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As On target has correctly pointed out, it's not just the primary objectives under assessment, the secondary objectives and especially the exploratory objectives will be highly significant to proceedings imho, and no doubt will add time to Prof Chalmers efficacy assessment for the publication of any detailed and comprehensive report, and as so the fact that we're still waiting for results suggests that there could be something encouraging....fingers crossed...Gla :-)

The trial will test the following hypothesis:

Treatment with SFX-01 in addition to standard care will be superior to placebo plus standard care in achieving improved clinical status in patients initially hospitalized with community acquired pneumonia (including patients investigated for suspected COVID19 infection).

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

Primary objective:

To evaluate the clinical efficacy of SFX-01 compared to placebo on top of standard care in adult patients initially hospitalized with community acquired pneumonia. Outcome measure:7 point ordinal scale measured on Day 15.

Secondary Objectives:

Evaluate the clinical efficacy of SFX-01 relative to standard care in adult patients hospitalized with suspected COVID-19

Evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm

Outcome measures:

Cumulative incidence of serious Adverse events (SAEs)

Discontinuation or temporary suspension of treatment

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

Exploratory objectives (All sites)

Biofire analysis of nasal swab or sputum sample

Subanalysis of outcomes according to the causative pathogen

Exploratory objectives (TAYSIDE ONLY)

Analysis of Nrf2 pathway activity in isolated peripheral blood mononuclear cells

Neutrophil functional studies in isolated cells

Measurement of interleukin-6, interleukin-1 beta and TNF-alpha in blood

https://star-covid19.com/

No news is good news I reckon, and I'm sure Huw would want any bad news out of the way by now so he could get on with updating the market on the rest of the pipeline, and Prof Chalmers appears to be an incredibly busy bloke , and so a comprehensive and detailed positive efficacy assessment presumably will take a lot longer than a negative one...Gla :-)

Another reason SFX 01 maybe overlooked is that it's British....;-)))

Boris is making an announcement on easing lockdown measures tomorrow at 5pm...I wonder if he'll have news on any progress made on his home pill Autumn target???...news from Prof Chalmers must be close...can you imagine if SFX-01 gets a mention. :-)

Maybe one of the reasons that SFX 01 is under the radar, unknown and/ or disregarded is that it's not an Antiviral....little do they know. :-)

"Sulforaphane exhibits in vitro and in vivo antiviral activity against pandemic SARS-CoV-2 and seasonal HCoV-OC43 coronaviruses."

25th March 2021 - John Hopkins University of Medicine, Baltimore USA

“The similar results observed between the coronaviruses evaluated suggest that SFN could have broad activity against coronaviruses, a feature that may prove invaluable as new strains of pathogenic coronaviruses enter the human population.”

Conclusion

We documented that SFN can inhibit the in vitro and in vivo replication of SARS-CoV-2 at pharmacologically and therapeutically achievable doses and can modulate the inflammatory response thereby decreasing the consequences of infection in the animal model when administered prior to infection. Given that SFN is orally bioavailable, commercially available, and has limited side-effects, our results suggest it could be a promising and easily scalable approach for the prevention and treatment of COVID-19 as well as other coronavirus infections.

https://www.biorxiv.org/content/10.1101/2021.03.25.437060v1.full

Scientists have said it will probably take years to develop a bespoke drug of this kind, explaining there has been a lack of investment in this field in recent decades. This also calls into question Downing Street’s recent plans to deliver two effective antiviral treatments to the population by autumn.

SFX-01 appears to be completely under the radar from mainstream opinion on finding a home pill treatment/ prevention...yet efficacy assessment data is expected imminently...positive data must see SFX 01 as prime candidate for Boris's Covid treatment taskforce, and may be planet Earths thereafter if efficacy data anywhere near correlates to John Hopkins University research on Sulforaphane as a promising agent for prevention as well as treatment....Gla Holders...Exciting times for all invested. :-)

https://www.google.com/amp/s/www.independent.co.uk/news/science/covid-pills-home-drug-treatment-latest-b1840270.html%3famp

There's a raft of potential material news expected from across the pipeline, news of which could drop at anytime, but near term all eyes are on SFX-01's efficacy data from the Covid/Ards trial which is expected imminently, positive data could send the sp to multiples of current bargain low, and then no doubt Huw would start updating the market on the other didease targets under development to add further value, and if SFX-01's efficacy data isn't convincing, then expect a 40% drop in sp which would take the market cap to around the £13m cash Evgen have in the bank, and then no doubt Huw will then update the market on the rest of the pipeline to temper any disappointment and would hopefully see the sp bounce back to fair value. Gl ;-)

Simões BM, Santiago-Gómez A, Chiodo C, Moreira T, Conole D, Lovell S, Alferez D, Eyre R, Spence K, Sarmiento-Castro A, Kohler B, Morisset L, Lanzino M, Andò S, Marangoni E, Sims AH, Tate E, Howell SJ and Clarke RB.

