Dwayne Hoover
Footballguy
Yeah, no catalyst until severe critical at this point.
We've got a few weeks of navigating potential drops in price.
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***OFFICIAL CYDY/Leronlimab Thread*** (3 Viewers)
- Thread starter This_Guy
- Start date
We've got a few weeks of navigating potential drops in price.
Moonlight
Footballguy
Maybe not. Interim results data collection to end soon. Speculation and "leaks" i.e.(NP had a big smile on his face) may drive SP up as we await formal announcement of interim results.
ex-ghost
Footballguy
Moonlight
Footballguy
For here yes. But I think that NP has developed a cult following through the constant pumps and humble origins stories.
⚡DEADHEAD⚡
Footballguy
Yeah, NP is a dope. Mid-level manager who stumbled into something good. And COVID made him rich. I still want to know how he bought the thing. I know his wife is rumored to have bought it for him.
Visionary, my ###. Dummy can't even spell. When he presented that cheap-### looking powerpoint a couple months back, I was taken aback at how poor the whole thing was. Your average MBA student from a lower-tier program could do better.
Yeah, I can't stand the guy. Total shyster.
Dwayne Hoover
Footballguy
Don Hutson
Footballguy
His wife gave $160,000 in 2008 to keep CytoDyn afloat. The company was in dire straits at the time. That is how Nader became CFO. Pro-140 was bought in 2012. Nader takes credit for the purchase of PRO-140 but others believe that it was the CEO who should be given credit. Nader became CEO shortly after the PRO-140 acquisition.
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kevzilla
Footballguy
Wait, I bought early and am freerolling with the remainder, but I haven't made a dime yet. Can I just stand in the corner or something?
Chaz McNulty
Footballguy
CGRdrJoe
Footballguy
I was out looking at golf clubs and went to sell when Apple decided to update my phone
I was locked out til after the closing bell. Not the worst thing to happen but wanted that profit for my 2 new hybrids.Lol!
Nader obviously lies to shareholders for weeks and this is the reaction.
Can anyone put together a timeline for Phase 3 moderate approval? “Long hauler” approval. Realize these are shiny objects to keep investors from dumping.
Moonlight
Footballguy
Expect a bump in share price as interim results near. Data collection ends Tuesday.
I also put $ in HGEN which I know you endorse. But as I look more closely at HGEN that drug is no bed of roses and there's manipulation going on there as well.
Don Hutson
Footballguy
Obviously, Nader lies. He was charged by the Federal Government for selling Vietnamese made Dream Catchers and claiming they were made by Native Americans. He is a charlatan. Bruce Patterson also lies. He told us that leronlimab would be a part of Operation Warp Speed. The stock went up the next day. Leronlimab was not a part of OWS.
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Chaz McNulty
Footballguy
For Covid it will all come down to the early peak for S/C trial. If the p-value at the halfway point is less than .05, then they will be granted emergency approval everywhere. If it's in the .06 or .07 range, they will probably need to fully finish the trial to get the p-value down. Anything over that, and its game-over for Covid.Whyatt said:
Chaz McNulty
Footballguy
Have you been drinking?Don Hutson said:
Don Hutson
Footballguy
Nope. I just don't think this should be a place where people are indoctrinated into investing into CYDY. Transparency and honesty should be mandatory.
Mr. STbugs would likely be interested in this update. Recall I was “touting“ this drug and suggested it could set a bar for Covid treatments.
”Failed” Covid drug Tocilizumab reported a successful p-value yesterday for progression to mechanical ventilation or death.
Primary endpoint was met: patients with COVID-19 associated pneumonia who received Actemra/RoActemra plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm.
https://www.roche.com/investors/updates/inv-update-2020-09-18.htm
”Failed” Covid drug Tocilizumab reported a successful p-value yesterday for progression to mechanical ventilation or death.
Primary endpoint was met: patients with COVID-19 associated pneumonia who received Actemra/RoActemra plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm.
https://www.roche.com/investors/updates/inv-update-2020-09-18.htm
Awesome. Love this part:
There was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo
Right, that’s my point. They set a primary end point that fits their drug but it’s not enough. There was some other drug that had a trial and touted (maybe a week ago) that with Remdesivir it reduced hospitalization time by 1 more day than Remdesivir alone. I mean, really? We need something that reduces mortality. People still dying everyday.
