The point is that there is information here that gives understanding to how the effectiveness of the drug is quantified and it is discussed for both mTNBC and NASH. In addition, some light is shed on the 3 mTNBC trials that will be discussed in the approaching ASCO meeting/conference.
I'm answering you here b/c I only have a limited # of posts.
This Proactive was in early January I think.
CytoDyn reveals results from part two of Phase 2 NASH clinical trial
Christine Corrado: Hello there, Welcome back to Proactive NY. With me this morning is Nader Poorhassan, CEO at CytoDyn. Nader, good to see you. Happy New Year. How are you?
Nader Poorhassan: Happy New Year. Good to see you. I'm doing great. Thank you.
CC: Nader, lots to get to today. Let's kick it off with the results you announced this week for your 350mg weekly dose of LL for your phase 2 NASH clinical trial. You have some apparent positive results here?
NP: Yeah, so, whenever there is analysis, there is a primary endpoint, the most important primary focus of everybody. Primary endpoint can be analyzed on the ITT, Intention To Treat population, that means everybody who comes into the trial. Or Per Protocol, PP. That means if somebody didn't finish a trial, or just got involved for a few weeks and got kicked out, or whatever the STAP, statistical analysis plan has dictated, then you take some of the patients out based upon that violation of the protocol and so forth. That's called Per Protocol, PP. So 1) ITT and 2) PP.
In Primary Endpoint, which was PDFF, the fatty deposits, we have hit our Primary Endpoint for both populations. Primary Endpoint, for both populations of ITT and Per Protocol.
Now, lets talk about Secondary Endpoint. That's what some people had confusion. The Secondary Endpoint, when you do the ITT, then you do PP. ITT is everybody. PP is the people who didn't finish the trial and all that. The ITT which showed that we had (a "p" value of ) 0.057. So we are getting close to 0.05. and the PP was like 0.02, it was statistically significant. Now, when we do this with a different methodology, we have all of them statistically significant. Because, there are different ways of doing them. But, we don't want to talk about those things because we want the FDA to get a chance to look at it. But our share holders are very eager, they always want to see the data, so we thought to give them a good news, we hit our Primary Endpoint and Secondary Endpoint in the PP Per Protocol, but the Primary Endpoint was also hit on ITT.
Now, what does that mean for the company? Well, we are sending this TopLine Report that we are finalizing, now, immediately to the FDA and other countries and right now, we are sending it to over 1,000 people from pharmaceuticals, biotech, bigger pharmaceuticals, all over the world, because this data, to us, is going to be able to go forward with Phase 3 and BTD. We believe that. And the data has told us by the statistician and the group that did this analysis, that it is "hands down", "very strong data". But again, we don't want to get to this 0.057. Why wasn't that one statistically significant for secondary endpoint in the ITT group? We can look at it other ways. I have data here that shows certain ways that you can analyze to get better. We did it very conservative. We gave it to a 3rd party. The folks were solid. They have generated all the tables. And we feel very strong about the data.
CC: OK, let's move on from NASH, to your Corona Virus Trial. In the past weeks, you've said you would start your Phase 3 to evaluate LL in Corona Virus in Critically Ill Patients. Have you started that yet?
NP: Well, we are working on that. That trial is CD20. It's for the United States. It will take us a little bit of time to set up the CROs which we are talking to and to date the trial. The focus of everybody should be like this: The FDA has allowed us to do meta-analysis. So, what we want to do is have the same thing perhaps in Brazil. So, we asked ANVISA if they would also give us meta-analysis, which means: you take your double blinded placebo controlled trial, which ever they are, and you can combine that data. So if we do that, with a meta-analysis in a critically ill population, Brazil data, we might only need another 15 or 20 patients, that's all. because you already have 62. So during that 10-15 more, or whatever that number turns out to be, we are talking to the Brazilian folks today, there were 2 weeks we haven't talked to them due to vacation, but this update is a huge update, because the number of cases in Brazil has really gone up, the number of dead, thank God has not gone up that way, but, our ventilation requirement and ICUs are getting more patients, so, we see where our data is, but we could be very very close to analysis of interim analysis in 20 patients perhaps, but these are not finalized, so what I'm saying, everybody should take it with a grain of salt. We are going to take a look at it, talk to Brazilian folks, talk to ANVISA and get back to everybody.
CC: OK, moving from Corona Virus to HIV. What is the status on your BLA?
NP: Well, the BLA on HIV, we are on time. We have got ourselves some really great experts that have added to our team. We moved away from Amarex obviously. So we have that under control now. And we feel very strong now that our BLA, 1st quarter is on track. We will also be meeting FDA hopefully soon and letting everybody know where we are at. But we are on track on that. We are working on the monotherapy Phase 3 Protocol, also, simultaneously.
