Member Info for spinnaker

Hi oil and marker, sorry I didn't see your posts until I had posted on the other Active-2 thread.

What do you think of my comments. Basically my point is that not all of the three treatments available on the trial would need to be started on the same date. We have already been told that other treatments may added.

Spinnaker

An interesting thread but the reason why we were not on Recovery is 'water under the bridge' at the moment. I agree with most that we are in a good place now although it is a crying shame that MAP hasn't been used to any extent or even at all and there are so many deaths and people on ventilators.

The phone number to sign up to Activ-2 was on the video from Kansas. Initially that implied to me that a suitable patient could sign up and be put on SNG-001 trial. However that isn't necessarily the case. If everything is not yet ready for SNG-001 to be supplied then the patient would just be put on one of the other two drug trials. I would expect it may not be the patient's sole choice which trial he would be put on although he could of course refuse any offered. Possibly part doctor's decision and part availability in location. One thing is that there could not be any delays due to the stringent requirement that patient should have been symptomatic for no more than seven days prior to first treatment.

I therefore do expect an RNS on first treatment as advised.

Exciting times here

Best to all

Spinnaker

Joey D
Hope you saw my email to Lord Winston and Bethel on other HoL tread.
Spinnaker

This extract from Clinical Trials show that at at least one of the arms is having trouble recruiting as did SNG home trial. I am not sure that the completion date this month is still on track. It started back in June 20.

Brief Summary:
This is a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection in symptomatic adult outpatients with COVID-19

Condition or disease Intervention/treatment Phase
SARS-CoV 2 Drug: EIDD-2801 Drug: Placebo (PBO) Phase 2

Detailed Description:

This is a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection in symptomatic adult outpatients with COVID-19. The study is a multicenter trial that will be conducted in the United States.

In this study up to approximately 108 participants will be randomized to receive EIDD-2801 or Placebo orally twice a day (BID) for 5 days. The study may enroll up to 5 parts with subsequent doses that may be higher or lower than doses studied in previous cohorts, and will be doses that have been studied for safety in a Phase 1 study. Doses will be chosen based on emerging virology and safety data from this and ongoing studies.
Study Design
Go to

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of EIDD-2801 to Eliminate Infectious Virus Detection in Persons With COVID-19
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : February 28, 2021

Spinnaker

Nice letter Tim. Good on you.

Spinnaker

I did mean to refer to Cautious Optimist's posts not Tommy's. Tommy has only posted secret microdots. Luckily I have a microdot reader as used by James Bond some years ago.

Spin

Tommy, I agree with you, Scinv, RM and others that SNG taken at early stage is likely to prevent long Covid. This certainly seems logical if it is able to prevent severe disease. Indeed, from what I have gathered many of the physiological changes to multiple organs brought about by serious disease and post disease inflammation would be unlikely to be wholly reversible.

However, cost will be a serious factor mitigating against wholesale treatment prior to hospitalisation. I expect that a targeted approach to treat those who either through age, genetic pre-disposition (already identified) or other co-morbidities are most likely to develop severe disease.

I think it will be some time before blood screening is undertaken on positive tested patients as a matter of course but surely this would be the way to go. It will become easier once the numbers infected reduce in the summer.

Spinnaker

Jp
Thanks for your efforts. I have voted 76,000 shares against all.
Spinnaker

I'm sorry the paragraphs seem to have been ignored in the copying process. Final bit here.

Spin

You mention that the government should be taking similar action in respect of likely effective treatments as they did in respect of vaccines and take a risk and pre-order stocks prior to final P3 trial results. It appears that Synairgen have had to fund their own P3 trials since no funding was available from the government following very successful Phase 2 trial results first published July 22 2020. Not only that but now the USA taxpayer is funding additional American trials for 'at home' treatment under the Activ 2 programme leading possibly to lack of treatment availability in the UK due to excess demand if and when the treatment is approved. It would be a great shame if British research and development is allowed to escape abroad with the result of massively increased death and severe illness to our population. I would hope and expect our government to have pre-ordered such vitally important potential treatments which will be effective against any subsequent mutations.
I am interested in the success you have in promoting this case and wish you good fortune in your fight with many others to allow the UK to come through with the least harm possible.
Many thanks'
Please let me know why we have not done our best to fund testing and manufacturing of the very best of potential treatments (broad spectrum anti-virals) of which SNG001 is the stand out candidate although there is an mcab treatment (nasal inhalation) called Foralumab which appears promising but at a very early stage of trials. Please check this one out also. There are currently as far as I am aware NO early intervention approved treatments for Covid.
Treatments are required right now to prevent our NHS and the population suffering and reduce the number of people dying and those with long Covid. Vaccination is essential but so is complementary treatment and both will be required for the long term. Also EARLY STAGE treatment is the preferred route since this will reduce hospitalisation period and 'long Covid'.
I am expecting the government to be innovative and not lag behind other countries such as the USA in promoting the health of the nation. This particular treatment SNG-001 is safe (very low dose compared to the doses of interferon long used in treatment of Parkinson's) and I see no logical reason why it has not already been granted an emergency use authorisation in the UK in the midst of this generational assault on the health of our population.
I look forward to your response.
Yours sincerely
David Mason
195c9ae705759b170c8c/a79fccdb9bd3f27c9551 (Signed with an electronic signature in accordance with section 7(3) of the Electronic Communications Act 2000.)

