Friends of Leronlimab
A New Therapeutic Drug for Covid #Leronlimab
Leronlimab is a monoclonal antibody therapeutic drug in the final stages of FDA approval.
Leronlimab is undergoing US FDA trials, as well as a trial in Brazil. Check the Cytodyn website https://www.cytodyn.com for availability.
This webpage will give you some information, videos & links for you and your doctor to explore and evaluate.
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CytoDyn Contact Info:

1111 Main Street Suite 660
Vancouver, WA 98660

Tel: 360-980-8524
Fax: 360-799-5954

info@cytodyn.com
https://www.cytodyn.com

Nader Z. Pourhassan, Ph.D.
Director, President and CEO
npourhassan@cytodyn.com

Scott A. Kelly, M.D.
Chief Medical Officer,
Head of Business Development
Chairman of the Board
Skelly@cytodyn.com
Links About Leronlimab (Vyrologix™)
View 1. FDA Expanded Access Program for Leronlimab
View 2. FDA Resumes eIND Approval
View 3. HHS Monoclonal Antibody (mAb) Treatment
View 4. HIV drug shows ‘impressive’ results in critically ill COVID-19 patients
View 5. ‘It Saved My Life’: OC Woman Survives Coronavirus
View 6. CytoDyn’s Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19 Patients Treated with Leronlimab
  “Today, there are no approved drugs to effectively address the unmet medical need for critically ill COVID-19 patients."
~ Nader Pourhassan, Ph.D., President and CEO of CytoDyn

“Leronlimab may be the only safe medication to help critically ill patients.”
~ Harish Seethamraju, M.D., Medical Director for the Mount Sinai Lung Transplantation Program
View 7. Dr. Otto Yang - UCLA Health Infectious Diseases
View 8. Case study of a critically ill person with COVID-19 on ECMO successfully treated with leronlimab
View 9. CytoDyn (OTCQB: CYDY) Stuns FDA with 400% Improvement in 14 Day Mortality
  The following (Phase 3 Trial) results demonstrate that leronlimab has taken dying off the table and is superior to any existing therapy and likely to receive FDA approval in the short run.

The genie is out of the bottle and doctors and clinicians are rising up on social media pleading with the FDA for an EUA.

The study (Phase 3 Trial) was a resounding success and showed 6 statistically significant endpoints.

The 28 day data set represents the strongest clinical data ever achieved in any randomized controlled clinical trial around the world.
View 10. Leronlimab in International Journal of Infectious Diseases
Videos & More About Leronlimab

90 Second Intro to Leronlimab

Discover that a single monoclonal antibody therapeutic drug can quiet the cytokine storm, kill the covid virus and re-build the immune system

3 Days From Ventilator To Hospital Release

Listen to Samantaha's personal story of how she survived Covid after being essentially marked for death with no hope of recovery after trying every treatment before Leronlimab.

Leronlimab for Cancer

98% of deaths result from cancer metastasis and not the primary tumor.
Leronlimab STOPS metastasis.

Leronlimab for HIV

Charlie Sheen gives an update on his health
No patient taking Leronlimab (Pro 140) in HIV FDA trials got Covid

Covid Long Haulers (Long Term Care)

Covid Long Haulers (Long Term Care)
Founded by the renowned Dr Bruce Patterson, Immunologist, Pathologist, Virologist and former head of Virology for Stanford University. It’s the only Long Hauler clinic in the country practicing precision medicine, both in person and through telemedicine, treating patients one cell at a time with the world’s first approved Covid and Long Haulers assays.
Visit Website

US firm developing experimental drug vs severe COVID symptoms

US firm developing experimental drug vs. severe COVID symptoms
The initial trials for Leronlimab, a product developed by US Biotech firm Cytodyn, show that it can treat patients with severe to critical symptoms and even prevent death among those infected for COVID-19

