Updated again OVERVIEW: A Monoclonal Antibody
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Posted On: 08/13/2020 2:09:12 PM
Updated again
OVERVIEW:
A Monoclonal Antibody (MAB), by the name of Leronlimab, has shown efficacy against COVID.
Cytodyn has recently submitted top line data from a double blinded, placebo controlled study to the FDA for Leronlimab. Leronlimab showed statistically significant improvement in NEWS2 score, a widely accepted metric for measuring the progression of COVID into the severe/critical phase. (p value .02)
In this study, Leronlimab increased the number of patients who showed clinical improvement in their NEWS2 score, by 150%. Additionally, the data showed statistically significant improvement by day 3.
In addition, Leronlimab showed anecdotal evidence of efficacy in the reducing mortality in the severe/critical population in over 70 emergency use indication patients.. A phase 3 trial is ongoing for this population, with an interim analysis of the data due in the coming weeks.
Finally, and perhaps most importantly, Leronlimab has been tested in over 1000 patients, with 0 Serious Adverse Events. This drug is safe.
Why haven’t you heard about it? Because Cytodyn is a small biotech company, that does not yet have an FDA approval in any indication. Don’t let that dissuade you, however as Leronlimab has shown early indication of efficacy in a whole host of diseases and the company is actively running trials in several of them.
We need your help to get the word out, so that this treatment can get to market and start saving lives. Please research Cytodyn, and reach out to the company for more information.
DETAIL:
8/11/2020
Primary endpoint shows early clinical improvement in symptom score. Leronlimab also demonstrated statistically significant improvement versus placebo in key secondary endpoint NEWS2 (National Early Warning Score 2 scale). Results submitted to FDA on 8/12/2020. Results being submitted to United Kingdom, European Union, Mexico and Israel for approval. https://www.cytodyn.com/newsroom/press-releas...ne-results
08/04/2020
Cytodyn receives positive DSMC recommendation for Leronlimab in Phase 3 trial, with no safety concerns. https://www.cytodyn.com/newsroom/press-releas...dation-for
7/21/2020
Leronlimab shows 64% reduction in SAE (Serious Adverse Events) in Phase 2b/3 trial vs placebo. https://www.cytodyn.com/newsroom/press-releas...ns-phase-2
www.cytodyn.com
Nader Pourhassan PhD CEO npourhassan@cytodyn.com
Scott Kelly, MD CMO skelly@cytondyn.com
Trial data may be accessed at www.clinicaltrials.gov
Note: This document was prepared by investors of Cytodyn, and not by the company. We are hoping to help the company get the attention that it needs in order to bring their life saving drug to market.
OVERVIEW:
A Monoclonal Antibody (MAB), by the name of Leronlimab, has shown efficacy against COVID.
Cytodyn has recently submitted top line data from a double blinded, placebo controlled study to the FDA for Leronlimab. Leronlimab showed statistically significant improvement in NEWS2 score, a widely accepted metric for measuring the progression of COVID into the severe/critical phase. (p value .02)
In this study, Leronlimab increased the number of patients who showed clinical improvement in their NEWS2 score, by 150%. Additionally, the data showed statistically significant improvement by day 3.
In addition, Leronlimab showed anecdotal evidence of efficacy in the reducing mortality in the severe/critical population in over 70 emergency use indication patients.. A phase 3 trial is ongoing for this population, with an interim analysis of the data due in the coming weeks.
Finally, and perhaps most importantly, Leronlimab has been tested in over 1000 patients, with 0 Serious Adverse Events. This drug is safe.
Why haven’t you heard about it? Because Cytodyn is a small biotech company, that does not yet have an FDA approval in any indication. Don’t let that dissuade you, however as Leronlimab has shown early indication of efficacy in a whole host of diseases and the company is actively running trials in several of them.
We need your help to get the word out, so that this treatment can get to market and start saving lives. Please research Cytodyn, and reach out to the company for more information.
DETAIL:
8/11/2020
Primary endpoint shows early clinical improvement in symptom score. Leronlimab also demonstrated statistically significant improvement versus placebo in key secondary endpoint NEWS2 (National Early Warning Score 2 scale). Results submitted to FDA on 8/12/2020. Results being submitted to United Kingdom, European Union, Mexico and Israel for approval. https://www.cytodyn.com/newsroom/press-releas...ne-results
08/04/2020
Cytodyn receives positive DSMC recommendation for Leronlimab in Phase 3 trial, with no safety concerns. https://www.cytodyn.com/newsroom/press-releas...dation-for
7/21/2020
Leronlimab shows 64% reduction in SAE (Serious Adverse Events) in Phase 2b/3 trial vs placebo. https://www.cytodyn.com/newsroom/press-releas...ns-phase-2
www.cytodyn.com
Nader Pourhassan PhD CEO npourhassan@cytodyn.com
Scott Kelly, MD CMO skelly@cytondyn.com
Trial data may be accessed at www.clinicaltrials.gov
Note: This document was prepared by investors of Cytodyn, and not by the company. We are hoping to help the company get the attention that it needs in order to bring their life saving drug to market.
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(1)CytoDyn Inc (CYDY) Stock Research Links
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