Member Info for Moneymunch

A sudden and significant re-rate at anytime to reflect true value of prospects and potential...Momnetum building, excitement building...;-))))

Looking good and strong in anticipation of potential transformational news. Gla ;-)

X 2...:-)

 0

2.2m buy at 12.30p...all bodes well.:-)

End of year according to Dundee university who are conducting the trials. Gl :-)

16/6/20

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

Ps I'm still convinced that a Strategic partner investor is in the pipeline, and the massive share transfers witnessed over the last couple months and obvious share accumulation is in preparation of deal completion, whereby the strategic partner makes the investment and in return receives a significant % share of the business., and perhaps why we're still awaiting news of the new CEO who potentially could be connected to the strategic partner...Gla ;-)

4 x 3.4m buys!!! Gla :-)

Lol, the trial was expected to start this month and so even I'm not expecting any news this early in proceedings .gl :-)

End point trial results are expected end of year, although nces are if SFX-01 is working and a positive therapeutic benefit is observed ( no Coronavirus deaths in Scotland since 12th July ), then it's highly possible they could report early on any positive indications after the 15 day clinical status, as was the recent case with Remdesivir where results were reported early ( that trial is still ongoing and Trump bought the world stock supply on early positive indications ) .Gl ;-)

16/6/20
"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.

Ps and of course since the Final Results, SFX-01 is now in phase 2/3 patient clinical trials for Covid-19, completely funded by Lifearc in collaboration with Dundee university. Gla holders:-)

o Cash balance at 31 March 2020 of GBP4.1m (31 March 2019: GBP2.0m)

Given the funding constraints suffered by small cap drug development companies in the UK, our strategy is to move to a business model where we facilitate multiple clinical trials on SFX-01 in risk-sharing arrangements, with the objective of attracting non-dilutive funding from grants and/or charities to wholly or substantially fund future clinical activity. This strategy has three key components:

(1) Our first priority is to ensure the continued development of the breast cancer programme. We will complete the trial design and cost a clinical trial protocol and then seek non-dilutive funding for Evgen and/or an affiliated clinical institution to sponsor the trial.

(2) In parallel we aim to leverage the extensive pre-clinical and clinical data that shows the potential for SFX-01, as a sulforaphane delivery platform, to be used in diseases that are beyond our capacity to pursue.

(3) In addition, we will pursue opportunities to apply our intellectual property on stabilised sulforaphane to non-pharmaceutical opportunities which offer a more rapid route to market.

We will therefore support a number of proposed Investigator-Initiated Trials - these are trials led by a clinician from a well-renowned institution, with that institution being the sponsor for the trial. Evgen will provide support as required (in the confines of an investigator sponsored study), sharing our knowledge, experience and the methods and laboratories used for pharmacodynamic and pharmacokinetic endpoints. All such trials are subject to grant funding being procured and Evgen will supply clinical centres with SFX-01 and, where appropriate, a placebo.

Evgen will have the right to access the clinical data on fair commercial terms to advance its clinical and commercial development. Since the principal funding for these trials will be obtained by the investigator/ institution they have limited impact on our cash reserves.

https://uk.advfn.com/stock-market/london/evgen-pharma-EVG/share-news/Evgen-Pharma-PLC-Final-Results/82655199

No problem, they have enough working capital until well into next year, and their programmes are developed by non-dilutive funding from their academic and charitable partners and as their pipeline is advanced and ultimately seek partnership JV's for their commercialisation. Gl :-)

It's also worth highlighting that the huge gulf in valuation between Evgen and Reata, was actually highlighted by Evgen's Executive Chairman in the latest Final results. Gla ;-)

There remains a strong rationale for clinically testing SFX-01 in any condition that is mechanistically linked to Nrf2, as evidenced by the recent positive developments at Reata (NASDAQ: RETA). Reata is developing Nrf2 activators based on triterpenoids and with positive top-line results in pivotal trials in Friedriech's Ataxia and Alport Syndrome has a current market capitalisation of circa US$5bn. This illustrates that the fundamentals of Nrf2 activation as a therapeutic strategy are sound and SFX-01 is a potent and well tolerated Nrf2 activator; on this basis we advance with confidence in SFX-01 and believe that the main driver to ultimate success is perseverance.

Given the funding constraints suffered by small cap drug development companies in the UK, our strategy is to move to a business model where we facilitate multiple clinical trials on SFX-01 in risk-sharing arrangements, with the objective of attracting non-dilutive funding from grants and/or charities to wholly or substantially fund future clinical activity. This strategy has three key components:

(1) Our first priority is to ensure the continued development of the breast cancer programme. We will complete the trial design and cost a clinical trial protocol and then seek non-dilutive funding for Evgen and/or an affiliated clinical institution to sponsor the trial.

(2) In parallel we aim to leverage the extensive pre-clinical and clinical data that shows the potential for SFX-01, as a sulforaphane delivery platform, to be used in diseases that are beyond our capacity to pursue.

(3) In addition, we will pursue opportunities to apply our intellectual property on stabilised sulforaphane to non-pharmaceutical opportunities which offer a more rapid route to market.

https://uk.advfn.com/stock-market/lo

Cheers cash, Reata has a market cap of $5.3 Billion and Evgen's is £16m , and so another reason why Reata or similar must be keeping an eye on SFX-01's development. The gulf in valuation is truly staggering, Reata's two lead drugs ( Nrf2 activators) are more clinically advanced , but unlike SFX-01 haven't been confirmed safe ( as per their website overview, and now that SFX-01 is in phase 2/3 Covid-19 patient trials, the gap on Reata's clinical development is rapidly closing. It also appears that SFX-01 could have a wider therapeutic spectrum, as well as the massive potential of the lucrative healthcare supplement market....and so the undoubted upside potential opportunity here is pretty obvious, yet still very much under the radar at the moment. Gl:-)

Reata

Bardoxolone methyl, omaveloxolone, RTA 901 and RTA 1701 are investigational drugs.

