Member Info for Moneymunch

Cheers Scoredagainsteps, the risk reward is firmly in our favour, massive upside on positive efficacy data from the Covid/ARDS patient trials news of which is fast approaching, and if it isn't good then any downside would be temporary as we still have multiple shots on multiple targets and c£13m cash in the bank with a raft of news expected this Q2 from the rest of the pipeline, although if Prof Chalmers delivers good news as hoped and efficacy data correlates with the recent stunning research from John Hopkins University suggesting that Sulforaphane is not only a promising treatment for Covid and several variants as well as ARDS etc, but also prevents you from getting it in the first place ,then Evgen will be propelled into the Covid global spotlight and the sp could be many multiples of 8p with any luck...Excitement building in anticipation. Gl ;-))))

Suck in buyer???....ho ho ho.....the complete opposite imho....the MM's continue to enourage the weak and worried to sell their shares cheaply ( all the way down to 7p !!! ) which are then accumulated on the cheap with the vast majority of the large trades priced as buys.....anyways, this is all about news now and nothing else....Gla Holders.....Tick tock...;-)

Conflicts of interests!!!???? ;-)

James D Chalmers
@ProfJDChalmers
·
5h

Looking forward to speaking with experts on public health, education, social sciences, politics and others tonight

Escaping to a post-COVID world (sounds good right?)

10:19 am · 17 Apr 2021·Twitter Web App

James D Chalmers
@ProfJDChalmers

Researchers: we used (insert incredibly complex dataset) to test (complex hypothesis) using machine learning and (complex statistics).

Also Researchers: Sorry we didn't declare our conflicts of interests, those forms are really complicated

https://twitter.com/ProfJDChalmers/status/1383349366912524292

Ps 102 patients recruited to SFX-01 Covid/ARDS trial as of 16th February 2021....14 days dosing and then 28 days observation takes the first 100 trial patients to the end of March and the likely start of Prof Chalmers preliminary efficacy assessment although some of the exploratory objectives could have been ongoing since the start of the trial, blood and cell analysis etc.....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/

The accumulation of cheap shares continues!!! Gla holders...Prof chalmers preliminary efficacy assessment imminent imho..:-)))

17th February 2021

Update on patient recruitment

STAR COVID-19 trial exceeds 100 patients

Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces that as of 16 February, a total of 102 patients had been recruited and randomised to the STAR trial ("SFX-01 Treatment for Acute Respiratory infections").

This Phase II/III trial is a randomised, placebo-controlled trial, sponsored by the University of Dundee and funded by the UK charity LifeArc. It is investigating whether the Company's lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome ("ARDS") in patients with suspected COVID-19. Patients may be included in the study if they are infected with SARS-CoV-2 or another respiratory infections causing community-acquired pneumoni

11th March 2021

Update on Data Safety Review for STAR COVID-19 trial

Review of Patient Safety and Data Quality confirms no concerns with trial

Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces that after a review of the first 60 patients enrolled, the Data Safety Monitoring Committee ("DMC") for the STAR COVID-19 ("SFX-01 Treatment for Acute Respiratory infections") trial has concluded that there are no concerns regarding patient safety or data quality that would prevent continuation of the trial.

The Phase II/III trial is a double blind, randomised, placebo-controlled study of the Company's lead asset, SFX-01, in patients with acute respiratory distress syndrome ("ARDS"). The trial is co-sponsored by the University of Dundee and NHS Tayside and funded by the UK charity LifeArc. It is investigating whether the Company's lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome in patients with suspected COVID-19. Patients may be included in the study if they are infected with SARS-CoV-2 or other respiratory infections causing community-acquired pneumonia.

Following this positive step, the next event in the trial involves an assessment of safety and futility by the DMC of unblinded data on the first 100 patients treated. In addition to the DMC safety and futility assessment, Dundee University has decided to review the top-level unblinded data in a preliminary assessment of possible efficacy. This may lead to adjustments to the design of the trial for remaining patients, including in-patient numbers, and possibly early termination for either safety, futility or alternatively, strong efficacy. It is expected that this initial data will be available during Q2 of the calendar year 2021.

Completion of recruitment to the STAR trial is anticipated at the end of 2021/early 2022, assuming there are no substantial changes in the total patients to be recruited.