CC: OK, now lets get to oncology. Specifically, mTNBC. It has been 2 months since you submitted your BTD application to the FDA for this. What is the status there?
NP: So the FDA had a new drug that was approved for mTNBC, which is called sacituzumab. So that drug is now standard of care SOC. Comparing ourselves to chemotherapy, the FDA has seen how strong our results are, but comparing with sacituzumab, we have to show superiority. We haven't done that, so FDA can not give us BTD when you compare it to sacituzumab, but FDA has told us, that we are welcome to give more data. Keep in mind, the data, the 28 patient's that we gave to FDA, if their overall survivability was 12.5 months, with sacituzumab, it's 12 months. So we are a little bit better, not substantially better. Which we need to be substantially better for BTD. But, it has been 3-4 months since we did the analysis, 2 months of waiting for the BTD and a month or so before that when we locked the data. So, that means that if the patients are still alive, we have substantially improved data. We don't know that. We are checking on that. And we do know that some of the patients, we believe most of them or quite a bit of them are alive, but I have to verify that 100% and give that to the FDA and then update our shareholders. There you update the data and submit it, that could be considered as a 2nd application, so it might be another 60 days of waiting. But we feel very very strong about our cancer program and all the patients that are still coming and seeing the results. Share holders should focus. We have patients and physicians talking about how strong this data is and if they have to wait a little bit, here or there, they should not make a big issue about that in my opinion.
CC: Yeah, I appreciate the update on all these indications. As we are now heading into, we are in the new year, 2022, give us a sense of what your cash position looks like. Where are we with funding?
NP: So the cash position is; we put an 8k out, sorry Q out there, I can't give an update on that right now. That showed I think $8million on our balance sheet. Now, we have 200,000,000 shares that were authorized to us by the shareholders. At this time, we are so close to so many amazing milestones, that we can utilize those 200million shares and raise the funds that we need to go forward. But people have to keep in mind also that right now, a partnership for our NASH looks very very solid. We can't wait to have a call with everybody which will be in about 10 days or so hopefully and lay out all the steps on what we are doing on each one of these indications and what are our milestones. NASH, when are we expected to get the BTD? file and get the result. Cancer, the same thing, when we going to update the numbers so we can get that moving and the BLA HIV and Covid 19. With that plan for 2022 and all the milestones laid out, we will do a fund raising based upon that and we believe it will be very successful and a very successful 2022.
CC: Alright, I appreciate the updates here Nader. Thanks so much.
NP: Thank you for having me. I appreciate it.
I'm answering you here b/c I only have a limited # of posts.
This Proactive was in early January I think.
CytoDyn reveals results from part two of Phase 2 NASH clinical trial
Christine Corrado: Hello there, Welcome back to Proactive NY. With me this morning is Nader Poorhassan, CEO at CytoDyn. Nader, good to see you. Happy New Year. How are you?
Nader Poorhassan: Happy New Year. Good to see you. I'm doing great. Thank you.
CC: Nader, lots to get to today. Let's kick it off with the results you announced this week for your 350mg weekly dose of LL for your phase 2 NASH clinical trial. You have some apparent positive results here?
NP: Yeah, so, whenever there is analysis, there is a primary endpoint, the most important primary focus of everybody. Primary endpoint can be analyzed on the ITT, Intention To Treat population, that means everybody who comes into the trial. Or Per Protocol, PP. That means if somebody didn't finish a trial, or just got involved for a few weeks and got kicked out, or whatever the STAP, statistical analysis plan has dictated, then you take some of the patients out based upon that violation of the protocol and so forth. That's called Per Protocol, PP. So 1) ITT and 2) PP.
In Primary Endpoint, which was PDFF, the fatty deposits, we have hit our Primary Endpoint for both populations. Primary Endpoint, for both populations of ITT and Per Protocol.
Now, lets talk about Secondary Endpoint. That's what some people had confusion. The Secondary Endpoint, when you do the ITT, then you do PP. ITT is everybody. PP is the people who didn't finish the trial and all that. The ITT which showed that we had (a "p" value of ) 0.057. So we are getting close to 0.05. and the PP was like 0.02, it was statistically significant. Now, when we do this with a different methodology, we have all of them statistically significant. Because, there are different ways of doing them. But, we don't want to talk about those things because we want the FDA to get a chance to look at it. But our share holders are very eager, they always want to see the data, so we thought to give them a good news, we hit our Primary Endpoint and Secondary Endpoint in the PP Per Protocol, but the Primary Endpoint was also hit on ITT.
