New interview with Dr. Lalezari, CEO of Quest Clin
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Posted On: 04/13/2020 3:50:55 PM
New interview with Dr. Lalezari, CEO of Quest Clinical Research and with NP. Here are the highlights:
- Dr. L has been working with hundreds of studies on HIV. Very active with most HIV drug tests sent to FDA.
- Has worked with Nader for 10 years
- 800+ patients on Leronlimab have shown it is safe
- Some Cytodyn patients that have been treated at his labs have now been successfully treated for 5/6 years
- Recent activities has been in breast cancer. Leronlimab in mTNBC has been shown to be safe again. Early signs indicate tumor size reductions and CTC counts dropping to zero.
- Same MOA should be applicable to the corona virus pandemic. Initial virus infection results in subsequent injury to the lungs. Immune response to this attack triggers the cytokines storm which kills.
- Lab results of emergency treated patients show that Leronlimab reduces the cytokines levels, restores normal immune hemostasis and severe immune suppression, all in 3 days! This is what allows patients to recover and get off of the oxygen and ventilators.
- Of course FDA needs to see the POC via a double blinded placebo trial. 75 patients is a fairly small test population. 50 will get Leronlimab and 25 placebo.
- NP said, for POC, 75 patient trial, 12 already enrolled in 2 sites. 3 more sites coming on tomorrow. Expect all 75 patients enrollment in 2 more weeks.
- DID NOT SAY, how much longer after that to complete the trial, gather all the data, prepare reports and further, how long will the FDA take to review.
Clearly the FDA needs this test to be completed before the next steps. Yes, there maybe interim data sets, e.g. after 50 patients, that will be presented to the FDA. I think this will help the eventual understanding by the FDA but they will wait for the final 75 patient data report before any action (partly for safety and partly for ensuring other companies do not expect short cuts either). IMO.
- Dr. L has been working with hundreds of studies on HIV. Very active with most HIV drug tests sent to FDA.
- Has worked with Nader for 10 years
- 800+ patients on Leronlimab have shown it is safe
- Some Cytodyn patients that have been treated at his labs have now been successfully treated for 5/6 years
- Recent activities has been in breast cancer. Leronlimab in mTNBC has been shown to be safe again. Early signs indicate tumor size reductions and CTC counts dropping to zero.
- Same MOA should be applicable to the corona virus pandemic. Initial virus infection results in subsequent injury to the lungs. Immune response to this attack triggers the cytokines storm which kills.
- Lab results of emergency treated patients show that Leronlimab reduces the cytokines levels, restores normal immune hemostasis and severe immune suppression, all in 3 days! This is what allows patients to recover and get off of the oxygen and ventilators.
- Of course FDA needs to see the POC via a double blinded placebo trial. 75 patients is a fairly small test population. 50 will get Leronlimab and 25 placebo.
- NP said, for POC, 75 patient trial, 12 already enrolled in 2 sites. 3 more sites coming on tomorrow. Expect all 75 patients enrollment in 2 more weeks.
- DID NOT SAY, how much longer after that to complete the trial, gather all the data, prepare reports and further, how long will the FDA take to review.
Clearly the FDA needs this test to be completed before the next steps. Yes, there maybe interim data sets, e.g. after 50 patients, that will be presented to the FDA. I think this will help the eventual understanding by the FDA but they will wait for the final 75 patient data report before any action (partly for safety and partly for ensuring other companies do not expect short cuts either). IMO.
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