Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
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A recent example of early reporting from a Covid-19 patient trial. Gla ;-)
Although the study is still ongoing, an independent data and safety monitoring board overseeing the trial reviewed the data and shared their preliminary analysis with NIAID. Due to the public health implications, NIAID made these primary results public, and they were published on May 22, 2020, in the New England Journal of Medicine.
https://www.nih.gov/news-events/nih-research-matters/early-results-show-benefit-remdesivir-covid-19
SNG announce phase II trial and their market cap is straight up over £50m. EVG announce a phase II/III trial and their market cap barely moves. EVG could even overtake SNG with an accelerated phase II/III combined trial. Confirmation that SFX-01 has passed phase II and is in phase III and the difference in market cap between SNG and EVG will close rapidly.
The end date for SFX-01's Covid-19 patient trials comes from Prof Chalmers research website, and so as well as early reporting being very likely form the Phase 2 stage of the trial, then given the nature of the Respiratory infections, Pneumonia, ARDS etc then it's highly plausible that a much earlier conclusion for Phase 3 stage could be reached....the investigators will know very quickly from data compared and computed from those administered SFX-01 and those on the placebo, given the 15 day treatment and 29 day evaluation, if SFX-01 is having a positive effect...or not.....all eyes on Evgen soon enough....this is going to go BIG time imho....Gla Holders . ;-)
A randomized controlled trial of SFX-01 to improve clinical outcomes in COVID-19 patients (STAR-COVID)
Chalmers, J. & Dinkova-Kostova, A.
LifeArc
1/10/20 ? 30/09/21
Project: Research
https://discovery.dundee.ac.uk/en/persons/james-chalmers
GSTM1 Deletion Exaggerates Kidney Injury in Experimental Mouse Models and Confers the Protective Effect of Cruciferous Vegetables in Mice and Humans
November 2019 Journal of the American Society of Nephrology
Abstract
Background: GSTM1 encodes glutathione S-transferase µ-1 (GSTM1), which belongs to a superfamily of phase 2 antioxidant enzymes. The highly prevalent GSTM1 deletion variant is associated with kidney disease progression in human cohorts: the African American Study of Kidney Disease and Hypertension and the Atherosclerosis Risk in Communities (ARIC) Study. Methods: We generated a Gstm1 knockout mouse line to study its role in a CKD model (involving subtotal nephrectomy) and a hypertension model (induced by angiotensin II). We examined the effect of intake of cruciferous vegetables and GSTM1 genotypes on kidney disease in mice as well as in human ARIC study participants. We also examined the importance of superoxide in the mediating pathways and of hematopoietic GSTM1 on renal inflammation. Results: Gstm1 knockout mice displayed increased oxidative stress, kidney injury, and inflammation in both models. The central mechanism for kidney injury is likely mediated by oxidative stress, because treatment with Tempol, an superoxide dismutase mimetic, rescued kidney injury in knockout mice without lowering BP. Bone marrow crosstransplantation revealed that Gstm1 deletion in the parenchyma, and not in bone marrow-derived cells, drives renal inflammation. Furthermore, supplementation with cruciferous broccoli powder rich in the precursor to antioxidant-activating sulforaphane significantly ameliorated kidney injury in Gstm1 knockout, but not wild-type mice. Similarly, among humans (ARIC study participants), high consumption of cruciferous vegetables was associated with fewer kidney failure events compared with low consumption, but this association was observed primarily in participants homozygous for the GSTM1 deletion variant. Conclusions: Our data support a role for the GSTM1 enzyme in the modulation of oxidative stress, inflammation, and protective metabolites in CKD.
13/2/20
University of Rochester Collaboration
Evgen Pharma (Evgen) and The University of Rochester School of Medicine and Dentistry have entered into a Memorandum of Understanding to advance SFX-01 towards a clinical trial in chronic kidney disease (CKD).
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."
Dr Stephen Franklin, CEO of Evgen Pharma, commented:
"We are delighted to be supporting the work of such a respected team and prestigious university. We very much hope the proposed trial will generate data demonstrating that SFX-01 could potentially improve the lives of patients suffering from CKD."
