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FDA WARP Speed operation for Covid -19 therapeutics responsibility:
Dr. Janet Woodcock; @DrWoodcockFDA; 22. Mai
In order to devote efforts full-time to the start-up of Operation Warp Speed’s therapeutics initiative, @DrWoodcockFDA will go on detail to the Office of the Commissioner. While she focuses on this work, CDER Deputy Director Dr. Patrizia Cavazzoni will serve as acting director.
— Dr. Stephen M. Hahn (@SteveFDA) May 22, 2020
MetlMann wrote on Twitter:
New drug being tested for COVID-19. It's called Leronlimab. The drug is very promising. But for some reason, Remdesivir sucks up all the attention, even though it is not all that effective. Leronlimab also treats HIV & cancers. Almost no side effects. #leronlimab #Remdesivir So und mit diesem Beitrag sind 10.000 Post im Thread also Tripple-Jubiläum!
https://twitter.com/Metl_Mann/status/1262597725918564353
Largest society in the Industry "Regulatory Affairs Professional Society" (RAPS) newly listed Leronlimab as therapeutic for Covid-19:
COVID-19 therapeutics tracker
Posted 22 May 2020 | By Jeff Craven
Updated 23 May to include new information on hydroxychloroquine, convalescent plasma, favilavir, EIDD-2081, leronlimab and sarilumab.
Drug: Leronlimab
Medication class: Humanized IgG4 monoclonal antibody
Developer: CytoDyn (as PRO 140)
Original proposed indication: Leronlimab has received FDA fast track designation for use with carboplatin to treat CCR5-positive metastatic triple-negative breast cancer and in combination with highly active antiretroviral therapy (HAART) in HIV.
Rationale: Leronlimab is a CCR5 antagonist that blocks the CCR5 co-receptor on the surface of immune cells like CD4 cells. It is believed that leronlimab can enhance the immune response in patients experiencing CRS from respiratory distress caused by COVID-19.
Trials: CytoDyn is planning two clinical trials evaluating leronlimab in patients with mild to moderate and severe cases of COVID-19. In the trial of severe COVID-19 cases, announced on 1 April, CytoDyn aims to enroll 342 patients and administer leronlimab or placebo for 2 weeks with a primary endpoint of 14-day mortality. Another trial in collaboration with the Mexican National Institutes of Health is also planned.
Outcome: FDA authorized use of leronlimab in COVID-19 patients under an eIND. Patients treated under the eIND have a lower level of cytokine storm and lower levels of IL-6 and TNF-alpha. A pre-print of results from the trial evaluating severely or critically ill COVID-19 patients showed leronlimab was effective at reducing IL-6 expression and in reversing immunosuppression, which led to a lower plasma viral load.
Status: A Phase 2b trial has enrolled 15 patients with mild-to-moderate COVID-19 and one patient with severe disease has been treated in a Phase 2b/3 trial, CytoDyn announced 15 April. On 30 April, CytoDyn’s CEO noted that 49 patients treated with leronlimab under eIND were responding “extremely well” and expects publication of their first results shortly.
https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-therapeutics-tracker
Einstein University report:
A Promising Drug for the Treatment of Severe Lung Inflammation in COVID-19 Patients: Montefiore-Einstein Scientists Lead Two Trials of Leronlimab Two Trials of Leronlimab
https://www.einstein.yu.edu/news/2350/a-promising-drug-for-the-treatment-of-severe-lung-inflammation-in-covid-19-patients-montefiore-einstein-scientists-lead-two-trials-of-leronlimab/
Leronlimab is the right choice and will be revealed on Tuesday - IMO!
https://www.zerohedge.com/technology/remdesivir-study-finally-out-drug-only-helped-those-oxygen-finds-mortality-too-high
Leronlimab discussed in Brasil medical study:
As Brasil has the most death toll in South America, this could be the next country after Mexico to take action with Leronlimab to fight Covid-19.
