Here is how I understand the results
And ohm or somebody please correct me if I'm wrong.
Cytodyn is running a phase 1/2 using leronlimab plus carboplatin (a standard chemo drug) with no placebo because these are cancer patients. There are 48 patients in the study. This is the dose escalation phase so 3 patients are given 350mg and if no issues the dose is increased for the next 3 patients up to 750mg.
There is also a compassionate use study in 30 patients going on. This trial allows doctors to use one of eight chemo drugs, including carboplatin, along with leronlimab at 350mg.
Of 30 patients taken from these two studies, we don't know the breakdown from each, 22 showed a reduction in circulating tumor cells.
This is the part I'm not sure about: Those 22 showed the big increases in the ratio(?) of modified progression-free survival to 12 month progression-free survival and in the ratio of modified overall survival to 12 month modified survival.
I'm not sure about the ratio part but that's what the PR seems to suggest to me
I believe the use of modified means that disease progression or deaths within 3 months of the beginning of the trial are not factored in to the analysis so as to give the treatment time to work.
So what does this mean exactly? It's hard to say. If it's correct that they are using a ratio, it's saying that, given time to work, leronlimab seems to be showing a showing a significant effect. The one issue is that we don't know how standardized the drug used with leronlimab is without knowing how many patients were from each study.
But these are very preliminary results, which hopefully bode well for the future. A big part of it is about the testing of circulating tumor cells, leronlimab's ability to reduce them and about correlating that reduction to positive clinical outcomes. Surely that will continue to be a focus of the medical team and hopefully will be something that can be shown to be a strong correlation, which would be great for leronlimab and the cancer community as a whole but, again, all of this is very preliminary.
And ohm or somebody please correct me if I'm wrong.
Cytodyn is running a phase 1/2 using leronlimab plus carboplatin (a standard chemo drug) with no placebo because these are cancer patients. There are 48 patients in the study. This is the dose escalation phase so 3 patients are given 350mg and if no issues the dose is increased for the next 3 patients up to 750mg.
There is also a compassionate use study in 30 patients going on. This trial allows doctors to use one of eight chemo drugs, including carboplatin, along with leronlimab at 350mg.
Of 30 patients taken from these two studies, we don't know the breakdown from each, 22 showed a reduction in circulating tumor cells.
This is the part I'm not sure about: Those 22 showed the big increases in the ratio(?) of modified progression-free survival to 12 month progression-free survival and in the ratio of modified overall survival to 12 month modified survival.
I'm not sure about the ratio part but that's what the PR seems to suggest to me
I believe the use of modified means that disease progression or deaths within 3 months of the beginning of the trial are not factored in to the analysis so as to give the treatment time to work.
So what does this mean exactly? It's hard to say. If it's correct that they are using a ratio, it's saying that, given time to work, leronlimab seems to be showing a showing a significant effect. The one issue is that we don't know how standardized the drug used with leronlimab is without knowing how many patients were from each study.
But these are very preliminary results, which hopefully bode well for the future. A big part of it is about the testing of circulating tumor cells, leronlimab's ability to reduce them and about correlating that reduction to positive clinical outcomes. Surely that will continue to be a focus of the medical team and hopefully will be something that can be shown to be a strong correlation, which would be great for leronlimab and the cancer community as a whole but, again, all of this is very preliminary.
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