Evgen Pharma Share Discussion Threads

[moneymunch] 29/11/2020 08:36

Reports

Whilst the overarching structure of the STAR-COVID19 is made up of phases and steps, the system also contains a number of REPORTS.

Reports are used to capture data that is recorded across various trial visits. For example, reports are used to record AEs, concomitant medications, vital signs and bloods.

Reports can also be used to record unscheduled events like the unscheduled assessment in the event of an AE or the discontinuation of trial medication form.

The majority of the reports featured on the STAR-COVID19 eCRF have been embedded into the trial phases and steps.

This means that you will be able to easily add reports as you complete the trial visit for a participant.

Below is an example of how to complete a VITAL SIGNS report for a trial visit.

Click on the appropriate step “Clinical Assessments” and then “Add measurement” button. The page will automatically redirect to the newly created vital signs report, as shown below.

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


Additional reports for positive SARS-CoV-2 tests

At each of the Day visits, within the step ‘Clinical Status’, there is a section which allows to add reports for any additional SARS-CoV-2 tests done.

It is important to note that only positive test results need to be added to this report.

All additional test results done during any of the phases will be visible in the reports table.

Visibility of individual reports

Any ConMeds or AEs reports added during the study will be visible at any of the Steps where the ConMeds and AEs reports are present.

Each of the reports can be edited at any time by selecting the individual report from the table. For e.g. a ConMed/AE report added during Phase-Day 3 will be visible at all other phases Day 5, Day 8, Day 11, Day 15 and Day 29.

Similarly, the ‘Date of Discharge’ reports table is also set up to show all reports added during any phase. However, this is not the case for Blood Results reports.



There are separate reports for each of the individual Phases Baseline, Day 3 and Day 15. A Blood results report added during one phase will not be visible at any otherphase.

[moneymunch] 29/11/2020 08:28

Background to the Trial 1

STAR-COVID 19 TRIAL

TRAINING BACKGROUND AND OVERVIEW

Community-acquired pneumonia is a leading cause of morbidity and mortality in the UK

There have been no new therapies for managing pneumonia since advent of antibiotics in 1950s

The global pandemic caused by novel coronavirus SARS-CoV-2, has highlighted the need for new drugs to treat pneumonia

Development of anti-inflammatory therapies that prevent late stage complications is needed

Such therapies are likely to be efficacious for a range of acute respiratory infections, including COVID-19

Patients with pneumonia and suspectedCOVID-19 are eligible for this trial. Patients do not require a positive COVID-19 test to be eligible

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

Background to the Trial 2


The nuclear factor-erythroid 2 p45-related factor 2 (Nrf2) is part of the human natural defence against inflammatory and oxidative stress such as the inflammation that occurs during a severe viral infection

In animal studies, pharmacological activation of Nrf2 reduces the severity of acute respiratory distress syndrome (ARDS)

SFX-01(stabilised sulforaphane), a drug developed by EvgenPharma, is an activator of Nrf2

SFX-01 has been tested in over 130 subjects in clinical trials and is well tolerated with main side effects being GI related and ameliorated by taking after food

In this study one 300mg capsule of SFX-01 is taken orally per day for 14 days

This is the first study of the effect of SFX-01 in humans with acute respiratory infections at risk of developing ARDS

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

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

[timbo003] 29/11/2020 08:10

Folks, can we give the subject on whether or not there will be an interim analysis of the data in the current preumonia trial a rest please. In the absence on hearing directly from the invistegator or the company it is a totally pointless. No one knows, there is no point speculating. We have heard the arguments for and against now ad nauseum, so unless someone obtains new relevant information from the investegator, we should just park the issue for now.

[bocker01] 28/11/2020 23:06

Yep looking forward to it!

Let’s not forget our new CEO has the contacts to make things happen on every front!

[bocker01] 28/11/2020 22:22

Haven’t looked at the Profs website yet Money but great stuff. And great info...