Leronlimab - Short History & How It Works

Leronlimab - Short History & How It Works

ER Dr. John Bream: The World Needs Leronlimab to Fight COVID-19

ER Dr. John Bream: The World Needs Leronlimab to Fight COVID-19

ER Dr. John Bream: Leronlimab and former Philippine President Estrada

ER Dr. John Bream: Leronlimab and former Philippine President Estrada

ER Dr. John Bream: COVID-19 Update: PASC

ER Dr. John Bream: The World Needs Leronlimab to Fight COVID-19

BATTLE in the Philippines

BATTLE in the Philippines
BATTLE in the Philippines: While Leronlimab is SAVING LIVES, including Joseph Ejercito Estrada Former President of the Philippines, the Philippine FDA like the USA FDA is dragging it's feet on approving Leronlimab. Meanwhile, thousands of people are dying.

Ex-Pres. Erap being treated with Leronlimab – Manila Bulletin

Ex-Pres. Erap being treated with Leronlimab – Manila Bulletin
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A Plea to the FDA

A PLEA TO THE FDA
You watch the ambulance pull out of the small town hospital emergency bay with your wife of 34 years, having just chatted for a few moments as the crew prepared her for the 100 mile ride to a large hospital, better able to handle the possibility that her lung function may continue to deteriorate. It would not be a surprise at this point. You've already watched her deteriorate over the last few days, not wanting to believe what you were seeing with your own eyes.

It was not a pleasant chat, what with a Bipap mask force feeding 15 litres of oxygen per minute to her. Even at that rate, the crew is struggling to keep her oxygen saturation at 90, the magic number. You cry, even though she begs you not too. She is obviously scared. You tell her not to give up. And they whisk her away.

No use following the ambulance. There's no visitation whatsoever at the Covid ICU unit where she's headed. Your mind is racing. You fear you many never see your mate again. The thought devastates you. You do your best to contact friends and family. It's a battle to hold back the tears with every call, a battle you usually lose.

Her lungs continue to lose the fight with Covid and her own immune system. Just one day later you get the call. They need to intubate her. You feel sick. Again, a short conversation, this time on the phone, through the woosh of the Bipap. The topic remains unspoken but you both realize this could be your final conversation....ever. You exchange "I love you's", and off she goes into a drug induced coma. The emotional pain you are feeling is nearly unbearable.

Once intubated, her chances of survival have dropped to 33-50%. And many that do survive are forever dependant on a ventilator, a result of the damage their lungs have sustained. Many wind up in long term care facilities. A few are lucky enough to have a loved one willing and able to keep them home and deal with the ventilator.

You get daily phone updates from her doctors. The rest of the time you pray the phone does not ring, for fear it will be THE CALL. The call you dread, the call that will change your life forever.

This nightmare that my wife and I lived through is being experienced by thousands of our fellow Americans every day. But it doesn't have to be that way. There is a drug that has proven to help people that are in the very situation that my wife was in....intubated and in critical condition.

Leronlimab is a monoclonal antibody owned by an American company called Cytodyn. It has yet to be approved for Covid19 treatment by our FDA. In a recent phase 3 trial, Leronlimab reduced mortality in this group by 82%.

This drug has saved the lives of countless Covid patients with one foot already in the grave, and numerous medical papers have been published documenting as much. Use of Leronlimab has resulted in zero serious adverse events in this trial and numerous previous trials. And yet, our FDA sits on its hands while our fellow Americans are dying each and every day.

There is not enough Leronlimab available to treat the entire world, and while our FDA fiddles, other countries are looking into acquiring quantities of Leronlimab for their citizens. Will the FDA be held accountable if this drug winds up saving lives in the Philippines, Brazil, Canada, the U.K.....instead of the United States?

My wife is one of the lucky ones. I was able to get Leronlimab for her under the FDA's paperwork laden Emergency Investigational New Drug procedure. She was not expected to survive, but she did. Not only that, she was also able to wean off the ventilator. She is home now, working to regain her strength and happy to be alive.

During the EIND process, FDA employees told my wife's doctor that they were not sure Leronlimab would benefit her, but they were confident that it would not harm her. Is there any reason, therefore, not to make this drug available to American patients and doctors RIGHT NOW?!

