Evgen Pharma Share Discussion Threads

[timbo003] 29/12/2020 00:17

>>>MM

You state "SFX-01's recruitment unlike the stop Covid trial, is from patients displaying symptoms of Ards and pneumnonia, regardless of testing positive and/or regardless of being hospitalised"

That is incorrect: All patients recruited to the study will be hospitalised.



>>>boker

All we know about timings is what the company has told us, i.e. data from the STAR COVID study could be potentially available in Q4 2021.

I have no reason to doubt that. Have you? It seems to me that you are implying that the company are misleading investors by failing to state that the data will be available earlier (in Q3 or even Q2?).

I do not know how many sites are involved in this early stage of the study, (and nor do any of the other contributers to this thread), although I suspect the number of sites involved at this stage it is one or two (based on my own experience in Clinical trials), but whatever the number, the only hard information we have is that they recruited 9 patients within a period of about two weeks.

As for extrapolating recruitment data, if they continue to recruit approximately 20 patients/month, a straight line extrapolation takes them to May for completing the first 100 patients and June for the BSDM review , the most logical time to ramp up the number of study sites would be in June (assuming the DSDM review gives the green light for futility and safety). This should then lead to a significant increase in recruitment rate and lead up to a reporting date which was entirely consistant with the company's own estimates of Q4.

As for my views on the timings of a BSDM review, we have no definitive information and it will depend on numerous fators, but any time between April and June seems like a reasonable assumption to me.



Anyway, this is now getting repetitive (and of little interest to most investors/potential investors) and the timings will have little consequence on what really matters and that is the outcome of the STAR-COVID study. I have let this debate run (despite the repetition) over the last few days as the markets have been closed.

I now propose to let you and MM have the last word on this and thereafter unless there is new information available on the topic, I will exercise my moderators discretion on repetitive posts made by any black posters.

[moneymunch] 28/12/2020 22:14

Anyone think that SFX-01 will struggle finding its first 100 patients???

Covid-19: Concern at 'unprecedented' infection level in England 28 December 2020 UK


England's "very high" Covid infection level is a "growing concern" as the NHS struggles to cope with rising patient numbers, a health official has said.

On Monday, a record 41,385 Covid cases and 357 deaths were reported in the UK .

NHS England said the number of people being treated for the virus in hospital is now 20,426, which is higher than the previous peak of about 19,000 in April.

Health officials in Wales and Scotland have also said they are at risk of becoming overwhelmed.

Monday's figure for new cases is the highest daily number reported by the UK government, and the first time the daily total has surpassed 40,000.

It is thought the infection rate was much higher during the first peak in April, but testing capacity was too limited to detect the true number.

[moneymunch] 28/12/2020 19:58

Anyways, regardless of the recruitment of SFX-01's first 100 patients, there's a raft of other material news that could drop at anytime that could add significant value, and so I'm expecting plenty of UPside momentum in anticipation in the coming days.....but Buyers beware, if the DSMB don't approve SFX-01 for the next stage of its Covid-19 patient trials, then the share price will drop like a stone initially , although it could bounce fairly well thereafter given the rest of the pipelines potential, and more some on any positive news on the other disease targets, and of course , if the DSMB report positive news and endorse the continuation of SFX 01's Covid-19 patient trial, then share price is likely to multibag from its current bargain low imho...Gla :-)

[moneymunch] 28/12/2020 18:41

Hmmm, definitely sad bocker, where reputation and credibility has to be questioned imho...we're in a World pandemic where doom and gloom prevails and so strange how optimism and positive speculation on the thread where you're heavily invested is continually undermined by those that clearly are averse and perhaps influenced by others in their opinion, to any suggestion of any early good news on SFX-01's Covid-19 patient trials...it looks clear as day to me, that the recruitment of the first 100 patients to SFX-01's Covid-19 patient trials will be rapid now the trial is UP and running and the subsequent assessment thereafter by DSMB will happen far sooner than some might hope. Gl :-)

[bocker01] 28/12/2020 17:33

Yep Money, sad and difficult to believe as it is, one cannot put the consistently dubious underminings down to coincidence! Can’t see the point though. It’s a big world out there and room for all.

