Member Info for Moneymunch

 I did get a lot of grief elsewhere and accused of misinformation by the self proclaimed clever b'stards for the reasonable speculation that Evgen could report early interim results on efficacy...but guess what...it looks like Evgen will report early. Gl...On and UP!!! :-)

Early reporting very likely, who would have thought???? Ho ho ho Gla ;-)

In addition to the DSMB safety and futility assessment, Dundee University ("the Sponsor") 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.

Update on patient recruitment

EVGEN PHARMA PLC

Released 07:00:10 17 February 2021

RNS Number : 3128P

Evgen Pharma PLC

17 February 2021

 

            Evgen Pharma plc

 ("Evgen" or the "Company")

 

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 pneumonia.

 

The trial design includes an assessment of safety and futility by a Data Safety and Monitoring Board ("DSMB") who will review unblinded data on the first 100 patients treated. In addition to the DSMB safety and futility assessment, Dundee University ("the Sponsor") 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 the second quarter of calendar 2021.

 

The Sponsor has also requested that the DSMB review data from the first 60 patients solely for safety and this process will be starting shortly. The outcome of this is expected to be available in early Q2 2021.

 

Completion of recruitment to the STAR trial is anticipated at the end of 2021/Q1 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 recruitment progress in this trial and would again like to thank Professor James Chalmers and his colleagues at Dundee for their considerable efforts in a very challenging clinical environment. Randomising over 100 patients is an important milestone in this trial and takes us a step closer to receiving the initial data from the study. We look forward to further updating the market as we progress through this important trial.''

Apologies for 3 duplicate posts....the first two didn't register this morning under SFX-01 and so i posted the third under "will we get support"......obviously a delay or glitch this morning. Gla ;-)

Very intersting that Sareum has noted the UK Governments Covid-19 initiative by RNS this morning. Evgen's Covid/ARDS patient trials are much more advanced which could suggest that the DSMB's assessment on the first 100 patients recruited will be much more detailed, possibly to decide whether SFX-01 is a "ground breaking treatmnet" and warrants Government funding and acceleration, 89 patients recruited by 1st February and so DSMB's assessment should be underway very soon imho.....a potential game changer. Gla ;-)

16/2/21

Sareum's CSO, Dr John Reader, commented:

"We are delighted that the UK government has created the AGILE clinical trial platform and has provided the funding needed to support this exciting and much needed initiative, which may represent a potential route of future funding for the Company. Despite the successful UK vaccination programme, we believe that there is still a clear need for new therapies to treat severe respiratory inflammation arising from viral infections such as Covid-19. Should the Company's current work programme be successful, we will consider this new initiative as a potential source of funding contributing towards advancing SDC-1801 as a potential treatment for Covid-19 patients."

The Company notes that at the recent launch of the AGILE clinical trial platform, Health and Social Care Secretary, Matt Han****, said:

"Today's news will ensure all phases of clinical trials for new treatments are done in the UK, protecting our supply chain and securing the world's best treatments for NHS patients at a much faster rate. I am immensely proud of the work that's been undertaken by the brilliant scientists behind these treatments and the thousands of UK patients who have taken part in the trials. Together, we can continue to ensure the UK is one of the best countries in the world for trialling and deploying the most ground-breaking medical advancements for both COVID-19 and for dangerous diseases in the future."

Very intersting that Sareum has noted the UK Governments Covid-19 initiative by RNS this morning. Evgen's Covid/ARDS patient trials are much more advanced which could suggest that the DSMB's assessment on the first 100 patients recruited will be much more detailed, possibly to decide whether SFX-01 is a "ground breaking treatmnet" and warrants Government funding and acceleration, 89 patients recruited by 1st February and so DSMB's assessment should be underway very soon imho.....a potential game changer. Gla ;-)

16/2/21

Sareum's CSO, Dr John Reader, commented:

"We are delighted that the UK government has created the AGILE clinical trial platform and has provided the funding needed to support this exciting and much needed initiative, which may represent a potential route of future funding for the Company. Despite the successful UK vaccination programme, we believe that there is still a clear need for new therapies to treat severe respiratory inflammation arising from viral infections such as Covid-19. Should the Company's current work programme be successful, we will consider this new initiative as a potential source of funding contributing towards advancing SDC-1801 as a potential treatment for Covid-19 patients."

