I sent this email to a Washington Post science writer. It is not brief as was suggested, but hopefully will be read nonetheless. My brother is good friend a major WaPost columnist, so I sent this to him to work the back channel to the WaPost science and news staff. Fingers crossed.
I am writing to you after reading your Washington Post article examining vaccine development for Covid-19.
There are hundreds of vaccines and therapeutics in development for Covid-19, to date none with significant clinical effect. However, Leronlimab is a monoclonal antibody (mAb) with demonstrated efficacy in treating Covid-19 disease and the associated cytokine storm of immune dysregulation. A clinical trial of Leronlimab is complete for the mild/moderate patient population. This trial demonstrated clinical and statistical significance and a request has been submitted to the FDA for Emergency Use Authorization.
Leronlimab blocks the binding site of the CCR5 receptor on macrophages, t-lymphocytes, and eosinophils. This stops chemotaxic trafficking of immune cells to areas of inflammation, halting the inflammatory cascade and the cytokine storm. Furthermore, blocking of CCR5 repolarizes macrophages and reverses exhaustion of CD8 lymphocytes, permitting normal immune function and resumption of antiviral activity through natural killer T-cells and granzyme-A antiviral production.
Former Stamford University Virologist Dr. Bruce Patterson in a manuscript from May 5 titled has described this mechanism of Leronlimab:
Disruption of the CCL5/RANTES-CCR5 Pathway Restores Immune Homeostasis and Reduces Plasma Viral Load in Critical COVID-19
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7277012/
Cytodyn, the maker of Leronlimab has submitted top line data from a double blinded, placebo-controlled study to the FDA for Leronlimab. Leronlimab demonstrates statistically significant improvement in NEWS2 (National Early Warning Score), a widely accepted UK clinical metric for measuring the progression of COVID into the severe/critical phase. (P=0.02). Leronlimab increased the number of patients who showed clinical improvement in the NEWS2 score, by 150%.
Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
https://clinicaltrials.gov/ct2/show/NCT043436...amp;rank=3
In addition, Leronlimab has demonstrated reduced mortality in the severe/critical population in over 70 EIND patients. A phase 3 trial is ongoing for this population, with an interim analysis of the data due in the coming weeks.
Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)
https://clinicaltrials.gov/ct2/show/NCT043472...amp;rank=4
Cytodyn is a small biotech company, which does not yet have an FDA approval in any indication, so with cessation of EIND authorization Leronlimab is unavailable to patients outside of clinical trial sites.
Please research Cytodyn, and reach out to the company for more information.
www.cytodyn.com
Nader Pourhassan, PhD CEO npourhassan@cytodyn.com
Scott Kelly, MD CMO skelly@cytondyn.com
I am writing to you after reading your Washington Post article examining vaccine development for Covid-19.
There are hundreds of vaccines and therapeutics in development for Covid-19, to date none with significant clinical effect. However, Leronlimab is a monoclonal antibody (mAb) with demonstrated efficacy in treating Covid-19 disease and the associated cytokine storm of immune dysregulation. A clinical trial of Leronlimab is complete for the mild/moderate patient population. This trial demonstrated clinical and statistical significance and a request has been submitted to the FDA for Emergency Use Authorization.
Leronlimab blocks the binding site of the CCR5 receptor on macrophages, t-lymphocytes, and eosinophils. This stops chemotaxic trafficking of immune cells to areas of inflammation, halting the inflammatory cascade and the cytokine storm. Furthermore, blocking of CCR5 repolarizes macrophages and reverses exhaustion of CD8 lymphocytes, permitting normal immune function and resumption of antiviral activity through natural killer T-cells and granzyme-A antiviral production.
Former Stamford University Virologist Dr. Bruce Patterson in a manuscript from May 5 titled has described this mechanism of Leronlimab:
Disruption of the CCL5/RANTES-CCR5 Pathway Restores Immune Homeostasis and Reduces Plasma Viral Load in Critical COVID-19
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7277012/
Cytodyn, the maker of Leronlimab has submitted top line data from a double blinded, placebo-controlled study to the FDA for Leronlimab. Leronlimab demonstrates statistically significant improvement in NEWS2 (National Early Warning Score), a widely accepted UK clinical metric for measuring the progression of COVID into the severe/critical phase. (P=0.02). Leronlimab increased the number of patients who showed clinical improvement in the NEWS2 score, by 150%.
Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
https://clinicaltrials.gov/ct2/show/NCT043436...amp;rank=3
In addition, Leronlimab has demonstrated reduced mortality in the severe/critical population in over 70 EIND patients. A phase 3 trial is ongoing for this population, with an interim analysis of the data due in the coming weeks.
Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)
https://clinicaltrials.gov/ct2/show/NCT043472...amp;rank=4
Cytodyn is a small biotech company, which does not yet have an FDA approval in any indication, so with cessation of EIND authorization Leronlimab is unavailable to patients outside of clinical trial sites.
Please research Cytodyn, and reach out to the company for more information.
www.cytodyn.com
Nader Pourhassan, PhD CEO npourhassan@cytodyn.com
Scott Kelly, MD CMO skelly@cytondyn.com
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