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Chaz McNulty
Footballguy
The primary endpoint for the C/S trial is death after 28 days. I am talking about this p-value.
Do you think they will not be granted approval if they hit a p-value of under .05 on their primary?
Chaz McNulty
Footballguy
It was actually enough for Remdesivir to originally get approved. But not many believe it was the actual drug that got them emergency approval.
That was all political and unfortunate because I think there’s a bunch of options that would have save lives by now if given the same treatment.
These post both contain message board conspiracy theories IMO.
Remdesivir didn’t get the pushback that plasma did recently, at least not from reputable sources.
Unfortunately, there is no other drug for Covid with a better p3 result than Remdesivir. None. Zero. It’s an unfortunate truth. There is an good argument that the US government could have pushed trials along faster, I agree with that if that is your point.
The expectation is to hit that value in the full trial, not the halfway point.
There are other factors also in play. What are other options might be available in the coming weeks? Can Cytodyn actually supply enough doses of the drug? What is the status of the safety data for the higher dose which held up the BLA?
Chaz McNulty
Footballguy
Really? Why bother having a mid-trial look if this is the stance.
The safety data can be looked at during the peak. Or they could look at the past 6 years of data. Manufacturing by all accounts is in place. Who cares if they cannot supply enough doses for the entire US population. Are you saying it would get turned down if they could only supply enough of a life saving medication for 50% of the US?
Dwayne Hoover
Footballguy
Im a little worried about this too, concerned that nothing less than a home run will do it.
The endpoint being deaths helps though. There certainly will be a lot more pressure on the FDA if it's saving lives, should they prove to be better than the placebo.
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Moonlight
Footballguy
Agree deaths as primary end point will make a difference for short term chances of approval.
Don Hutson
Footballguy
One of the more knowledgeable IHub posters claims he has had email correspondence with Nader and Nader said that we won't find out the data from the interim analysis of the first 195 patients unless the trial is stopped. I knew that the first interim analysis was for safety only and that we'd only hear the results if the trial was stopped. But I was under the impression that we would get the results from midway point interim analysis of the first 195 patients regardless if the trial was stopped or not. Was I mistaken?
Don Hutson
Footballguy
CR69
Footballguy
Don Hutson
Footballguy
HIV
1. We are 6-9 months away from potential approval and that is being optimistic
2. HIV is not lucrative like cancer and Covid treatments
Cancer
1. According to a knowledgeable long who is in correspondence with Dr Lalezari, the basket trial for cancer has been temporarily suspended because they want to up the dosage because they weren't getting the results they wanted. There is a lot of smoke that the cancer trials aren't going well at all. But you're not going to hear Nader tell you that. Instead, he has been mostly quiet on the subject.
2. Cancer approval can't happen for a long, long time from now because trials take a long time unless it is an immediate concern like Covid. Look at how long the HIV trial is taking.
Covid
1. Bruce Patterson is not considering leronlimab for long-haulers according to Dr Yo. Dr Yo and Patterson are writing a paper together about other drugs to solve the long-hauler problem.
2. M2M is currently a dead end. Complete waste of time at this stage of the pandemic when S/C is all any government entity cares about.
3. According to knowledgeable longs on the message boards, we will not see the results of the interim analysis of the first 195 patients unless the trial is halted for extreme efficacy or extreme futility. Only the DSMB will see the results. The DSMB already did an interim analysis of the first 149 patients and decided not to halt the trial. Why is it going to be different with 195 patients?
4. The first 195 patients were enrolled 27 days ago. There were 210 patients enrolled as of 11 days ago according to the Sept 10th CC. That is approximately 1 patient being enrolled per day. At the current pace, it will take about 180 days to enroll the 180 patients to get from 210 patients to the required 390 patients. Plus 28 days to complete the study and some time for results to be released. In other words, we aren't going to see the results of the completed S/C trial until next spring unless trial enrollment quickens.
1. We are 6-9 months away from potential approval and that is being optimistic
2. HIV is not lucrative like cancer and Covid treatments
Cancer
1. According to a knowledgeable long who is in correspondence with Dr Lalezari, the basket trial for cancer has been temporarily suspended because they want to up the dosage because they weren't getting the results they wanted. There is a lot of smoke that the cancer trials aren't going well at all. But you're not going to hear Nader tell you that. Instead, he has been mostly quiet on the subject.