Dr Huw Jones, CEO of Evgen, commented : "We are pleased with the conclusion of the data monitoring committee with regard to safety and data quality in the STAR COVID 19 study. The former conclusion reinforces what we know about the positive safety and tolerability of SFX-01 from previous studies and the latter is yet another testament to the excellent work carried out by Professor James Chalmers and his colleagues at Dundee under challenging circumstances."

The market's awaiting Prof Chalmers preliminary efficacy assessment on SFX-01's Covid/ARDS patient trial, this will explode into life on positive data and there will be a mad dash for share from new investors, and then Huw has multiple newsflow from the rest of the pipeline to report thereafter that could also add significant value.........Gla Holders.....Excitement building in anticipation of Prof Chalmers update that could be very close imho. ;-)

The calm before the storm....news from Prof Chalmers on SFX-01's preliminary efficacy assessment for Covid/ARDS coming soon, and maybe in time for the following two Covid-19 presentation/discussions this month where Prof Chalmers is involved. Gla ;-)

Escaping to a post-Covid world. 17 April 2021

“However, it has also highlighted some of our major strengths. There has been incredible innovation during the Covid-19 pandemic, with acceleration of digital technologies, better ways of delivering healthcare and developments in vaccines and treatments that could be applied to many common diseases.

“We all have a stake in the post-Covid future and we all get to play a part in building it. That starts with a broad conversation about where we are going and what we want the future to look like. Hopefully that’s the conversation we will start at this event.”

https://www.dundee.ac.uk/stories/experts-discuss-what-post-covid-world-might-look

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

COVID-19: State of the art – DRAGON IMI project

29 April, 2021 Online

A full-day virtual event dedicated to COVID-19, where top level faculty will share the latest advances, data and best practices relating to SARS-CoV-2 and COVID-19.

“This event brings together world-leaders tackling COVD-19 and how different digital approaches to big data will help us to defeat the pandemic”

https://www.ersnet.org/events/covid-19-state-of-the-art-dragon-imi-project/?preview_id=129976

Lol...I'm expecting more than an interview on positive efficacy data, that was the last thing on my mind regardless of how lovely Miss Pilbeam's might be....Gl ;-)

I'm hoping this statement from Prof Chalmers is a reference to SFX-01's potential to treat Covid-19, ARDS, Pneumonia and other common Respiratory diseases/infections and a hint that he already has the eagerly awaited preliminary efficacy assessment data from SFX-01's Covid/ARDS patient trial...news next week??? Gla :-)

"There has been incredible innovation during the Covid-19 pandemic, with acceleration of digital technologies, better ways of delivering healthcare and developments in vaccines and treatments that could be applied to many common diseases."

It the same one!!! :-)

This is most recent Proactive Investor interview to date.

Evgen Pharma CEO , Huw Jones, interviewed by Proactive Investors - 26th January 2021

https://www.youtube.com/watch?v=xwflrBd83kg&feature=youtu.be

This one should work On target, it was released shortly after the SHP2 Rns....Gl ;-)

https://youtu.be/xwflrBd83kg

Huw's interview, he talks about the potential of SHP2 over multiple cancer targets and "a very rare developmental disorder in children" and are now in the process of figuring out which disease to target as the one with the highest unmet medical need.

News expected in the coming weeks on whether or not this is related to the IND application in the US . Gla :-)

https://youtu.be/xwflrBd83k

"and treatments that could be applied to many common diseases."

Press Release

Experts to discuss what a post-Covid world might look like

Published on 9 April 2021

A panel of experts will discuss what impact the Covid-19 pandemic and consequent lockdowns have had on society and consider what the future might look like in an upcoming University of Dundee public talk

Poster - Escaping to a post-Covid world. 17 April 2021 6pm

In the online event ‘Escaping to a post-Covid world’, a group of University experts from clinical and respiratory medicine to public health, as well as education and social work, will explore the challenges brought by the pandemic and its restrictions and consider how these may shape the future.

The talk is the last event in this year’s Saturday Series. It takes place on Saturday 17 April.

As vaccination rates increase, the world is beginning to think about what a post-Covid future might look like. The panel of professionals spanning medical and social sciences will consider what we might hope for as we emerge at the other side, discussing both negative and positive impacts of Covid-19 and lockdown.

