Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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Conflicts of interests!!!???? ;-)
James D Chalmers
@ProfJDChalmers
·
5h
Looking forward to speaking with experts on public health, education, social sciences, politics and others tonight
Escaping to a post-COVID world (sounds good right?)
10:19 am · 17 Apr 2021·Twitter Web App
James D Chalmers
@ProfJDChalmers
Researchers: we used (insert incredibly complex dataset) to test (complex hypothesis) using machine learning and (complex statistics).
Also Researchers: Sorry we didn't declare our conflicts of interests, those forms are really complicated
https://twitter.com/ProfJDChalmers/status/1383349366912524292
Hi Kenneth, interesting that you are now an investor here.
Did SFX-01 help your father? Did he complete the trial?
Ps 102 patients recruited to SFX-01 Covid/ARDS trial as of 16th February 2021....14 days dosing and then 28 days observation takes the first 100 trial patients to the end of March and the likely start of Prof Chalmers preliminary efficacy assessment although some of the exploratory objectives could have been ongoing since the start of the trial, blood and cell analysis etc.....Gla ;-)
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
hTtps://star-covid19.com/
The accumulation of cheap shares continues!!! Gla holders...Prof chalmers preliminary efficacy assessment imminent imho..:-)))
17th February 2021
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 pneumoni
11th March 2021
Update on Data Safety Review for STAR COVID-19 trial
Review of Patient Safety and Data Quality confirms no concerns with trial
Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces that after a review of the first 60 patients enrolled, the Data Safety Monitoring Committee ("DMC") for the STAR COVID-19 ("SFX-01 Treatment for Acute Respiratory infections") trial has concluded that there are no concerns regarding patient safety or data quality that would prevent continuation of the trial.
The Phase II/III trial is a double blind, randomised, placebo-controlled study of the Company's lead asset, SFX-01, in patients with acute respiratory distress syndrome ("ARDS"). The trial is co-sponsored by the University of Dundee and NHS Tayside 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 in patients with suspected COVID-19. Patients may be included in the study if they are infected with SARS-CoV-2 or other respiratory infections causing community-acquired pneumonia.
Following this positive step, the next event in the trial involves an assessment of safety and futility by the DMC of unblinded data on the first 100 patients treated. In addition to the DMC safety and futility assessment, Dundee University 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 Q2 of the calendar year 2021.
Completion of recruitment to the STAR trial is anticipated at the end of 2021/early 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 conclusion of the data monitoring committee with regard to safety and data quality in the STAR COVID 19 study. The former conclusion reinforces what we know about the positive safety and tolerability of SFX-01 from previous studies and the latter is yet another testament to the excellent work carried out by Professor James Chalmers and his colleagues at Dundee under challenging circumstances."
I’m a new investor here, have we had final patient dosed per the 100 clinical trial as of yet? If not we could be 2 months away before and data from this trial?