Good Saturday morning.
A not so quick recap of where we stand with Leronlimab.
Cytodyn released a PR Monday which, IMO foretells regulatory approval coming within three weeks from MHRA, FDA and Health Canada.
Quote:
CytoDyn in Discussions with U.S. FDA, MHRA and Health Canada After Unblinding its CD12 Trial Data for Severe-to-Critically Ill COVID-19 Patients
Quote:
CD12 COVID-19 trial data has been unblinded and the results will be reported when the Company has concluded its ongoing discussions with regulators.
Quote:
We are eager to reach conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks.” Details of the Company’s ongoing discussions with the regulatory agencies are confidential.
This followed resumption of EINDs and addition of open label administration at CD12 trial sites, administration which has continued AFTER the FDA received unblinded CD12 data:
Quote:
FDA Accepts Protocol for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients
The agency also provided specific guidance for inclusion/exclusion criteria for patients seeking leronlimab under eIND authorization
The CD12 trial was completed after DSMB interim analysis with trial recommended to continue to completion without modification. Cytodyn announcing:
Quote:
. CytoDyn Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial
DSMC recommends CytoDyn continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint
The CD12 trial for severe/critical Covid has an apparent observed mortality of 22%, when recently completed trials of other immunomodulators had mortality of 30% or more. The difference IMO, the decreased mortality of the 2/3 of patients who were treated with leronlimab.
The CD10 trial, despite claims of “failure” reduced NEWS2 scores (clinical deterioration), 55% of leronlimab treated patients had improved scores versus 23% in placebo (p<0.023)
SAEs were reduced from and incidence of 39% in placebo to 14% in CD10, a reduction of 64%.
These trials, of course, followed and were guided by the experience of 65 patients treated under EIND in the spring, with >50% intubated yet mortality under 25% at a time ICU mortality was over 50%.
Finally, let’s not forget the observations of Dr. Patterson in his analysis of the Montefiore EIND cohort.
Anti-CCR5 humanized monoclonal antibody restored CD8 counts in COVID patients.
CD8 levels inversely correlated with decreases in plasma viral load (pVL) by day 14 (p=0.0013)
CCL5/RANTES up 3–5-fold in mild/moderate patients and >100-fold in critical ones.
First report of highly sensitive, quantitative pVL by ddPCR in COVID patients.
Statistically significant drop in IL-6 by day 14 of treatment.
Better days lie just ahead for Covid patients in need.
GLTA
A not so quick recap of where we stand with Leronlimab.
Cytodyn released a PR Monday which, IMO foretells regulatory approval coming within three weeks from MHRA, FDA and Health Canada.
Quote:
CytoDyn in Discussions with U.S. FDA, MHRA and Health Canada After Unblinding its CD12 Trial Data for Severe-to-Critically Ill COVID-19 Patients
Quote:
CD12 COVID-19 trial data has been unblinded and the results will be reported when the Company has concluded its ongoing discussions with regulators.
Quote:
We are eager to reach conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks.” Details of the Company’s ongoing discussions with the regulatory agencies are confidential.
This followed resumption of EINDs and addition of open label administration at CD12 trial sites, administration which has continued AFTER the FDA received unblinded CD12 data:
Quote:
FDA Accepts Protocol for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients
The agency also provided specific guidance for inclusion/exclusion criteria for patients seeking leronlimab under eIND authorization
The CD12 trial was completed after DSMB interim analysis with trial recommended to continue to completion without modification. Cytodyn announcing:
Quote:
. CytoDyn Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial
DSMC recommends CytoDyn continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint
The CD12 trial for severe/critical Covid has an apparent observed mortality of 22%, when recently completed trials of other immunomodulators had mortality of 30% or more. The difference IMO, the decreased mortality of the 2/3 of patients who were treated with leronlimab.
The CD10 trial, despite claims of “failure” reduced NEWS2 scores (clinical deterioration), 55% of leronlimab treated patients had improved scores versus 23% in placebo (p<0.023)
SAEs were reduced from and incidence of 39% in placebo to 14% in CD10, a reduction of 64%.
These trials, of course, followed and were guided by the experience of 65 patients treated under EIND in the spring, with >50% intubated yet mortality under 25% at a time ICU mortality was over 50%.
Finally, let’s not forget the observations of Dr. Patterson in his analysis of the Montefiore EIND cohort.
Anti-CCR5 humanized monoclonal antibody restored CD8 counts in COVID patients.
CD8 levels inversely correlated with decreases in plasma viral load (pVL) by day 14 (p=0.0013)
CCL5/RANTES up 3–5-fold in mild/moderate patients and >100-fold in critical ones.
First report of highly sensitive, quantitative pVL by ddPCR in COVID patients.
Statistically significant drop in IL-6 by day 14 of treatment.
Better days lie just ahead for Covid patients in need.
GLTA
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