Now, what does that mean for the company? Well, we are sending this TopLine Report that we are finalizing, now, immediately to the FDA and other countries and right now, we are sending it to over 1,000 people from pharmaceuticals, biotech, bigger pharmaceuticals, all over the world, because this data, to us, is going to be able to go forward with Phase 3 and BTD. We believe that. And the data has told us by the statistician and the group that did this analysis, that it is "hands down", "very strong data". But again, we don't want to get to this 0.057. Why wasn't that one statistically significant for secondary endpoint in the ITT group? We can look at it other ways. I have data here that shows certain ways that you can analyze to get better. We did it very conservative. We gave it to a 3rd party. The folks were solid. They have generated all the tables. And we feel very strong about the data.
CC: OK, let's move on from NASH, to your Corona Virus Trial. In the past weeks, you've said you would start your Phase 3 to evaluate LL in Corona Virus in Critically Ill Patients. Have you started that yet?
NP: Well, we are working on that. That trial is CD20. It's for the United States. It will take us a little bit of time to set up the CROs which we are talking to and to date the trial. The focus of everybody should be like this: The FDA has allowed us to do meta-analysis. So, what we want to do is have the same thing perhaps in Brazil. So, we asked ANVISA if they would also give us meta-analysis, which means: you take your double blinded placebo controlled trial, which ever they are, and you can combine that data. So if we do that, with a meta-analysis in a critically ill population, Brazil data, we might only need another 15 or 20 patients, that's all. because you already have 62. So during that 10-15 more, or whatever that number turns out to be, we are talking to the Brazilian folks today, there were 2 weeks we haven't talked to them due to vacation, but this update is a huge update, because the number of cases in Brazil has really gone up, the number of dead, thank God has not gone up that way, but, our ventilation requirement and ICUs are getting more patients, so, we see where our data is, but we could be very very close to analysis of interim analysis in 20 patients perhaps, but these are not finalized, so what I'm saying, everybody should take it with a grain of salt. We are going to take a look at it, talk to Brazilian folks, talk to ANVISA and get back to everybody.
CC: OK, moving from Corona Virus to HIV. What is the status on your BLA?
NP: Well, the BLA on HIV, we are on time. We have got ourselves some really great experts that have added to our team. We moved away from Amarex obviously. So we have that under control now. And we feel very strong now that our BLA, 1st quarter is on track. We will also be meeting FDA hopefully soon and letting everybody know where we are at. But we are on track on that. We are working on the monotherapy Phase 3 Protocol, also, simultaneously.
CC: OK, now lets get to oncology. Specifically, mTNBC. It has been 2 months since you submitted your BTD application to the FDA for this. What is the status there?
NP: So the FDA had a new drug that was approved for mTNBC, which is called sacituzumab. So that drug is now standard of care SOC. Comparing ourselves to chemotherapy, the FDA has seen how strong our results are, but comparing with sacituzumab, we have to show superiority. We haven't done that, so FDA can not give us BTD when you compare it to sacituzumab, but FDA has told us, that we are welcome to give more data. Keep in mind, the data, the 28 patient's that we gave to FDA, if their overall survivability was 12.5 months, with sacituzumab, it's 12 months. So we are a little bit better, not substantially better. Which we need to be substantially better for BTD. But, it has been 3-4 months since we did the analysis, 2 months of waiting for the BTD and a month or so before that when we locked the data. So, that means that if the patients are still alive, we have substantially improved data. We don't know that. We are checking on that. And we do know that some of the patients, we believe most of them or quite a bit of them are alive, but I have to verify that 100% and give that to the FDA and then update our shareholders. There you update the data and submit it, that could be considered as a 2nd application, so it might be another 60 days of waiting. But we feel very very strong about our cancer program and all the patients that are still coming and seeing the results. Share holders should focus. We have patients and physicians talking about how strong this data is and if they have to wait a little bit, here or there, they should not make a big issue about that in my opinion.
CC: Yeah, I appreciate the update on all these indications. As we are now heading into, we are in the new year, 2022, give us a sense of what your cash position looks like. Where are we with funding?
NP: So the cash position is; we put an 8k out, sorry Q out there, I can't give an update on that right now. That showed I think $8million on our balance sheet. Now, we have 200,000,000 shares that were authorized to us by the shareholders. At this time, we are so close to so many amazing milestones, that we can utilize those 200million shares and raise the funds that we need to go forward. But people have to keep in mind also that right now, a partnership for our NASH looks very very solid. We can't wait to have a call with everybody which will be in about 10 days or so hopefully and lay out all the steps on what we are doing on each one of these indications and what are our milestones. NASH, when are we expected to get the BTD? file and get the result. Cancer, the same thing, when we going to update the numbers so we can get that moving and the BLA HIV and Covid 19. With that plan for 2022 and all the milestones laid out, we will do a fund raising based upon that and we believe it will be very successful and a very successful 2022.
CC: Alright, I appreciate the updates here Nader. Thanks so much.
NP: Thank you for having me. I appreciate it.
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