The following, published Septmber 2020 is the latest research from University of Rochester , New York on Gstm1 and its roll in Chronic Kidney Disease....SFX-01 is under evaluation for patient clinical trials following compelling research published November 2019 on the clinical positive effects of Sulforphane, and so more potential material news in the pipeline. Gla ;-)
Abstract P046: Variable Effect Of Gstm1 Knockout In Mice
Yves T Wang
, Keith Nehrke
, Paul S Brookes
, Thu H Le
Originally published9 Sep 2020
hTtps://doi.org/10.1161/hyp.76.suppl_1.P046Hypertension. 2020;76:AP046
Abstract
Glutathione S-transferase µ-1 (GSTM1) is an enzyme that has a role in the detoxification of electrophiles, including xenobiotics and products of oxidative stress. In humans, the GSTM1(0) null allele deletion variant is highly prevalent and is associated with both an increase in oxidative stress and an increased risk/severity of a variety of diseases, including cancers, chronic kidney disease, hypertension, and coronary artery disease.Recently, we generated a Gstm1 knockout (Gstm1-/-) mouse line on a 129S6 background. Using these animals, we demonstrated that the loss of GSTM1 resulted in increased oxidative stress and greater kidney injury with either subtotal nephrectomy-induced chronic kidney disease or angiotensin II-induced hypertension, in accordance with clinical data.Following myocardial infarction, reperfusion of the heart results in additional tissue damage that is also mediated by acute oxidative stress. Here, we used an ex vivo Langendorff-perfused heart model of acute cardiac ischemia-reperfusion injury (IRI). Contrary to the expectation that hearts from Gstm1-/- mice would be more susceptible to IRI, we found that the loss of the antioxidant enzyme GSTM1 was protective in males compared to age-matched wild-type controls. In contrast, the Gstm1-/-genotype was deleterious in female hearts as expected.To explore the hypothesis that the loss of GSTM1 causes compensatory upregulation of other GSTs and that this effect varies based on both tissue and sex, we examined mRNA expression of a, ?, ?, µ, and p classes of Gst genes via qPCR and corresponding protein expression via HPLC and western blot. We found significant differences between male vs. female and heart vs. kidney in several GSTs both in their expression in wild-type mice and in the change in expression between wild-type and Gstm1-/- mice. These results suggest that the severity of cardiac IRI may depend on the adaptive response mediated by genes encoding GST enzymes.
It would appear those from the secret squirrel club are desperate to try and undermine EVG's prospects, and a further appearance from the halfwit kingelf in another feeble and futile attempt to hold back the tide...ho ho ho ho, and it's laughable not to expect an early update from the Covid-19 patient trials if phase 2 stage proves to be positive. Gl to all holders...Evgen is firmly in the spotlight and investor focus. ;-)
......
Finncap 15/6/20..Research note only focussed on SFX-01's breast cancer potential.....pre phase 2/3 Covid-19 patient trials....and Jim Mellon's £250k plus the ex CEO £80k and so even more cash in the bank on Finncap's forecast..... Gla ;-)
Forecasts and valuation.
We have increased operating expenses in FY 2021 to
reflect the delayed phasing of pre-clinical costs and completion of CMC package.
We introduce FY 2022 forecasts, with the cash runway extending into Q3 CY 2021.
We maintain our target price of 25p, which is based on an rNPV for SFX-01 in mBC only. This excludes any value attributable to other indications, such as in autism or NASH,which will be pursued through non-dilutive financing sources, or the potential value of SFX-01 as a sulforaphane delivery platform.
Https://researchlibrary.finncap.com/File/View?file=c0021c92-9b4c-4987-82d5-825e28dc7824
Forget the noise. SNG were valued at 3 times this when they announced a phase II trial. This is the cheapest stock with a potential treatment for ARDS that you will find.
Funny how my comments are more correlated to the actual share price movement then all these other pump and dream merchants.
Exciting times ahead. The combined phase II/III trial is great because once they get positive results from phase II they can go straight in to phase III without delay. Confirmation that the trial has moved from phase II to phase III will be a lot quicker than people think. Early next year or maybe even late this year is possible.
Another sad attempt at a a deramp by kingalf. Obviously has nothing better to do. You've got to wonder what kind of person puts this much effort into a share they don't own.
Evgen has done all the development work on SFX-01. They have over £3m cash. They advance studies through partnerships and collaborations. Juvenescence deal has already provided $250k and over $10m still to come.
They will definitely need another share placing by then to strengthen the balance sheet.
My personal view is that it will happen sooner rather than later and the likes of FinnCap will help organise it.
You might be interested in comments from the last issue , funds remaining on the balance back then are now back to todays levels which is why I think it will happen very soon, hence the non advancement of the share price.
EVGEN PHARMA SET FOR MULTIMILLION-POUND PLACING
8 May 2019 North West Deals Matthew Ord
Evgen Pharma set for multimillion-pound placing
Clinical stage drug development company Evgen Pharma, which has operations in Cheshire and Liverpool, is set to secure £5m through a further share placing.
At the company's latest general meeting, all resolutions were passed. This included plans – as revealed in April – to raise the money through two placings of 13,057,489 and 20,275,840 shares on AIM.