What is the FDA waiting for?

To our Food and Drug Administration, I pray that you approve this drug and make a survival story like ours possible for thousands of our fellow Americans.

Please do your job!

Mark S, Jamestown ND

CORPORATE PRESENTATION

CORPORATE PRESENTATION
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Former President of the Philippines Receiving Leronlimab

Former President of the Philippines Receiving Leronlimab
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The FDA Should Issue an EUA Now

The FDA Should Issue an EUA Now
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Hope for Critically Ill Covid-19 Patients-Hanging on a pValue

On March 29th, CytoDyn Inc., a small US biotech, released results from a Covid-19 study indicating an unprecedented 82% reduction in death measured at Day 14 in a group of 62 critically ill patients (ie, on a ventilator) who received a drug called leronlimab compared with a placebo. This marks the first time any therapy has demonstrated a signal of improving survival in this patient population in a randomized, doubleblind, placebo-controlled study, the gold-standard of clinical medicine. This striking result aligns with published reports of other critically ill Covid-19 patients successfully treated with leronlimab under compassionate use programs.

Unfortunately, this is where things get a bit complicated. The “pvalue”, or test of statistical significance of the 82% survival benefit, was reported as 0.023 which, being less than 0.05, would normally indicate the result had a less than 1 in 20 chance of having randomly occurred. However, the critically ill patients were only a “subgroup” within the larger CytoDyn study. In order to prove the claim, CytoDyn will need to enroll a new study of just critically ill patients that will take months to complete. In the meantime, the FDA has refused to approve CytoDyn’s request for an Emergency Use Authorization (EUA). The consequences of this decision for critically ill Covid -19 patients, their ICU medical teams, and the US economy during a potential 4th wave of infection due to mutant strains of virus could be disastrous.

The FDA is given the authority and flexibility to exercise judgement and grant an EUA in the setting of an urgent unmet medical need when available evidence suggests the potential benefit of a treatment outweighs its potential risk. The agency has granted EUAs for other Covid-19 therapies that are thought to directly attack the virus but are potentially effective only if given early in the course of illness. None of the antiviral therapies have proven to help patients during the latter or “hyperinflammatory” stage of the illness during which a disordered immune response, rather than the virus itself, appears to drive complications including death. Dexamethasone, a potent steroid, is thought to help but has not been tested in a double-blind, placebocontrolled trial in this patient population. In contrast to antiviral approaches, leronlimab is a monoclonal antibody that treats the latter stages of Covid-19 illness including Covid pneumonia by disrupting the signaling within the body that brings inflammatory cells into the lungs and other tissues. Importantly, since the proposed mechanism of action is independent of the virus, leronlimab should remain effective in patients harboring mutant strains.

On the other side of the EUA calculation is the important question of safety. Here too, the FDA’s inaction is difficult to understand. Leronlimab has been safely administered to more than 1200 patients, including patients in studies of HIV, cancer, and Covid-19. Some patients with HIV have received the drug by injection under the skin weekly for up to six years without any discernable safety issues.

Crucial questions remain. The survival benefit in the CytoDyn study disappointedly tapered off from 82% compared to placebo at Day 14 down to 24% at Day 28. The tapering of benefit may have occurred because patients were not given the drug for the final two weeks of the study per FDA guidance. What will overall survival be when critically ill patients are permitted to receive the full 4 weeks of dosing as originally proposed? Studies are underway to answer these urgent questions. In the meantime, the future of the pandemic remains deeply uncertain. Even as the US starts to reopen, we are confronting a growing surge of mutant strains that appear to be more infectious, possibly more lethal, and likely a greater threat to younger individuals. The FDA has the authority and mandate to act with common sense in a crisis. Janet Woodcock, the acting Commissioner of the FDA, has opined on “the cost of failing to approve an effective therapy” when “there may be thousands of lives to be lost if you delay.” Commissioner Woodcock tellingly added “people say they want placebo-controlled trials, but I always ask them would you be willing to die to give a p-value?”

