Member Info for Moneymunch

"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....:-)

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/

All good things.......Gl :-)

or maybe the Champagne Bar.....;-)

More options exercised....need the cash, expecting a rise in sp or an ex employee cashing them in before a restructuring of share options in place, prior to a merger/strategic partnership???

C'mon Evgen, where's the new CEO and who's been accumulating the massive share transfers the last couple of months??? Gla:-)

Franklin had plenty of time before his stock options expired, and so the timing could be significant, very often on merger, aquisition or strategic partnership, stock options in place are generally restructured and can be cancelled completely, especially to ex-employees.

£100k cash in the bank for EVG, and he had a year or two before the options expired, and so the timing could be significant. Gl :-)

Looks like the ex CEO has exercised options with Expiry dates 20/11/21 and 22/12/23, hopefully because he's expecting a significant rise in sp as good new arrives. Gla ;-)

https://evgen.com/wp-content/uploads/2015/10/Evgen-Annual-Report-2020.pdf

RNS Number : 0460S
Evgen Pharma PLC
06 July 2020




Evgen Pharma plc

("Evgen" or "the Company")



Share option exercise and issue of equity



Evgen (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, announces that it has received notice to exercise options over 2,957,600 ordinary shares in the Company. The options have been exercised pursuant to grants under the Company's share option plans.



Accordingly, the Company has issued and allotted 2,957,600 new ordinary shares of 0.25 pence each ("New Ordinary Shares"). The New Ordinary Shares rank pari passu with the Company's existing issued ordinary shares. Application has been made to admit the New Ordinary Shares to trading on AIM and dealings in these shares are expected to commence at 8.00 a.m. on 9 July 2020.



There are no shares held in treasury, therefore following the admission of the New Ordinary Shares the total number of voting rights in the Company will be 135,613,863. This figure may be used by shareholders in the Company as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest under the Disclosure and Transparency Rules.

Yep, it s a bit, although All good things come to those who wait.....confirmation of the appointment of a new CEO and an update on proceedings surely must be close, and maybe in time for the AGM 16th July.....Evgen's upside potential and prospects are well documented and so fingers crossed for a stellar Rns or two in the coming days. Gl ;-)

FRDA is one of Reata's lead disease targets, and the following abstract published 15th October 2019, gives a detailed summary of Phase 2/3 trial results which appear far from convincing imho, and another reason why they ( or any other Major player ) might be very interested in developing SFX-01's potential side by side for FRDA and many other disease targets. Gla ;-)

Orphan Drugs In Development For The Treatment Of Friedreich’s Ataxia: Focus On Omaveloxolone

MOXIe (RTA 408)

The MOXIe trial (NCT02255435, Reata Pharmaceuticals Inc) was conducted to assess the safety and efficacy of Omav in patients with FRDA between 2015 and 2017.15 The trial was a multicenter, double blind, randomized, placebo-controlled Phase 2/3 clinical trial in FRDA patients.

..............................................

Other Nrf2 Activators

Other members of the class of Nrf2 activators, such as sulforaphane (SFN) and dimethyl fumarate (DMF), have also been studied for potential positive effects on FRDA.14 SFN is a naturally occurring Nrf2 activator noted for its anti-inflammatory mechanisms and ability to quickly cross the blood-brain-barrier. DMF, another Nrf2 activator that efficiently crosses the blood-brain-barrier, is an approved treatment for Multiple Sclerosis. In a recent 2017 in-vitro study, the molecules were evaluated for their potential neuroprotective effects on frataxin-silenced neurons. Both DMF and SFN exhibited significant upregulation of Nrf2 and its associated target genes. This was evidenced by tremendous increases in Nrf2 mRNA levels and Nrf2-regulated phase 2 enzymes. Both SFN and DMF effectively reverse oxidative stress buildup and function to protect the neurons from the neurodegenerative phenotype in frataxin deficient cells.21

Nrf2 activators mechanism of action make them a viable option in the treatment of many diseases associated with oxidative stress in addition to FRDA, including several neurodegenerative diseases. Neurodegenerative diseases such as Alzheimer’s disease (AD), Parkinson’s Disease (PD), Multiple Sclerosis (MS) and Amyotrophic Lateral Sclerosis (ALS) have all been linked to abnormalities in the Nrf2 pathway.22

https://www.dovepress.com/orphan-drugs-in-development-for-the-treatment-of-friedreichs-ataxia-fo-peer-reviewed-fulltext-article-DNND

Importantly, the levels of this transcription factor decrease with age. The loss of Nrf2 allows oxidative stress to go unchecked and drives the frailty associated with aging due to disrupted proteostasis, altered genomic stability, increased susceptibility to infection, and cell death.

“It is this age-related frailty that often defines the most vulnerable population in situations such as the one we currently face with the coronavirus pandemic,” writes Joe McCord (Pathways Bioscience, Aurora, USA) and colleagues.
Investigating the effects of Nrf2 activation in human cells

For a virus to be able to replicate, it needs to sustain oxidative stress at a higher level than usual, but not so high as to destroy host cells. Viruses have “learned” to manipulate the Nrf2 pathway in ways that confer survival and enable them to take control from host cells.

Recently, McCord and the team described a potent Nrf2 activator called PB125, which they have now investigated the effects of in human liver-derived HepG2 cells and pulmonary artery endothelial cells.

The team wanted to investigate the changes in gene expression as a result of Nrf2 activation that may be involved in antiviral activity overall, as well as those specifically involved in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the associated COVID-19.

https://www.news-medical.net/news/20200518/Potential-new-treatment-approach-to-fatal-COVID-19.aspx