The first tranche was submitted on 18 April, with the remainder of the £5m set to be secured today (9 May).
Evgen will use the net funds to strengthen the balance sheet for future partnering, develop product formulation for use in STEM II and other investigator-led clinical studies, and conduct further toxicology studies that will remove current restrictions on the duration of clinical trial treatment phases.
At the time the proposals were originally announced, chief executive Stephen Franklin said: "The funds strengthen the company's balance sheet following the recent announcement of the successful final read-out of our phase II STEM clinical trial in breast cancer and ahead of the final read-out of our phase II SAS clinical trial in subarachnoid haemorrhage.
"The additional funds will enable us to further progress our development work whilst also supporting business development and out-licensing activities."
FinnCap and WG Partners both worked on the deal.
Where is this September 2021 date from for the trial results? All RNS on the subject just say 2021.
I can’t see why it would take a year to treat 300 patients, especially given its over what 10 different sites? That would be a very slow rate of treatment.
Moneymunch thank u for sharing, great opportunity in front if us...
Here's an example phase 2 and phase 3 combined. Gla :')
Phase 2 and 3 Combination Designs to Accelerate Drug Development
For late-stage clinical development, we propose combining phase 2 and 3 trials via a two-stage adaptive design. In the first stage, short-term safety and efficacy are examined, after which low doses that lack efficacy and high doses that cause safety concerns are eliminated from further evaluation. The trial continues to the second stage with doses that are not eliminated. For the second stage, the required sample size is adjusted to maintain power. All patients, including those enrolled in the first stage, are evaluated using a clinical endpoint requiring a longer follow-up. For the second stage, trend statistics are adaptively chosen based on the estimated dose-response curve in the clinical endpoint of the first-stage patients. At the end of the trial, pairwise statistics for the first stage and adaptive trend statistics for the second stage of the clinical endpoint are combined to establish dose-response and to identify the lowest effective dose. A notable feature is that the adaptation rule governing dose selection, sample size calculation, and derivation of test statistics for the second stage need not be specified in advance to maintain the validity of the trial. The phase 2/3 combination design is effective in achieving robust statistical power and is also efficient, because the number of patients and time needed are substantially reduced.
SFX-01's Phase 2 and Phase 3 combined Covid-9 patient trials.....Top Line Results expected Septmenber 2021, although it's reasonable to speculate that early reporting would be highly likely given that the trial is combined Phase 2 and Phase 3, as well as the urgency in finding an effective treament for Covid-19 and also the fact that clinical trial data on ongoing Covid-19 trials are very often shared with other world health organisations......a very exciting time for those invested in Evgen regardless, with more material news expected from the rest of their multiple disease pipeline. Gla Holders....Full market appreciation and investor interest on its way, with so much potential transformational UPside from this lowly £18m market cap....an absolute bargain....On and UP!!! ;-)
......................
A randomised, double-blind, placebo-controlled trial of SFX-01 or placebo on a backbone of best standard care, to improve outcomes in patients with community acquired pneumonia and suspected or confirmed SARS-CoV-2 infection
*for the avoidance of doubt, this trial permits inclusion of patients presenting with acute respiratory infections whether or not the test for SARS-CoV-2 is positive. Patients can be randomised to the study while awaiting the results of the test for SARS-CoV-2.
TIMEPOINTS of EVALUATION
E.5.1.1 Timepoint(s) of evaluation of this end point: Day 15 (where day 1 is the first day of treatment)
E.5.2 Secondary end point(s): Clinical Severity;
Time to an improvement of one category from admission using 7-point ordinal scale.
Daily whilst hospitalised
Participant clinical status on 7-point ordinal scale. Days 3, 5, 8, 11, 15 and 29.
Participant change from baseline on 7-point ordinal scale. Day 15.
Proportion of participants showing improvement on 7-point ordinal scale. Day 15.
Mean change in the 7-point ordinal scale. Baseline to days 3, 5, 8, 11, 15 and 29
NEWS;
Time to discharge or to a NEWS of = 2 and maintained for 24 hours, whichever occurs first
Change from baseline Days 8, 15, 29
Oxygenation;
Oxygen free days 0-29 days
Incidence and duration of new oxygen use during the trial 0-29 days
Mechanical Ventilation:
Ventilator free days 0-29 days
Incidence and duration of new mechanical ventilation use during the trial 0-29 days.
Duration of hospitalisation; date of admission and discharge
15day and 28day mortality; date of death
Cumulative incidence of serious Adverse events (SAEs) 0-29 days
Discontinuation or temporary suspension of treatment 0-29 days