695c1a9af.filesusr.com/ugd/178f68_22652f16ebd14f5db6c2c9ec1fa5bae9.pdf
Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of
COVID-19 in Hospitalised Patients
Master Protocol Number: ACCORD-2-001
https://6ad9fcf8-fbac-43e4-a470-d2b695c1a9af.filesusr.com/ugd/178f68_22652f16ebd14f5db6c2c9ec1fa5bae9.pdf
Redigert 21.01.2021 kl 08:40
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BioBull
19.10.2020 kl 08:03
3170
Repetisjon - se siste del av analysen fra Juni 2020.
https://www.trinitydelta.org/wp-content/uploads/2020/06/BerGenBio-Outlook-200629.pdf
Other oncology trials with bemcentinib
In addition to the bemcentinib studies being conducted by BerGenBio, there are also several investigator-initiated trials (IIT) ongoing, in various oncology indications and in combination with different therapies. The IIT are in:
▪ glioblastoma (monotherapy),
▪ NSCLC (with docetaxel),
▪ metastatic melanoma (with pembrolizumab or dabrafenib/trametinib),
▪ pancreatic cancer (with chemotherapy),
▪ high risk MDS/AML (monotherapy), and
▪ mesothelioma (with pembrolizumab).
These studies demonstrate the level of academic and clinical interest in bemcentinib and could help to broaden its potential into other indications. The data from the MDS/AML trial will be particularly valuable to BerGenBio as it plans a pivotal study in these indications; this trial is fully recruited and data is expected to be presented at the ASH 2020 conference in December.
https://www.trinitydelta.org/wp-content/uploads/2020/06/BerGenBio-Outlook-200629.pdf
Other oncology trials with bemcentinib
In addition to the bemcentinib studies being conducted by BerGenBio, there are also several investigator-initiated trials (IIT) ongoing, in various oncology indications and in combination with different therapies. The IIT are in:
▪ glioblastoma (monotherapy),
▪ NSCLC (with docetaxel),
▪ metastatic melanoma (with pembrolizumab or dabrafenib/trametinib),
▪ pancreatic cancer (with chemotherapy),
▪ high risk MDS/AML (monotherapy), and
▪ mesothelioma (with pembrolizumab).
These studies demonstrate the level of academic and clinical interest in bemcentinib and could help to broaden its potential into other indications. The data from the MDS/AML trial will be particularly valuable to BerGenBio as it plans a pivotal study in these indications; this trial is fully recruited and data is expected to be presented at the ASH 2020 conference in December.
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BioBull
19.10.2020 kl 08:15
3104
https://www.google.no/amp/s/www.bbc.com/news/amp/health-54120753
A new antibody treatment is to be trialled on Covid-19 patients in UK hospitals.
Monoclonal antibodies, which are potent, laboratory-made antibodies, will be given to about 2,000 people to see if they are effective against coronavirus.
It forms part of the UK Recovery Trial, which found that a cheap steroid called dexamethasone could save lives.
The first patients will be given the new drugs in the coming weeks.
Prof Martin Landray from the University of Oxford, who is co-leading the Recovery Trial, said: “This is the first type of treatment that's targeted for this specific virus.
“There are lots of good reasons for thinking it might well be effective - stopping the virus from reproducing, stopping the virus from causing damage, improving survival for patients.
“We need to know, and the way to know is to do the trials that will tell us whether that hope turns into reality.”
What are monoclonal antibodies?
Antibodies could be described as the "warriors" of the immune system.
When coronavirus infects your body, antibodies attach to the spikes of the virus, blocking it from entering your cells.
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klaesp
19.10.2020 kl 08:31
3047
Vanskelig og tolke om studiene er i gang eller om de informerer markedet om at de første pasientene har startet dosering.
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MiniMe
19.10.2020 kl 09:17
2880
Jaggu på tide at mest lovende Covid 19 medisin rykker noe på seg. Snakk om å være notert på feil børs er min påstand!
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Yngling ØH
19.10.2020 kl 09:28
2843
Om de ikke får rekruttert pasienter nå med dette trykket, så er det nok ikke håp:
https://amp-theguardian-com.cdn.ampproject.org/c/s/amp.theguardian.com/world/2020/oct/18/revealed-some-manchester-area-hospitals-already-full?utm_source=upday.samsung.browser&utm_medium=referral
https://amp-theguardian-com.cdn.ampproject.org/c/s/amp.theguardian.com/world/2020/oct/18/revealed-some-manchester-area-hospitals-already-full?utm_source=upday.samsung.browser&utm_medium=referral
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BioBull
19.10.2020 kl 11:49
2704
Jeg tror ikke 2 fond har solgt seg ned. De har bare lånt ut aksjer til short posisjoner :
Se Finanstilsynet’s oversikt :
https://www.finanstilsynet.no/
Søk på Shortregister , så på BerGenBio
ACC. SHORT #
777 388
ACC. SHORT %
0,89%
LATEST POSITION
02.10.2020
Active positions
POSITION HOLDER SHORT POSITION SHORT PERCENT POSITION DATE (DD.MM.YYYY)
VOLEON CAPITAL MANAGEMENT LP 777 388 0,89% 02.10.2020
SUM 777 388 0,89%
Se Finanstilsynet’s oversikt :
https://www.finanstilsynet.no/
Søk på Shortregister , så på BerGenBio
ACC. SHORT #
777 388
ACC. SHORT %
0,89%
LATEST POSITION
02.10.2020
Active positions
POSITION HOLDER SHORT POSITION SHORT PERCENT POSITION DATE (DD.MM.YYYY)
VOLEON CAPITAL MANAGEMENT LP 777 388 0,89% 02.10.2020
SUM 777 388 0,89%
Redigert 21.01.2021 kl 08:40
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