Excerpt:
As shown in Table 3, a multiplicity of immunosuppressive drugs or
therapies have been used to reverse the cytokine release syndrome in Covid-19 trials. The tested immunomodulating and/or anti-inflammatory drugs cover a broad range of compounds and modes of action such as classical glucocorticoids or agonists of glucocorticoid receptor (dexamethasone, methylprednisolone, budesonide), biologicals including some of the newest ones (anti-IL-6 monoclonal antibodies tocilizumab and siltuximab, the antibody against CCR5 receptors on T-lymphocytes leronlimab
, and an antibody against cytokine fusion protein CD24Fc), ruxolitinib (Janus kinase JAK1 and JAK2 selective inhibitor and blocker of cytokine signalling)
54
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/download/1596/1152
700 Club Interactive about New Coronavirus Drug? HIV Drug Leronlimab's Stunning Results:
Presentation Beckman Coulter with Notes (from Yahoo-Board):
Dr. Bruce Patterson thanks Beckman Coulter for the invitation.
He wants to talk about Rantes/CCL5.
These are levels we've never seen before in Covid patients.
How do these immune cells get to sites of inflammation?
Rantes is an "immune magnet."
We have looked at a set of very critical patients at Albert Einstein.
You see a very complex disease.
Rantes seems to be acting as the quarterback to bring cells to where they are needed.
But it brings them to such an extent that you get sequestration in lungs, liver, etc. The cytokyne storm is triggered.
Macrophages and NK cells and lymphocytes come in and bring in new cells.
See in mild to moderate patients but this immune disruption/chaos doesn't start for a while.
It is tipped from the expression of Rantes.
It is well described in slide - initial virologic phase/sometimes asymptomatic - then uncontrolled response which leads to immune chaos/immune suppression and more cytokines.
We were always trying to find a way to control.
Leron blocks binding of CCL5/Rantes and controls all the effects of Rantes.
We also found the immune disruption.
Severely decreased CV4-CV8 cells also present.
We've been luck that we have tools to measure all the manifestations of Covid.
[Brags on his hardware]
One of the discrepancies in the world is that no one knows why these drugs are working.
We have developed a suite of diagnostics that show what is happening.- i.e. increasing cells, decreasing IL6, decreasing viral lode.
This is the panel we've been using: i.e. T-Cell exhaustion.
We see dramatic decreases in IL6 in patients across the country
We are able to do cytokine panels right on the cytoplex.
We can do profiling all on the same machine with three different assays.
In Covid patients, Rantes is increased to 3x to 5x quickly and that's the trigger from a viral disease to an immune disease.
That is borne out.
Platelets go up and are activated.
You can see why there may be issues with Thrombosis and coagulation.
C-reactive protein is high and it is brought down significant in patients on Leron.
Liver enzymes come down on Leron.
Recurring theme. The body is on fire in Covid. When you put out that fire, the viral load goes down which is remarkable.
These are all the key parameters. A lot of people talk about targeting various items i.e. IL6.
The diff with CCL5 is that it is initiating this storm.
The beauty is that Leron blocks CCL5 and brings down IL6.
The amazing thing about Rantes is that it crashes at day 14.
In some of the very severe patients, it comes down at day 21.
It determines two things 1) when do you initiate and 2) when do you stop.
The most astonishing finding in study under peer review: we were first to find and quantify viral load using droplet ...ICR. It is perfect technology.
We did find it in every single patient.
Plasma viral load came down in these patients on Leron even though it is an immune modulator.
It essentially restores the immune system.
And quiets the cytokine storm.
All viral loads went down to undetectable at day 14.
Some things are not in paper.
We saw decreases in immune exhaustion and markers.
Patients with renal failure had higher exhaustion.
The data has already been submitted for Leron in HIV.
Initially, when we advanced the theory that Leron might be effective in Covid, there was criticism, but we found the Rantes issue.
What we are finding in Covid immunologically also impacts the research in cancer and HIV.
All needs far more invest.
But these are exciting mechanisms previously undescribed.
In summary Covid, is biphasic heterogenous in 4 stages.
Very different distinctions in these phases.
Rantes signals the transition from virologic to immunologic disease.
Some patients were on life support and came off life support and are now home and at rehab facilities.
It is anectodal, but my response is anectdotes don't come off life support.
We know what we have to do to prove to the community at large, but with 25 years experience, you know when something is working.
The effect is dramatic in moderate and severe.
The double blind studies are underway.
To date, there has been a disconnect between mechanism and outcome.
We see that in several other agents.
There are a number of hurdles for other drugs that can't be used.
By looking at immunology of covid, we've learned a lot about this drug.
It is exciting to see something work like this beyond simply blocking a cytokine receptor.
Now questions:
Any competitors that have drugs that do same?