Targeting STAT3 signalling using stabilised sulforaphane (SFX-01) inhibits endocrine resistant stem-like cells in ER-positive breast cancer. Oncogene. 2020 May 30.

https://doi.org/10.1038/s41388-020-1335-z.

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

Dr Howell and Prof Clarke are both on Evgen's Scientific Advisory Board.

In addition, Dr Howell also works closely with the Breast Biology Group of Professor Rob Clarke and has translated the findings of the group into successful treatment trials, with publications expected in 2021

http://www.breastcentre.manchester.ac.uk/Portals/12/Documents/Manchester_Breast_Centre_Report_2019-2020.pdf

News/UPdate on SFX-01's Breast Cancer programme at anytime. Gla ;-)

Rob Clarke
@RobClarkeLab
·
3h
Check out our @MCRBreastCentre report for 2019-2020 to find out how we’re translating basic and clinical breast research into patient benefit. Mancunian research academics doing #teamscience = better research

· May 7
We are thrilled to present the latest MBC Report for 2019-2020 which highlights our recent breast research and publications.

hTtps://bit.ly/3haQQQr

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

The major research interests of the group are breast development, where we focus on hormonal regulation of luminal progenitors and cancer where bone metastasis and endocrine resistance are major interests.

Recently, we established a role for the human bone microenvironment in promoting colonisation of breast cancer cells through secretion of interleukin 1 beta (IL1ß). We showed that IL1ß induces Wnt signalling in the cancer cells and that drives colony-forming activity using novel models of patient-derived bone marrow and breast cancer cells (Refs 1 & 2).

Our research on estrogen receptor-positive (ER+) breast cancer aims to identify drivers of resistance to current standard of care treatments including endocrine and CDK4/6 inhibitor therapies.

We previously established that ALDH+ cancer stem cells (CSCs) were responsible for anti-estrogen resistance driven by Notch4 receptor signalling (Simoes et al., Cell Reports, 2015), and more recently have shown that this is inhibited by peptides derived from FKBPL protein (3).

We also exploited patient-derived samples from endocrine resistant patients to demonstrate a role for PAK4 kinase in resistance and validated the efficacy of a potent kinase inhibitor currently licenced by Cancer Research UK Commercial Partnerships (4). In exciting work published in Oncogene (5), we showed that endocrine resistant ALDH+ CSCs from patients could be inhibited by a stabilised formulation of sulforaphane (SFX-01).

This research led from ‘bench to bedside’ providing the basis for the clinical trial (STEM01) in metastatic breast cancer led by MBC Medical Oncologist Sacha Howell. Finally, we used single cell gene expression analysis of endocrine resistant CSCs to establish that there is a dormant population of cells remaining after treatment that are dependent on the IL1ß signalling pathway (6).

This links to our work in bone metastasis outlined above which indicates that endocrine resistant CSCs will respond to the bone microenvironment and may be sensitive to IL1ß inhibitors such as Anakinra and Canakinumab. We hope our MBC clinical colleagues will test this in future clinical trials.

Lol...."SNG is doing not that bad"....ha ha ha....you tell that to the majority of punters who bought in £1 plus plus, £2 plus plus towards £3.....no one got in sub £1 ( or very few ) on the day of their stellar rise....in the meantime, let's hope SFX-01's phase2/3 efficacy assessment for Covid/Ards is a tad more conclusive than SNG's latest ambiguous results. Gla holders....Tick Tock. ;-)

Lol...and don't you get tired of hanging around share forums in different guises where you're not invested....ho ho ho....the sp moved from c3p to c 15p and back to c8p on £11m placing, and so the sp hasn't been standing still.....we're now awaiting the potential blockbuster RNS on SFX-01's Covid / Ards patinet trial.....if you want a bit of movement , postive efficacy data could send the sp off the scale....ha ha ha ha ....Gla Holders..Tick Tock!!! ;-)

The Directors have got far more "skin in the game" than of any of us....ie lots of share options, incentivised to increase shareholder value.....they're also in a "Closed Period" with potential blockbuster transformational efficacy results expected at anytime as well as material news from the rest of the pipeline, and so can't buy any shares at this time.....Tick Tock....;-)

Ps and it's not just the primary objectives that are crucial to proceedings , as the exploratory objectives could also be highly significant to Prof Chalmers assessment, and so hopefully a very positive and fully comprehensive efficacy report is heading our way....along with tremendous Transformational UPside!!! Gla ;-)

The trial will test the following hypothesis:

Treatment with SFX-01 in addition to standard care will be superior to placebo plus standard care in achieving improved clinical status in patients initially hospitalized with community acquired pneumonia (including patients investigated for suspected COVID19 infection).