The current evidence is clear: leronlimab is safe and can save the lives of critically ill patients with Covid-19. The FDA should issue an EUA now while further studies are completed. Hope and relief for the sickest and most vulnerable among us cannot be held hostage to a p-value any longer.

Jacob Lalezari, MD, Medical Director, Quest Clinical Research, San Francisco, CA

Nicholas Agresti, MD, Southeast Georgia Health, Brunswick, GA

Harish Seethamraju, MD,Professor of Medicine, Pulmonary Critical Care, Mount Sinai School of Medicine

Leronlimab SAVES LIVES

Leronlimab SAVES LIVES
Leronlimab SAVES LIVES

US FDA Phase 3 Clinical Trials were completed in December 2020.

Over 100,000 Americans have died with Covid and unable to try Leronlimab.

WHY??

Leronlimab SAVES Woman's Life

Experimental COVID treatment may have saved ND woman's life; husband wants more to receive it
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Dr.Jay Lalezari, MD Update on Leronlimab

Dr.Jay Lalezari, MD Update on Leronlimab
Dr. Jacob Lalezari, MD is a internal medicine specialist in San Francisco, CA. He currently practices at QUEST CLINICAL RESEARCH. Dr. Lalezari is board certified in Internal Medicine.
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FDA/Big Pharma Corruption Exposed

FDA/Big Pharma Corruption Exposed
The curious case of Leronlimab and the FDA
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Brazil Phase 3 Trial with 4 IV Doses

Brazil Phase 3 Trial with 4 IV Doses
FINALLY, a 4 dose trial giving an adequate amount of Leronlimab to knock out Covid in Critically Ill Patients. Hospital Israelita Albert Einstein, São Paulo Brazil.
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Updates on Leronlimab from Philippines

Updates on Leronlimab - A monoclonal antibody used to treat Covid-19 patients under CSP
Nader Pourhassan, Ph.D.
Scott Kelly, MD
Otto Yang, MD
Richard Nicolas, MD
Francis Gomez, MD
Peter Chua, MD

Samantha Mottet Open Letter to FDA

Samantha Mottet Open Letter to FDA
(Editor's note) No one has ever died from #LERONLIMAB. Can't be said about the vaccine.

Monoclonal antibody prevents HIV infection in monkeys, study finds

Monoclonal antibody prevents HIV infection in monkeys, study finds
Leronlimab to be studied as potential HIV PrEP drug in an early human clinical trial
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Leronlimab: The Little Drug That Could

Leronlimab: The Little Drug That Could

Leronlimab: Positive Preliminary Results from Long-Haulers Trial

Leronlimab: Positive Preliminary Results from Long-Haulers Trial
Clinically meaningful improvements in leronlimab over placebo were observed for cough, stuffy/runny nose, shortness of breath, tightness of chest, feeling of fast heartbeat, fatigue, muscle aches/cramps, muscle weakness, joint pain/swelling, chills/shivering, feeling hot or feverish, difficulty in concentration, sleep disturbance/insomnia, headache, dizziness, tingling/numbness, sense of taste, and sense of smell.
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Connecting the Dots on CytoDyn’s Valuation

Connecting the Dots on CytoDyn’s Valuation
"... myopically focused on the short term perspective and lack the patience to see the amazing endgame that is unfolding."
"The company also has an excellent possibility of receiving 2 Breakthrough Therapy Designation’s (BTD) in cancer and in COVID-19 Long-Haulers well before the end of the year."
“There are none so blind as those who do not wish to see.”
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CytoDyn (CYDY) at Crossroads: Past and Current Leadership Collide in Epic Grudgematch

CytoDyn (CYDY) at Crossroads: Past and Current Leadership Collide in Epic Grudgematch
"The 13-D group includes old hands such as Pestell and Carrociolla, the very people that arguably were responsible for a considerable amount of dilution and missteps."
"The 13-D group seems ill-equipped to manage the Company and had very blatant ulterior motivations that would undermine shareholder equity"
"While the 13-D group is very vocal they have gained no traction and have managed to irritate the longs that see them no better than the shorts."
“...the 13-D group could repeat many of the mistakes of the past that lead to more delays and more dilution.”
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CytoDyn’s Robust Platform Technology Keeps Expanding Into Breakthrough Therapy Designation Territory