2. Cancer approval can't happen for a long, long time from now because trials take a long time unless it is an immediate concern like Covid. Look at how long the HIV trial is taking.
Covid
1. Bruce Patterson is not considering leronlimab for long-haulers according to Dr Yo. Dr Yo and Patterson are writing a paper together about other drugs to solve the long-hauler problem.
2. M2M is currently a dead end. Complete waste of time at this stage of the pandemic when S/C is all any government entity cares about.
3. According to knowledgeable longs on the message boards, we will not see the results of the interim analysis of the first 195 patients unless the trial is halted for extreme efficacy or extreme futility. Only the DSMB will see the results. The DSMB already did an interim analysis of the first 149 patients and decided not to halt the trial. Why is it going to be different with 195 patients?
4. The first 195 patients were enrolled 27 days ago. There were 210 patients enrolled as of 11 days ago according to the Sept 10th CC. That is approximately 1 patient being enrolled per day. At the current pace, it will take about 180 days to enroll the 180 patients to get from 210 patients to the required 390 patients. Plus 28 days to complete the study and some time for results to be released. In other words, we aren't going to see the results of the completed S/C trial until next spring unless trial enrollment quickens.
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Don Hutson
Footballguy
I do want to say that I'm not necessarily advocating selling right now. $3.40 is pretty low for this stock. It will likely go up at some point in the next week or two in anticipation of the interim analysis. Cytonites do not lack in the hope department.
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Moonlight
Footballguy
The last CC has drained enthusiasm.
This was posted on the yahoo board by askeptic and provides some hope for LL:
Not sure if this has been posted. However, if you are interested to learn about Leronlimab from an unbiased source follow paragraph (copied a section from a review article on Antibody based therapy) might be useful
From the journal Expert opinion on biological therapy: https://www.tandfonline.com/doi/full/10.1080/14712598.2020.1745770
4.3. Leronlimab
Leronlimab (previously known as PRO140) is a humanized IgG4 targeting CCR5 which CytoDyn is progressing through multiple stages of clinical development for a variety of diseases, namely CCR5-tropic HIV infection, metastatic TNBC, metastatic colorectal cancer, nonalcoholic steatohepatitis (NASH), and graft-versus-host disease (GvHD) with a variety of preclinical studies ongoing in an oncology setting [66].
CytoDyn acquired leronlimab from Progenics Pharmaceuticals in 2012. The mechanism of action inhibits viral entry by masking CCR5, but does not interfere with normal CCR5 signaling thereby protecting healthy T cells; in addition, CCR5 has been shown to play a significant role in cancer and immune-mediated conditions. Another mechanism of action demonstrated by leronlimab is the ability to block calcium channel signaling of CCR5-positive cancer cells intrinsic to the progression of tumor invasion and metastasis. Currently, this mAb is at the pre-registration stage and approval for leronlimab, in combination with HAART, is anticipated in the first half of 2020 for HIV infection, having previously been granted Fast-Track Designation by the FDA. In March 2019, CytoDyn submitted the first part of the BLA application using the FDA’s rolling review process. On successfully gaining FDA approval, this mAb would represent the third GPCR-targeting antibody to be marketed. A Commercialization and License Agreement (CLA) and Supply Agreement with Vyera Pharmaceuticals was completed in December 2019. CytoDyn plans to use leronlimab both in combination and as a monotherapy for CCR5-tropic HIV infection (NCT02859961). Another attractive property of this mAb is that it can be self-administered as a subcutaneous injection, in addition to standard intravenous delivery.
Recent data from an ongoing monotherapy dose-escalation Phase 2b/Phase 3 clinical trial (NCT02859961) demonstrated that patients who received leronlimab maintained viral load suppression at approximately one year and even longer for a number of participants. The estimated primary completion date is July 2020. Leronlimab has successfully completed nine clinical trials in over 800 people, including a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients) where 81% of patients completing the trial achieved an HIV viral load suppression of less than 50 cp/mL, thereby meeting the primary endpoint [67].