A: there are, like [I can't ge names]___, which make CCL5 inhibitors. But, Leron is very close to submitting its trials to the FDA and we have a body of data that aligns the mechanism of operation with outcome. If we can remove the specter of death and intubation, we can get back to normal.
HIV Drugs in Clinical Trials to Treat COVID-19—What You Need to Know
Excerpt:
There is another investigational HIV drug soon to enter a clinical trial for COVID-19, this one in an entirely new class of drugs. Leronlimab is a monoclonal antibody. Leronlimab binds to a protein on the surface of human CD4 cells called CCR5—a receptor that HIV hijacks to enter human CD4 cells—thereby preventing HIV from entering the CD4 cell.
The drug is manufactured by Oregon-based CytoDyn, Inc., and leronlimab is the only drug in their pipeline at this time. In addition to a phase 2 trial for COVID-19, leronlimab is in phase 3 trials for HIV, and in various phases of trials for a number of cancers and some autoimmune conditions, including Crohn’s disease and multiple sclerosis.
https://www.thebody.com/article/hiv-drugs-clinical-trials-to-treat-covid-19
Excerpt:
Biotech firm CytoDyn is working on a clinical trial that would combine remdesivir with the drug leronlimab, which inhibits viral infection and also has shown some anti-inflammatory effects.
https://dailymemphian.com/section/coronavirus/article/14263/baptist-remdesivir-stephen-threlkeld-jon-mccullers
WebMD:
Excerpt:
The Washington state-based biotech firm CytoDyn is preparing a clinical trial that would combine remdesivir with leronlimab, a drug that inhibits viral infection and also has shown some anti-inflammatory effects, the company announced this week.
https://www.webmd.com/lung/news/20200521/combination-drug-therapy-for-covid-treatment#1
Again a post with Leronlimab along Remdesevir.
Combining Remdesivir With Other Meds Could Boost COVID-Fighting Power:
https://www.usnews.com/news/health-news/articles/2020-05-21/combining-remdesivir-with-other-meds-could-boost-covid-fighting-power
Not seen this Leronlimab mentioning post:
https://connection.asco.org/blogs/potential-and-promise-overview-strategies-explored-treatment-mitigation-covid-19
New Funds and Institutional buyers:
2020-05-13 13F L & S Advisors Inc 1.85 50,500 223.72 135 743.75
2020-05-05 13F Inverness Counsel Llc /ny/ 1.83 15,000 0.00 40 166.67
https://fintel.io/so/us/cydy
Yes Dieselpro from my perspective lots of good signs coming that will drive the PPS!
I wouldn't be surprised when Cytodyn gets Compassionate Use next week.
A lot of attention due to Dr. Patterson study and several panels he will join, will do more pressure on FDA in my opinion.
Just a gut feeling.
Talking about IL-6 Blocker (starting 3:38 min):
Dr. James “Brad” Cutrell, Medical Director of Antimicrobial Stewardship at Clements University Hospital, provides an inside perspective on clinical trials and the search for coronavirus therapies, ranging from Remdesivir to convalescent plasma to potential vaccines. Watch the entire series at
COVID-19 and Cancer: a Comprehensive Review
Not sure this was posted it mentions Leronlimab.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7206576/
AGC Japan NR: CytoDyn's new drug candidate for the new coronavirus, “Leronlimab”, outsourced by AGC, is undergoing clinical trials in the US
https://translate.google.com/translate?hl=en&sl=ja&u=https://www.agc.com/news/detail/1200758_2148.html&prev=search
News: CytoDyn to Offer No-Cost Exploratory Laboratory Testing for Childhood Inflammatory Disease Associated with COVID-19
https://www.cytodyn.com/newsroom/press-releases/detail/431/cytodyn-to-offer-no-cost-exploratory-laboratory-testing-for
Cytodyn named top 4 choices for a possible corona crisis winner!
Regeneron: Market capitalization $ 64 billion
Gilead Sciences: Market capitalization $ 96.7 billion
GlaxoSmithKline: Market capitalization $ 96.5 billion
far behind (ironically meant)
Cytodyn: market capitalization $ 1.44 billion.
There should still be a little bit of potential for Cytodyn!
What do you think !?!?
https://finance.yahoo.com/news/biotech-companies-lead-search-coronavirus-121612489.html
It doesn't bother me, because Vancouver firstly in the rest of the world is connected with Canada.
