Member Info for Moneymunch

Targeting STAT3

SFX-01 is inspired by a natural compound which is found in cruciferous vegetables such as rocket, broccoli and kale.

In a recent clinical trial, called STEM, it was found to delay the disease getting worse in women with secondary breast cancer whose disease had already developed resistance to hormone therapy. In the trial, 25% of participants benefitted from the addition of SFX-01 to hormone therapy, but the reason this worked wasn’t known until now.

In this new research, the team found that SFX-01 blocks an important chain of reactions, called the STAT3 signalling pathway, in breast cancer cells. As a result, it reduced the ability of breast cancer cells to form tumours in mice.

The detailed understanding of how this drug works will now allow researchers to find when it’s most effective. They hope that in future it could be added to hormone therapies from the outset of treatment to increase their effectiveness in women with primary breast cancer.

Co-author Dr Bruno Simões, Research Fellow at the University of Manchester, further explained their findings:

‘We are excited by our findings that combining standard hormone therapies with SFX-01 could improve treatment of some breast cancer patients by reversing resistance driven by the STAT3 signalling pathway.’

Simon added: ‘This important discovery reveals exactly how SFX-01 can help overcome hormone therapy resistance. We hope it could now open the door to it being used from the outset of treatment, to prevent resistance from developing in the first place.’
Fine-tuning the results

Using these findings, the researchers’ next steps are to understand why some people’s tumours are more sensitive to SFX-01. They also want to know if looking at the activity of the STAT3 signalling pathway could provide a new test to determine who would benefit the most from the new drug.

‘With the success of the recent clinical trial in secondary breast cancer, we hope that further studies will now help to identify which patients may benefit the most from this drug so that it could soon reach the clinic,’ said Bruno.

Simon added: ‘We look forward to results of further trials to fully understand who is likely to benefit most and at what stage of treatment it should be added to hormone therapy to give patients the best chance of survival.’

This study was presented at the UKIBCS.

https://breastcancernow.org/about-us/news-personal-stories/novel-drug-inspired-cruciferous-vegetables-could-reverse-drug-resistance-in-oestrogen-receptor-positive-breast-cancer

Major problem

Scientists from the Universities of Michigan, Liverpool and Edinburgh were closely involved in the study led by Dr Bruno Simões and Professor Rob Clarke from The University of Manchester

Dr Simões said: “Resistance to anti-oestrogen therapies in breast cancer patients is a major problem and one which cancer scientists have been trying to address for many years. Many drugs have been investigated by scientists as a possible combination therapy taken with anti-oestrogen therapies and we are still searching for a solution for these patients.

“However, most of these drugs target actively dividing cells whereas we are trying to also target cells that are in a dormant state. So we hope that these women who have increased numbers of cancer stem cells and do not respond to currents treatment could one day benefit from combination therapy.

“There’s a very long way to go before we can say if this approach will help these women but we are excited by our findings.”

The study is published in the journal Stem Cell Reports.

Justin Stebbing, professor of cancer medicine and medical oncology at Imperial College London, said: “Stem cells represent a very important target to understand better and eradicate, because they are responsible for some of the most worrying aspects of cancer, such as its ability to regrow, or be resistant to treatment. They are also a rare population but this laboratory research shows that cancer stem cells have on their surface a protein that we have a drug for – interestingly one that is being trialled in Covid-19 too.

“Hopefully, we can in the future link this laboratory work to research in women in the clinic, helping to reduce recurrence rates by eradicating rare stem cell populations that contribute to recurrence.”

https://inews.co.uk/news/health/breast-cancer-drug-target-manchester-university-scientists-563735

"They are also a rare population but this laboratory research shows that cancer stem cells have on their surface a protein that we have a drug for – interestingly one that is being trialled in Covid-19 too."

Drug target for aggressive breast cancer found by team of UK and US scientists
Researchers said their work could eventually lead to combination drug therapies on previously untreatable forms of the disease
July 27, 2020

A team of British and American scientists have discovered a way to slow the growth of breast cancer stem cells in the lab, which could eventually lead to combination drug therapies on previously untreatable forms of the disease.

