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Actually I believe even more impressive in March of 12 with advances in SOC, reducing overall mortality greatly from one year ago. Easy to say in hindsight what should of been done but it seems clear the drug works and we are in the middle of a pandemic and need to save lives.
News 3 looks at COVID-19 patients with symptoms that have lasted for months
Dr. Scott Kelly is the Chief Medical Officer and Head of Business Development at CytoDyn Inc., which is a biotechnology company that is about to start a clinical trial about long haulers. He said, “We're starting to see more and more of this and this is a real phenomenon.”
https://www.wtkr.com/news/coronavirus/news-3-looks-at-covid-19-patients-with-symptoms-that-have-lasted-for-months
Now, the intensive-care mortality rate for people with the illness is down to 30%, and for those on ventilators it is around 45–50%. “This itself was a relief,” says Vijayaraghavan.
https://www.nature.com/articles/d41586-020-03132-4
Then
According to research published in Clinical Infectious Diseases, ICU patients receiving mechanical ventilation had a 70.5% mortality rate compared to 21.4% of hospitalized patients not requiring intubation.
https://rtmagazine.com/disorders-diseases/critical-care/icu-ventilation/covid-19-mortality-significantly-higher-for-patients-needing-intubation/
https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1268/5898276
Dr. Patterson paper out soon:
Leronlimab doesn’t decrease RANTES, it blocks it from binding CCR5! Revised paper out very soon! https://t.co/YVeXQpKEbq
— Bruce K. Patterson MD (@brucep13) August 30, 2020
Survivor study with Leronlimab: studying the effects of the drug Leronlimab on COVID-19 survivors seeking relief after several weeks of battling the illness.
https://ung.edu/news/articles/2020/07/ung-faculty-and-alumni-involved-in-covid-19-research.php
Trump on Therapeutics during press conference on new drug pricing executive order. Go to 18:30.
potential for 3 BTD’s in metastatic Triple Negative Breast Cancer, metastatic cancer, and COVID-19.
STUDY IN ICU FINDS 30.9% MORTALITY RATE FROM COVID-19
This number varies from 30 to 50 % based on the study, and in NY 88%.
NP states that we have quite a bit of data, and unfortunatley quite a number of deaths reported as serious adverse advents in the severe/critical trial.
About 120 patients enrolled 40 on placebo, 30 percent is 12 deaths. 40 percent is 16 deaths and 50 percent is 20 deaths, definitely could all be in the placebo arm. Hopefully significant correlation so one does not have to break down against age, etc.
https://www.futurity.org/covid-19-mortality-rate-2377362-2/
Contact the President https://www.whitehouse.gov/contact/
and implore him to fund Leronlimab.
Dr. Been discussing Leronlimab tonight 6:00PM PST. 1 million trusted followers.
We will discuss the mechanism of action of Leronlimab today.
— Dr. Mobeen Syed (@drbeen_medical) May 21, 2020
6 pm Pacific standard time.
Facebook and YouTube live.
Dr. Yo and Dr. Patterson on Youtube
From recent NATURE article mentioning Leronlimab:
The antiviral drugs, such as Selzentry (maraviroc) and Leronlimab (PRO 140), have been successfully used for treatment of AIDS.25 It is therefore of great interest to study whether these drugs can block cardiac in?ltration of CD8+ T cells thereby reduce hypertensive cardiac injury of COVID-19 patients.
https://rdcu.be/b4aqp
Leronlimab included in FDA News:
The toxicity of these agents and many others is under evaluation in clinical trials to determine their effectiveness against COVID-19. Data has already begun to be shared with the FDA from some clinical trials, such as leronlimab, which had data recently published in a pre-print manuscript online. The FDA intends to engage with pharmaceutical sponsors and other government agencies to facilitate patient access to these potential treatments as soon as favorable results are seen.
