Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Yes, we just kicked off Phase 3 of “imminent “
:-)
ACTIC 2 first patient was dosed on Feb 10th, so 28 days is 9th March.
Contd..
“ Temporary authorization for use has been granted for the bamlanivimab antibody. However, some are worried about this decision. Can you explain to us why?
DG : This temporary authorization for use concerns in part fragile and immunocompromised people. However, if we administer to immunocompromised people an antibody which works more or less, there is a risk of creating a medium favoring the emergence of variants resistant to this antibody. If these mutants spread through the population, we would have an additional problem. For this reason, patient support is provided for under this authorization: they will remain in the hospital to be monitored. What is paradoxical for a treatment supposed to avoid their aggravation … The main purpose of antivirals is indeed to prevent the progression of the disease, ideally so that patients do not have to go to the hospital.
Ideally, these antibodies should only be given to people who do not have excessively long forms of the disease. In other words, they should rather be reserved for people who arrive at the hospital at the start of the infection, with high viral loads.
This problem does not only apply to monoclonal antibodies, but also to other potential antivirals. When using antivirals, the room for maneuver is extremely narrow, as selection pressure promotes the emergence of resistance.
To avoid such a situation, it would be necessary to be able to resort to ****tails of several molecules, like what is being done in the fight against HIV. By combining three really effective treatments, resistance is no longer a problem.”
Dominique Costagliola is Deputy Director of the Pierre-Louis Institute of Epidemiology and Public Health (Sorbonne University, Inserm). Member of the Academy of Sciences, she participates in the scientific council of the REACTing consortium.
“ What are the most interesting antiviral avenues right now?
Dominique Costagliola: To my knowledge, the only molecules that have vaguely shown anything in this area are monoclonal antibodies and interferon beta, for which there is at least one article that shows an effect on viral load.
Regarding monoclonal antibodies, work has suggested a beneficial clinical effect of those of Eli Lilly (bamlanivimab, LY-CoV555; and etesevimab, LY-CoV016). However, all this remains quite fragile: the results of a first study to test bamlanivimab in the context of a phase 2 clinical trial, therefore preliminary, on a small number of patients, had shown some efficacy of this antibody compared to placebo. However, work aimed at furthering these results has not confirmed this effect of bamlanivimab used alone. On the other hand, they suggested a beneficial clinical effect in combination with etesevimab.
In terms of antivirals, that’s about all we have so far. All the studies concerning other molecules are even less solid …”
https://www.archyde.com/what-are-the-most-serious-avenues-for-therapy/
A NEW STUDY WILL EXAMINE THE DEVASTATING TOLL COVID-19 HAS TAKEN IN LONG-TERM CARE HOMES:
“ A new study led by a MUHC researcher will attempt to determine why some residents of long-term care homes (CHSLDs) have been hit harder than others by the novel coronavirus.
The Canadian government will spend $2.7 through the COVID-19 Immunity Working Group on the study to identify the factors that make one resident more likely than another to develop a severe form of the disease and possibly die from it.”
“ Likewise, new therapeutic avenues may open up if, for example, it is determined that the sickest seniors are deficient in interferon, a safe molecule that has been used for years to fight multiple sclerosis and hepatitis C.“
SNG might fit the bill..
https://montreal.ctvnews.ca/a-new-study-will-examine-the-devastating-toll-covid-19-has-taken-in-long-term-care-homes-1.5342740
On manufacturing - Without having manufacturing evidence in hand, I don’t think any company big or small can even reach anywhere close to FDA WIFI zone to kick off trials.
Hence Synairgen had to raise £80 mil out of which half of it is for manufacturing.
On a a separate note, I think we have/are seamlessly moved/moving from ACTIV to phase 3 as Texas is being fully geared up. Next might be Mississippi?
ATB
If first patient was dosed on Feb 10th, today would be day 28 wouldn’t it and is it why FOMO is kicking in?
Very good report:
https://am.jpmorgan.com/content/dam/jpm-am-aem/global/en/insights/eye-on-the-market/covid-19/section-3.pdf
Apologies if this had already been discussed and is old news.
I was reading this as:
ACTIV 2 phase 2(I assume) started with first patient dose on Feb 10th and NIH press release was on Feb 12th which is a Friday.
In this morning’s articles from MarketWatch and morningstar mentioning “The National Institutes of Health said Thursday..” I got excited as yesterday was Thursday and that SNG seamlessly moved from ACTIV 2 Phase 2 to Phase 3.
Also starting from Feb 10th till yesterday it was 23 days which was closer to 28 days mentioned by NIH adding to the excitement.
I personally think this is excellent news and is not old news.
Snippet from NIH on Feb 12th:
“ The added sub-studies will test four interventions for safety and efficacy: SNG001, an inhalable beta interferon delivered by nebulizer, (Synairgen); AZD7442, a long-acting monoclonal antibody combination that will be studied as both an infusion and an intramuscular injection (AstraZeneca); and Camostat mesilate, an orally administered serine protease inhibitor that may block SARS-CoV-2, the virus that causes COVID-19, from entering cells (Sagent Pharmaceuticals). The first volunteer enrolled in the SNG001 sub-study on February 10. The other agents under study are expected to begin enrolling participants soon.
