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We still need Covid-19 treatments as well as vaccines

Intensive care physician and researcher Charlotte Summers has spent the pandemic advising on treatments – and the work isn't over

Monday 7 December 2020

https://www.wired.co.uk/article/covid-treatments-vaccine-charlottle-summers

The $1.35 billion deal recently signed by Novartis for a ARDS/Covid treatment still in clinical trial, has now received FDA fast track designation after the release of early interim results.....and so a striking example of SFX-01's potential value and prospects for ARDS/Covid, if positive data is observed. Gla ;-)

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Novartis Inks $1.35 Billion Deal with Mesoblast for Remestemcel-L for COVID-19 ARDS

Published: Nov 20, 2020

Novartis inked an exclusive worldwide license and collaboration deal with Australia-based Mesoblast to develop, commercialize and manufacture remestemcel-L for acute respiratory distress syndrome (ARDS), including when it is linked to COVID-19. The company plans to launch a Phase III trial in non-COVID-19-related ARDS shortly after closing the deal. The drug is currently being evaluated in a Phase III trial in COVID-19-related ARDS.

hTtps://www.biospace.com/article/novartis-inks-deal-with-mesoblast-for-remestemcel-l-for-covid-19-ards/

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

December 3, 2020

The Food and Drug Administration (FDA) has granted Fast Track designation to remestemcel-L (Mesoblast) for the treatment of acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19).

Remestemcel-L consists of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is believed to work by down-regulating the production of proinflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

The designation is supported by results from a pilot study evaluating remestemcel-L in ventilator-dependent COVID-19 patients with moderate to severe ARDS during March and April of 2020 at Mount Sinai hospital in New York City. Findings showed 83% survival in ventilator-dependent COVID-19 patients with moderate/severe ARDS (n=10/12) following 2 intravenous infusions of remestemcel-L within the first 5 days; 75% of ventilator-dependent patients (n=9/12) were successfully discharged from the hospital at a median of 10 days.

The Company is currently investigating remestemcel-L in a randomized controlled phase 3 trial in up to 300 ventilator-dependent COVID-19 patients with moderate to severe ARDS; the trial is approximately two-thirds enrolled. The primary end point is the overall mortality at day 30, and the key secondary end point is days alive off ventilatory support through day 60.

A final interim analysis will be performed by an independent data safety monitoring board (DSMB) once 180 patients have completed 30 days of follow-up; the DSMB recommended the trial continue following interim analyses performed after 90 and 135 patients were enrolled.

For more information visit mesoblast.com.

https://www.empr.com/home/news/drugs-in-the-pipeline/remestemcel-l-mesoblast-ards-acute-respiratory-distress-syndrome-covid-19/

ps to give a comparison in potency, SFX-01 for Covid-19 is administered in 300mg capsules. Gla ;-)

Well And Good searched worldwide to find the best organic grower of Sulforaphane-yielding broccoli sprouts and was delighted to find them just across the ditch in Queensland. The baby sprouts get sent from there to Nelson for encapsulation at New Zealand’s leading GMP-certified manufacturer.

“In Australia, one supermarket chain reported a seven per cent lift in the sprout category last year and one of the most popular varieties is the broccoli sprout with its large amount of sulforaphane,” says Duder.

Each FourHealth Green capsule contains a full strength dose of Sulforaphane (between 7 and 9mg per capsule) and the recommended two a day is equal to eating 1kg of cooked broccoli.

“Broccoli is a great green but that’s a lot to consume in one go. It’s just so much easier to knock back a couple of capsules, and no other product comes close to the power of FourHealth Green.”

FourHealth Green boosts your body’s production of antioxidants, which leads to:

· Improved immunity – fewer colds and infections

· Better heart health

· Improved clearing of toxins (from alcohol and tobacco)

· Mental clarity – no more foggy head

· Support for joint, immune, brain, digestive and lung health

· Better skin

· Enhanced wellbeing

About Us:

https://www.scoop.co.nz/stories/BU2012/S00114/kiwi-health-start-up-really-know-their-greens.htm

Kiwi Health Start-up Really Know Their Greens

Friday, 4 December 2020, 10:42 am

Press Release: Well And Good Ltd

The post-Covid economy is not fazing one Kiwi start-up which is relying on the power of green – vegetables that is, not money – to boost their business and our lives.