The Company notes that at the recent launch of the AGILE clinical trial platform, Health and Social Care Secretary, Matt Han****, said:

"Today's news will ensure all phases of clinical trials for new treatments are done in the UK, protecting our supply chain and securing the world's best treatments for NHS patients at a much faster rate. I am immensely proud of the work that's been undertaken by the brilliant scientists behind these treatments and the thousands of UK patients who have taken part in the trials. Together, we can continue to ensure the UK is one of the best countries in the world for trialling and deploying the most ground-breaking medical advancements for both COVID-19 and for dangerous diseases in the future."

Very intersting that Sareum has noted the UK Governments Covid-19 initiative by RNS this morning. Evgen's Covid/ARDS patient trials are much more advanced which could suggest that the DSMB's assessment on the first 100 patients recruited will be much more detailed, possibly to decide whether SFX-01 is a "ground breaking treatmnet" and warrants Government funding and acceleration, 89 patients recruited by 1st February and so DSMB's assessment should be underway very soon imho.....a potential game changer. Gla ;-)

16/2/21

Sareum's CSO, Dr John Reader, commented:

"We are delighted that the UK government has created the AGILE clinical trial platform and has provided the funding needed to support this exciting and much needed initiative, which may represent a potential route of future funding for the Company. Despite the successful UK vaccination programme, we believe that there is still a clear need for new therapies to treat severe respiratory inflammation arising from viral infections such as Covid-19. Should the Company's current work programme be successful, we will consider this new initiative as a potential source of funding contributing towards advancing SDC-1801 as a potential treatment for Covid-19 patients."

The Company notes that at the recent launch of the AGILE clinical trial platform, Health and Social Care Secretary, Matt Han****, said:

"Today's news will ensure all phases of clinical trials for new treatments are done in the UK, protecting our supply chain and securing the world's best treatments for NHS patients at a much faster rate. I am immensely proud of the work that's been undertaken by the brilliant scientists behind these treatments and the thousands of UK patients who have taken part in the trials. Together, we can continue to ensure the UK is one of the best countries in the world for trialling and deploying the most ground-breaking medical advancements for both COVID-19 and for dangerous diseases in the future."

Good luck Mazik, this should go big time with the placing downand dusted 1st week of March, Evgen be fully funded for the foreseeable, c £13mcash in the bank to dramatically accelerate the development of their pipeline, multiple shots on multiple targets, and so plenty of potential news stacking up all of which could drive Evgen's sp to new highs...we should also get disclosure of the major players who have participated in the placing including the new high quality investors that the CEO has already given a warm welcome...Undoubted Transformational upside potential and news on SFX-01 'a Covid-19 ARDS trial expected soon on the assessment of the first 100 patients recruited, the greenlight from the Data Safety Monitoring Board will be a huge endorsement, and if SFX 01 is deemed to be a ground breaking treatment, then this could go into orbit....:-)))

SFX-01...a ground breaking treatment???........Every chance!!! Gla ;-)

13 February 2021

From:

Department of Health and Social Care

Groundbreaking COVID-19 treatments to be fast-tracked through clinical trials

The world’s most innovative treatments for COVID-19 will soon be fast-tracked through the UK’s clinical trial system, as the government announces funding for the most promising treatments.

Government awards multi-million-pound funding to phase 1 clinical trial platform to fast-track innovative treatments
NHS patients could receive cutting-edge COVID-19 treatments in months rather than years
Move will bring in the world’s best researchers to trial treatments in the UK

The move marks a landmark development in COVID-19 research that could see results for brand new treatments in months rather than years, and will enable the government to get even more safe and effective treatments to the NHS rapidly through a more streamlined process.

Currently, the government funds phase 2 and 3 trials, such as the RECOVERY trial, which brought life-saving treatments dexamethasone and tocilizumab to the NHS. Phase 1 trials, usually arranged by the researchers, are the earliest stage of human trials that ensure treatments are safe and show a signal of benefit in treating a disease.

The funding has been awarded to expand the AGILE clinical trial platform and will allow for global innovators to progress cutting-edge treatments for COVID-19 through all 3 clinical trial phases in the UK, further protecting our supply chain. This in turn will attract the brightest of researchers and manufacturers from around the world to trial their medicines here in Britain.

Health and Social Care Secretary Matt Han**** said:

Today’s news will ensure all phases of clinical trials for new treatments are done in the UK, protecting our supply chain and securing the world’s best treatments for NHS patients at a much faster rate.