[moneymunch] 28/12/2020 16:15

Hi bocker, it does make you wonder, almost seems that those heavily invested in another Covid-19 play, are aghast at the thought of early reporting on SFX'01's patient trials , to the point that they were all proved wrong with the announcement that SFX 01's first 100 patients will be assessed by the DSMB before given the greenlight for the trial to continue to Top line Results, and somewhat incredulous that they even tried to down play the importance of DSMB's assessment to a small cap Bio with a market cap of only £15m....DSBM's approval will be massive news for Evgen, and once again it is perfectly reasonable to speculate positively on the likely numbers to SFX-01's trial so far , given all the information at hand from Prof Chalmers Stop Covid recruitment, much more reasonable than it is to suggest that DSMB assessment will not happen for many months!!!??? Gl :-)

[bocker01] 28/12/2020 15:58

Lol too Timbo, you posted on Christmas Day

“ On possible timings for completing 100 patients: They recruited nine patients in the first two weeks, this corresponds to approximately 20 patients /month, so it would be reasonable to assume that they might have recruited 100 patients by end of April 2021 and completed 100 patients by end of May 2021, the DSMB analysis might take 2 weeks, in which case it would be mid June 2021 when DSMB report.”

I do not think that is reasonable at all!

However right now, 3 days later, you Timbo write, “ Thanks for that, so LifeArc (the paymasters) state up to 6 sites, which suggests to me that they will start with one or two and this may increase to up to six”.

I guess the first extrapolation was erroneously based on just one site for the whole period Timbo? Are you going to revise based on more or do you feel that they will do a go slow just for the hell of it... then risk having a patient shortage in six months time?

I would agree with the initial ramp up theory but two of the few available REAL facts are that Prof Chalmers has patients due to current circs and a demonstrable record of speedy enrolment which falls closer to Money’s estimates than yours Timbo, sadly. A further point is that reading Chalmers pronouncements, he is clearly very diligent, personally involved and anxious to make a difference.

[moneymunch] 28/12/2020 15:26

ps timbo...the 6 sites from Lifearc is dated news....it is 10 sites according to the trial protocal data, and so why on earth would you suggest "that they will start with one or two and this may increase to up to six", on what basis, on what factual evidence???.

[moneymunch] 28/12/2020 15:24

Lol....the date of Q4 2021 is the expected date for Top Line results ie the end of the trial if the trial progresses that far following the DSMB's assessment, and therefore given what we know about the speed of recruitment of Prof Chalmer's Stop Covid Trial and the fact that along with Tayside Trials Clinical Unit and Tayside NHS , they only have two Covid patient trials in progress, then all priorities will now be focussed on SFX-01's recruitment imho , given the very strong likelihood that the Stop Covid trial will have recruited its 300 patients.

SFX-01's recruitment unlike the stop Covid trial, is from patients displaying symptoms of Ards and pneumnonia, regardless of testing positive and/or regardless of being hospitalised and therefore recruitment could be rapid and it's more than reasonable to suggest that the first 100 patients , required for DSBM's assessment could be very close, the Scottish medical leaders today have confirmed the surge in numbers including the expected surge in winter respiratory illnesses, and so SFX-01's 100 patient recruitment and DSBM's assessment could arrive far sooner than you're suggesting, and those intent on deflating near term expectations and positive speculation no doubt might deter investors who might miss out on a significant re-rate at a time when good news could arrive.

The fact that SFX-01's Covid trial wasn't initially included in the UPH priority list, probably explains why the trial didin't start and first patient wasn't recruited until 23/10/20 as opposed to the expected start of July, but now the trial is up and running, then the recruitment will very likely be rapid for the numerous and sound reasons i have highlighted .....Gla holders.....Good news on the Covid trial as well as the rest of the pipeline could drop at anytime which potentially could add significant value.....Tick Tock...;-)

[timbo003] 28/12/2020 14:37

>>>On Target,
Thanks for that, so LifeArc (the paymasters) state up to 6 sites, which suggests to me that they will start with one or two and this may increase to up to six




>>>>mm

You ask:

ps timbo, once again you appear somewhat over keen to downplay any positive speculation on SFX-01's near term prospects, why is that???...


On the contrary, I am positive on the company's prospects. I think given the risk reward ratio they look very undervalued and I have a meaningful amount invested here, however, I believe that investors need to take a realistic view on prospects and timings.

If investors have unrealistic expectations on timings (based on bulletin board speculation) then when those expectations are not met, it is likely to lead to investor disappointment, some of which will be misdirected at the company, rather than those responsible for inflating expectations. No one benefits from that, except (possibly) short term traders.


I'm afraid that that an end of January completion date for a Data and Safety Monitoring Board review on the first 100 completed patients is totally inconsistant with what the company recently announced on December 10th, when they stated that data from the STAR COVID study could be potentially available in Q4 2021. If recruitment were occuring as quickly as you believe, then surely then the data from the completed trial would be available in Q3 or even Q2? So why wouldn't the company refer to that in the statement on Dec 10th?