Well And Good Limited has been set up by a group of New Zealand friends who worked together in the healthcare industry for more than 30 years, and who strongly believe in the healing power of food and nutrition.

They’ve just launched the new business with their hero product FourHealth Green, a twice-a-day capsule containing the wonder ingredient Sulforaphane, which is found in three-day-old broccoli sprouts. It can be purchased online at www.fourhealth.co.nz or at selected pharmacies.

FourHealth Green director Mary-Lou Duder says: “It’s so common these days to hear people talking about how tired and rundown they are, with no idea of what to do about it.

“We got frustrated with the healthcare industry focusing so much on pharmaceuticals and surgery so we set out to find evidence-based products that could deliver genuine proactive health benefits.

“Of course, eating well, exercising and staying connected are of the utmost importance. But if we can give people an extra bit of help to be the best they can be, why wouldn’t we? That’s the idea behind FourHealth and we will only be launching products that are backed by proven scientific research” says Duder.

That’s certainly not an issue for the hero product FourHealth Green, as more than 2,600 studies have been done around the world outlining the benefits of Sulforaphane.

They include helping your body produce its own natural antioxidants, especially in the liver. It can also enhance immunity and counteract the effects of stress, poor diet, alcohol, smoke and air pollutants, and UV radiation. In addition, Sulforaphane supports disease prevention, anti-aging and cognition, and protects against cardiovascular and neurodegenerative illness.

The evidence of its effectiveness includes ongoing research by the prestigious Johns Hopkins University in Baltimore, which has been a leading player in the US response to Coronavirus pandemic.

“They’ve been investigating Sulforaphane for more than 20 years,” says Franklin. “Their scientists first found that cruciferous vegetables like broccoli offered protection from illness, and then they isolated Sulforaphane as the key molecule responsible. Subsequently, they proved three-day-old broccoli sprouts were the most concentrated source of Sulforaphane.

“Research has also shown Sulforaphane is nature’s most potent antioxidant inducer – up to 25 times more potent than curcumin (the active ingredient in turmeric).”

25/11/20

Impact of Glucoraphanin-Mediated Activation of Nrf2 on Non-Alcoholic Fatty Liver Disease with a Focus on Mitochondrial Dysfunction
.......
Concluding Remarks and Future Directions

The prevalence of NAFLD is increasing worldwide due to the increase in the number of obese individuals. NAFLD is caused by the impaired regulation of hepatic lipid and glucose homeostasis. Unfortunately, the sequence of events that occurs during the pathogenesis of NAFLD is unclear. A variety of factors—including insulin resistance, cytokines, oxidative stress, the microbiota, and mitochondrial dysfunction—are involved in the pathogenesis of NAFLD. To adapt to lipid accumulation, hepatic mitochondria increase fatty-acid ß-oxidation and electron-transport-chain activity, resulting in ROS generation. Oxidative stress due to ROS plays a key role in the development of insulin resistance and NASH. Therefore, therapeutic approaches have focused on antioxidant compounds to counteract ROS. Studies involving NAFLD mice have shown that lipotoxicity-induced insulin resistance and hepatic steatosis can be prevented by antioxidants. Moreover, these compounds can ameliorate pathological features such as inflammation and hepatic fibrosis, which are typical of advanced NAFLD. Notably, the anti-obesity agents sulforaphane and glucoraphanin prevent hepatic steatosis by increasing energy utilization and preventing lipogenesis and oxidative stress in the liver. Moreover, they improve mitochondrial dysfunction. Thus, future studies are needed to determine the effect of sulforaphane and glucoraphanin on mitochondrial dysfunction in NAFLD.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6929181/

5/12/19

Evgen Pharma (AIM: EVG) a clinical stage drug development company focused on the treatment of cancer and neurological conditions, announces it has entered into a Memorandum of Understanding with the The University of Dundee ("The University") to advance SFX-01 towards a clinical trial in non-alcoholic steatohepatitis ("NASH") and liver fibrosis. Evgen has agreed to supply SFX-01 to support a potential future clinical trial led by John Dillon, Professor of Hepatology and Gastrenterology in the University's School of Medicine.

With the assistance of Evgen, Professor Dillon will lead the process to secure appropriate grant funding and obtain clinical trial regulatory approval. The intention is to utilise advanced MRI scanning technology to investigate whether SFX-01 can reverse the hallmarks of NASH in a proof-of-concept clinical trial. Clinical data arising from a successful trial will support subsequent development, regulatory approval and commercialisation of SFX-01 in NASH and liver fibrosis. Evgen will be granted an option to the clinical data on fair commercial terms to enable it to advance development and commercialisation.