[moneymunch] 28/11/2020 22:19

Professor of philosophy Peter Achinstein’s new book, Speculation: Within and About Science, is a powerful intervention in this timely debate. Scientists must speculate, says Achinstein. 

[moneymunch] 28/11/2020 22:14

Real Scientists speculate , otherwise they're made redundant for standing still. Gl :-)

[moneymunch] 28/11/2020 22:11

" Each participant will take either one SFX-01 capsule or one placebo capsule every day for 14 days."

One could reasonably assume that they might have a very good idea if the drug is working before they progress to phase 3 stage...Gla :-)

[moneymunch] 28/11/2020 21:54

The website for the STAR-COVID trial is now live -  UK Clinical trial testing a novel anti-inflammatory treatment for COVID19. Supported by

[moneymunch] 28/11/2020 21:48

and for the avoidance of doubt....the man who know's it all....Unbelievable!!! Ha ha ha ;-)

Ps better get on the phone to Prof Chalmers and tell him not to bother...:-)

Nobbygnome

19 Sep '20 - 09:00 - 3773 of 5870

0  0 1

>> MM

I haven't laughed so much for ages. SFX-01 a competitor for SNG001? That is such a completely ridiculous statement. I will put my head above the parapet and say that IMHO SFX-01 will never be approved for use in Covid 19 patients.

Meanwhile SNG001 easily has the best data in Covid 19 patients from a placebo controlled trial......

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

Nobbygnome

19 Sep '20 - 09:26 - 3777 of 5870

0  0 0

And I know it is hard for you to accept but my long experience in the industry means that I probably would know as much as Prof Chalmers and could hold my own in any debate with him!

[moneymunch] 28/11/2020 21:30

Home

Trial title: SFX-01 Treatment for Acute Respiratory Infections (STAR-Covid19)

COVID-19 is the illness caused by a new strain of coronavirus first identified in Wuhan city, China. It can cause a cough and/or a fever/high temperature. Generally, coronavirus can cause more severe symptoms in people with weakened immune systems, older people and those with long term conditions such as diabetes, cancer and chronic lung disease.

COVID-19 can affect the lungs and airways and cause difficulty breathing. There are no drugs at the moment which we know will definitely help people with COVID-19. Research is needed for therapies that will improve symptoms and survival of patients with COVID-19.

Professor James Chalmers and colleagues are running the STAR-COVID19 trial to see if a new drug, SFX-01, can help people with pneumonia or COVID-19. We think that SFX-01 may help people with pneumonia by reducing the amount of inflammation and damage in their lungs.

The trial is being Sponsored by the University of Dundee & NHS Tayside and is being managed by Tayside Clinical Trials Unit.

[moneymunch] 28/11/2020 21:27

James D Chalmers

@ProfJDChalmers

·

11m

The website for the STAR-COVID trial is now live - A UK Clinical trial testing a novel anti-inflammatory treatment for COVID19. Supported by

@TASC_TCTU

@dundeeuni

@EvgenPharma

Funded by Lifearc-

SFX-01 - LifeArc

lifearc.org

3

4

James D Chalmers

@ProfJDChalmers

·

20m

We are looking for a research technician to join our team at

@dundeeuni

@UoDMedicine

to work on COVID-19 clinical trials. Come and work with an awesome team

@MereteLong

@KeirHolly

@Shoemelia

@GiamAshley

and help find new treatments for #COVID19

[moneymunch] 28/11/2020 21:07

Lol...imho...you need to read everything that is posted mate....punters should be allowed to speculate on their investment on the the thread that they're invested in a reasonable manner...which is exactly what I do , backed up by solid research from industry and academia , and very often with information that is from the academics who are involved in the evaluation of SFX-01 in their disease target research...and i do not highlight EVG's anywhere else...but you appear happy with a bloke that's spent most of his time promoting another stock at the expense of EVG, the very same bloke who gets incensed at any speculation that might undermine the stock he's boasted about and the profit made, and freely admits ( ha ha ha ) that he sold out on the drop back to £2.....which now sits at sub 90p....and also is on record that SFX-01 stands no chance of being approved for a treatment for Covid-19...Hello....is there anybody in there??? ;-))))

[nobbygnome] 28/11/2020 21:01

There is no dose selection in this trial......which is why there is no separate phase II part!

