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Lenzilumab exclusion critieria:
If lenzilumab clinical trial is not testing ARDS or mechanical ventilation, then we will never know if lenzilumab will work in severe/critical!
To me this is similar to M2M and nothing more!
Leronlimab is in clinical trial for severe/critical, so will know if leronlimab will work for all COVID patients!
Leronlimab already finished M2M so we will see the results soon.
Totally different comparison, in regards to clinical trial, in comparing lenzilumab vs leronlimab.
I prefer leronlimab.
Lenzilimab exclusion criteria:
Cant' give to ARDS, uncontrolled viral infection, PAP, invasive mechanical ventilation, age over 85
This is not severe/critical - this is M2M study but calling it severe!
Exclusion Criteria:
Confirmed diagnosis of ARDS
Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline
Known medical history of tuberculosis or a risk for tuberculosis exposure
Known history of hepatitis A, hepatitis B, hepatitis C or HIV infection
History of pulmonary alveolar proteinosis (PAP)
Requiring invasive mechanical ventilation upon hospitalization prior to randomization
Women of childbearing potential who are pregnant or breastfeeding
Known hypersensitivity to lenzilumab or any of its components
Use of anti-IL-6 therapy or any other potent immunomodulatory or immunosuppressive therapy or live vaccine within 8 weeks of randomization (corticosteroid use is permitted)
Use of GM-CSF agents (e.g., sargramostim) within prior 2 months of randomization
Expected survival < 24h in the opinion of the investigator
Patient > 85 years of age
Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study
Biggest news from NP was HIV Cure.
This is huge.
If look at it, science makes sense.
They already have 2 HIV patients that needs bone marrow transplant and they can be given leronlimab
This is huge.
NP says 10% of HIV needs bone marrow transplant due to various diseases. All of these patients could be cured.
NP said death was seen severe, not M2M.
I saw video twice and he definitely said death was seen in severe.
Most of the death could have been in placebo.
Doctor mentioning leronlimab on Fox at 18:38
Check this vide. She was in Leronlimab clinical trial
Signed non-binding agreement for distribution of leronlimab.
Even though it's non-binding, at least one company wants to distribute it.
Have 4-5 more interested parties.
I am a new investor (2 months) and if I bought some shares very recently (within a week or so), I would have been very confused after reading positive and negative posts.
However, I did my due diligence and I think leronlimab may have a good chance of helping many people, not just for CoVID-19 but other diseases as well.
I think this is my first time where I spent many hours of reading and watching videos on leronlimab and mechanism of action. This was my due diligence. I had lots of time last 2 1/2 months since I could not work due to shelter in place.
I have many shares now and I put all my shares on limit selling price at $100 but I think I am going to change limit selling price higher because I think the price can go above $100. This way hopefully shorters cannot use my shares.
To new investors, I would recommend doing some research and finding more about leronlimab before investing.
Because they did not have 75 patients.
That was the # of patients FDA wanted (or design of the study).
They can unblind the study if there r enough patients enrolled.
Once unblinded then trial is over, not finished, just over.
Once the trial is unblinded, then the trial study is over.
Then everyone can see the results, including the doctors and cytodyn
They can continue to monitor the patient to give an update of the patient's condition but study is done.
I prefer to finish the study with 75 patients, which would be stronger study (more patients the better) but it will take longer.
I like NP answer in that let's see how many patients they get at 2 weeks from now.
If they do not get 75 patients in next 2 weeks, then they have an option to unblind the study since they have 5o patients and 50th patient enrolled will have at least 2 weeks of treatment.
If they get 75 patients in next 2 weeks, that is what FDA wanted, I prefer they finish the study. This will give us a clear answer and there will be no questions from FDA in regards to the validity of the results. But will need to wait another 2 weeks, which will be a month from now.
I hope I did not confuse anyone!
Next 2-3 months will be exciting!
Another study on Remdesivir...
This paper is from NEJM (DOI: 10.1056/NEJMoa2007016)
Compassionate Use of Remdesivir for Patients with Severe Covid-19
This was not a randomized controlled trial (RCT), which means there was no comparison to placebo.
This paper showed that "clinical improvement was observed in 36 of 53 patients (68%)" But this was NOT RCT. It did not compare to placebo or any other medications.
However Remdesivir showed high adverse effects:
1) A total of 32 patients (60%) reported adverse events during follow-up (Table 2). The most common adverse events were increased hepatic enzymes, diarrhea, rash, renal impairment, and hypotension.
2) A total of 12 patients (23%) had serious adverse events. The most common serious adverse events — multiple-organ-dysfunction syndrome, septic shock, acute kidney injury, and hypotension — were reported in patients who were receiving invasive ventilation at baseline.
