Chris Heminway, Exec-Chair at Time To ACT, explains why now is the right time for the Group to IPO. Watch the video here.
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Remdesivir when compared with placebo was associated with clinical improvements in some of the outcomes and fewer serious adverse events.
The findings in the review suggest that factors to consider when using remdesivir as a treatment option for COVID-19 in patients with mild or moderate, or severe disease include the timing of initiation of treatment at the onset of symptoms, disease severity (this includes the need for oxygen support, non-invasive ventilation, invasive ventilation or organ support, most of the patients in the studies had severe COVID-19) and the underlying clinical status of the patient and age. These may have important effects on the outcomes of treatment. Remdesivir should only be administered by intravenous infusion which may limit its use.
.....
In the large-scale ACTT-1 study conducted by the National Institutes of Health, intravenous remdesivir already showed it could cut recovery time by four days, or about 31%, among hospitalized patients. But its benefits appear less significant for patients with mild or moderate disease.
Early positive indications from SFX-01's Covid-19 patient trials, will very likely be made public Imho... gla :')
....
Although the study is still ongoing, an independent data and safety monitoring board overseeing the trial reviewed the data and shared their preliminary analysis with NIAID. Due to the public health implications, NIAID made these primary results public, and they were published on May 22, 2020, in the New England Journal of Medicine.
https://www.nih.gov/news-events/nih-research-matters/early-results-show-benefit-remdesivir-covid-19
Early positive indications of the orally administered SFX-01 could be made public or at least information shared with other world health authorities, especially now that the US has bought the entire world supply of the only drug that has shown to be effective in current ongoing Covid-19 patient trials , so far!!! Gl ;-)
"Remdesivir, the only drug cleared to treat COVID-19, is given by intravenous infusion, making it a great choice for hospitalized patients, but less convenient for outpatients."
..........................
Coronavirus: US buys up almost entire world supply of COVID-19 drug remdesivir
American officials have bought up all of the remdesivir available for July and 90% of stocks for August and September.
Wednesday 1 July 2020
The US has bought up almost the entire global supply of one of two drugs used to treat coronavirus which UK patients helped test.
Remdesivir, which was developed to treat Ebola, is produced almost exclusively by US pharmaceutical giant Gilead Sciences - and it has been priced at $2,340 (£1,892) per patient in wealthier nations.
The company has agreed to send nearly all of its supply of the drug to the US over the next three months.
Nadhim Zahawi believes that competition for coronavirus drugs undermines spirit of making treatment available for everyone.
This means remdesivir will not be available for use on patients in the UK and Europe until October, Dr Andrew Hill, a senior visiting research fellow at Liverpool University, told Sky News.
He said: "This deal that's been struck by America means that people with COVID-19 in the UK can't get access to these treatments that would get them out of hospital quickly and might improve their chances of survival.
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"So far, we know that for the next three months there will be no supplies of remdesivir - America will take the drugs and we won't have access to them. That's the case in the UK and Europe."
UK patients took part in the clinical trials that showed that the drug worked, Dr Hill said. "A lot of drugs haven't worked, so I think the people in Britain deserve something in return from the United States," he said.
"SFX-01 Covid-19 patient trials will be conducted in up to six sites across Scotland and the north of England."
SFX-01 working??? Gla holders:-)
11/7/20
Seven new cases of coronavirus have been confirmed in Scotland.
There have been no new deaths from the virus in the last 24 hours meaning the death toll of those who have tested positive remains at 2490.
It was also confirmed that 323 were in hospital with the illness as of last night - three of whom were in intensive care.
An additional three people were in intensive care with suspected COVID-19.
https://www.google.com/amp/s/www.dailyrecord.co.uk/news/scottish-news/coronavirus-scotland-seven-new-cases-22339769.amp
World / United States & Canada
US reports 65,000 new coronavirus cases, a daily record, as Bolivian president becomes latest leader to test positive
Trump has downplayed the latest surge, tweeting that higher caseload is because ‘our testing is much bigger and better’
World Health Organisation, under fire from Trump, opened an inquiry into its response on Thursday with initial findings due next year
https://www.scmp.com/news/world/united-states-canada/article/3092617/us-records-65000-new-coronavirus-cases-daily-record
ps the US has just reported 65,000 new cases in a single day........i'm sure Trump would be very interested in any potential therapeutic treatment that showed early positive indication in improving clinical outcome after 15 days , especially one like SFX-01 with very few side effects. Gla ;-)
SuperSonicBoom, your first ever post on Lse........ ha ha ha ha ha ;-)
EVG's Rns did state results by 2021, but Dundee University who are organising the trial have stated end of this year, and Lifearc who are funding the trial has announced that primary outcome of the trial is the clinical status of patients on day 15 based on a seven point scale, recommended by the World Health Organisation as the optimal clinical trial endpoint for COVID-19 studies.
