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Is there a possibility that WHO would make representation to regulators, or does that NEVER happen?

If Remdisivir was allowed to market with less efficacy and a lower quality trial than SNG016, surely RM will be using this information to leverage his stance for SNG001 authorisation without phase 3.
He will definitely be using the fact that interferon has been widely used for many years with no safety concerns (that I am aware of anyway).

From RNS 18th Mar 2020 - Synairgen to start trial of SNG001 in COVID-19 imminently.

Richard Marsden, CEO of Synairgen, commented: "We have worked intensively with the relevant authorities and collaborators to enable SNG001 to be assessed in COVID-19 patients. SNG001 has been well tolerated in clinical trials in over 200 respiratory patients to date and has accelerated lung function recovery in two Phase II asthma trials in patients with a cold or flu infection. A successful outcome from this trial in COVID-19 patients would be a major breakthrough in the fight against this coronavirus pandemic."

Professor Tom Wilkinson, Professor of Respiratory Medicine at the University of Southampton and Trial Chief Investigator, commented: "We are facing an unprecedented health challenge with COVID-19 which desperately requires the rapid development of new therapeutic strategies. There are a limited number of candidate new treatments available and so it is vital we can rapidly generate high quality evidence on the role of these in COVID-19 patients. The UK research delivery and regulatory teams have worked incredibly effectively to enable this world leading trial to achieve approvals so rapidly which has enabled our motivated and highly expert team of researchers to get this vital study running straight away."

Professor Stephen Holgate, Medical Research Council (MRC) Professor of Immunopharmacology, commented: "The reduced innate immune response that exists in the lung of those at most risk of serious COVID-19 disease such as older people and those with pre-existing lung disease makes such patients ideal candidates to receive inhaled SNG001 to replace their interferon deficiency. This is especially so because SARS-CoV-2, along with MERS-CoV and SARS-CoV, is equipped to evade this first line of viral defence. In the absence of a suitable vaccine, increasing the host's own immunity to enhance protection and virus elimination would seem a logical therapeutic approach."

I can't vote on this, but for the record I believe SNG will NOT have to perform a phase 3 study.

Apart from the fact that they will have data from Asthma, COPD and possibly 'at home' trials to view, and draw conclusions from, regulators will have more than the normal amount of pressure to 'do something' with death rates going through the roof as they sit on their backsides ruminating.

SNG have proved Interferon in the doses used is not detrimental to health.

The phase 2 COVID - 19 trials were set up in agreement with some regulators, so to say that 100 patients is not a sufficient sample won't wash.

You have to ask, what will a phase 3 trial achieve that cannot be deduced from previous trials.
I think it's time to approve this without a phase 3, and minimise the deaths and agony.

If you think SNG will NOT have to perform a phase 3 trial for COVID-19, recommend this post,
Ballot ends 16:30

If you think SNG will have to perform a phase 3 trial for COVID-19, recommend this post,
Ballot ends 16:30

RNS 18 March 2020: "Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, today announces that it has received expedited approvals.. to conduct a trial of SNG001 (inhaled formulation of interferon-beta-1a) in COVID-19 patients."

Note the SNG001 (inhaled FORMULATION of interferon-beta-1a).
"Synairgen's SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulisation.
It is pH neutral, and is free of mannitol, arginine and human serum albumin, making it suitable for inhaled delivery direct to the site of action."


New Trial ACTT-3:
..will evaluate the combination of interferon beta-1a (administered intravenously) and remdesivir compared to remdesivir alone.

The marvellous SNG001 efficacy reported in the phase 2 results reported recently is I believe not 100% attributable to the use of interferon-beta-1a alone.
1 There is a factor in the success reported that is attributable to the use of the specific nebuliser to treat lung infection directly.
2 Another factor in the success reported is the presence of other materials beside interferon-beta-1a (the FORMULATION).

I assume if the FORMULATION were to contain active drugs it would have to be listed beside interferon-beta-1a, so I'm assuming it is ONLY to aid the job of interferon. Thanks for your post SalaciousC.

The ACTT-3 trial uses intraveneous injections, not a nebuliser, so they are not treating the site of infection directly.
The trial just adds interferon beta 1a to remdesivir to observe improvement.
Also as pointed out by Joey Diamond:
"The study will compare different investigational therapeutic agents to a control arm. New arms can be introduced according to scientific and public health needs. There will be interim monitoring to allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s).

The Primary outcomes are dissimilar:

Primary Outcome Measures SNG001 - phase 2:
Ordinal Scale for Clinical Improvement [Time Frame: Day 1 to day 28]
Change in condition measured using the Ordinal Scale for Clinical Improvement during the dosing period - minimum of 0 (patient is well) to a maximum of 8 (death)

Primary Outcome Measures ACTT-3 - phase 3:
Time to recovery [Time Frame: Day 1 through Day 29]
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.