Due to high adverse effects, not sure if Remdesivir is the drug of choice for COVID-19
https://www.nejm.org/doi/full/10.1056/NEJMoa2007016?query=featured_home
There r many medications currently being tested for COVID-19.
Another drug has failed:
"Fujifilm shares slumped last week after Kyodo reported that an interim study showed no clear evidence of efficacy for Avigan in COVID-19 cases"
https://www.yahoo.com/news/japan-gives-approving-avigan-covid-015429736.html
Leronlimab is looking better every day!
Let's see...
Published treatments in peer reviewed journal (this month).
Including Remedesivir, to me, these are not effective treatments.
If data from leronlimab is good and Dr, P's paper gets published, then FDA has to take take action and support/fund leronlimab.
This will put leronlimab on top of treatment protocol.
1) Remedesivir vs placebo (DOI: 10.1056/NEJMoa2007764 - shortened hospital stay but no difference in mortality rate. 114/541 patients taking Remdesivir showed ADVERSE side effects.
2) Lopinavir and ritonavir (N Engl J Med 2020; 382:1787-1799
DOI: 10.1056/NEJMoa2001282)
"Conclusions: In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir–ritonavir treatment beyond standard care."
3)Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19 (DOI: 10.1056/NEJMoa2012410
Conclusion: "In this observational study involving patients with Covid-19..., hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death."
4)Association of Treatment With Hydroxychloroquine or Azithromycin With In-Hospital Mortality in Patients With COVID-19 in New York State ( JAMA.May 11, 2020 doi:10.1001/jama .2020. 8630
Conclusion: "Among patients hospitalized in metropolitan New York with COVID-19, treatment with hydroxychloroquine, azithromycin, or both, compared with neither treatment, was not significantly associated with differences in in-hospital mortality."
Another published article mentioning leronlimab
I am not sure if anyone posted this publication.
This article is about covid-19 therapeutics and their toxicities.
Leronlimab shows " There are no serious side effects or adverse events reported so far". However, this finding was not from COVID-19 studies.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7192319/
Remdesivir study showed 114 out 541 showed adverse side effects in Covid-19 studies.
No serious or adverse events is one of the major advantages over other medications. This is what Dr. Otto Yang at UCLA also mentioned as well. He is involved in 2 leronlimab studies in UCLA.
Price of 2 SQ injections of leronlimab.
Someone from one of youtube post mentioned that 2 SQ of leronlimab is $2500 ($1250 per injection).
It's not cheap but, to me, this is very reasonable price to save lives.
Mylan was charging $500-650 for Epipen!
If leronlimab is effective, I would pay so much more than that to save lives.
This is so sad!
They amputated his right leg due to clotting problem.
I am not sure leronlimab was given but doctor should at least try it, if not given, since leronlimab has no adverse side effect.
I just think that many doctors do not know about leronlimab!
I think it might be same study.
Now, it's published in one of the well known journals, NEJM.
Now more scientific communities around the world will know about it.
Leronlimab has the best chance
So far:
1) Remdesivir is not much of treatment in my mind (after reading the article from NEJM)
2) No vaccine in sight, there r talks but nothing concrete in the horizon, and will take months to years before coming out
3) Even with vaccine or anti-viral, still need treatment
4) Even though anecdotal, leronlimab looks promising. I cannot wait till the preliminary data comes out soon from several clinical trials , maybe and hopefully next week
5) Mexico and China might start using leronlimab soon or started already
6) If leronlimab shows positive in Mexico, this will spread to Central and South America, which is now the epicenter of the world fpr COVID-19
7) Leronlimab may be helpful for bunch of other diseases
8) BLA submitted to FDA for HIV treatment
Not sure how high it will go. Probably better to ask Black-Ops for that!
Politics and big pharma may get in the way but Science will always wins.
I think I am going to buys some shares on Tuesday!
Link to article in NEJM about Remdesivir
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764?query=featured_home
If I get sick, I do not want Remdesivir, after reading this study.
It's little better than placebo.
I am going to ask for Leronlimab or anyone that gets sick.
R u kidding me? 114 out of 541 patient taking Remdesivir reported SERIOUS adverse event!
No wonder why death rate is so high in US.
This is from an article in NEJM:
Remdesivir for the Treatment of Covid-19 — Preliminary Report
This is double blinded study (Remdesivir vs placebo)
Summary:
Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%).
Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was NOT significant (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04; 1059 patients).
Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew consent (13).
One of their conclusions:
However, given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient.
This was funded by (Dr. Fauci's dept NIAID):
The trial was sponsored and primarily funded by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD.
WOW, that's a lot of shares.