CytoDyn’s Robust Platform Technology Keeps Expanding Into Breakthrough Therapy Designation Territory
"Looking back over the last 12 to 18 months investors have witnessed CytoDyn move from being a one trick pony for HIV to a platform technology in cancer and a slew of other indications in the immunological category, with more in the future."
"Leronlimab has 9 clinical trials on clinicaltrial.gov, 7 of which were started in 2020 including the cancer basket trial, metastatic Triple Negative Breast Cancer (mTNBC), NASH, Long-Haulers and Covid-19. Most of these have results coming out this year."
"Multiple Cancer Indications"
"Rising NASH Leader"
"HIV Franchise Forming"
"Possibilities seem endless with CCR5 implicated in strokes, Alzheimer’s, Parkinson’s, Lyme disease, MS and many other diseases."
"CYDY is building a platform drug that has the potential of surpassing HUMIRA’s revenues ($19.83 billion)."
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ANVISA approved, on this date, the start of phase 3 clinical study of the monoclonal antibody leronlimab in Brazil

ANVISA approved, on this date, the start of phase 3 clinical study of the monoclonal antibody leronlimab in Brazil
"The trial, which will be carried out in 35 brazilian research centers with 612 patients who are hospitalized and in need of oxygenation support, aims to prevent the disease from evolving into a more severe case, requiring invasive mechanical ventilation."
"Leronlimab acts to prevent an excessive immune system response in patients infected with the new coronavirus, reducing the overproduction of inflammatory cytokines, also known as “cytokine storms”. This inflammatory storm, which significantly aggravates the clinical condition, can often lead to the patient's death."
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Rio Times Brazil - Brazil’s health regulator authorizes Biomm to conduct phase 3 trials of anti-Covid drug

Rio Times Brazil - Brazil’s health regulator authorizes Biomm to conduct phase 3 trials of anti-Covid drug
Trials will be conducted in 35 centers and will involve 612 Covid-19 diagnosed patients who are hospitalized and requiring oxygen support.
The goal of the drug is to prevent the disease from evolving into a more severe condition that requires invasive mechanical ventilation.
Leronlimab is a biological drug and acts to prevent an excessive response from the immune system of patients infected with the novel coronavirus, thereby reducing the overproduction of inflammatory cytokines, also known as "cytokine storm."
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How Leronlimab Works

How Leronlimab Works
Leronlimab Mechanism of Action Against COVID 19
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Valor Globo Brazil - Anvisa authorizes Biomm to carry out a phase 3 drug study against covid-19

Valor Globo Brazil - Anvisa authorizes Biomm to carry out a phase 3 drug study against covid-19
The survey will be conducted in 35 centers and will involve 612 patients with covid-19 who are hospitalized and in need of oxygen support
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CNN Brazil - Covid-19: Anvisa authorizes a clinical study with the monoclonal antibody leronlimab

CNN Brazil - Covid-19: Anvisa authorizes a clinical study with the monoclonal antibody leronlimab
The survey evaluates the use of the drug in the treatment of patients with pneumonia caused by Covid-19
The investigation will be carried out in 35 research centers with 612 patients who are hospitalized and in need of oxygen support. The purpose of the drug, according to the pharmacist, is to prevent the disease from evolving into a more serious case, requiring invasive mechanical ventilation.
Leronlimab acts to prevent an excessive immune system response in patients infected with the new coronavirus, reducing the overproduction of inflammatory cytokines, also known as "cytokine storms". "This inflammatory storm, which significantly aggravates the clinical condition, can often lead the patient to death," says Biomm.
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ClinicalTrials.gov - Leronlimab in Moderatelly Ill Patients With COVID-19 Pneumonia