https://www.targetedonc.com/view/fda-advances-development-of-new-options-for-covid-19-prevention-and-treatment
"Your immune system is overreacting to the virus, and because these are inflammatory diseases, this overreaction can cause a Kawasaki-like disease," Dr. Glenn Budnick, a pediatrician in Pomona, New Jersey, said on CNN Newsroom Saturday.
https://www.cnn.com/2020/05/12/health/coronavirus-symptoms-blood-clots-inflammation/index.html
Update today-None Locations added, including Yale for Moderate/Mild study
https://clinicaltrials.gov/ct2/history/NCT04343651?A=1&B=4&C=Side-by-Side#StudyPageTop
Eleven sights added today to Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)
https://clinicaltrials.gov/ct2/history/NCT04347239?A=1&B=4&C=Side-by-Side#StudyPageTop
Comments regarding effectiveness By Dr. Yang.
The slide shown by NP had a total of 23 patients, I believe Dr. Yang said 24 yesterday.
Six were critically ill. Five out of Six either improved or 83%.
17 were severely ill. Two were just enrolled, so that's 15. 11 improved, 2 were stable, and 2 have not improved yet, but perhaps did not decline.
That's 13 out of 15 with two stable or 86%.
Eight patients discharged out of the 11 improved with an average discharge time of 5 days.
What we do not know is the severity and the underlying conditions of the patients, but there was probably some reason to resort to an EIND as they were more than likely at risk due to age or underlying condition.
Yang indicate 50 to 67% success rate off the cuff. Waiting for clinical trial conditions where Cytodyn has a controlled patient population:
Exclusion Criteria for mild to moderate trial:
Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening;
History of severe chronic respiratory disease and requirement for long-term oxygen therapy;
Subjects showing signs of clinical jaundice at the time of screening;
History of moderate and severe liver disease (Child-Pugh score >12);
Subjects requiring Renal Replacement Therapy (RRT) at the time of screening;
History of severe chronic kidney disease or requiring dialysis;
Any uncontrolled active systemic infection requiring admission to an intensive care unit (ICU); Note: Subjects infected with chronic hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation.
Note: Subjects infected with HIV-1 will be eligible for the study with undetectable viral load and are on a stable ART regimen. Investigators are required to review the subjects' medical records to confirm HIV-1 RNA suppression within the previous 3 months.
Note: Empirical antibiotic treatment for secondary bacterial infections is allowed during the course of study.
Patients with malignant tumor, or other serious systemic diseases;
Patients who are participating in other clinical trials;
Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible; and
Inability to provide informed consent or to comply with test requirements
Low on Oxygen, get a dose of Leronlimab.
https://theconversation.com/the-puzzling-questions-of-the-coronavirus-a-doctor-addresses-6-questions-that-are-stumping-physicians-137578
Dr. Yang slides courtesy cems70 on Yahoo
https://www.dropbox.com/s/9pz7o226i73259y/2020.5.20%20LABEST%20presents%20COVID-19%20Spotlight%20Series%20UCLA_Dr%20Yang%20presentation%20slides.pdf?dl=0
Leronlimab listed a potential treatment Nature May 6, 2020
Table 1 Possible therapeutic targets linked to macrophage activation in COVID-19
Table
https://www.nature.com/articles/s41577-020-0331-4/tables/1
Article
https://www.nature.com/articles/s41577-020-0331-4
NNC Pale Springs coverage of Leronlimab trial-Medical breakthrough in the making!
https://nbcpalmsprings.com/2020/05/05/hiv-treatment-to-be-tested-on-covid-19-patients/
IN Cytodyn's 2018 Clinical update they set the market based on $ 24,000 per annum or 1.2 Billion for 49,000 Patients.
I calculated price equivalent at $ 2000 per patient for two doses.
The cost of Covid last reported ranges form 163 to 654 BILION. Spend a couple billion to save 100's of billions.
Also viral load suppression of HIV:
Completed - CD02 Phase 3, pivotal trial in combination therapy for HIV
• Achieved primary endpoint (p=0.0032)
• 81% of patients achieved suppressed viral load (VL) with plasma HIV-1 RNA <50 copies/mL
• No serious adverse events (SAEs) related to PRO 140 (over 650 patients exposed to PRO 140).