I have over 200K shares but I got in late, between 2.50 - 3.20
More and more I learn about leronlimab, more and more I am confident that science behind it will work!
As we all know Chinese market is huge and if it goes well there, then leronlimab will save many lives there as well.
Live Dr. Yo on Youtube
Bought another 1K shares.
2 UCLA clinical trials
I was fortunate to talk to Dr. Yang several weeks ago when he was using leronlimab as eIND for COVID-19 patients.
Dr. Yang is actually HIV expert but got into COVID-19 due to pandemic. He already knew about leronlimab before pandemic occurred and he also knows about safety of leronlimab compared to other medications. Safety of leronlimab is one of the major reasons he prefers leronlimab over other meds.
With use of eIND patients, he says he saw good results He also mentioned that leronlimab probably will not work 100% but looks promising. That is why he is doing double blinded clinical trials at UCLA. He is looking forward to the results himself.
These are the 2 clinical trials that are being conducted in UCLA with Dr. Otto Yang
1)Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.
2) Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.
Trials with leronlimab & Remdesivir
Glad that they are doing 3 clinical trials
1) placebo
2) Remdesivir & leronlimab
3) Leronlimab
It would interesting to see 2) & 3) results.
If leronlimab works better alone, Remdesivir maker will be crying!
If leronlimab works better alone, then it will be a game changer!
Vaccine will still be needed but it will not work for everyone because some or many people will have weaker or compromised immune system.
In order for vaccine to work, body has to have good immune system.
We just need data from all these clinical trials!
If trials produce positive results, many lives will be saved and stock price will skyrocket!
Thanks, I guess that is why I still need to keep my day job!
LOL!
Just send a message to WH to look into and fund leronlimab.
Looks like there were some selling after the market closed.
Stock price dropped $0.03 after market.
Is this right?
Webinar is over. I do not know if there is a recording.
Check youtube or Beckman & Coulter website.
Smart doctor from Germany.
I don't know if you noticed during the webinar (during panel discussion) that he was frantically typing on his laptop, maybe putting a order to buy some CYDY stocks!
LOL!
It may be the German doctor from Beckman & Coulter webinar
There was a doctor from Germany and he works at the biggest research centers (72 in German centers) in Europe.
One of things that his research centers does is testing various medications for COVID-19 to see if they are effective or not.
If that German doctor is smart, I am sure he is brilliant, he might be buying up the shares now!
Not sure if there is recording.
I would probably check Beckman & Coulter website and youtube.
Every share holders should watch the webinar if available so that share holders know more about leronlimab for themselves.
This is a preview of the paper that will be published. If don't like reading and do not have science background, watching this will help alot.
Dr. Patterson mentioned that he is answering the questions that reviewer is asking. He says he won't mention the journal, which to me is something big, setting up for a big suspense and surprise!
His data were very convincing!
If clinical trial data are positive and his paper is published, then leronlimab will be the drug of choice, until something better comes out but do not see anything good in near future.
I am glad that Dr. Patterson did not hyped leronlimab (even though he could have) but just gave the facts, data, and what it can be capable of doing. He is not the most eloquent speaker but he presents like a scientist, which is what I would like hear if I am listening about science, not a scientist that has eloquent voice and dramatic presentation but without much data!
I bought 8K shared today because I am more convinced now than before after listening to Dr. Patterson!
WOW, WOW!
My take on today's Beckman & Coulter webinar with my immunology background.
He was outstanding! There was no hype of leronlimab, he just presented many data on what leronlimab can do. This is what the doctors/researchers want to see, DATA, DATA, DATA!!!!
No one can argue with data and his presentation was absolutely convincing and fascinating!
I can tell from looking at the other 2 speaker's face that they were also interested, fascinated and dumbfounded because there were so many data on so many cytokines with all positive results with leronlimab! I think Dr. Patterson looked at 9-10 cytokines.
One of the speakers was a researcher group from Germany and they are testing many medications for COVID-19. I hope his group will test leronlimab.
I think once the paper is published, many doctors around the world will know about RANTES and leronlimab.
Someone mentioned that there was big stock order to buy at 9:46 am. I think it might have been one of the speakers!! That was when Dr. Patterson was speaking! LOL!
Science will win!!!
I listen to COVID-19 symposium webinar today. My take from one the speakers.
One of the speakers was a researcher from a lab in Alabama that helps pharmaceutical companies research/find vaccines.
This speaker mentioned that, even if there is vaccine, there also needs to be treatment/cure.
Medical community know that in order for the vaccine to work, people need to have "adequate/strong/capable" immune system.
Vaccine will slow down the virus but, in addition, body's immune system needs to kick in to eradicate rest of the virus.
Vaccine will not help everyone because there will be patients that have will not have "strong" immune system or body's immune system is "exhausted" from combating the disease.