Therefore it's more than conceivable that if a therapeutic benefit was witnessed in patients on SFX-01 after 15 days, then this could be made public, as is the case with several other other drugs in trial, whereby if positive indications are observed then other health authorities around the world are informed as information is shared on potential treatments.
Besides Covid-19, Evgen has SFX-01 in evaluation for multiple disease targets in collaboration with several high profile Universities and Hospitals, whereby good news could drop at anytime on progress and development or even potential lucrative commercial JV partnership, and the current bargain low sp and lowly market cap does not reflect true value and upside potential.....Gla Holders....this is far from a punt, given the high regard the industry has in SFX-01's potential. ;-)
ps news of the new CEO must be very close by now. ;-)
Dundee University
The study will recruit up to 300 volunteers from hospitals across the UK, with patients offered the chance to participate immediately after their diagnosis. Half the group will receive SFX-01 in addition to standard hospital care while the other half will receive a placebo. Results are expected by the end of the year.
https://www.dundee.ac.uk/stories/clinical-trial-potential-covid-19-treatment
Lifearc - 16/6/20
Researchers secured funding from LifeArc to conduct an investigator led, prospective, randomised, double-blind placebo-controlled trial, conducted in the UK, of patients hospitalised with COVID-19.
Investigating a sample size of 300 subjects, the study will compare outcomes for 300mg SFX-01 taken orally, once daily, plus best standard of care (BSC) versus placebo taken orally, once daily plus BSC. The primary outcome of the trial is the clinical status of patients on day 15 based on a seven point scale, recommended by the World Health Organisation as the optimal clinical trial endpoint for COVID-19 studies.
The trial will be conducted in up to six sites across Scotland and the north of England with first patient visit anticipated to happen in July.
htTps://www.lifearc.org/funding/covid-19-funding/sfx-01/
Chances are SFX-01 has already been administered, and highly possible they could report early on any positive indications after the 15 day clinical status...Gla Holders and fingers crossed for some material news in time for next Thursday's AGM. ;-)
"with patients offered the chance to participate immediately after their diagnosis"
The primary outcome of the trial is the clinical status of patients on day 15 based on a seven point scale, recommended by the World Health Organisation as the optimal clinical trial endpoint for COVID-19 studies.
Researchers from the University’s School of Medicine will work with drug development company Evgen Pharma to test whether the drug, known as SFX-01, improves outcomes for Covid-19 patients. This study is being supported by a grant from the medical research charity LifeArc, as part of its activities to address the need for new Covid-19 therapies.
Covid-19 causes the development of slowly worsening lung damage called acute respiratory distress syndrome (ARDS) in around 10% of patients admitted to hospital. When this occurs, no currently available drug can slow the progression of ARDS and patients ultimately require mechanical ventilation in intensive care until the inflammation resolves itself and the lungs begin to heal.
Unfortunately, some 30% of patients with ARDS may go on to die, while the number of patients requiring ventilation for ARDS has been one of the major challenges for healthcare systems. Finding treatments that can prevent the development of ARDS and improve patient recovery is therefore one of the top priorities for Covid-19 research.
Evgen Pharma develops medicines for the treatment of multiple diseases based on sulforaphane, a naturally occurring compound known to have anti-inflammatory properties. Its core technology is Sulforadex®, a method for synthesising and stabilising sulforaphane and its lead product is SFX-01.
“SFX-01 is an anti-inflammatory medication that we believe may have the potential to reduce some of the worst outcomes of Covid-19,” said James Chalmers, British Lung Foundation Professor of Respiratory Research at the University. “The body defends itself against inflammatory and oxidative stress by increasing levels of chemical called Nrf2. SFX-01 activates the Nrf2 system and puts it into overdrive to enhance defences against inflammatory damage.
“There is evidence that Nrf2 activation can reduce the severity of acute lung injury and ARDS. As such, we hypothesise that early treatment with an Nrf2 activator in patients hospitalised with COVID-19 may prevent deterioration and help to preserve precious ICU resources in the context of the pandemic. This is a completely new mechanism as there is currently no drug that targets Nrf2.”