ClinicalTrials.gov - Leronlimab in Moderatelly Ill Patients With COVID-19 Pneumonia
ClinicalTrials.gov Identifier: NCT04901676
Sponsor: Hospital Israelita Albert Einstein
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Leronlimab Provides a Significant Survival Benefit in Metastatic Triple-Negative Breast Cancer

Leronlimab Provides a Significant Survival Benefit in Metastatic Triple-Negative Breast Cancer
Leronlimab yielded a notable increase in overall survival and progression-free survival in patients with metastatic triple-negative breast cancer.
The use of leronlimab (PRO 140) in patients with metastatic triple-negative breast cancer (mTNBC) resulted in a notable increase in both overall survival (OS) and progression-free survival (PFS), according to a press release on a phase 1b/2 trial (NCT04313075) from CytoDyn
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FLORIDA: Monoclonal Antibody Therapy Treatments Available Now

FLORIDA: Monoclonal Antibody Therapy Treatments Available Now
Monoclonal Antibody Treatments (MAB) for COVID-19 can prevent severe illness, hospitalization and death among high-risk individuals. This treatment is available widely in Florida.
Monoclonal antibody treatments can prevent severe illness, hospitalization and death in high-risk patients who have contracted or been exposed to COVID-19. These treatments are widely available in Florida.
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Leronlimab & COVID-19 long haulers

Leronlimab & COVID-19 long haulers
On the US West Coast, CytoDyn is testing its CC-motif chemokine receptor 5 (CCR5) antagonist leronlimab, a humanized IgG4 monoclonal antibody, in a phase 2 trial
Leronlimab has already been tested in a phase 2b/3 clinical trial as add-on therapy for respiratory illness in patients critically ill with COVID-19
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Leronlimab & Emerging Growth Conference 10/13/2021

Leronlimab & Emerging Growth Conference 10/13/2021
Keynote speakers:
Dr. Nader Pourhassan, President / CEO
Dr. Scott Kelly, Chief Med. Officer.

Leronlimab & Dr. Richard Nicholas, Sec. Greco Belgica

Leronlimab & Dr. Richard Nicholas, Sec. Greco Belgica
Dr. Richard Nicholas talks about his research & experience with #Leronlimab and treating Philippines Sec. Greco Belgica
This is an excerpt video. Full Video

Diagnosed With Covid? Follow These Steps - Dr. Gary Sy

Diagnosed With Covid? Follow These Steps - Dr. Gary Sy
Gary S. Sy, popularly known as Dr. Gary Sy, is a renowned medical practitioner, former television host and health columnist of Manila Bulletin and People's Journal, and author in the Philippines. He is one of the few doctors specializing in Geriatric Medicine in the country.

Share this website! What is your PLAN B?

What is your PLAN B?
Are you worried about Covid?
Vaccine or no vaccine?
Mask or no mask?
Social distancing?
What if you do all that and STILL get Covid?
What is your PLAN B?

Well we have some good news for you!
There is an exciting new therapeutic drug for Covid
It's called Leronlimab
This short video will introduce you to the new drug and a website with tons of information that you can learn about it.

The website is getLeronlimab.com
Share this website & videos with your friends, family & doctors.

Remember, don't fear Covid
Learn about LL and prepare your Plan B Action Plan
Learn About Monoclonal Antibodies (mabs)

JAMA Monoclonal Antibodies for COVID-19

What Is a Monoclonal Antibody?
"Monoclonal antibodies, designed to mimic the body’s natural immune response, are available as treatment for COVID-19 for patients at high risk of progression to severe disease."

"There are several approved treatments for coronavirus disease 2019 (COVID-19) in hospitalized patients but few for patients who are not sick enough to be hospitalized. Monoclonal antibodies are a new treatment for outpatients with COVID-19 who are at risk of progression to severe disease."

JAMA Patient Page February 5, 2021
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How Monoclonal Antibodies are Made

Learn about Hybridoma technology
TALK TO YOUR DOCTOR ABOUT LERONLIMAB
This website is not giving any medical advice.

TALK TO YOUR DOCTOR ABOUT LERONLIMAB

Do your own due diligence and learn about Leronlimab.
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