• Rolling BLA submission expected to be complete in 1H19 Underway - CD03 Phase 3 HIV investigative monotherapy trial
• 366 patients enrolled, enrollment continuing
• ~70% response rate at 525 mg
• ~90% response rate at 700 mg
Underway - Phase 2 graft-versus-host disease (GvHD)
• Modified protocol to improve enrollment and reflect positive preclinical findings
• If interim results are positive, BTD will be filed for expedited approval. TNBC is a unmet medical need New, Underway - Phase 1b/2 triple negative breast cancer
• Interim data review following treatment of first 10
patients in the new protocol
• Interim results could be announced in 1st Q of 2019
• CTC (Circulating Tumor Cell) test will be conducted with all
patients and the test is conducted every 21 days.
Leronlimab (PRO 140) for HIV: Clini
https://content.equisolve.net/cytodyn/media/1951d5b26286740bff0641b757c0b8c1.pdf
Gilead's breakthrough coronavirus drug sparks concerns over how much it'll cost
Perfect they have a drug that does not work very well and costs over twice as much as Leronlimab, and requires daily IV. Leronlimab two injections at a doctors office over two weeks.
https://finance.yahoo.com/news/gileads-breakthrough-with-remdisivir-sparks-concerns-over-pricing-163751383.html
Precursor from Nature:
https://www.nature.com/articles/s41467-020-16256-y
CYTODYN 10-! from April 9 2020 describing 30 million payment schedule with Samsung for sipply of Leronlimab. Obviously time is of the essence for the sake of saving lives. Extraordinary times require extraordinary measures.
https://www.cytodyn.com/investors/sec-filings/all-sec-filings/content/0001193125-20-102675/0001193125-20-102675.pdf
During the fourth quarter of fiscal 2019, the Company entered into a Master Services Agreement and Product Specific Agreement (collectively, the
“Samsung Agreement”) with Samsung BioLogics Co., Ltd. (“Samsung”), pursuant to which Samsung will perform technology transfer, process validation,
manufacturing and supply services for the commercial supply of leronlimab. In April 2019 the Company delivered to Samsung a purchase order for
$33 million worth of process validation and technology transfer services related to the manufacture of leronlimab, with payments by the Company
scheduled to be made throughout calendar 2020. Under the Samsung Agreement, the purchase order is binding and the Company is obligated to pay the
full amount of the purchase order. Under the terms of the Samsung Agreement, the Company is obligated to make specified minimum purchases of
leronlimab from Samsung pursuant to forecasted requirements which the Company is required to provide to Samsung. The first forecast, due March 31,
2020, is currently in process along with the first rolling quarterly forecast setting forth the total quantity of commercial grade leronlimab that the Company
expects to require in the following years. The Company estimates that initial ramp-up costs to manufacture commercial grade leronlimab at scale could
total approximately $60 million, with approximately $30 million payable over the course of calendar 2020, and approximately $30 million payable in the
first quarter of 2021. Thereafter, the Company will pay Samsung per 15,000L batch according to the pricing terms specified in the Samsung Agreement.
The Samsung Agreement has an initial term ending in December 2027 and will be automatically extended for additional two-year periods unless either
party gives notice of termination at least six months prior to the then current term. Either party may terminate the Samsung Agreement in the event of the
other party’s insolvency or uncured material breach, and the Company may terminate the agreement in the event of a voluntary or involuntary complete
market withdrawal of leronlimab from commercial markets, with one and half year’s prior notice. Neither party may assign the agreement without the
consent of the other, except in the event of a sale of all or substantially all of the assets of a party to which the agreement relates.
Survivability increases by 300% at Montefiore immunosupressed patients compared to NY health system reported in news.