Investors would be best advised to base there investment decisions on verifiable statements from the company, not uninformed bulletin board speculation by anonymous avatars.

[moneymunch] 28/12/2020 13:23

ps looks like the UoM have been filing patents related to Sulforphane....there is another patent for a nano-particle delivery by UoM which includes a host of drugs and Sulforaphane gets a mention....and so news from Huw on the Solid Tumour could be very close if related. Gla ;-)

Novel application of sulforaphane and pharmaceutical composition containing sulforaphane

Abstract

Embodiments of the invention provide the novel application of sulforaphane to preparation of a TFEB activator and to preparation of a drug for treating and/or preventing lysosomal storage diseases, and a pharmaceutical composition containing the sulforaphane. The embodiments of the invention prove that the sulforaphane can promote biosynthesis of lysosome and improve the activity of the lysosome by activating TFEB, so stored substances in the lysosome are degraded; and since the sulforaphane has the above functions, the sulforaphane can be used for preparing the drug for treating and/or preventing the lysosomal storage disease.

hTtps ://worldwide.espacenet.com/patent/search/family/070206774/publication/CN111012773A?q=university%20of%20michigan%20sulforaphane

[muddy_40] 28/12/2020 13:08

When you listen to the proactive interview. Huw says at about 2 minutes there is a good number of covid cases in the study. That interview was about 2 weeks after 1st patient. So sounds like it is ramping up.

[moneymunch] 28/12/2020 12:47

Yes indeed bocker, a positive DSMB will be a rocket booster for the share price and potentially will add significant value to the rest of the pipeline. The disclosure of the Solid Tumour collaborator offers further upside given how excited Huw is over the pre-clinical data , the best there is.....the following link is Scientific published paper from University of Michigan and dosen't actually detail the STAT3 inhibitor ( Stat3i ) , but so easily could be SFX-01 given the timing and strong similarities of Huw's description and the UoM's....???? Gl ;-)

[moneymunch] 28/12/2020 12:38

ps timbo, once again you appear somewhat over keen to downplay any positive speculation on SFX-01's near term prospects, why is that???....i personally believe that the first 100 patients have been recruited or very nearly, and have provided plenty of good reasons/ solid research on why this is very likely....Gla holders...a potential transformational January ahead on good news from DSMB as well as news on the rest of the pipeline. ;-)

[bocker01] 28/12/2020 12:36

Well Money that's clarified... (numbers of sites) ... again! LOL

Lots of irons in the fire will hopefully lead to lots of newsflow. Only takes one positive bit of news on one iron to ignite interest in everything else and: BOOM!

[moneymunch] 28/12/2020 12:30

ps timbo, you're also forgetting that the supply of SFX-01 by Evgen to Prof Chalmers is little or no cost, and costs will also be kept to a minimum as SFX-01 will be presribed to patients who can administer themselves at home ( 14 day course ) if they don't require hospitalisation or are discharged from hospital before 14 days.....Prof Chalmers and Tayside Clinical Trials Unit are currently conducting 2 Covid patient trials, and the recruitment of the 300 Stop-Covid trial is eveidently complete....all effort and resources now on SFX-01's recruitment....No doubt!!! Gl ;-)

[moneymunch] 28/12/2020 12:20

Lol timbo....Number of Recruitment/study sites = 10....i reckon 100 patients have already been recruited or very close....a positive assessment on the first 100 patients and the green light for the trial to continue from Data Safety and Monitoring Board will be a game changer for Evgen's prospects and will offer transformtional upside on confirmation. Gl ;-)

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

E.8.4.1 Number of sites anticipated in Member State concerned = 10

[on target] 28/12/2020 12:15

LifeArc webpage suggests 6 sites:


10 sites anticipated according to the clinical trials register (link in header):

[bocker01] 28/12/2020 11:40

Yep Money, some extraordinarily pertinent points there! Certainly they will take on the patients for trial whilst they are there. Not just because of uncertainties about numbers later but because ARDS is a huge problem affecting real people right now and Chalmers just doesn’t mess about.

[moneymunch] 28/12/2020 10:47

No shortage of patients by the looks of it...;-(

James D Chalmers Retweeted
RCPEdin
@RCPEdin
·
18h

"Our plea to the public is simple, please do not let your guard down now. You must continue to play your part to protect the NHS and save lives." We have signed this joint statement along with other members of @scotacademy


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

Scottish medical leaders warn of 'perfect storm' facing NHS

27 Dec 2020

The Royal College of Physicians of Edinburgh, along with other members of the Scottish Academy of Medical Royal Colleges and Faculties, have joined together to highlight the importance of controlling the spread of COVID-19 amid concerns the NHS may not be able to cope with a surge in cases.