Around three quarters of women who have breast cancer have what are known as oestrogen receptor positive tumours. Some breast cancer cells have receptors that bind to the hormone oestrogen and depend on it to grow. Though anti-oestrogen drugs such as tamoxifen and fulvestrant are able to prevent reoccurrence in most of these breast cancers, tumours reoccur in 1 out of 4 cases.

Many of the women relapse after several years, because some of the cancer cells remain after treatment. The cells, called cancer stem cells, lay dormant in the body and cannot be targeted by anti-oestrogen therapies.

Scientists have now found that cancer stem cells resistant to anti-oestrogen drugs express an immune system-related receptor, called interleukin 1 receptor. They also found that Anakinra, a drug used to treat rheumatoid arthritis, was able to reduce the ability of the cancer stem cells to grow.

However, the team said further research in animals and humans is needed before they can confirm if drugs targeting interleukin 1 receptor could be used as an effective treatment.

For any newbies...Gl ;-)

The following reasearch paper was released November 2019 by the highly prestigous University of Rochester in New York, and 3 months later they signed a MoU with Evgen to undertake a clinical trial on SFX-01 in patients with CKD and strongly illustrates the high regard that the industry has for SFX-01's potential over multiple disease targets.....Development news could drop at anytime, on another potential transformational blockbuster. Gla ;-)

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

GSTM1 Deletion Exaggerates Kidney Injury in Experimental Mouse Models and Confers the Protective Effect of Cruciferous Vegetables in Mice and Humans

November 2019

Significance Statement

GSTM1 encodes a member of a superfamily of antioxidant enzymes, and a highly prevalent GSTM1 deletion variant is associated with kidney disease progression in two human study cohorts. In this study, the authors demonstrate that Gstm1 knockout mice exhibit increased oxidative stress, kidney injury, and inflammation in models of CKD and hypertension, and that Gstm1 loss in the parenchyma but not in bone marrow–derived cells drives renal inflammation. Importantly, consumption of broccoli powder or cruciferous vegetables was protective against kidney disease only in Gstm1 knockout mice, and was observed mainly in the human participants in the Atherosclerosis Risk in Communities Study who were homozygous for GSTM1 deletion. These findings suggest that targeting antioxidant therapy specifically in individuals carrying the GSTM1 deletion variant may be effective in delaying kidney disease progression.

https://jasn.asnjournals.org/content/31/1/102.abstract

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

Evgen Pharma PLC University of Rochester Collaboration

13/02/2020

Professor Le and colleagues have previously published research showing an association between CKD patients with the GSTM1 null allele and more rapid CKD progression, and also that consumption of cruciferous vegetables (a source of sulforaphane) is associated with lower risks of kidney failure, with stronger effects in those having the GSTM1 null allele. On this basis, Professor Le approached Evgen, the developer of SFX-01, a stable form of sulforaphane that has demonstrated excellent safety and tolerability in previous clinical trials.

Thu Le, Professor of Medicine, and Chief of the Division of Nephrology at the University of Rochester Medical Center said: "We are pleased that Evgen will support our plans to undertake a clinical trial on SFX-01 in patients with CKD. Increased oxidative stress is a major molecular underpinning of CKD progression and our research suggests that patients with the GSTM1 null allele may particularly benefit from sulforaphane treatment via SFX-01 dosing."

https://uk.advfn.com/stock-market/london/evgen-pharma-EVG/share-news/Evgen-Pharma-PLC-University-of-Rochester-Collabora/81743058

https://twitter.com/search?q=sulforaphane&src=typed_query

hTtps://twitter.com/search?q=sulforaphane&src=typed_query

Presumably, the 6 trial sites across Scotland ( and North of England ) must cover all of Scotland's hospitals that focus on Covid-19 and admit Covid patients, and so has SFX-01 already been made available to patients diagnosed during the month of July when the patient trials were expected to start and new Covid patients were going to be offered immediately on diagnosis.....??? Gla ;-)
" with patients offered the chance to participate immediately after their diagnosis"

"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."

16/6/20

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/

 0 0

No new coronavirus deaths in Scotland for 15th day but 30 new cases

31/7/20

The number of those testing positive for the virus is now 18, 627.

There were no new deaths overnight in Scotland from coronavirus, however 30 new positive cases have been announced.