[prharry] 28/11/2020 20:51

Money, I appreciate your enthusiasm and to be honest your initial posts were why I lumped in on EVG. But your obsession with thinking others are trying to belittle the stock is completely unfounded Please stop thinking people are against you. Everyone here wants EVG to do well, we are all invested.
You keep bringing us SNG, you are taking things personally and you are badmouthing other investors. Please just post facts or RNS or at least say ‘in my opinion’ and finally please stop thinking other members are against you. It’s boring and also unhealthy

[moneymunch] 28/11/2020 19:47

Lol...Dennis wants to join a desperate EVG thread run by a bloke who rates SFX-01's chances for Covid-19 at Zero....ha ha ha ...Unbelievable!!! :-)

Ps Dennis , I've already voted yes, and so with the other usernames used, he must have enough for a 5 a side with you in goal.;-)

[moneymunch] 28/11/2020 18:56

A review of phase 2-3 clinical trial designs


Abstract

This article reviews phase 2-3 clinical trial designs, including their genesis and the potential role of such designs in treatment evaluation. The paper begins with a discussion of the many scientific flaws in the conventional phase 2 --> phase 3 treatment evaluation process that motivate phase 2-3 designs. This is followed by descriptions of some particular phase 2-3 designs that have been proposed, including two-stage designs to evaluate one experimental treatment, a design that accommodates both frontline and salvage therapy in oncology, two-stage select-and-test designs that evaluate several experimental treatments, dose-ranging designs, and a seamless phase 2-3 design based on both early response-toxicity outcomes and later event times. A general conclusion is that, in many circumstances, a properly designed phase 2-3 trial utilizes resources much more efficiently and provides much more reliable inferences than conventional methods.

[moneymunch] 28/11/2020 18:46

Phase 2/3 trial design.... Gla :-)


Seamless Design Vs. Adaptive Seamless Design

A seamless design combines two separate trials (individual Phase 2 and Phase 3 trials) into one trial. This type of design is called operationally seamless.

An adaptive seamless design makes use of information (data) from patients enrolled before and after adaptation (pulls together data collected in both the Phase 2 and Phase 3 trials) in the final analysis. Thus, an adaptive seamless design is inferentially seamless.

The primary purpose of using the adaptive seamless design is to combine both the dose selection and confirmation phases into one trial, so information from the learning stage (Phase 2) can be combined with the confirmatory analyses of Phase 3.

Adaptive Seamless Design Can Reduce Time And Costs

Since we can combine Phase 2 and Phase 3 data in an adaptive seamless design, we can use data from the Phase 2 trial to inform Phase 3. This is the Bayesian way of thinking. Combining the information allows us to:

More efficiently use patient data to infer strong conclusions

Reduce the number of patients who must be enrolled at Phase 3, thus saving time and money

Improve selection of target doses and participants in Phase 3

Investigate possible covariates between short-term endpoints derived from Phase 2 and long-term clinical outcomes in Phase 3

Continue to follow patients on terminated treatment groups from Phase 2 throughout Phase 3, providing more information on time effects of treatment as well as safety

Change or cut treatments during the study, resulting in patients having a greater chance of receiving safe and efficacious treatment.

[dennisbergkamp] 28/11/2020 18:46

Nobby, I'll join a separate thread on evg.

D

[moneymunch] 28/11/2020 10:29

jeez..i haven't claimed anything....i've speculated that there is every chance they could report early....every other treatment/vaccine have all reported early...and what milestones do you think EVG will be reporting on during the trial....Pray tell...;-)