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Posted On: 03/05/2024 1:52:52 PM
Post# of 148863
According to Dr. Lalezari today:
Quote:
The inflammation study will be a randomized double-blind placebo controlled trial comparing two doses of Leronlimab in 90 study subjects. The study will enroll 45 disgender men and women and 45 transgender women. The subjects will become eligible to participate in the study after demonstrating evidence of chronic inflammation extreming as determined by elevated levels of C reactive protein or CRP.
Eligible subjects will then be randomized either 350 or 700 mg of weekly subterfuge Leronlimab or placebo and treated for 24 weeks.
The current primary endpoints for the study are C reactive protein and another biomarker of inflammation called En-rage, both of which we believe showed earlier signs of disarming to Leronlimab during our NAT trial. Given the exploratory nature of this study, we will also be evaluating the effect of Leronlimab on a host of other secondary biomarker endpoints as well.
I believe the inflammation study as described is the most cost effective way to clearly establish Leronlimab's biologic mechanism of action. If successful, I believe this proof of concept study would create the opportunity to intervene or partner in a host of other inflammatory conditions. Establishing proof of Leronlimab's activity as an anti- inflammatiory could also create the opportunity for CytoDyn to study its potential to reduce heart attacks, strokes and other inflammatory vascular events, which remain the number one cause of death in people living with HIV.
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