Non-alcoholic fatty liver disease ("NAFLD") is now regarded as the most common liver condition in the developed world, affecting up to 30% of the general population. NAFLD represents a spectrum of phenotypes ranging from simple steatosis (fatty infiltration), through NASH to cirrhosis. Approximately 30% of adults in the general population have NAFLD, and 10%-20% of these have NASH. Amongst patients with NASH, 20-30% are at risk of developing cirrhosis and subsequently dying from end-stage liver disease within 20 years. In view of the tens of thousands of individuals who are likely to develop NASH in the next decade, it is clear that this disease will represent a major burden to healthcare in the UK.

Professor John Dillon and colleagues have previously published research that showed that drug-induced activation of the Nrf2 pathway could reverse insulin resistance, suppress hepatic steatosis, and mitigated against NASH and liver fibrosis. On this basis, Professor John Dillon approached Evgen, the developer of SFX-01, a development stage drug that is known to activate the Nrf2 pathway and has demonstrated excellent safety and tolerability in previous clinical trials.

John Dillon, Professor of Hepatology and Gastrenterology at the University of Dundee's the School of Medicine said: "We are delighted that Evgen will support our plans to undertake a clinical trial on SFX-01 in patients with NASH. Oxidative stress is pivotal to the development of NASH and our research suggests that activation of the Nrf2 pathway, which in turn reduces oxidative stress, can reverse the pathology."

Maybe an update on SFX-01's evaluation for NASH/NAFLD in the pipeline. Gla ;-)

3/12/20

John Dillon Retweeted

Jeffrey V. Lazarus
@JVLazarus
·
7h
Looking forward to co-chairing the Wilton Park-EASL International Liver Foundation dialogue on NAFLD/NASH -

https://wiltonpark.org.uk/event/wilton-park-series-nonalcoholic-fatty-liver-disease-nafld-and-nonalcoholic-steatohepatitis-nash-wp1736/
#NoNASH @WiltonPark
@EASL_ilf

hTtps://twitter.com/profjohndillon?lang=en

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Wilton Park Series: Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic steatohepatitis (NASH) (WP1736)
Wilton Park Series: Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic steatohepatitis (NASH) (WP1736)

Date
Wednesday 2 - Friday 4 December, 2020
Venue
Virtual
Event no.
WP1736V3

In partnership with the EASL International Liver Foundation

Non-alcoholic fatty liver disease (NAFLD) is a rapidly growing global health challenge. Currently affecting an estimated 2 billion people, 25% of the global population, the scale of the issue is expected to grow in the coming decade, most significantly in areas where obesity rates are increasing rapidly. Comorbidities, such as obesity and NAFLD, increase the risk factor and severity for patients with the COVID-19 virus.

The silent epidemic
(WP1736V3)

WP1736V3 Programme

This event will bring together some 50 experts, thought leaders, practitioners, industry executives and high-level government officials from various disciplines and sectors to engage in solution-oriented dialogue with the view to initiating a coordinated and collaborative response to this challenge. This dialogue forms part of the wider series which aims to holistically address a broad range of issues related to the NAFLD agenda.

"The data announced today, is one important step in the process of developing and understanding mechanisms of action of this nutraceutical-based approach towards immune modulation and hopefully towards viral inhibition" said Timothy Dixon, President and CEO of the Company. "I am thankful for our collaborators who continue pushing the limits of medicine and science in our quest to fight against this invisible enemy."

https://www.prnewswire.com/news-releases/therapeutic-solutions-international-announces-positive-quadramune-clinical-trial-data-301182688.html

Encouraging "early" trial data on a treatment for Covid-19 released from Therapeutic Solutions, with Sulforaphane a key ingrediant, which bodes well for SFX-01's Covid-19 patient trials imho....Gla ;-)

Therapeutic Solutions International Announces Positive QuadraMune™ Clinical Trial Data

Immune Cells from QuadraMune™ Treated Volunteers Possessed Almost Double Therapeutic Activity after 1 Week

News provided by
Therapeutic Solutions International

Dec 01, 2020, 09:30 ET

OCEANSIDE, Calif., Dec. 1, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), announced today new data from its clinical trial demonstrating an almost doubling of immune cell activity in healthy volunteers which were ingesting QuadraMune™ daily for a week.