In addition to HIV, CytoDyn is evaluating the safety and efficacy of leronlimab in Phase 2 clinical trials of patients with metastatic colorectal cancer and NASH [68]. Fast-Track designation has been granted for use in combination with carboplatin for the treatment of metastatic TNBC (NCT03838367) where strong clinical responses have already been observed [69] and Orphan Drug designation has been received for the prevention of GvHD (multiple Phase 2 clinical studies, e.g., NCT02737306) with results expected in the first half of 2020. Thus, this mAb has significant potential for a positive therapeutic impact in multiple therapeutic areas, including a recent announcement for an IND filing for a Phase 2 trial for the treatment of patients with respiratory complications due to infection with the COVID-19 coronavirus.
Less
(2020). A review of antibody-based therapeutics targeting G protein-coupled receptors: an update. Expert Opinion on Biological Therapy: Vol. 20, No. 8, pp. 925-935.
(2020). A review of antibody-based therapeutics targeting G protein-coupled receptors: an update. Expert Opinion on Biological Therapy: Vol. 20, No. 8, pp. 925-935.
www.tandfonline.com
Article highlights
GPCRs are implicated in many diseases and present valuable opportunities for targeting with mAbs and other antibody-based therapeutics
Significant progress has been made in the generation of functional GPCR-targeting mAbs for therapeutic applications over the past decade where two-thirds of the GPCR-antibody pipeline are directed to Family A GPCRs (half of which are chemokine receptors)
There are now two mAbs approved in the US and EU (mogamulizumab and erenumab) with a third mAb (leronlimab) that is anticipated to attain FDA approval in 2020
Many GPCR-targeting antibodies are now in early clinical studies in addition to the emergence of next-generation modalities, such as alternative scaffolds, bispecific antibodies, antibody-drug conjugates (ADCs), and chimeric antigen receptor T-cell therapy (CAR-T), as successful targeting strategies
This box summarizes the key points contained in the article.
This was posted on the yahoo board by askeptic and provides some hope for LL:
Not sure if this has been posted. However, if you are interested to learn about Leronlimab from an unbiased source follow paragraph (copied a section from a review article on Antibody based therapy) might be useful
From the journal Expert opinion on biological therapy: https://www.tandfonline.com/doi/full/10.1080/14712598.2020.1745770
4.3. Leronlimab
Leronlimab (previously known as PRO140) is a humanized IgG4 targeting CCR5 which CytoDyn is progressing through multiple stages of clinical development for a variety of diseases, namely CCR5-tropic HIV infection, metastatic TNBC, metastatic colorectal cancer, nonalcoholic steatohepatitis (NASH), and graft-versus-host disease (GvHD) with a variety of preclinical studies ongoing in an oncology setting [66].
CytoDyn acquired leronlimab from Progenics Pharmaceuticals in 2012. The mechanism of action inhibits viral entry by masking CCR5, but does not interfere with normal CCR5 signaling thereby protecting healthy T cells; in addition, CCR5 has been shown to play a significant role in cancer and immune-mediated conditions. Another mechanism of action demonstrated by leronlimab is the ability to block calcium channel signaling of CCR5-positive cancer cells intrinsic to the progression of tumor invasion and metastasis. Currently, this mAb is at the pre-registration stage and approval for leronlimab, in combination with HAART, is anticipated in the first half of 2020 for HIV infection, having previously been granted Fast-Track Designation by the FDA. In March 2019, CytoDyn submitted the first part of the BLA application using the FDA’s rolling review process. On successfully gaining FDA approval, this mAb would represent the third GPCR-targeting antibody to be marketed. A Commercialization and License Agreement (CLA) and Supply Agreement with Vyera Pharmaceuticals was completed in December 2019. CytoDyn plans to use leronlimab both in combination and as a monotherapy for CCR5-tropic HIV infection (NCT02859961). Another attractive property of this mAb is that it can be self-administered as a subcutaneous injection, in addition to standard intravenous delivery.
Recent data from an ongoing monotherapy dose-escalation Phase 2b/Phase 3 clinical trial (NCT02859961) demonstrated that patients who received leronlimab maintained viral load suppression at approximately one year and even longer for a number of participants. The estimated primary completion date is July 2020. Leronlimab has successfully completed nine clinical trials in over 800 people, including a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients) where 81% of patients completing the trial achieved an HIV viral load suppression of less than 50 cp/mL, thereby meeting the primary endpoint [67].
