HIV Drug Leronlimab, Which Successfully Treats Coronavirus, Moving to Phase 2 Trials

2,518 Views | 7 Replies | Last: 4 yr ago by Rapier108
Rapier108
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Quote:

An experimental HIV drug that has been used to successfully treat COVID-19 patients is in its second phase of testing with the Food and Drug Administration and could potentially be approved for use in four weeks, its manufacturer says.

Leronlimab, made by the biotech company CytoDyn, was used to treat a handful of severely ill patients in New York City hospitals; a couple were able to be removed from their ventilators.

"I think the FDA will be willing to work with us," CytoDyn CEO Nader Pourhassan told The Post. "I am hoping it will be expedited I don't see how the FDA couldn't approve it."

<snip>

Initial studies suggest leronlimab can reduce the overactive immune response, known as a cytokine storm, that can be triggered by the coronavirus infection. Cytokine storms can result in pneumonia and even death.
https://nypost.com/2020/04/04/hiv-drug-that-treats-coronavirus-moving-to-phase-2-trials/
"If you will not fight for right when you can easily win without blood shed; if you will not fight when your victory is sure and not too costly; you may come to the moment when you will have to fight with all the odds against you and only a precarious chance of survival. There may even be a worse case. You may have to fight when there is no hope of victory, because it is better to perish than to live as slaves." - Sir Winston Churchill
74Ag1
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AG
Great to hear
We're gonna beat this
Aggie95
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AG
how many phases are there with vaccines and drugs? and what are each phases "called"?
Rapier108
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Aggie95 said:

how many phases are there with vaccines and drugs? and what are each phases "called"?
https://www.fda.gov/patients/drug-development-process/step-3-clinical-research

https://www.nccn.org/patients/resources/clinical_trials/phases.aspx
"If you will not fight for right when you can easily win without blood shed; if you will not fight when your victory is sure and not too costly; you may come to the moment when you will have to fight with all the odds against you and only a precarious chance of survival. There may even be a worse case. You may have to fight when there is no hope of victory, because it is better to perish than to live as slaves." - Sir Winston Churchill
culdeus
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Someone linked a rivals forum thread about this drug in an earlier post here. I'm not clear how to search on here for it. That rivals forum had much more info.
2PacShakur
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AG
With a reasonably sized phase 2, it could advance to approval with a commitment for post-marketing research and data collection. Since it's a label extension then safety data is probably reasonably characterized, and all they need to show is the drug improves outcomes.
Necrosis
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Can't wait for this drug to be unavailable in 4 weeks.
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Copperpot
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AG
COVID-19 Trial with Leronlimab
Rapier108
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Quote:

The experimental coronavirus treatment leronlimab has shown a "very promising" response in COVID-19 patients with mild-to-moderate symptoms, according to developer CytoDyn.

Leronlimab is a viral-entry inhibitor that targets HIV and breast cancer. The drug has also been attracting attention as a potential coronavirus treatment. In a statement released Monday CytoDyn gave an update on over 30 patients COVID-19 patients recently treated with leronlimab in more than 4 hospitals and clinics across the U.S. Patients have received leronlimab as part of Emergency Investigational New Drug (EINDs) treatments authorized by the FDA and two CytoDyn clinical trials.

"More than 25 patients have been administered leronlimab under EINDs authorized by the U.S. Food and Drug Administration (FDA)," the biotech explained. "Rate of response in mild-to-moderate patients under EIND has been very promising with the first five patients treated being removed from oxygen."
https://www.foxnews.com/science/experimental-coronavirus-treatment-leronlimab-very-promising-response-in-some-covid-19-patients
"If you will not fight for right when you can easily win without blood shed; if you will not fight when your victory is sure and not too costly; you may come to the moment when you will have to fight with all the odds against you and only a precarious chance of survival. There may even be a worse case. You may have to fight when there is no hope of victory, because it is better to perish than to live as slaves." - Sir Winston Churchill
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