Investigators analyzed blood for production of an immunological protein called "interleukin-2" after stimulation with anti-CD3 and anti-CD28. The substantial increase in interleukin-2 is believed to predict that immunological cells such as T cells and NK cells, which are needed to fight viruses such as SARS-CoV-2, possess enhanced function after QuadraMune™ administration.

Currently the Company is running a clinical trial on QuadraMune™ for preventing COVD-19 in health care workers1. The clinical trial is listed on the National Institutes of Health Clinical Trial Database www.clinicaltrials.gov.

"Last week we reported stunning clinical data that QuadraMune™ enhances natural killer cell activity in healthy volunteers as well as in diabetics taking metformin2. Natural killer cells are the front line immune system cell fighting coronaviruses and are dysfunctional in people with COVID-193. It is conceivable that by stimulating T cell and NK cell activity, QuadraMune™ may be beneficial in protecting from infection" said Famela Ramos, Vice President of Business Development. "We will not know efficacy until the clinical trial is complete."

QuadraMune™, is composed of 4 main ingredients: a) Pterostilbene, an inhibitor of SARS-CoV-2 infection4; b) Epigallocatechin gallate, a potent antioxidant and immune booster5; c) Sulforaphane, a lung protector6, and d) Thymoquinone, which inhibits organ failure and viral infections, as well as acting as a precursor to hydroxychloroquine7.

The Company previous showed that QuadraMune affects a variety of immunological functions including reducing myeloid suppressor cells8, which inhibit immunity, downregulating interleukin-69, which is associated with COVID-19 mortality10, and downregulated inflammation induced coagulopathy11, which is a major cause of COVID-19 associated deaths.

Pfizer vaccine approved in the UK....Gla ;-)

Any positive data from the Covid trial will see the sp multi-bag regardless of any Major Pharma JV imho, and any good news on the following from the breast cancer programme, expected soon, could add significant value and take Evgen one step closer to a JV. ;-)

July 2020

Extensive review of clinical pathway to approval close to completion

Supplementary preclinical work required to confirm CDK4/6i resistance-breaking hypothesis

New commercial ready solid tablet formulation to be completed in H3 2020

Non-dilutive capital e.g. partnering to fund the next trial(s)

Targeting CTA/IND in H1 2021 with first patient first dose in Q2/Q3 2021

0  0 0

Trial Information

Background to the trial:

Patients who are admitted to hospital with pneumonia caused by infection with COVID19 or another bug may have difficulties breathing. Many need oxygen and some need help to breathe (put on a ventilator) before they get better. However, a small number of people don’t get better. Their lungs can over-react to the infection and become inflamed. Over time their lungs may gradually become more and more damaged.

Overview of the trial drug:

A company in the UK, Evgen Pharma, have developed a drug called SFX-01 which we think might help people with pneumonia. The drug isn’t licenced for doctors to prescribe yet but the company has done trials using the drug to check that it is safe. We think that SFX-01 may help people with pneumonia by reducing the amount of inflammation and damage in their lungs. We want to know if taking SFX-01 shortens your time in hospital. We also want to find out if you’re less likely to need oxygen for a long period or put on a ventilator and if you’re more likely to recover.

Trial population:

The trial will recruit patients who have been hospitalised with pneumonia or suspected COVID-19. This trial aims to recruit 300 patients from hospitals in the UK.

Trial treatment:

All participants taking part in the trial will receive the usual standard of care. Participants will be randomised (by chance) to receive either the trial drug (SFX-01) or a placebo. Each participant will take either one SFX-01 capsule or one placebo capsule every day for 14 days.

Trial aims:

We think that SFX-01 may help people with pneumonia by reducing the amount of inflammation and damage in their lungs. We want to know if taking SFX-01 shortens your time in hospital. We also want to find out if you’re less likely to need oxygen for a long period or put on a ventilator and if you’re more likely to recover.

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.