I am immensely proud of the work that’s been undertaken by the brilliant scientists behind these treatments and the thousands of UK patients who have taken part in the trials.

Together, we can continue to ensure the UK is one of the best countries in the world for trialling and deploying the most groundbreaking medical advancements for both COVID-19 and for dangerous diseases in the future.

The funding has been awarded by the Medical Research Council (MRC) and co-funded though the National Institute for Health Research (NIHR).

https://www.gov.uk/government/news/groundbreaking-covid-19-treatments-to-be-fast-tracked-through-clinical-trials

A great find Nolupus.......let's hope SFX-01 is viewed as a ground breaking treatment as the DSMB makes its assessment on the first 100 patients. Gl ;-)

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Ps if there any other fully funded Bio's out there with the same prospects and potential at 8p a share and £13m quid in the bank , could you please let me know. :-)

  

Given the urgency of finding treatments to alleviate the suffering of the unfortunates, affected by this global pandemic, then i reckon its reasonable to speculate that the data on SFX-01's assessment by the DSMB could be made public if the suggested a significant therapeutic benefit, there have been numerous other trials in the Covid-19 space, that have reported early. Gla holders , Evgen will have c£13m cash in the bank 1st week of March with a market cap of c£20m at 8p a share, with multiple shots on multiple targets, all of which could provide incredible upside on success, and there could be a flurry of positive newsflow across the pipeline in the current weeks ahead, not to mention disclosure of the new high quality investors who are participating in Evgen's placing....and people are waiting for sub 9p and/or determined to drive the sp down to sub 9p....ha ha ha ha....Fill ya Boots!!! Gla Holders ;-)

Abstract

Randomized controlled clinical trials, leading to large-scale meta-analyses, are considered the gold standard for research evaluating new drugs and other therapeutic interventions. To promote scientific integrity and prevent the adoption of potentially fallacious early trends, emerging information is commonly shielded from sponsors, investigators, and other clinical trial actors, including through the use of independent Data and Safety Monitoring Boards (DSMBs). Once established, a DSMB is usually the only body to have access to unblinded information until trial completion or the crossing of pre-specified, and often highly stringent, stopping boundaries. Yet, in certain circumstances, clinical trial actors have legal obligations to trial participants and others to use or disclose emerging information.

Evgen Pharma plc

("Evgen Pharma" or "the Company")

 

Posting of Circular

and

Notice of General Meeting

 

Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces that further to its announcement of the proposed Fundraising on 2 February 2021 (the "Placing Announcement"), a Circular, including the notice of General Meeting, a Form of Proxy and (where applicable) an Open Offer Application Form are today being posted to shareholders. The General Meeting will be held at 10:00 a.m. on 3 March 2021.  In light of the current restrictions in place with respect to the COVID-19 pandemic and, in particular, the UK Government's response (including guidance on working from home in place at the date of this notice), the Company's Board of Directors have concluded that the General Meeting will be held as a closed meeting. The Company will make arrangements such that the legal requirements to hold the General Meeting can be satisfied through the electronic attendance of the minimum number of shareholders, drawn from members of the Board. No other shareholder will be able to attend the General Meeting and are, instead, requested to complete the Form of Proxy, appointing the chairman of the meeting, rather than a third party, as their proxy by the relevant time.  Copies of the Circular and Form of Proxy will be made available on the Company's websitewww.evgen.com.

Lol....you're now sounding ridiculously desperate kingelf, jog on mate. :-)

Ps nothing wrong with the recruitment process, 89 patients recruited as of the 1st February, a rapid increase from the previous update, equating to c50 a month, which suggests the first 100 have now been recruited and the assessment by the Data and Safety Monitoring Board will starting very soon....timbo from Advfn reckons the process should take a couple of weeks and Huw has stated that he will update the market on the progress of the trial and if its working , and so the greenlight will be a huge endorsement and Transformational for all concerned, and no doubt the very reason why the £10m placing has been over subscribed, including new high profile investors.....a very exciting and potential game changer period ahead. Gla holders:-)

Looking forward to DSMB's assessment on the first 100 patients recruited to SFX-01's Covid/ARDS trial and Huw's interim update , as well as disclosure of the new "high quality " investors now on board. Gla holders..potential transformational upside ahead!!! :-)

"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."

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."