The study will recruit up to 300 volunteers from hospitals across the UK, with patients offered the chance to participate immediately after their diagnosis. Half the group will receive SFX-01 in addition to standard hospital care while the other half will receive a placebo. Results are expected by the end of the year.
SFX-01 is a patented composition of synthetic sulforaphane and alpha-cyclodextrin that has been shown to halt the growth of, or even shrink, tumours of breast cancer patients in clinical trials whilst causing very few side effects.
hTtps://www.dundee.ac.uk/stories/clinical-trial-potential-covid-19-treatment
Press Release
Covid-19 brings research switch for Ashley
Published on 25 June 2020
When Ashley Giam left Singapore for the UK, she could not have imagined that the move would lead to her working on potential treatments for the deadliest pandemic the world has seen for a century.
The projects Ashley has worked on include STOP-COVID19, the clinical trial of brensocatib, an anti-inflammatory drug that is hoped may help to prevent the worst ravages of the novel coronavirus. Ashley is also now playing a leading role in the study of another new anti-inflammatory drug called SFX-01. This medication reduces lung damage through the pathway that Ashley has been studying during her PhD. She is now working in the laboratory to understand whether this medicine could reduce the number of coronavirus patients requiring mechanical ventilation and, ultimately, cutting death rates from the disease.
“With the Covid-19 outbreak, the priorities of labs around the world shifted and here at Dundee we changed direction to focus on what we could do given the expertise here,” continued Ashley. “From the top researchers to PhD students like myself, everyone has been given the chance to play their part. I have been trying to embrace this opportunity and learn all I can from it. PhD students here are involved in research with the potential to make a real difference to people around the world, but obviously I never expected to be working on anything like this.
hTtps://www.dundee.ac.uk/stories/covid-19-brings-research-switch-ashley
Don't be so ridiculous radar SFX-01 's Phase 2/3 breast cancer patient trials are being formulated/developed for the coming months and phase 2 trials were life changing for some patients and so every chance of a JV with a major player given it's outstanding results so far, SFX-01 is also in evaluation for multiple disease targets with several high profile University collaborations, not to to mention the highly prestigious University of Rochester in New York where patient trials are planned for Chronic Kidney disease for SFX-01, and as far as the Covid-19 patient trials are concerned , Lifearc selected SFX-01 from over 120 drug candidates which illustrates the high regard that the industry has in SFX-01's potential, and is going straight into patient trials this month, and so far no other drug has been confirmed as a definite treatment for Covid-19 and so if SFX-01 was proven to be of therapeutic benefit, then the sp would sky rocket....an early indication could very possibly be made public if it meant that lives could be saved or suffering lessened....SFX-01 is a potential panacea for many disease targets and the current bargain low sp and ridiculously low market cap does not reflect prospects and potential....and the real chance that a major may want to invest in SFX-01's development....watch this space. News of the new CEO and an update on proceedings very likely in time for next Thursday's AGM....:-)
They would have been much better off sticking to what they know best that’s cancer treatment.
The covid vaccine space is packed out and at the way it’s going there will be multiple cures for covid.
They should stick to what they know best.
Not a good strategy to jump on every bandwagon passing.
Of course they can report early success if patient are showing improvement after 15 days , in the same way the trial can be halted if an adverse effect was witnessed. The US has just bought all the available stock of Remdesivir after early positive indication , yet that trial is still in process , and so if early positive indications are witnessed with SFX-01 then they will make it public imho...Gl :-)
The SFX-01 Covid-19 patient trial is expected to run throughout the year, but early indications could be reported far sooner given the primary outcome status of patients on day 15.....Gla ;-)
16/6/20
Researchers secured funding from LifeArc to conduct an investigator led, prospective, randomised, double-blind placebo-controlled trial, conducted in the UK, of patients hospitalised with COVID-19.
Investigating a sample size of 300 subjects, the study will compare outcomes for 300mg SFX-01 taken orally, once daily, plus best standard of care (BSC) versus placebo taken orally, once daily plus BSC. The primary outcome of the trial is the clinical status of patients on day 15 based on a seven point scale, recommended by the World Health Organisation as the optimal clinical trial endpoint for COVID-19 studies.
The trial will be conducted in up to six sites across Scotland and the north of England with first patient visit anticipated to happen in July.
https://www.lifearc.org/funding/covid-19-funding/sfx-01/