Letter to Lord Bethell pasted below:-

Spin

Friday 5 February 2021
Lord Bethell House of Lords London SW1A 0PW
Dear Lord Bethell,
I have today written to Lord Winston with regard to his question to you on 2 February in the House of Lords. I have attached a copy below. The mail was sent today 5 Feb 2021 but there does not appear to be a 'cc' facility on this web site.
Please note, I am very pleased with the government's performance in respect of vaccine promotion and roll-out so far but less satisfied in many other aspects including, failing to shut down our borders in February, failing to test and trace arrivals from abroad for the entire time since February 20 and many other areas. I would admit that it has not been easy balancing NHS , health and economy.
One area where the government has frustrated me has been its total focus on vaccines. Yes i admit there is the Recovery programme but this appears to be collecting a huge amount of data on Convalescent Plasma treatment which has already been trialed with poor results. The massively exciting Interferon Beta 1a therapy through nebulisation, patented and developed by a Southampton based British company at the forefront of this area of Biotech named Synairgen, founded, I believe by your fellow Lord, Professor Lord Stephen Holgate, which could have been instrumental in preventing thousands of deaths in this second wave, has been almost ignored.
Britain is at the forefront of these developments and you will see from my attached letter to Lord Winston how disappointed I and the entire electorate will be to hear that you were not aware of Activ 2. SNG001 has been brought on to this US trial, funded entirely by the US government. The UK government has taken their eye off the ball in this regard and you have a liability as Under Secretary for Health.
'Dear Lord Winston,
I note and thank you that on 2 February 2021 you raised the question of the necessity for the government to assess and promote development of anti-viral medication in the fight against Covid-19 in the Upper House and asked Lord Bethel the actions of the government in this regard. You specifically mentioned Synairgen and its inhaled product SNG-001. You also mentioned Activ 2 but it appears that Lord Bethel may have thought this was another anti-viral drug rather than part of the US Warp Speed programme to promote treatments effective against the disease. This is somewhat worrying! It implies that the government does not have its finger on the pulse in this area.
You mention that the government should be taking similar action in respect of likely effective treatments as they did in respect of vaccines and take a risk and pre-order stocks prior to final P3 trial results. It appears that Synairgen have had to fund their own P3 trials since no funding was available from the government following very successful Phase 2 trial results first published July 22 2020. Not only that but now the USA taxpayer is funding additional Americ

Great letter Matt
I too have written to both LL. Winston and Bethell. Copy to Lord Winston attached.

Your letter to Lord Winston

Friday 5 February 2021
Dear Lord Winston,
I note and thank you that on 2 February 2021 you raised the question of the necessity for the government to assess and promote development of anti-viral medication in the fight against Covid-19 in the Upper House and asked Lord Bethel the actions of the government in this regard. You specifically mentioned Synairgen and its inhaled product SNG-001. You also mentioned Activ 2 but it appears that Lord Bethel may have thought this was another anti-viral drug rather than part of the US WarpSpeed programme to promote treatments effective against the disease. This is somewhat worrying! It implies that the government does not have its finger on the pulse in this area.
You mention that the government should be taking similar action in respect of likely effective treatments as they did in respect of vaccines and take a risk and pre-order stocks prior to final P3 trial results. It appears that Synairgen have had to fund their own P3 trials since no funding was available from the government following very successful Phase 2 trial results first published July 22 2020. Not only that but now the USA taxpayer is funding additional American trials for 'at home' treatment under the Activ 2 programme leading possibly to lack of treatment availability in the UK due to excess demand if and when the treatment is approved. It would be a great shame if British research and development is allowed to escape abroad with the result of massively increased death and severe illness to our population. I would hope and expect our government to have pre-ordered such vitally important potential treatments which will be effective against any subsequent mutations.
I am interested in the success you have in promoting this case and wish you good fortune in your fight with many others to allow the UK to come through with the least harm possible.
Many thanks
Yours sincerely
David Mason
cc Lord Bethell
195c9ae705759b170c8c/a79fccdb9bd3f27c9551 (Signed with an electronic signature in accordance with section 7(3) of the Electronic Communications Act 2000.)

Hi Kenneth

Further to my post last night, thanks for the update and I hope your father comes through this horrendous trauma.