But on the other side Foreign Affairs Magazine, published by the Council on Foreign Relations since 1922, has again been ranked #1 in influence by U.S. opinion leaders in a recent national study conducted by Erdos & Morgan, the premier business-to-business research firm. Founded in 1970 by Samuel Huntington and Warren Demian Manshel, and now published by the Slate Group, a division of Washingtonpost. Newsweek Interactive, LLC, in Washington, D.C., FOREIGN POLICY is the premier, award-winning magazine of global politics, economics, and ideas.
They really should know better and adjust accordingly this report. Might someone should give them a hint ?
Wow - a must read!
Excerpt: Then there’s Samsung’s biopharmaceutical arm, Samsung Biologics. In the first quarter of this year, ending in March, sales for Samsung Electronics rose 5.6 percent year over year, while sales for Samsung Biologics jumped 65.3 percent. The company also ranked first in March for brand reputation among Korean pharmaceuticals. Last month, it clinched a $362 million deal to make coronavirus antibodies for a U.S. start-up and signed a collaboration deal with Asia’s largest pharmaceutical company, Takeda. Also last month, a Canadian biotech firm reported promising results in treating coronavirus patients with its HIV drug leronlimab, which Samsung Biologics will supply for up to $1 billion over the next few years.
https://foreignpolicy.com/2020/05/13/south-korea-pandemic-democracy-chaebol-samsung-corporate-reform/
Excellent! Leronlimab: The Ultimate Solution for Corona Virus | Syska Series | Ep. 12
https://www.youtube.com/embed/IDSmPY7kCA4
The Coronavirus Coping Portfolio (QDEL, GILD, QBIO, CYDY)
https://www.wallstreetpr.com/the-coronavirus-coping-portfolio-qdel-gild-qbio-cydy-43097
2 more medical studies naming and mentioning of Leronlimab as a monoclonal antibody!
Somehow it seems that Cytodyn is working out and positioning itself - worldwide!
Philippines:
https://pps.org.ph/wp-content/uploads/2020/04/LOGO-PSAAI-COVID-19-Immunomodulator-Review-4-22-2020-DBA1.pdf
In India:
https://osf.io/3qzm2
Cytodyn's and Leronlimab is trending up nearly worldwide
Cytodyn search (last day by countries):
https://trends.google.de/trends/explore?date=now%201-d&q=%2Fg%2F1dtt2r0k
Leronlimab search (last day by countries):
https://trends.google.de/trends/explore?date=now%201-d&q=Leronlimab
search for monoclonal antibody +650% (worldwide):
https://trends.google.de/trends/explore?q=%2Fm%2F01tr0r&date=now%201-d
I would say it looks excellent so far!
GLTA
Interview with Dr. Jacob Lalezari:
Development of PRO-140 (Leronlimab) as a treatment for COVID-19
Dr. Jacob Lalezari – Quest Clinical Research, USA
Published on April 21, 2020 20 min
https://hstalks.com/t/4246/development-of-pro-140-leronlimab-as-a-treatment-f/
Hello Chuckles,
in 2021 it is a 1 time dilution considered of 100 mn shares with the price of pps appr. $ 25-35, that gives Cytodyn around $ 2,5-3 bn for the indication to be successful in clinical trials over the next 2-3 years.
It is just an assumption, that this amount should be enough to fulfill the study due to existing data and safety of Vyrologix (Leronlimab;Pro140).
Might this answers your question ?
Thank you for your feedback.
Cheers Ümit
Mail is sent to you.
Cheers
Sunny
Chuckles759, they are both to be considered, 1st chart is Revenue of CYDY, 2nd is an overlay with pps and vials needed.
Hope this clarifies your question ?
GLTA
Sunny
Study was gathered by myself, so therefor i didn't understand your question, sorry for might high-spirited question, wasn't in my intention to be cheecky.
Best wishes from Germany
Sunny
Take a look at page 7, there is the database for vials needed in mn.
BR
Sunny
Zuess421, i suppose doing a good DD gives me a benefit and some safety in my investment decision.
What does it tell you ?
Please send me your mail-address in a Board Mails and i will provide you the presentation, if this is ok for you ?
Greetings from Germany
Sunny
Very welcome Chuckles759, this really makes sense as it works like
swarm intelligence.
Appreciate input to optimize the database and adjust...
Cheers
Thank you for all your good DD and input you provide...it is a pleasure to give something back...
Greetings from Germany
Sunny
You are welcome for any input or opinion to optimize the data base.
Cheers Sunny