Perspective: 88% of patients died on ventilator in a New York Health System. At Montefiore this was lowered to 74%. This was the sickest of the sick including many patients that were on immunosuppresive regimen due to transplants, not something you want to be on with Covid 19. Of these patients you have a 300 % decrease in mortality or for every 100 patients 12 vs 36 patients survive. If you use the other locations you are looking at 45% survivability and a 378% improvement in mortality or 12 vs 45. The comparison is only so good as when you are cherry picking patient for EIND it pretty much means it is a path of last resort. Once the studies are done we could probably see 80% survivability rate or an 800% improvement compared to the NY hospital system mentioned in the press, just a guess.
The data looks extremely promising. If you then look at treatment cost and other factors, you can use your imagination.
Gilead (NASDAQ: GILD) Shares Jump On Trial Results and Fauci Despite 9.3% Mortality Rate After 14 Days
https://insiderfinancial.com/gilead-nasdaq-gild-shares-jump-on-trial-results-and-fauci-despite-9-3-mortality-rate-after-14-days/179865/
COVID-19 Mortality Hits Almost 30% in Kidney Transplant Patients
https://www.medscape.com/viewarticle/929585
Clinical trial begins for ‘promising’ COVID-19 drug called Leronlimab
https://www.corneliustoday.com/clinical-trial-begins-for-promising-covid-19-drug-called-leronlimab/
Coronavirus Treatment: Experimental Drug Shows 'Impressive' Results As COVID-19 Cure
https://www.ibtimes.com/coronavirus-treatment-experimental-drug-shows-impressive-results-covid-19-cure-2966041
Dr. Yo recommending Leronlimab
https://www.instagram.com/tv/B_do6c8hVlS/?igshid=lvfplf0aow6k
Of the hospitalized patients, nearly all had viral pneumonia and 11 were intubated. In terms of treatment, 86% of these patients received hydroxychloroquine. Six severely ill patients received the CCR5 inhibitor leronlimab (PRO 140, CytoDyn), while two received interleukin-6 receptor antagonist tocilizumab, the authors said. They noted the patient with the lowest interleukin-6 level "remained in stable condition without intubation."
https://www.medpagetoday.com/infectiousdisease/covid19/86156
A portion of the article in the San Francisco chronicle
Dr. Warner Greene, a senior investigator with the Gladstone Institutes who has been studying the coronavirus, said leronlimab appears to be “more surgical in its effect.” Colchicine, though well known and widely used, “seems like a blunt instrument for the job at hand,” he said.
Greene said leronlimab is a more targeted kind of drug that would be “interfering with a fundamental part of the process that is causing the trouble.”
“Colchicine may be doing that, but it’s having its effect all over the body,” he said. “That said, if it blocked the cytokine storm ... that would be wonderful.”
Doctors studying leronlimab think it could be broadly effective. While CytoDyn would like to use the drug on ICU patients, its greatest benefit will likely be on patients in earlier stages of COVID-19 — hospitalized people with symptoms more severe than mild shortness of breath, said Lalezari of CytoDyn.
Dr. Bruce Patterson, CEO of the San Carlos single-cell diagnostic company IncellDx that has been working on leronlimab, said the drug is exciting because it appears to impact some of the most essential elements of the viral disease, “not just a piece of what COVID is all about.”
“This is the ideal drug to meet everybody’s needs about reopening the country,” Patterson said. “If we had something that we could say we can treat the severe (patients) and we can keep the mild-to-moderates from getting severe, then it becomes the flu. Then we’re not so scared of people getting infected.”
Leronlimab plus what to make the cocktail to fight Covid 19?
https://www.sciencemag.org/news/2020/04/how-does-coronavirus-kill-clinicians-trace-ferocious-rampage-through-body-brain-toes?utm_campaign=news_daily_2020-04-20&et_rid=682137486&et_cid=3293026#
Cytokine Storms May Be Fueling Some COVID Deaths
https://www.webmd.com/lung/news/20200417/cytokine-storms-may-be-fueling-some-covid-deaths