I am a holder of Evgen shares as well as Synairgen but have done little research into their products.
It seems as though the Phase2b/3 trial sponsored by Lifearc/Dundee Uni at Dundee hospital only started in December 2020 and they are seeking 300 patients see below.

Cut and pasted from Evgen's website.

'SFX-01: Other clinical programmes (Status: Phase II ready)'
'Patient recruitment commenced in early December 2020 on the STAR trial sponsored by the University of Dundee. This is a Phase IIb/III trial using SFX-01 for acute respiratory distress syndrome (“ARDS”) including COVID-19 patients.'

I am sure you are right to have your father put on this trial but if it was me I would still try all I could to access the MAP for SNG001 and get your doctor to order the product from Clinigen at least so long as your father is not on a ventilator. You could do this in parallel with the trial for SFX-01. Obviously if your dad takes the Synairgen product he would have to drop out of the Evgen trial. However his health is more important than any trial.

I am really feeling for you and all genuine readers of this BB will be wishing you and your father the very best outcome. Good luck.

Spinnaker

Good luck Kenneth.

I very much hope your dad is ok and it's great that he had an oximeter available. If he has to go to hospital I am sure you will do your best to organise MAP access through Clinigen with Prof Wilkinson's help. My email exchange with Clinigen revealed that they will only deal with the doctor in hospital responsible for the patient and not the patient himself or family.

It might be an idea to get your father to sign a written request for urgent SNG001 treatment under MAP as soon as he gets to hospital if he has to go there and his doctor agree with you that it should be the best and most suitable treatment. I would be very interested to find out if the doctors are aware of MAP access for SNG001 and if they have used it yet or if this would be the first time.

Very good luck and my thoughts are with you and your parents.

Spinnaker

Please excuse the typo acceleration.

Spin

Thanks Sharesting for posting that.

I too cannot believe Horby's response to Q252. Surely he was being disingenuous and should have been well aware of SNG001 on 4 November when he was being questioned by the Committee and should have been careful to inform the members.
He had the ideal opportunity to champion accelleration of trials of one of the only proven safe early treatments in the world which happened to be developed in the UK, less than 100 miles from Oxford.

Spinnaker

Sorry I hadn't read all the other replies before I came back to the response I started before dinner.

I think you have a fair bit of comparison info now Loot.

Best

Spinnaker

I think this is a good question Loot.

I understand that although are totally different substances and work in different ways they have three main points in common.
a) They do not require a hospital or clinic setting for treatment
b) They appear to be potentially broad acting and should be effective against different strains of Covid-19.
c) They are suitable for early stage illness.

The answer is probably that the market will be big enough for both and there may not be only one winner. Another more well versed than me should explain the science.

Differentiation between the two treatments may include:-
1) First to market will have an advantage obviously subject to authorisation
2) Efficacy overall and within various sub-groups (the latter will require a load more research and trials to determine, (eg. genetic lack of interferon production)
3) Suitability and reduction/increase in effectiveness when co-dosed with other drugs commonly used such as cortico-steroids
4) Perceived ease of use in practice
5) Cost
6) Availability and marketing (may include backing or J/V with one or more large Pharmas
7) Side-effects and contra-indications
8) Protection of IP

There may be others. Don't underestimate the importance of No 6, recall VHS and Betamax

Early days for both at present. Results of larger trials will be needed.

Spinnaker

Star Knight

Thanks for your comment. I am sorry but don't have time to write to the BoD but perhaps you could. This is a link to the Active 2 trials in USA and I believe but it hasn't been officially confirmed by the NIH that Synairgen's SNG001 has been admitted to the trial https://www.niaid.nih.gov/clinical-trials/covid-19-activ2 I think that Activ 3 is in-patient trials and Activ 2 is at home. At the moment there are only two drugs in Activ 2 and Synairgen pending but I am sure there would be room for more. This is all part of Warp Speed.

The UK also have several programmes running but I think they are all in-patient and I don't have links.

Best wishes to you and all investors.

Spinnaker

Star Knight

The experience of Synairgen who had fantastic P2 trial result released on July 20 2020 and have just started P3 would indicate that may be a bit hopeful. However sentiment has changed and will continue to change with the eventual realisation both here and in the USA that vaccines are not the only requirement and effective early stage treatments are essential.

The best thing to happen to TILS in respect of Foralumab would be if they lobbied the movers and shakers, Fauci etc. and managed to get included in the Activ 2 trials in the US. This would have 2 fantastic benefits, firstly funded by US government and secondly done fast and efficiently with a follow on to P3 if deemed effective. This where Synairgen is now. Hopefully starting trial imminently.

Best Spinnaker

It is possible the UK gov would get organised to include Foralumab on one of the home trials here in the UK of course. We can but wish.

Spinnaker

Why do you think we might have seen off a finish?
Also what did you mean to say?