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Contrary to the opinion of some, I reckon SFX-01's dual activation of STAT3 and NRF2, makes it a very strong candidate to treat Covid-19 and ARDS judging by the number of high profile research papers recently published, and no doubt the very reason why it was selected for Covid-19 patient trials from over 130 drug application candidates by LifeArc...Gla holders, confirmation that the trials are underway will be very well received and so a very exciting period ahead, in anticipation. :-)
“It is crucial to understand the most appropriate context for introducing an anti-inflammatory therapy to complement an antiviral therapy. Such therapy must control inflammation without altering the ability of the host to mount an efficient adaptive immune response against the virus.
We propose that boosting endogenous cellular defenses by targeting the cytoprotective transcription factor Nrf2 (gene name NFE2L2) will promote the resolution of COVID-19 associated inflammation and also restore redox homeostasis and facilitate tissue repair.
The isothiocyanate sulforaphane (SFN) is the most potent naturally occurring NRF2 activator, with well-documented antioxidant and anti-inflammatory effects. The high bioavailability of SFN makes it an excellent candidate for alleviating excessive anti-inflammatory responses and protecting the lungs.
Interesting tweet from Pro Dillon at University of Dundee, who has had SFX-01 under evaluation for clinical trials for NASH since December 2019.....maybe news could be close. Gla ;-)
John Dillon Retweeted
Journal of Hepatology
@JHepatology
·
Oct 15
Reliability of hepatopathologists’ liver #biopsy evaluation using currently accepted criteria is suboptimal and has major implications for #NASH clinical trials.
http://bit.ly/31s8nvK
........................
5/12/19
Evgen Pharma (AIM: EVG) a clinical stage drug development company focused on the treatment of cancer and neurological conditions, announces it has entered into a Memorandum of Understanding with the The University of Dundee ("The University") to advance SFX-01 towards a clinical trial in non-alcoholic steatohepatitis ("NASH") and liver fibrosis. Evgen has agreed to supply SFX-01 to support a potential future clinical trial led by John Dillon, Professor of Hepatology and Gastrenterology in the University's School of Medicine.
With the assistance of Evgen, Professor Dillon will lead the process to secure appropriate grant funding and obtain clinical trial regulatory approval. The intention is to utilise advanced MRI scanning technology to investigate whether SFX-01 can reverse the hallmarks of NASH in a proof-of-concept clinical trial. Clinical data arising from a successful trial will support subsequent development, regulatory approval and commercialisation of SFX-01 in NASH and liver fibrosis. Evgen will be granted an option to the clinical data on fair commercial terms to enable it to advance development and commercialisation.
Non-alcoholic fatty liver disease ("NAFLD") is now regarded as the most common liver condition in the developed world, affecting up to 30% of the general population. NAFLD represents a spectrum of phenotypes ranging from simple steatosis (fatty infiltration), through NASH to cirrhosis. Approximately 30% of adults in the general population have NAFLD, and 10%-20% of these have NASH. Amongst patients with NASH, 20-30% are at risk of developing cirrhosis and subsequently dying from end-stage liver disease within 20 years. In view of the tens of thousands of individuals who are likely to develop NASH in the next decade, it is clear that this disease will represent a major burden to healthcare in the UK.
Professor John Dillon and colleagues have previously published research that showed that drug-induced activation of the Nrf2 pathway could reverse insulin resistance, suppress hepatic steatosis, and mitigated against NASH and liver fibrosis. On this basis, Professor John Dillon approached Evgen, the developer of SFX-01, a development stage drug that is known to activate the Nrf2 pathway and has demonstrated excellent safety and tolerability in previous clinical trials.
John Dillon, Professor of Hepatology and Gastrenterology at the University of Dundee's the School of Medicine said: "We are delighted that Evgen will support our plans to
This is one of the drugs Trump was on, the US bought up the entire world supplies a few months back when early observations suggested Remdesivir might a have a therapeutic benefit.
Financial Times
@FinancialTimes
Breaking News: The Covid-19 treatment remdesivir has no substantial effect on a patient’s chances of survival, a clinical trial by the World Health Organization has found
https://on.ft.com/319YsKh
Some chunky late buys in after close at 13.75p....All bodes well for Monday...Gla ;-)
Seems like it ....
Looks like a nice UPward surge into close is definitely on the cards....Gla ;-)))
On and UP!!! ;-)
Scottish numbers: Continue to rise dramatically and so surely news that SFX-01's Covid-19 patient trials are underway is imminent.
16 October 2020
Summary
1,196 new cases of COVID-19 reported; this is 16.9%* of newly tested individuals
9 new reported death(s) of people who have tested positive
58 people were in intensive care yesterday with recently confirmed COVID-19
629 people were in hospital yesterday with recently confirmed COVID-19
21,057 new tests for COVID-19 that reported results
.......................
Scottish numbers:
30 September 2020
640 new cases of COVID-19 reported; this is 10.3% of newly tested individuals.
7 new reported death(s) of people who have tested positive
15 people were in intensive care yesterday with recently confirmed COVID-19.
137 people were in hospital yesterday with recently confirmed COVID-19.
15,629 new tests for COVID-19 that reported results.
Perhaps the biggest piece of near term news, which has been overlooked , would be the 20 year patent extension.....confirmation news would be massive and would add significant UPside imho....Gla ;-)
15/6/20
INTELLECTUAL PROPERTY UPDATE
Our IP portfolio continues to be strengthened with a number of key patents being granted. The current status of the intellectual property portfolio is as follows:
-- From the "parent" patent family entitled "Stabilised Sulforaphane" patents are granted in Australia, Canada, EU, US, Japan and Hong Kong.
