from a Proactive in early November 2021:
CytoDyn reveals results for cancer and NASH patients receiving its flagship drug leronlimab
Christine: Today or actually, this week, we saw results for TNBC and NASH trials. Lets first start off with TNBC. What did you see here from patients?
Nader: So the TNBC results and all the compassionate use data that patients and doctors had put quite a bit of testimony in the public had been very impressive.
The data, (I want to make sure everybody understands), there were 28 patients, not 30, (30 included 2 emergency ind patients. We took them out.) We concentrated on mTNBC. 28 patients. 10 of them were from the clinical trials, phase 1b-2, which is currently phase 2 eventually.
That trial gave us 10 patient's data. Breakthrough Designation requires 5 patient's data. That data was great. Now, what was the data from the 28 patients? When we compare that 28 patient's data with the data of standard of care, we were as good in progression free survival, (pfs) for 12 months or overall survival (os), for 12 months. But, if you look at the cc, circulating cells, which was the average/aggregate that microtechnology had to come up with as a diagnostic lab; with that test, if your cc, circulating cells in patients was lower, after induction with Leronlimab, or if it were already low, then, if we saw a completely different kind of results; and that amount, 73% were like that. So when you compared that 70% with the other 30%, the results of overall survivability, almost 3,600% better. And when you look at the progression free survival, over 400% or 500% better. Some number out of the charts.
But we are comparing the 2 Leronlimab arms. The one that lowered the circulating cell count after induction to Leronlimab, but if you look at overall, and you look at Standards of Care, which is chemotherapy, and we know from past experience, how Leronlimab, in clinical trials has demonstrated no significant toxicity, is not there; then hands down, anybody would love to have Leronlimab vs. chemotherapy. So that's why we immediately wanted to file BTD. It got delayed several times, because we kept finding that these patients had brain metastases. We looked at those patients. We realized we had another breakthrough designation that we will be filing. But we delayed it a little bit. But it will be filed by the end of this week. Today. Friday. So hopefully, we are announcing it on Monday. We have a very, very, crucial item. And 60 days later, (1/8/2022), we are very hopeful that we will get BTD.
Christine: We will look forward to that. And then how about NASH? From your Phase 2 trial?
Nader: Yeah, and again, there was a lot of talk, that the NASH data, we said, just 5 patients are open label arm. There was 60 patients, double blinded. We have an unblinded. 1/2 placebo, 1/2 Leronlimab 700mg. Dr. Recknor has added 30 patients, open arm with 350mg and open arm for means that you can see the data. So when we looked at the 1st 5 patients, their fatty deposits and fibrosis which are the 2 key biomarkers were very, very nice. Strong results, very strong results. Now, we said, the 5 patients had at most 45% fatty deposits reduction and everybody keeps saying, "the highest means maybe one of them?? was it 1%? No, the average was somewhere around 25% or so fatty deposit drop. The fibrosis, as much as 10% drop. Fibrosis is like a scar on the liver. How do you fix that? Has anybody have any data like that? So with 5 patient's data, we are preparing BTD. But, we think, the next 5 days or so, we will have 5 more patients. So, we are going to have 10 patients as part of this BTD for NASH. We believe our results, is one of the best results anybody could ever produce in this small number of patients, but all the patients, the results are coming out by the end of the month. So we are very excited, and we wanted to make sure our share holders know that the results of 350mg are really stunning.
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
Understanding the Significance of 3,600% Improvement in Overall Survival
It indicates that the 1 year Overall Survival is improved by 3,600% over Standard of Care
Let's put this in perspective: Hypothetically,
If you have 1,000 patients with mTNBC. With Standard of Care, let's say that after 1 year, 980 on average die and 20 remain. (This is for example purposes. I have no idea how many typically die and at what stage this decline begins at.)
A 3,600% improvement would make it such that, if treatment with Leronlimab was implemented, then 36 x 20 = 720. 720 would remain and 280 would die.
If fewer people than 980 typically die out of 1,000 with mTNBC, lets say 972 die and 28 remain. Then a 3,600% improvement resulting from treatment with Leronlimab leads to 36 x 28 = 1,000. Every person treated with Leronlimab survives the full year.
As I understand mTNBC, I think with Standard of Care, the average OS overall survival is about 6 months. The vast majority don't make it much past that. So, with SOC, out of a 1,000 with mTNBC, maybe 7 would still remain. Now with Leronlimab, 36 x 7 or 252 would remain and 748 would likely live much longer than they otherwise would have if Leronlimab were not used. IMO, the FDA should look very favorably on this data.
It will be very interesting to see what the 2 year, 3 year, 4 year and 5 year overall survivability will be as the time comes. This is an amazing data point and I think we will get BTD because of this.