So, even with vaccine, we will need treatment or cure, such as Leronlimab or other medications.
Hopefully, vaccine and Leronlimab or other meds will help to eradicate this virus.
Dr. Patterson will be speaking at Beckman & Coulter COVID-19 synmposium on May 21, 2020.
It should be a good and more people will know about Leronlimab.
His webinar title is: Disruption of the CCL5/RANTES-CCR5 pathway 1 restores immune homeostasis and reduces plasma viral load in critical COVID-19.
Here is the link to register. It may be full. I was able to register.
https://beckman.zoom.us/webinar/register/7715875629440/WN_AZiFPh1VQcyKrXa2qW423A
Here is link to symposium info.
https://pages.beckman.com/fmna-liqh-covid19-symposium-20-04-wbn-usa_00-lp-register8.html?utm_medium=website&utm_source=homepage&utm_campaign=fmna-liqh-covid19-symposium-20-04-wbn-usa&utm_content=covid-19-webinar&utm_term=field-marketing_leadgen_top
If we know the mechanism of action, which looks like cytokine storm, then Leronlimab will treat any diseases and infections (viral or bacterial) that can trigger the cytokine storm.
If Leronlimab can calm the storm and cause homeostasis of the patient's immune system to combat the virus, then this will be a game changer for sure.
I think there are other CCL5 receptor antibodies, like Leronlimab, but Leronlimab has shown outstanding safety record in clinical trials with HIV. This gives Leronlimab the edge over other CCL5 receptor antibodies.
I cannot wait till the data from double blinded studies is revealed.
This will be the answer to many of the questions we currently are asking.
Once this data comes out and papers are published in the journal, then there is nothing that can stop Leronlimab!
If data is positive, then Leronlimab will save many lives!
My gut feeling why I like Leronlimab:
1) Remdesivir is not the answer for this viral infection. It will work for a few that takes this medication in the earlier phase of the infection. Once it manifests enough, Remdesivir will not do much. Remdesivir is much like Tamiflu. If you do not take Tamiflu in the early phase of infection, you will most likely still get a flu and need to ride it out. If taken early, it may help for a few but not all.
2)If Remdesivir is the answer, most of the clinical trials will be stopped or useless. There are so many clinical trials because researchers and doctors know that Remdesivir is not the answer.
3) More and more researchers are looking beyond the virus itself, such as cytokine storm because there are so many illnesses that are associated with this viral infection. Almost all end organs are being "attacked" simultaneously. This is different than other viral infections.
I found about Cytodyn while watching CNBC a few weeks ago. There was a mentioning of several pharma companies and CYDY was at the bottom of the list. They did not mention CYDY butit caught my attention.
I got in late in the game but I think, as of now, Leronlimab has a very good chance of doing very well.
This can save many lives!
I am sort of dumbfounded that FDA and Dr. Fauci touts so highly of Remdesivir after one study which is not even double blinded clinical trial.
Most or all the doctors rely on double blinded (both doctors and patients do not know what they are getting so that there is no bias) studies to determine if the medication is effective or not.
Once again, Remdesivir clinical trial was NOT double blinded study.
Therefore, if patient got better, that does NOT mean Remdesivir was effective.
Their clinical trial is little better anecdotal findings but not much better than that!
Dr. Fauci keep mentioning about evidence based, not anecdotal, findings from clinical trials (double blinded study) to determine if medication is effective but, without double blinded study, he recommended Remdesivir.
To me, he is going against what he believes, which is hypocrisy.
Maybe he is trying to get something out there quickly that is somewhat effective. Maybe pressure from politics or big pharma.
By touting Remdesivir so highly, it may deter on-going research and clinical trials of other medications, which is or may be much better than Remdesivir.
As of now, I think Leronlimab has the best chance of coming out on top!
To me, it looks the Gilead is trying to flood the market with Remdesivir so that no other meds can get into the market.
I do not think Remdesivir is the drug of choice for COVID-19, according to the clinical trial (which was not double blinded prospective, (placebo vs Remdesivir) study, which means that the study is not very strong) and doctors that I have talked to. One positive note on Remdesivir clinical trial is that they did enrolled 8000 patients and that is about it. BUT not double blinded study, which, to me, does not say much!
With Leronlimab, they are doing double blinded studies, which mean that the clinical trials will tell if Leronlimab will work or not. Whether it will work or not, there will be no doubts from the scientific community due to the fact that these clinical studies are double blinded placebo vs Lerolimab, which are done at UCLA and other places.
If the studies come out positive, the share price will skyrocket because studies proved that Leronlimab worked!!!!!
I can't wait till the data from clinical studies come out in a few weeks or month.