-- The principal manufacturing patent application, entitled "Methods of Synthesising Sulforaphane" is granted in Australia, China, Europe, Japan and further applications are pending in Brazil, Canada, US and India.
-- A second manufacturing patent which is directed to methods of isolating and purifying sulforaphane or analogues from natural sources has been granted in Europe, US, Japan and China.
-- The patent application providing protection around novel analogues based on sulforaphane, and entitled "Sulforaphane-Derived Compounds" is granted in Australia, China, Europe, Japan and the US and pending in Canada.
During the year composition of matter SFX-01 patents were granted both in Japan and Europe with a product claim for a complex of sulforaphane and alpha-cyclodextrin. The Group has long held broad compositional patent protection in the United States since patent grant in 2011 and in Canada since grant in 2014.
Furthermore, new composition of matter filings have been made which, if successful, would add a further 20 years of patent life to the key patent family.
News on the status of the Covid-19 trial surely must be imminent, and plenty of other news on the rest of the pieline must be close. SFX-01 has been in evaluation for multiple disease targets for clinical trials from several academic research organisations since the start of the year and so news could drop at anytime, as well as the high profile breat cancer research, which is now in the planning for phase 2b trials with Manchester Unversity, and the following outlines the planned work programme and so news on the progress very likely. I aslo think there is a high chance of news on a strategic investor or early commercial JV which would certainly explain the massive share transfer/accumulation over several months or at least a TR1 at the very least with disclosure of who or why!!!??? Gl ;-)
.........
Breast Cancer Current and planned work programme
All preclinical breast data published in high impact journal in June 2020
Extensive review of clinical pathway to approval close to completion
Supplementary preclinical work required to confirm CDK4/6i “resistance-breaking” hypothesis
New “commercial ready” solid tablet formulation to be completed in H3 2020
Non-dilutive capital e.g. partnering to fund the next trial(s)
Targeting CTA/IND in H1 2021 with first patient first dose in Q2/Q3 2021
http://evgen.com/wp-content/uploads/2020/07/EVG-AGM-presentation-2020-16Jul20.pdf
A fair few buys coming in..
Yes with the primary endpoint being patient condition on day 15 they will quickly build up data on the effectiveness of SFX-01. There is every reason to believe it will be effective. The phase II/III trial design is great because it allows them to really accelerate things if results are positive. Of course there will be updates along the way that could give great upside to the share price.
I reckon we should have a good day today from those anticapating news this coming week, the chart couldn't looked more primed for the next leg UP. ;-)
SFX-01's Covid-19 patient trial is phase 2/3 which is "Phase 2 and 3 Combination Design to Accelerate Drug Development ", we already know that SFX-01's safety profile is safe and sound from SFX-01's phase 2 SAH and SFX-01's phase 2 breast cancer trials, and so if an early therapeutic benfit is observed in the Covid-19 trials, then presumably the trial will be accelerated into phase 3.......Top Line results are expected September 2021, but no doubt early reporting will be made on any positive indications from the phase 2 stage of the trial.......news next week that the trial is already in progress would be very well received. Gla ;-)
"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.
See SNG are gearing up for a phase III trial starting in Q4. EVG need to get their phase II/III trial going and let the market know about it asap. In the case of EVG we are talking about a low cost powder or possibly tablet for patients to take. No special equipment required so in addition to hospital treatment this could be taken at home and prevent vulnerable patients needing to go to hospital in the first place.
"Evgen will supply clinical centres with SFX-01 and a placebo as its contribution to the trial. No additional financing is required as the costs of providing SFX-01 for the trial are not material."
"Preclinical studies have shown that up-regulating the Nrf2 pathway reduces the severity of ARDS, the progressive lung damage observed in COVID-19 patients which can result in the need for invasive ventilation in an intensive care unit."
I haven't tried. I always assume that they're not going to tell you anything otherwise they are seriously breaking market rules.
Has anyone tried to get in contact with the new CEO?
The scale of the opportunity is huge Nolupus. This is the time to get news out and let the market know all about the trial and the potential of SFX-01. I know patience is required but they also need to be aware of seizing the opportunity. If they had got their trial underway earlier in the year like SNG did then the market cap could have been measured in hundreds of millions by now.
fairview,
Should'nt be much longer but one has to be patient with EVG and the new CEO has to find his mark....Patience is the key here
All the dots are joining together for EVG to announce their trial is underway and how many patients they have treated so far. Don't know why there isn't more of a buzz around this. I'd be surprised if we didn't hear something this week.
Extremely grim news and worrying for all, but no shortage of patients for SFX-01's long awaited Covid-19 patient trials...here's hoping Evgen and other UK Bio's zuch as SNG can come up with an effective treatment or two. Gl :-)
........
Hospitals in England now have more coronavirus patients than they did when lockdown restrictions were first announced in March, a senior NHS official has revealed.
And with admissions rising, numbers of Covid-19 patients in the worst-hit region of the northwest could within four weeks top the levels seen during the peak of the first wave in the spring.
The medical director of NHS England, Prof Stephen Powis, said that without additional measures to control the spread of the disease, deaths would rise to a level “too great to bear”
Prof Powis dismissed as “wishful thinking” claims that elderly and vulnerable people could be shielded from the rising rates of infection among the younger population.
Details of the surge in infections were revealed as NHS Nightingale hospitals in Manchester, Sunderland and Harrogate were ordered to mobilise to prepare for a second wave of patients overwhelming NHS capacity in the north of England.
It came as Boris Johnson chaired a meeting of the government’s Cobra emergencies committee ahead of today’s announcement of a new three-tier system of restrictions, expected to include the closure of pubs and bars in the worst-hit parts of the country.