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

Primary objective:

To evaluate the clinical efficacy of SFX-01 compared to placebo on top of standard care in adult patients initially hospitalized with community acquired pneumonia. Outcome measure:7 point ordinal scale measured on Day 15.

Secondary Objectives:

Evaluate the clinical efficacy of SFX-01 relative to standard care in adult patients hospitalized with suspected COVID-19

Evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm

Outcome measures:

Cumulative incidence of serious Adverse events (SAEs)

Discontinuation or temporary suspension of treatment

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

Exploratory objectives (All sites)

Biofire analysis of nasal swab or sputum sample

Subanalysis of outcomes according to the causative pathogen

Exploratory objectives (TAYSIDE ONLY)

Analysis of Nrf2 pathway activity in isolated peripheral blood mononuclear cells

Neutrophil functional studies in isolated cells

Measurement of interleukin-6, interleukin-1 beta and TNF-alpha in blood

https://star-covid19.com/

Yep, no doubt, but it's the collective data that matters, the condition of some on the placebo could have improved, but hopefully Prof Chalmers assessment will give a strong indication of efficacy from those who were administered SFX-01 , as it's an improvement of a certain percentage of those on SFX 01 against those on the placebo group which we're looking for, which appears to be one the problems experienced by SNG's recently reported phase 2 data, whereby no definitive conclusion could be made it seems because their patient groups came from those displaying mild symptoms at home, whereas as SFX 01's recruitment is made up from hospitalised patients , and so efficacy data should be much more likely to be observed. Gl :-)

That should read " so No one will know" :-)

It's  a double blind, randomised, placebo-controlled study , and so one will know until the data is unblinded, which is the case now with Prof Chalmers current interim efficacy assessment....only Prof Chalmers and his close team will have access to the data initially. Gl :-)

Everything firmly crossed for good news Prof Chalmers...can't be long now, although maybe a good sign that we're still waiting as I'm sure Huw would want any bad news out of the way by now, with so much potential material newsflow from the rest of the pipeline stacking up....Positive efficacy data from the Covid/Ards patient trial will be truly sensational....Bring it on!!! ;-)

The new, high quality shareholders who participated in the placing are also very impressive players.....the UK's leading and most powerful VC group, Octopus , have just invested £1.75m in Evgen, along with Chelverton Assest Management's £1m and RAB Capiatl's £700k as well as AXA inreasing their holding by another £1m plus and Seneca by £750k, a supreme show of confidence in Evgen's prospects and potential going forward. Gl ;-)

I think the change of mind is down to Huw Jones who was only appointed as the new CEO in October 2021, to realise his "new redefined strategy" to take Evgen forward to the next level, and along with validation/confirmation of efficacy across the pipeline, his two recent appointments can only add weight and increase the chances of attracting a commercial partner or two imho. Gl ;-)

2/2/21

Placing and Open Offer to raise up to GBP11 million

Commenting on the Fundraising, Huw Jones, CEO of Evgen Pharma plc, said:

"This heavily oversubscribed fundraising is transformative for us and allows us to accelerate both our future clinical and current pre-clinical work dramatically, together with expanding our senior management team to support our growth. We are very pleased with recent progress of our work on SFX-01 and are most grateful for the support shown in this placing by existing shareholders. The Placing also brings a number of new, high quality shareholders to our register and we offer a warm welcome to them as we accelerate our progress in a range of cancers and acute respiratory distress."

26/4/21

Appointment of Chief Medical Officer

Dr Huw Jones CEO of Evgen commented: "We are delighted to have someone of Glen's experience and knowledge join our team. As we progress further with our clinical programmes, Glen's depth of understanding in the fields where we are active will be invaluable. Glen will also be a key member of the team involved in leveraging our relationships with our many partners. His unique skillset has seen him take responsibility for a number of large, complex projects and he has published over 50 academic papers on various cancers."

22/3/21
Appointment of Chief Business Officer

Dr Huw Jones CEO of Evgen commented: "We are delighted to appoint Helen to a key senior role within the Company as we increase our focus on potential partnering activities for SFX-01. Helen will also have a key role within the team in providing a commercial focus on our indication selection, horizon scanning and competitor intelligence activities."