"Since we are doing a clinical trial, for metastat
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Posted On: 07/28/2025 4:46:46 PM
Re: Buddyboy20 #155371
"Since we are doing a clinical trial, for metastatic CRC, it should be very interesting to see how our treatment performs in those patients with metastasis to the liver. This could very well segue into treating liver cancer. I'm really getting very excited about the data collected from this clinical trial."
This is an excellent observation/insight, Buddyboy. I share your excitement. Those liver tumors may end up being the most-studied, well-characterized metastatic tumors in history. If tumors can be famous... they will be!
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This brings up the general idea that leronlimab will likely help improve the health of anyone fortunate enough to take it, no matter what the initial indication it is prescribed for. (We've all thought about it!). If I was Cytodyn I'd be gathering as much peripheral data as possible--on, say, inflammatory markers--from the cancer patients that are soon going to be treated with leronlimab. Imagine the data base on five or ten thousand patients! I suspect this kind of data collection would have to be written into the trial protocols, and it would cost CYDY (or partner) some cash... but the data would be priceless. Even anecdotal observations might help the company identify and prioritize the next indications to pursue... though hard data would clearly be better.
I am wondering if we will see a hint of this in the soon-to-be-published safety review of 1600 people treated with leronlimab. My question to the scientific savants and medical people on the board--given that patients have been trialed in HIV, cancer, covid, and mash--what kind of bio-markers that are commonly tested in clinical trials that could quantify leronlimab's salutary effects on human health? Any low-hanging fruit out there?
I recall that Dr Lalezari, before the cancer news reoriented the company's priorities, talked about doing a study of inflammation in HIV patients. Cytodyn must have seen a signal in previous studies to consider that. My guess would be the HIV patients given leronlimab might be the group of people most likely to offer some sort of hard numbers to indicate positive effects on bio-markers of human health. And since the most common medical measurements--blood pressure and lipids and weight--aren't particularly relevant here... What are?
There is one obvious bio-marker, or end point if you will, that I came up with... And that would be--drum roll, please--all-cause mortality! If significantly fewer of those HIV patients on leronlimab died of cancer or atherosclerosis... well, that would be quite a signal.
(I hate to say this, but I can imagine the crew at the FDA, when they see this, just scratching their heads and going--"Jeeze... Really? What do we do with this now?"
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I remain optimistic... hopeful?... that the safety study will provide a surprise or two to the upside. As I recall, it's completed and under peer-review as we speak. And that should be published with no regards to the NDAs that we all assume Cytodyn is currently under. Certainly well worth waiting for.
This is an excellent observation/insight, Buddyboy. I share your excitement. Those liver tumors may end up being the most-studied, well-characterized metastatic tumors in history. If tumors can be famous... they will be!
* * * *
This brings up the general idea that leronlimab will likely help improve the health of anyone fortunate enough to take it, no matter what the initial indication it is prescribed for. (We've all thought about it!). If I was Cytodyn I'd be gathering as much peripheral data as possible--on, say, inflammatory markers--from the cancer patients that are soon going to be treated with leronlimab. Imagine the data base on five or ten thousand patients! I suspect this kind of data collection would have to be written into the trial protocols, and it would cost CYDY (or partner) some cash... but the data would be priceless. Even anecdotal observations might help the company identify and prioritize the next indications to pursue... though hard data would clearly be better.
I am wondering if we will see a hint of this in the soon-to-be-published safety review of 1600 people treated with leronlimab. My question to the scientific savants and medical people on the board--given that patients have been trialed in HIV, cancer, covid, and mash--what kind of bio-markers that are commonly tested in clinical trials that could quantify leronlimab's salutary effects on human health? Any low-hanging fruit out there?
I recall that Dr Lalezari, before the cancer news reoriented the company's priorities, talked about doing a study of inflammation in HIV patients. Cytodyn must have seen a signal in previous studies to consider that. My guess would be the HIV patients given leronlimab might be the group of people most likely to offer some sort of hard numbers to indicate positive effects on bio-markers of human health. And since the most common medical measurements--blood pressure and lipids and weight--aren't particularly relevant here... What are?
There is one obvious bio-marker, or end point if you will, that I came up with... And that would be--drum roll, please--all-cause mortality! If significantly fewer of those HIV patients on leronlimab died of cancer or atherosclerosis... well, that would be quite a signal.
(I hate to say this, but I can imagine the crew at the FDA, when they see this, just scratching their heads and going--"Jeeze... Really? What do we do with this now?"
. I remain optimistic... hopeful?... that the safety study will provide a surprise or two to the upside. As I recall, it's completed and under peer-review as we speak. And that should be published with no regards to the NDAs that we all assume Cytodyn is currently under. Certainly well worth waiting for.
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