This is a link to a post which I did comparing our mTNBC trials to Paclitaxel and the outlook for Leronlimab in treating mTNBC:
https://old.reddit.com/r/CYDY/comments/pd2vrb...for_ll_on/
CytoDyn reveals results for cancer and NASH patients receiving its flagship drug leronlimab
Christine: Today or actually, this week, we saw results for TNBC and NASH trials. Lets first start off with TNBC. What did you see here from patients?
Nader: So the TNBC results and all the compassionate use data that patients and doctors had put quite a bit of testimony in the public had been very impressive.
The data, (I want to make sure everybody understands), there were 28 patients, not 30, (30 included 2 emergency ind patients. We took them out.) We concentrated on mTNBC. 28 patients. 10 of them were from the clinical trials, phase 1b-2, which is currently phase 2 eventually.
That trial gave us 10 patient's data. Breakthrough Designation requires 5 patient's data. That data was great. Now, what was the data from the 28 patients? When we compare that 28 patient's data with the data of standard of care, we were as good in progression free survival, (pfs) for 12 months or overall survival (os), for 12 months. But, if you look at the cc, circulating cells, which was the average/aggregate that microtechnology had to come up with as a diagnostic lab; with that test, if your cc, circulating cells in patients was lower, after induction with Leronlimab, or if it were already low, then, if we saw a completely different kind of results; and that amount, 73% were like that. So when you compared that 70% with the other 30%, the results of overall survivability, almost 3,600% better. And when you look at the progression free survival, over 400% or 500% better. Some number out of the charts.
But we are comparing the 2 Leronlimab arms. The one that lowered the circulating cell count after induction to Leronlimab, but if you look at overall, and you look at Standards of Care, which is chemotherapy, and we know from past experience, how Leronlimab, in clinical trials has demonstrated no significant toxicity, is not there; then hands down, anybody would love to have Leronlimab vs. chemotherapy. So that's why we immediately wanted to file BTD. It got delayed several times, because we kept finding that these patients had brain metastases. We looked at those patients. We realized we had another breakthrough designation that we will be filing. But we delayed it a little bit. But it will be filed by the end of this week. Today. Friday. So hopefully, we are announcing it on Monday. We have a very, very, crucial item. And 60 days later, (1/8/2022), we are very hopeful that we will get BTD.
Christine: We will look forward to that. And then how about NASH? From your Phase 2 trial?
Nader: Yeah, and again, there was a lot of talk, that the NASH data, we said, just 5 patients are open label arm. There was 60 patients, double blinded. We have an unblinded. 1/2 placebo, 1/2 Leronlimab 700mg. Dr. Recknor has added 30 patients, open arm with 350mg and open arm for means that you can see the data. So when we looked at the 1st 5 patients, their fatty deposits and fibrosis which are the 2 key biomarkers were very, very nice. Strong results, very strong results. Now, we said, the 5 patients had at most 45% fatty deposits reduction and everybody keeps saying, "the highest means maybe one of them?? was it 1%? No, the average was somewhere around 25% or so fatty deposit drop. The fibrosis, as much as 10% drop. Fibrosis is like a scar on the liver. How do you fix that? Has anybody have any data like that? So with 5 patient's data, we are preparing BTD. But, we think, the next 5 days or so, we will have 5 more patients. So, we are going to have 10 patients as part of this BTD for NASH. We believe our results, is one of the best results anybody could ever produce in this small number of patients, but all the patients, the results are coming out by the end of the month. So we are very excited, and we wanted to make sure our share holders know that the results of 350mg are really stunning.
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
Understanding the Significance of 3,600% Improvement in Overall Survival
It indicates that the 1 year Overall Survival is improved by 3,600% over Standard of Care
Let's put this in perspective: Hypothetically,
If you have 1,000 patients with mTNBC. With Standard of Care, let's say that after 1 year, 980 on average die and 20 remain. (This is for example purposes. I have no idea how many typically die and at what stage this decline begins at.)
A 3,600% improvement would make it such that, if treatment with Leronlimab was implemented, then 36 x 20 = 720. 720 would remain and 280 would die.
If fewer people than 980 typically die out of 1,000 with mTNBC, lets say 972 die and 28 remain. Then a 3,600% improvement resulting from treatment with Leronlimab leads to 36 x 28 = 1,000. Every person treated with Leronlimab survives the full year.
As I understand mTNBC, I think with Standard of Care, the average OS overall survival is about 6 months. The vast majority don't make it much past that. So, with SOC, out of a 1,000 with mTNBC, maybe 7 would still remain. Now with Leronlimab, 36 x 7 or 252 would remain and 748 would likely live much longer than they otherwise would have if Leronlimab were not used. IMO, the FDA should look very favorably on this data.
It will be very interesting to see what the 2 year, 3 year, 4 year and 5 year overall survivability will be as the time comes. This is an amazing data point and I think we will get BTD because of this.
This is a link to a post which I did comparing our mTNBC trials to Paclitaxel and the outlook for Leronlimab in treating mTNBC:
https://old.reddit.com/r/CYDY/comments/pd2vrb...for_ll_on/
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