ACTT-3 may lead down many paths of exploration, which might provide many reasons to delay the end date IMO.

mortgagefreeman - I would have thought positive news on BAMS will also move the sp, but would agree that lft news would move it further.

"In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. There are also a number of independent trials of Actemra/RoActemra in this setting. Actemra/RoActemra has not previously been studied in, nor approved for, COVID-19 associated pneumonia."

Sounds like Roche are plucking at straws here.

The bill for all these studies would mount rapidly if they followed through on their plans.

Roche should cut their losses and see if BoJo is happy for an overseas bid..

https://www.roche.com/investors/updates/inv-update-2020-07-29.htm

From todays RNS:
"The SARS-COV-2 neutralising Affimer to be developed in combination with AffyXell's cell and gene
technology is expected to be an innovative solution for COVID-19 patients suffering cytokine release syndrome."

Just so we can measure the size of this opportunity, - can anyone advise how many people outside of Covid-19 die each year of 'cytokine release syndrome', I've searched and can't find this data?
++++

Storm central:
A cytokine storm occurs in a variety of conditions:

Macrophage activation syndrome (MAS) often occurs in people with an autoimmune disorder such as lupus, juvenile arthritis or Still’s disease.

Hemophagocytic lymphohistiocytosis (HLH) is a genetic condition that causes too many active immune cells to be made. It is deadly in infants but can be treated with a bone marrow transplant, which replaces the faulty immune system with a functional one.

Viral infections — such as Epstein-Barr virus, cytomegalovirus and other herpes viruses — can trigger a cytokine storm, sometimes referred to as reactive HLH or MAS.

Sepsis, a blood infection, can also be a trigger.

Leukemia and lymphoma are blood cancers that sometimes create a cytokine storm.

Cytokine release syndrome develops in some people with leukemia who receive immunotherapy, such as infused antibodies or immune cells.

Graft-versus-host disease occurs when transplanted bone marrow produces immune cells that attack the recipient’s tissues. Scientists suspect that a cytokine storm underlies the condition.
source: https://www.knowablemagazine.org/article/health-disease/2020/what-cytokine-storm

Newbee007:
ICMR recommends use of rapid antigen kits for testing in containment zones, healthcare settings

https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/icmr-recommends-use-of-rapid-antigen-kits-for-testing-in-containment-zones-healthcare-settings/articleshow/76384822.cms

:)

BBC1 - 19:30 - China's Coronavirus cover-up (30mins).

BBC1 - 19:30 - China's Coronavirus cover-up (30mins).

BBC1 - 19:30 - China's Coronavirus cover-up (30mins).

I take it you are unable to answer my question Wolfie, but if an ex-colony has become independent, I believe they are not subject to EU decision making.
Of course France plays its part in developing EU Drug and Medical decision making as much as ever.

We should try to keep abreast of the seismic changes in the market for air travel due to Covid-19 pandemic.
For instance :
British Airways have flown their entire 747 fleet to the desert for scrap. 31 aircraft.
Of the 12 strong A380 fleet, - 11 are currently stored at Chateauroux airport 170 miles south of Paris.
Sources - Daily Mail, Friday and Saturday.

Read across this kind of drop in bums on seat numbers to other airlines, and airport testing becomes seen as a less lucrative income stream.
A BA quote provided on news of 747 withdrawal :
"We don't see passenger numbers returning to normal until 2024 at the earliest, and we cannot foresee a time when we will use that size of aircraft again."

"There has been speculation about the future of BA's A380 fleet, but a company source said 'no further decision has been made at present".

"BA is currently operating 15 % of its normal schedule, and continues to burn through £20 million pound per day".

Won't be long before more A380 decisions are made..

Keeping eyes pealed should the BA (and thus other airline) situation changes.

ShaunP -
In your spreadsheet you have "Protecting Novacyt Sa from foreign take-overs", then quote a UK gov web address.
I think the inclusion of measures taken for the same problem published by the French govnt some time ago are just as valid.

https://www.skadden.com/insights/publications/2020/05/france-moves-to-protect-strategic-assets
https://www.bloomberg.com/news/articles/2020-04-29/france-moves-to-stop-foreign-investors-preying-on-weakened-firms

There are probably better references, but these will have to do for now I fear.

Review RNS 07.10.2019 - Molecular respiratory panel ready for US market.
Much of the work on Flu and RSV has been done for the new panel, only C-19 to add to a platform NCYT have experience in creating.

8 CS posts and 9 other mentions in the last 100 posts.
What does he do with his earnings, - buy NCYT perhaps?
He is a waste of valuable time for posters on this board.

Too late Shaun, - he's already buried.

In the same way that FDA approval decisions are rubber stamped by minor nations, are the decisions France makes rubber stamped by ex-French colonies and the like?

Algeria, Vietnam, Syria, Martinique, Guadeloupe, French Polynesia, Haiti?

I don't expect a late coming Novacyt Covid-19 test targeting 2 genes to be popular unless there are clear benefits over those tests already in this 2 gene market.