If an investigational agent shows promise by demonstrating safety and reducing COVD-19 symptoms through 28 days following administration, the ACTIV-2 trial is designed to expand seamlessly from a Phase 2 to a Phase 3 study to gather additional critical data from a larger pool of volunteers without delay. ”
https://www.nih.gov/news-events/news-releases/four-potential-covid-19-therapeutics-enter-phase-2-3-testing-nih-activ-2-trial
Same on Morningstar - https://www.morningstar.com/news/marketwatch/20210304814/nih-to-study-three-experimental-covid-19-treatments
“ The National Institutes of Health said Thursday that it is putting three more investigational COVID-19 treatments into Phase 2/3 clinical trials. The experimental therapies are: an inhalable beta interferon developed by Synairgen's SNG ; AstraZeneca's AZN AZN monoclonal antibody combination, which will be tested as an infusion and also as an injection; and Sagent Pharmaceuticals Inc.'s oral serine protease inhibitor. ”
https://www.marketwatch.com/story/nih-to-study-three-experimental-covid-19-treatments-2021-03-04
“ Our expert on lung diseases from the University of Southampton in Great Britain, where the final phase of the development of the medicine against corona prof. Dr. Ratko Djukanovic.”
“ Prof. Dr. Djukanovic also emphasizes the need to continue efforts to find effective drugs for Kovid. He hopes to start a study in Serbia soon, which began in Southampton, as part of the third, final phase of testing the drug interferon beta for the treatment of COVID-19. The results of the second phase of the study showed that, compared to placebo, interferon beta reduced disease progression by 80 percent.”
https://pink.rs/drustvo/281054/jedan-od-najvecih-svetskih-strucnjaka-za-bolesti-pluca-prof-dr-ratko-djukanovic-revakcinacijom-na-12-nedelja-duplira-se-imunitet-na-koronavirus
Sorry wrong board
“ Our expert on lung diseases from the University of Southampton in Great Britain, where the final phase of the development of the medicine against corona prof. Dr. Ratko Djukanovic.”
“ Prof. Dr. Djukanovic also emphasizes the need to continue efforts to find effective drugs for Kovid. He hopes to start a study in Serbia soon, which began in Southampton, as part of the third, final phase of testing the drug interferon beta for the treatment of COVID-19. The results of the second phase of the study showed that, compared to placebo, interferon beta reduced disease progression by 80 percent.”
https://pink.rs/drustvo/281054/jedan-od-najvecih-svetskih-strucnjaka-za-bolesti-pluca-prof-dr-ratko-djukanovic-revakcinacijom-na-12-nedelja-duplira-se-imunitet-na-koronavirus
“ However, the work of the team and many other groups shows that bringing target cells into contact with these same interferons in the hours before infection greatly reduces the ability of the virus to replicate: the replication rate is divided by at least ten.”
https://presse.inserm.fr/en/covid-19-les-cellules-hotes-du-sars-cov-2-incapables-de-stopper-la-replication-virale-a-cause-dun-probleme-de-timing/42313/
COVID-19: Cuba to Administer Nasalferon to People at Risk:
“ The administration of the drug, which will be carried out at home, will be in charge of family doctors and nurses. (Photo: ACN).
As part of the improved protocol for the confrontation of COVID-19, which begins today in Havana, Nasalferon will be applied to contacts of positive cases and to their cohabitants isolated in their homes.
This was highlighted on Twitter by the Cuban president, Miguel Diaz-Canel Bermudez, who added that the use of the drug to this population at risk will be extended to the rest of the country.
The administration of the drug, which will be carried out at home, will be in charge of family doctors and nurses, as well as students in their final grades of medicine.
According to a statement from the Cuban Presidency’s website, the country’s aim is to ensure that no contact is left without institutional isolation, but in areas such as Havana, where the highest number of infections is reported, home isolation includes measures similar to the care provided in isolation centers.
Nasalferon is a Cuban biotechnology drug, derived from Interferon, which, according to specialists, prevents the replication of the SARS-CoV-2 virus and modifies the number of colonies present in the body, as well as
strengthening the immune system.
With 93 percent effectiveness, it has been applied to medical personnel in the red zone of hospitals where COVID-19 is being fought, and to health collaborators.”
http://en.escambray.cu/2021/covid-19-cuba-to-administer-nasalferon-to-people-at-risk/
“ All our recent progress with Covid-19 could be wiped out by variants, CDC director says. 'Please stay strong' “
“(CNN) The US is at risk of losing all its recent gains in the battle against Covid-19 as highly contagious variants take advantage of Americans getting lax with safety measures.
"Please hear me clearly: At this level of cases with variants spreading, we stand to completely lose the hard-earned ground we have gained," said Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention.
After weeks of tumbling case numbers, new infections are on the rise again -- about 2% more this past week compared to the previous week, Walensky said Monday.“
https://www.cnn.com/2021/03/01/health/us-coronavirus-monday/index.html
It’s high time we introduce interferon(SNG001) cannons to deal with this virus and any new variants as we know SNG001 is variant agnostic.
GLA
“ The team is taking part in further studies to see if existing treatments for other conditions or diseases or new drugs may be used to treat people with COVID-19.
Interferon beta ('IFN-beta') is part of the body's first line of defence against viruses. There is growing evidence that deficiency in IFN-beta production by the lung could explain 'at-risk' patient groups enhanced susceptibility to developing severe disease during respiratory viral infections such as SARS-CoV-2. Furthermore, SARS-CoV-2 seem to suppress its production as part of its strategy to evade our immune systems. Synairgen’s SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulisation. Phase I and II trial data have shown that SNG001 activates lung antiviral defences and has been well tolerated in approximately 280 asthma/COPD/COVID-19 patients to-date. The Royal Bournemouth Hospital is participating in SPRINTER (SG018) a placebo-controlled phase III trial of SNG001 who are hospitalised due to COVID-19 and require standard oxygen therapy. 12 patients have been enrolled so far.”