In addition to HIV, CytoDyn is evaluating the safety and efficacy of leronlimab in Phase 2 clinical trials of patients with metastatic colorectal cancer and NASH [68]. Fast-Track designation has been granted for use in combination with carboplatin for the treatment of metastatic TNBC (NCT03838367) where strong clinical responses have already been observed [69] and Orphan Drug designation has been received for the prevention of GvHD (multiple Phase 2 clinical studies, e.g., NCT02737306) with results expected in the first half of 2020. Thus, this mAb has significant potential for a positive therapeutic impact in multiple therapeutic areas, including a recent announcement for an IND filing for a Phase 2 trial for the treatment of patients with respiratory complications due to infection with the COVID-19 coronavirus.
Less
(2020). A review of antibody-based therapeutics targeting G protein-coupled receptors: an update. Expert Opinion on Biological Therapy: Vol. 20, No. 8, pp. 925-935.
(2020). A review of antibody-based therapeutics targeting G protein-coupled receptors: an update. Expert Opinion on Biological Therapy: Vol. 20, No. 8, pp. 925-935.
www.tandfonline.com
Article highlights
GPCRs are implicated in many diseases and present valuable opportunities for targeting with mAbs and other antibody-based therapeutics
Significant progress has been made in the generation of functional GPCR-targeting mAbs for therapeutic applications over the past decade where two-thirds of the GPCR-antibody pipeline are directed to Family A GPCRs (half of which are chemokine receptors)
There are now two mAbs approved in the US and EU (mogamulizumab and erenumab) with a third mAb (leronlimab) that is anticipated to attain FDA approval in 2020
Many GPCR-targeting antibodies are now in early clinical studies in addition to the emergence of next-generation modalities, such as alternative scaffolds, bispecific antibodies, antibody-drug conjugates (ADCs), and chimeric antigen receptor T-cell therapy (CAR-T), as successful targeting strategies
This box summarizes the key points contained in the article.
Dwayne Hoover
Footballguy
I believe the first analysis was only for safety though? They are going to have more to analyze here I believe.
Don Hutson
Footballguy
At the time of the first interim analysis, it was said that the trial could be stopped if the results were extremely good. Maybe @Whyatt could help us understand this.
Charlie Harper
Footballguy
Dwayne Hoover
Footballguy
I feel like there is a ton of conflicting information out there about how these trials work in terms of interim results. Maybe its because people post things and dont know what they are talking about but its hard to follow.
Clinical trial design isn’t an area I have expertise in, but here is what I think I know. Realize that trials are based on written protocols which can have nuances between them.
This is a Phase 2b/3 trial, meaning phase 2 and 3 are combined together, for speed and efficiency. As phase 2 intends to inform efficacy for phase 3, the sponsor (or DSMB) can evaluate the data around midpoint and try to understand if the full trial can be successful. For example, say your endpoint is death, what happens when you evaluate the data and there are significantly fewer deaths in both placebo and with the drug? You will need more patients to prove efficacy, or maybe you decide you should look at length of hospital stay instead. That is the primary purpose of the look. The earlier look was likely safety only, where the DSMB looked to be sure the drug isn’t causing safety issues,SAEs, with patients.
The holy grail is when the data at the review is overwhelming to the point it’s unethical to not give placebo. I believe this needs to be well below p value = 0.05. This is rarely done, but when it is, it is to provide great benefit like saving lives. So this trial has the potential to qualify.
Don Hutson
Footballguy
There is a good chance that it'll get back to $5 in the next few weeks. But if the trial isn't halted from the interim analysis, the stock price is going to plummet. It is the last real catalyst for a long time.
Don Hutson
Footballguy
CYDY has been stuck on $3.41 since last Thursday. Someone has accumulated a ton of stock at that level.
ChiefD
Footballguy
Caesar
Footballguy
Caesar
Footballguy
Do people actually believe there is going to be some sort of announcement from NP on DR Been tonight?
I would be happy if there is something substantial, but my guess is the contract with Proactive ran out and he is just itching to spew nonsense again.
This is me being positive, btw.
I would be happy if there is something substantial, but my guess is the contract with Proactive ran out and he is just itching to spew nonsense again.
This is me being positive, btw.