Safety and efficacy have not been established by any agency.

Overview

In Alport syndrome (AS), bardoxolone methyl targets molecular pathways that promote the resolution of inflammation, which if unchecked, leads to chronic inflammation, and ultimately, progressive loss of kidney function. Bardoxolone methyl is being studied in Reata’s pivotal, registration, phase 2/3 CARDINAL trial

In Friedreich’s ataxia (FA), omaveloxolone targets the chronic inflammation and mitochondrial dysfunction associated with this neurologic disorder. Omaveloxolone is being studied in the pivotal, registration, MOXIe trial

Reata’s lead drug candidates, bardoxolone methyl and omaveloxolone, have novel mechanisms of action that target the underlying pathogenic pathways involved in chronic inflammation. Research has shown that prolonged mitochondrial dysfunction and oxidative stress, including their molecular components, proinflammatory mediators called cytokines and ROS, are major contributors to chronic inflammation.

https://www.reatapharma.com/our-science/pipeline/

Can activation of NRF2 be a strategy against COVID-19?

Journal - Trends in Pharmacological Sciences

14 Jul 2020

Abstract

Acute respiratory distress syndrome (ARDS) caused by SARS-CoV-2 is largely the result of a dysregulated host response, followed by damage to alveolar cells and lung fibrosis.

Exacerbated pro-inflammatory cytokines release (cytokine storm) and loss of T-lymphocytes (leucopenia) characterize the most aggressive presentation. Here we propose that a multi-faceted anti-inflammatory strategy based on pharmacological activation of nuclear factor erythroid 2 p45-related factor 2 (NRF2), can be deployed against the virus.

The strategy provides robust cytoprotection by restoring the redox and protein homeostasis, promoting resolution of inflammation, and facilitating repair. NRF2 activators such as sulforaphane and bardoxolone methyl are already in clinical trials.

The safety and efficacy information of these modulators in humans, together with their well-documented cytoprotective and anti-inflammatory effects in preclinical models, highlight the potential of this armamentarium for deployment to the battlefield against COVID-19.

https://discovery.dundee.ac.uk/en/publications/can-activation-of-nrf2-be-a-strategy-against-covid-19

Evgen ahead in the game with phase 2/3 Covid-19 patient trials.....One of Reata's Nrf2 activator drugs to be evaluated in phase 2 Covid-19 patient trials. Gla ;-)

https://www.globenewswire.com/news-release/2020/07/28/2068482/0/en/Reata-Announces-Initiation-of-Investigator-Sponsored-Study-Evaluating-Bardoxolone-for-Complications-Associated-with-COVID-19.html

Lol SOYO, you numptie, Do some reseach on EVG's potential and prospects....SFX-01 is already in phase 2/3 patient trials for Covid-19, selected and funded by Lifearc and Dundee Univeristy from over 130 drug application candidates, it's also under clinical evaluation with a host of high profile academic partners, and is being prepared for Phase 2/3 patient trials for Breast Cancer following the outstanding phase 2 trial that was life changing for some patients.....news of a new CEO is imminent, and very chance of an early update from the Covid trials which would send the sp into orbit on positive data ...Gla Holders....potential transformational news stacking UP!!! ;-)

16/6/20

"with patients offered the chance to participate immediately after their diagnosis"

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/

"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.

Coronavirus in Scotland: No Covid-19 deaths for ninth day in a row

25 July 2020

now 11 days in a row.....the SFX-01 effect??? Gla ;-)

Scottish numbers: 27 July 2020

3 new confirmed cases of COVID-19; this is 0.1% of newly tested individuals.
0 new reported death(s) of people who have tested positive (noting that Register Offices are now generally closed at weekends)
2 people were in intensive care last night with confirmed COVID-19.
270 people were in hospital with confirmed COVID-19.
4,315 new tests for COVID-19 that reported results
1 new suspected COVID-19 case in adult care homes on 26 July.

The ex CEO has exercised 4,751,178 share options over the last couple of weeks, and looks like he's got another 1,521,869 to go......watch this space. Gla ;-)

Lol radar, you scoffed at the speculation that SFX-01 could be considered for a potential treatment for Covid-19, and then down played the news that EVG had received funding for SFX-01's Covid-19 patient trials by suggesteing that the Covid-19 vaccine space was packed and there would be multiple cures as a result......ha ha ha....SFX-01 is not a vaccine and is being trialed as a treatment for Covid lung disorders and not a cure, and as far as your conviction that EVG should stick to what they know best is totally ridiculous ....SFX-01 is in evaluation for multiple disease targets and is a potent inducer of Nrf2 and STAT3 signaling pathways which are associated with a myriad of diseases and condiions, from Breast Cancer, (where SFX-01's phase 2 results were outstanding and life changing for some patients ) , to MS , Autism, NASH, Chronic Kidney Disease and many others as well as the anti-inflammatory properties that Evgen believe may have the potential to reduce some of the worst outcomes of COVID-19.

SFX-01 is a potential pancea for multiple disease targets under evaluation by Evgen's collaborative high profile Academic partners , providing multiple opportunities for SFX-01's commercialisation with a Major Pharma/Bio, and of course with SFX-01 already in Covid-19 phase 2/3 patient trials , positive indications would be transformational for all concerned and although full results aren't expected until end of year, early reporting of positive results could be highly likely.

In the meantime, get ready for news on the appointment of Evgen's new CEO along with potential news of progress and commercial JV opportunities, including the non pharma market.

Gla Holders.....potential transformational news stacking UP, on several fronts......coming soon!!! ;-)