James D Chalmers

@ProfJDChalmers

·

11m

The website for the STAR-COVID trial is now live - https://star-covid19.com 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 https://jobs.dundee.ac.uk/fe/tpl_uod01.asp?s=4A515F4E5A565B1A&jobid=104524,9314158671&key=148691674&c=41214641157854&pagestamp=sefnexizrwepjipipx

Published: 30 May 2020

Targeting STAT3 signaling using stabilised sulforaphane (SFX-01) inhibits endocrine resistant stem-like cells in ER-positive breast cancer

Abstract

Estrogen receptor (ER) positive breast cancer is frequently sensitive to endocrine therapy. Multiple mechanisms of endocrine therapy resistance have been identified, including cancer stem-like cell (CSC) activity.

Here we investigate SFX-01, a stabilised formulation of sulforaphane (SFN), for its effects on breast CSC activity in ER+ preclinical models. SFX-01 reduced mammosphere formation efficiency (MFE) of ER+ primary and metastatic patient samples.

Both tamoxifen and fulvestrant increased MFE and aldehyde dehydrogenase (ALDH) activity of patient-derived xenograft (PDX) tumors, which was reversed by combination with SFX-01.

SFX-01 significantly reduced tumor-initiating cell frequency in secondary transplants and reduced the formation of spontaneous lung micrometastases by PDX tumors in mice.

Mechanistically, we establish that both tamoxifen and fulvestrant induce STAT3 phosphorylation. SFX-01 suppressed phospho-STAT3 and SFN directly bound STAT3 in patient and PDX samples.

Analysis of ALDH+ cells from endocrine-resistant patient samples revealed activation of STAT3 target genes MUC1 and OSMR, which were inhibited by SFX-01 in patient samples.

Increased expression of these genes after 3 months’ endocrine treatment of ER+ patients (n?=?68) predicted poor prognosis. Our data establish the importance of STAT3 signaling in CSC-mediated resistance to endocrine therapy and the potential of SFX-01 for improving clinical outcomes in ER+ breast cancer.

https://www.nature.com/articles/s41388-020-1335-z

10p opening on Monday looks like a dead cert, and maybe more if we get an update on patient recruitment for the Covid/ARDS trial, and maybe news on SFX-01's breast cancer status following Prof Clarkes seminar today, who also has a presentation at San Antonio Breast Cancer Symposium 8th December, and so hopefully reporting on progress made.....Gla ;-)

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Rob Clarke Retweeted
Mcr Breast Centre
@MCRBreastCentre
·
2h
Big thank you to all the presenters & the organising committee for an excellent Internal Seminar today, sponsored by @BreastCancerNow

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@SABCSSanAntonio
breast cancer symposium #SABCS20 8th December.

Special topics in ER+ breast cancer: mechanisms of therapeutic resistance
Robert Clarke, PhD
Manchester Breast Centre
Manchester, United Kingdom

https://www.sabcs.org/

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ps and plenty of big hitters in attendance who could be interested in a JV....;-)

https://www.sabcs.org/2020-SABCS-sup-sup/Support-Exhibits-Virtual/2020-Exhibitor-List

I wonder if Prof Clarke has any progress to report on SFX-01's STEM trial at today's seminar??? Gla ;-)

Rob Clarke Retweeted
Mcr Breast Centre
@MCRBreastCentre
·
19h
We're excited about tomorrow's Internal Seminar, sponsored by @BreastCancerNow
, when researchers at all levels from the Manchester Breast Centre will get together (virtually of course) to share their work, learn from, and network with each other.

https://twitter.com/MCRBreastCentre/status/1331943033869271040/photo/1

As far as we know 300 patients will be administered to the phase 2/3 trial and so presumably numbers of patients administered will be made public as the trial makes progress....which would suggest internal milestones, but no doubt the most important internal milestone would be positive indications from the phase 2 stage of the trial, before they progress to phase 3, and obviously material information of such importance, no doubt would be made public...ie early reporting....there's no way they would be able or no reason they would want to keep that quiet...Very exciting times for those invested, no guarantees of success but enough documented information and research from industry and academia to suggest that the risk reward is firmly in our favour....positive data would be truly Transformational for all invested......10 times, 20 times, 30 times and more at the very least of current value would be the order of the day...Gl :-)

Excellent info and courtesy of Bocker on Advfn. Gl ;-)

26 Nov '20 - 18:22 - 5836 of 5839

Seems the trial has internal milestones throughout which EVG did not reveal to me. I was not surprised. But they did say that when the milestones are reached RNS’s will be follow. My question to them concerned publication of release of numbers partaking. Anyway it seems that there will be updates as we go along....

However, I am most impressed with their communication. Response within 3 hours. Unusual and to be commended.