Major players such as the following who have declared their hand early and only fot £175k.....which other Major players have had the other £9.25m???? Looking forward to disclosure throughout March....could be very interesting especially if the likes of Jim Mellon has grabbed a few. Gla holders ;-)

Ps the 1.3m sell earlier, is priced at a buy at 10p when the sp bounced back up...)

Ps nlondon....it's snowed for 3 days and its bloody freezing, although the snow hasn't settled that much...off to Bushey Park soon to watch a potential future Olympian....On and UP!!! :-)

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IN BRIEF: Intuitive Investments Buys Shares in Evgen For GBP175,000

Wed, 3rd Feb 2021 11:49

Intuitive Investments

 Group PLC - closed-end investment company focused on life sciences sector - Acquires 2.2 million shares in Liverpool-based clinical stage drug development company Evgen Pharma PLC for 8 pence each, or GBP175,000 in total.

Acquisition was part of Evgen Pharma raising GBP10 million through an oversubscribed placing of 125 million shares at 8p each, the proceeds of which went towards "preclinical work for metastatic breast cancer, glioma and a further cancer indication yet to be announced" as well as as possible clinical trial in glioma patients.

This is Intuitive's fourth investment following its initial public offering in mid-December.

The Major players participating in the placing must also have confidence in a succesful conclusion imho, and allows them to take a significant position prior to any good news that might be delivered. Gla Holders.....Exciting times , with near term newsflow on multiple targets that could add significant value, stacking UP!!!! ;-)

Abstract and Figures

The effect of sulforaphane on nuclear factor erythroid 2-related factor 2 (Nrf2) and its protective mechanism for lung injury in rabbits with acute respiratory distress syndrome (ARDS) were investigated. Thirty rabbits were randomly divided into control (n=10), model (n=10) and experimental groups (n=10). Rabbits in model group and experimental group were treated with femoral venous injection of oleic acid to establish the ARDS model, while those in control group were injected with the same volume of normal saline. The experimental group received intravenous injection of sulforaphane. Twelve hours after modeling, the clinical manifestations and deaths of rabbits in each group were recorded and compared, including blood gas indexes, lung index (LI), alveolar damage coefficient, serum Nrf2 expression, as well as messenger ribonucleic acid (mRNA) and protein expression of Nrf2 in lung tissues. Pink frothy sputum and death were observed in rabbits in model group and experimental group, but the number of such cases in experimental group was smaller than that in the model group (p<0.05). Compared with those in control group, LI and IQA in model group and experimental group were increased, but LI and IQA in the experimental group were significantly decreased compared with those in the model group. Compared with those in the model group, the blood gas indexes (PaO2, PaCO2 and SaO2) in the experimental group were significantly increased (p<0.05). Nrf2 in serum and lung tissues of rabbits in experimental group was significantly increased compared with that in model group (p<0.05). Sulforaphane significantly inhibits ARDS in rabbits and plays a protective role in ARDS through upregulating Nrf2.

https://www.researchgate.net/publication/324237365_Protective_mechanism_of_sulforaphane_in_Nrf2_and_anti-lung_injury_in_ARDS_rabbits

Abstract

Inflammation is an essential part for the general or innate immune defenses to defend against tissue damage and accelerate the curing process by providing protection against pathogens. Sulforaphane (SFN) is a natural isothiocyanate that has potential properties against inflammation, along with other protective functions. The purpose of this study was to examine the mechanism of its protective effect on lipopolysaccharide (LPS)-induced inflammation in Raw 264.7 macrophages. Here, we compared LPS-challenged macrophages with or without SFN pretreatment. Macrophages were pre-incubated for 6 h with a wide range of concentrations of SFN (0 to 50 µM), and then treated with LPS for 24 h. Nitric oxide (NO) concentration and gene expression of different inflammatory mediators, i.e., interleukin (IL)-6, tumor necrosis factor (TNF)-a, and IL-1ß, were measured. SFN neither directly reacted with cytokines, nor with NO. To understand the mechanisms, we performed analyses of the expression of regulatory enzyme inducible nitic oxide synthase (iNOS), the transcription factor NF-E2-related factor 2 (Nrf2), and its enzyme heme-oxygenase (HO)-1. Our results revealed that LPS increased significantly the expression of inflammatory cytokines and concentration of NO in non-treated cells. SFN was able to prevent the expression of NO and cytokines through regulating inflammatory enzyme iNOS and activation of Nrf2/HO-1 signal transduction pathway.

https://www.mdpi.com/2076-3921/8/12/577/htm