Calling for increased cross-Government working and efforts from the public to reduce the spread of the virus, the group of medical experts has expressed concern that increased community transmission over the festive period, combined with the spread of the new highly infectious variant of COVID-19 and the normal winter surge in respiratory illness and hospital admissions, may combine to form a ‘perfect storm’ which threatens to overwhelm the health service.

With all of mainland Scotland moving to Level 4 restrictions on Boxing Day, the Scottish Academy, including also including representatives from the Royal College of Anaesthetists, the Royal College of General Practitioners, the Royal College of Physicians and Surgeons of Glasgow, and the Royal College of Surgeons of Edinburgh, have released the following statement:

[moneymunch] 28/12/2020 09:57

Good Morning bocker, judging by Prof Chalmers recruitment performance for his Stop-Covid trial, i reckon the recruitment of the first 100 patients to SFX-01 trial must be near enough complete or very close, given the rising numbers and that the recruitment process is much more straightforward than the Stop-Covid trial because unlike that trial, patients only have to display symptoms of Ards/pneumonia regardless of testing positive or being hospitalised, and so patients could be given their 14 day course of SFX-01 and then sent home early, if their condition improved or wasn't too severe to require hospitalisation, and the rate of recruitment would no doubt increase as hospital staff became familiar with SFX-01's recruitment protocol.

One other important point, is that although SFX-01's patient trials will be carried out at 10 sites across Scotland and the North of England, it is essentially a Scottish trial led by Prof Chalmers from University of Dundee and administered by Tayside Clinical Trials Unit and Tayside NHS, they only have two Covid-19 treatment trials in progress, the Stop-Covid trial and SFX-01's trial, and so the concerns raised by those that claimed SFX-01's recrutiment would be delayed and/or slow because it hadn't been awarded UPH Prioirty, are totally unfounded imho given that Tayside Clinical Trial and Prof Chalmer's resouces and priority will very likely now be focussed on SFX-01 now that the recuitment of the Stop-Covid trial is presumably complete.

From 5th October, it took 17 days for the recruitment of the first 100 patients to Stop-Covid trial, and then 200 were confirmed by 11th November and 250 by 30th November and so no doubt the full 300 have been recruited, and so very likely that all resources and priorites are now focussed on the recruitment of the first 100 patients to SFX-01's trial. Gl Exciting times!!! ;-)

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

Tayside Clinical Trials Unit
@TASC_TCTU
·
Nov 10

UKCRC registered CTUs have played a major part in the response to COVID-19 in the UK. 60% of interventional trials have CTU involvement.

TCTU currently has one in progress and another due to start soon.

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

Tayside Clinical Trials Unit Retweeted
James D Chalmers
@ProfJDChalmers
·
Nov 30

250th patient enrolled to the STOP COVID trial today at @NHSForthValley



Thanks @NHSHighland
@NHSLanarkshire
for enrolling patients today.

Target for study completion is 300 patients. Nearly there!

Amazing effort from teams across the UK. @TASC_TCTU


James D Chalmers
@ProfJDChalmers

· Nov 11

200 patients now enrolled to the @NIHRresearch Urgent Public Health Trial STOP COVID -
Testing a new anti-inflammatory treatment for hospitalized patients with severe COVID-19

Recruiting across the UK. Thanks to all investigators and teams #COVID19

Tayside Clinical Trials Unit Retweeted
TASC Research UK
@TASC_Research
·
Oct 22

100 participants recruited to STOP-COVID19 #clinicaltrial nationally! A huge thank you to all the patients and research teams involved! @ProfJDChalmers
@dundeeuni

Tayside Clinical Trials Unit Retweeted
James D Chalmers
@ProfJDChalmers
·
Oct 5

Thanks to @NHSGrampian

for enrolling their first patient in the @NIHRresearch
urgent public health STOP-COVID study -

Teams across the UK are working incredibly hard to find new ways to treat #COVID19

[bocker01] 27/12/2020 21:46

Yep, Money, more patients around than in the first wave. I would imagine that Prof Chalmers will have no problem in maintaining his staggeringly impressive recruitment rates. Can’t see him doing any kind of deliberate go slow to prolong this one. Nope he’ll recruit the patients as usual - fast while they are there and get this one to the finish line in double quick time! 10 weeks from start Dec is max for the full 300 based on his last trial, STOP-COVID. Yep , a master stroke if it comes off, an ARDS treatment at no cost in double quick time made possible (sadly) only by the current pandemic.

[timbo003] 26/12/2020 17:36

Value Tracker, post #6213 was unprovoked and blatently inaccurate, please desist