The School of Medicine’s Professor James Chalmers, one of the UK’s leading lung experts, will join University colleagues on the panel. Over the past year, he and his team have treated hundreds of patients hospitalised with Covid-19 and undertaken some major research initiatives, from finding treatments to conducting clinical trials.

He said, “We will be dealing with the consequences of the pandemic long after the virus is controlled. Covid-19 has highlighted some of the major problems in our society, from obesity to smoking and health inequalities.

“However, it has also highlighted some of our major strengths. There has been incredible innovation during the Covid-19 pandemic, with acceleration of digital technologies, better ways of delivering healthcare and developments in vaccines and treatments that could be applied to many common diseases.

“We all have a stake in the post-Covid future and we all get to play a part in building it. That starts with a broad conversation about where we are going and what we want the future to look like. Hopefully that’s the conversation we will start at this event.”

https://www.dundee.ac.uk/stories/experts-discuss-what-post-covid-world-might-look

Lol....i think they have every clue, and not long before we find out, could be related to to SHP2 where Huw stated in a recent interview that they were still deciding on the specific cancer target for SHP2, or potentially it could be related to the University of Rocherster in New York, where SFX-01 has been under evaluation for Chronic Kidney Disease. Gl ;-)

Use of Proceeds

The Fundraising will raise gross proceeds of up to GBP11 million - admission date 4th March 2021

The net proceeds of the Fundraising are intended to be used as follows:

to fund further preclinical work for metastatic breast cancer (mBC), glioma and a further cancer indication yet to be announced;

subject to further pre-clinical progress, potentially fund a clinical trial in glioma patients;

to complete the formulation and scale up manufacturing of SFX-01;

to complete all preparatory work required to file an Investigational New Drug application in the US in respect of SFX-01; and

to fund the Group's operations through to mid-2023 including two key senior hires, being a Chief Business Officer and a Chief Scientific and Medical Officer.
.............

Solid tumour oncology target

In a collaboration which will be disclosed when patent filings and a scientific paper have been prepared, strong preclinical data has been generated when SFX-01 was evaluated in a model of a cancer with very poor life expectancy, and for which current treatments are limited.

In particular, in vitro studies with patient-derived cell lines showed dose-dependent reduction in proliferation and migration. Further, in vivo orthotopic xenograft models, treatment with SFX-01 increased disease-free survival and lengthened tumour progression times, an effect that is synergistic with radiotherapy.

Further preclinical work will be initiated shortly to complete the data set required for a clinical trial application and/or partnering discussions. The preclinical work should be completed by the middle of 2021 and a phase Ib/II could commence in Q1 of 2022.

Blood cancer target

Professor Philip Eaton at Queen Mary University of London has shown that SFX-01 inhibits activity of the non-receptor phosphotyrosine phosphatase, SHP2 (coded by the ptpn11 gene). SHP2 is thought to be a significant factor in some cancers and we have recently agreed to support work in well-renowned university to investigate whether SFX-01 has potential in a specific blood cancer disease.

Multiple newsflow expected from Huw across the pipeline, including Prof Chalmers preliminary efficacy assessment for Covid/ARDS, where positive data will be a complete game changer for all invested, and news on the IND could also be close which could be very well received. Momentum and excitement building in anticipation. Gla ;-)

SIGNIFICANT LANDMARK

An ambition (and a potential significant landmark/catalyst for the business) will be the filing of an investigational new drug application (IND) in the US for SFX-01, though medical indication for the drug hasn’t been decided.

Some nice chunky buys hoovering UP the cheap shares, as usual....back to double figures soon enough imho in anticipation of multiple material newsflow expected from Huw this Q2....looking good and strong!!! Gla ;-)

Maybe an opportune time to report any progress on any oncology target. Gla :-)

AACR ANNUAL MEETING 2021Virtual MeetingWeek 1: April 10-15; Week 2: May 17-21

The AACR Annual Meeting program covers the latest discoveries across the spectrum of cancer research—from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy—and highlights the work of the best minds in research and medicine from institutions all over the world.

https://www.aacr.org/meeting/aacr-annual-meeting-2021/