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For those who did not go to reddit to look at the post, the original poster posted this quote by Dr. JL in addition to the link:
@ 26:14. “So, what is the next study that CytoDyn can do to come off clinical hold and generate data that is not ambiguous and that tests this hypothesis around its activity affecting signaling around CCR5? The consensus with the HIV consultants has been that we circle back to HIV, but instead of looking at leronlimab as an antiviral we are looking now at leronlimab as a modulator of immune activation. Is that a relevant end point? It is. Because immune activation inflammation is the primary driver of mortality in HIV patients: Strokes, heart attacks, and kidney disease. It is unfortunately a much more difficult endpoint to assess than simply following an HIV viral load, but it is in the wheelhouse of what we believe leronlimab is capable of. So, the proposed next study is to look at leronlimab in HIV+ ambulatory subjects (we know it is safe in that group) in individuals who demonstrate elevations of immune activation levels, so known evidence of immune activation and inflammation, and tentatively looking at both doses (350 and 700) and looking at a nested placebo arm, so that at the end of 24 weeks of treatment we can at least get a real measurement of whether leronlimab has moved the needle there or not. I think that is a study that the FDA is going to have a hard time not wanting to see done. There is currently no therapy for immune activation in HIV. Half of the patients we are going to enroll are going to be transgender women who have elevated activation markers because of the hormonal therapy they are taking, and in fact what I had mentioned earlier is that the FDA, having received the protocol, has asked if they can cross reference the IND file for NASH -- which is exactly the right question to be asking which is ‘what other evidence do we have that leronlimab is mediating inflammation and immune activation?' So that is what we are waiting to hear, and I believe the clock is ticking, and that we are expecting to hear one way or another from the FDA in the next two weeks and from there we are either off clinical hold and we are raising money and we are launching this study, or we are dealing with whatever else is being sent our way.”
Webinar Not Available
This webinar or its recording was removed. Please contact the organizer for more information.
For those who did not go to reddit to look at the post, the original poster posted this quote by Dr. JL in addition to the link:
@ 26:14. “So, what is the next study that CytoDyn can do to come off clinical hold and generate data that is not ambiguous and that tests this hypothesis around its activity affecting signaling around CCR5? The consensus with the HIV consultants has been that we circle back to HIV, but instead of looking at leronlimab as an antiviral we are looking now at leronlimab as a modulator of immune activation. Is that a relevant end point? It is. Because immune activation inflammation is the primary driver of mortality in HIV patients: Strokes, heart attacks, and kidney disease. It is unfortunately a much more difficult endpoint to assess than simply following an HIV viral load, but it is in the wheelhouse of what we believe leronlimab is capable of. So, the proposed next study is to look at leronlimab in HIV+ ambulatory subjects (we know it is safe in that group) in individuals who demonstrate elevations of immune activation levels, so known evidence of immune activation and inflammation, and tentatively looking at both doses (350 and 700) and looking at a nested placebo arm, so that at the end of 24 weeks of treatment we can at least get a real measurement of whether leronlimab has moved the needle there or not. I think that is a study that the FDA is going to have a hard time not wanting to see done. There is currently no therapy for immune activation in HIV. Half of the patients we are going to enroll are going to be transgender women who have elevated activation markers because of the hormonal therapy they are taking, and in fact what I had mentioned earlier is that the FDA, having received the protocol, has asked if they can cross reference the IND file for NASH -- which is exactly the right question to be asking which is ‘what other evidence do we have that leronlimab is mediating inflammation and immune activation?' So that is what we are waiting to hear, and I believe the clock is ticking, and that we are expecting to hear one way or another from the FDA in the next two weeks and from there we are either off clinical hold and we are raising money and we are launching this study, or we are dealing with whatever else is being sent our way.”
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