The Scottish Government released figures revealing the number of cases has increased by 30 in the last 24 hours - the largest increase in recent days.
And the number of patients getting treatment for confirmed or suspected cases of the virus in hospital is 255 - with four currently in intensive care an increase of two since yesterday.

......

Yet prior to 16th June's announcement that SFX-01 trials were expected to start July, Scotland had one of worst records in Europe...just a coincidence or something incredible!!!??? :-)

friday july 31 2020

CORONAVIRUS

Coronavirus in Scotland: Country third worst in Europe for excess deaths in pandemic

Scotland came behind only England and Spain for excess deaths in Europe

Friday July 31 2020, 5.00pm, The Times

Scotland had the third highest level of excess deaths in Europe for the first half of this year, according to the UK’s first official international comparison of mortality rates.

The country came behind only England and Spain in research by the Office for National Statistics, which compared similar statistics in different countries to measure the impact of the coronavirus pandemic.

Cheers Oranoilio, looks like the share accumulation is in full flow....Gl ;-)

ps has anyone got access to FinnCap's reseach portal, as they've got a Sector note on Evgen dated 28/7/20??? ;-)

https://researchlibrary.finncap.com/Public/Details/Evgen%20Pharma

Every chance of a surge in sp by close, back to 15p as witnessed yesterday, in anticipation of potential transformational news this coming week.....in the meantime it looks like any sells by those happy to give up their shares cheaply are being mopped up. Gla ;-)

As fas as valuation is concerned, It's also worth noting the huge gulf in valuation between Evgen and Reata, which was actually highlighted by Evgen's Executive Chairman in the latest Final results.

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 given that as well as its Nrf2 pathway activation , SFX-01 also an inducer of the STAT3 signalling pathway associated with cancer and several other disease targets.

15/6/20 Final Results

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.

James D Chalmers
@ProfJDChalmers
·
Jul 29
Roche announces no benefit of Tocilizumab (Anti-IL-6) in treatment of COVID-19 pneumonia.
Other trials also looking at this so may not be the last word, but suggests IL-6 may be a marker but not a "maker" in terms of pathophysiology of #COVID-19 severity

A little taster of what's to come. .........potential transformational news stacking UP, on several fronts...Gla ;-)

Not for a while Muntainman, but they still have plenty time to close a deal for RTO....Gl ;-)

Cheers mrshoubs, and all the very best, i didn't mention the low amount of share in issue, the majority now held tightly and in very safe hands , although i did post the following which gives an idication. Gl ;-)

Looks that way and still cheap as chips for SFX-01's panacea potential. .....£1 a share would only equate to a market cap of £136m.......a drop in the ocean, if SFX-01 was confirmed a therapeutic benefit for the treatment of Covid-19 ...Gl ;-)

16/7/20

Next steps and summary

Focus on the strong efficacy data in breast cancer by planning and executing a Phase IIb trial

PhaseII/III trial in ARDS patients commencing shortly - COVID-19

Reduce risk and increase probability ofsuccess by expanding breadth of clinical programmes:

Grant-funded, investigator-led clinical trials (no/smallcost to Evgen)

Inindications with a strong mechanistic rationale (four collaborations announced todate in non-cancer indications)

Seek commercial partnerships based on PhaseII results

Continue to explore other opportunities to monetise our IP assets

CEO recruitment process well-advanced

http://evgen.com/wp-content/uploads/2020/07/EVG-AGM-presentation-2020-16Jul20.pdf

Looks that way and still cheap as chips for SFX-01's panacea potential. .....£1 a share would only equate to a market cap of £136m.......a drop in the ocean, if SFX-01 was confirmed a therapeutic benefit for the treatment of Covid-19 ...Gl ;-)

A new high in sp for 2020 on the cards by close imho....Gla ;-)

ps radar, don't you just love it....ha ha ha ha , ho ho ho ;-)))

If SFX-01 was confirmed a therapuetic benefit for the treatment of some of the worst outcomes of COVID-19 , then this would literally go into orbit...£1 a share, £2 a share...even £5 a share would only equate to a market cap of £680m....which would still look cheap on the World stage for a confirmed treatment for Covid-19 at all stages of the condition...Fill Ya Boots... imho!!! ;-)

SFX-01 is in clinical 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 coming days and weeks.

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......On and UP!!! ;-)