BioPharma Terug naar discussie overzicht

Heeft CytoDyn het ultieme anti-HIV-middel??

1. [verwijderd] 4 april 2020 00:14

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   En een ander artikel, net uit.
   
   A small trial finds that hydroxychloroquine is not effective for treating coronavirus
   
   Katherine Seley-Radtke, Professor of Chemistry and Biochemistry and President-Elect of the International Society for Antiviral Research, University of Maryland, Baltimore County
   
   3 April 2020 - On Saturday the Food and Drug Administration approved the use of two antimalarial drugs, hydroxychloroquine and a related medication, chloroquine, for emergency use to treat COVID-19. The drugs were touted by President Trump as a “game changer” for COVID-19.
   
   However, a study just published in a French medical journal provides new evidence that hydroxychloroquine does not appear to help the immune system clear the coronavirus from the body. The study comes on the heels of two others - one in France and one in China - that reported some benefits in the combination of hydroxychloroquine and azithromycin for COVID-19 patients who didn’t have severe symptoms of the virus.
   
   I am a medicinal chemist who has specialized in discovery and development of antiviral drugs for the past 30 years, and I have been actively working on coronaviruses for the past seven. I am among a number of researchers who are concerned that this drug has been given too much of a high priority before there is enough evidence to show it is indeed effective.
   
   There are already other clinical studies that showed it is not effective against COVID-19 as well as several other viruses. And, more importantly, it can have dangerous side effects, as well as giving people false hope. The latter has led to widespread shortages of hydroxychloroquine for patients who need it to treat malaria, lupus and rheumatoid arthritis, the indications for which it was originally approved.
   
   The idea that the combination of hydroxychloroquine with an antibiotic drug, azithromycin, was effective against COVID-19 gained more attention after a study published on March 17. This study described a trial of 80 patients carried out by Philippe Gautret in Marseille, France. Although some of their results appeared to be encouraging, it should also be noted that most of their patients only had mild symptoms. Furthermore, 85% of the patients didn’t even have a fever – one of the major telltale symptoms of the virus, thus suggesting that these patients likely would have naturally cleared the virus without any intervention.
   
   In another study, posted on medRxiv, which has not yet been peer-reviewed, Chinese scientists from Renmin Hospital of Wuhan University, in Wuhan, China, gave hydroxychloroquine to patients with only mild infections who were free of medical issues, similar to the Gautret study. The results showed that the 31 patients who received the drug showed a lessening of their symptoms 24 hours earlier than patients in the control group. In addition, pneumonia symptoms improved in 25 of the 31 patients versus 17 of 31 in the control group. As noted in several of the comments associated with the manuscript, there are issues related to the translation of the paper, thus clouding interpretations of some of the results. The paper also appears to focus more on pneumonia than COVID-19. However, these issues may be cleared up or addressed once the paper finishes the peer-review process.
   
   But two other studies have conflicting results.
   
   A second French group, led by Jean-Michel Molina, has now tested the hydroxychloroquine-azithromycin combination treatment in 11 patients at the Hôpital Saint-Louis in Paris, France, and their results were strikingly different.
   
   Like the Marseille study, the Molina trial was also a small pilot study. Molina and colleagues used the same dosing regimen as Gautret. In contrast, however, to the Gautret study, eight of the 11 patients had underlying health conditions, and 10 of 11 had fevers and were quite ill at the time the dosing began.
   
   These Paris researchers found that after five to six days of treatment with hydroxychloroquine (600 mg per day for 10 days) and azithromycin (500 mg on day 1 and 250 mg on days 2 to 5), eight of the 10 patients still tested positive for COVID-19. Of these 10 patients, one patient died, two were transferred to the ICU and another had to be removed from the treatment due to serious complications.
   
   In addition, a similar study in China also showed no difference in viral clearance after seven days either with or without the hydroxychloroquine with the patients in the trial. This supports Molina’s findings.
   
   Thus, despite the recent approval of this drug for use against COVID-19, questions remain as to the efficacy of this treatment. As Molina and colleagues note: “Ongoing randomized clinical trials with hydroxychloroquine should provide a definitive answer regarding the alleged efficacy of this combination and will assess its safety.”
   
   news.yahoo.com/small-trial-finds-hydr...
2. [verwijderd] 4 april 2020 09:07

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   Het interview met Nader op Seatle News Videos.
   
   www.kiro7.com/video/?id=4878809
   
   A drug used to treat HIV and cancer patients has shown success in treating some of the most severe COVID-19 patients, and just got cleared by the FDA to start a phase 2 clinical trial. Much of the work behind the drug is happening right in Washington State.
   
   The drug was developed by a company called CytoDyn in Vancouver, Washington.
   
   It’s manufactured by a company in Bothell, AGC Biologics, which makes a special molecule that’s the key ingredient in the drug.
   
   Scientists at CytoDyn figured out it could work to treat COVID-19 and the first severely sick patients who’ve tried it have shown improvement.
   
   The drug is called leronlimab and comes in a vial and is a two-shot per week dose, over two weeks.
   
   It’s being tried on 10 of the most critically ill COVID-19 patients at Montefiore Medical Center in New York City, the University Hospital for Albert Einstein College of Medicine.
   
   The patients are on ventilators and some are barely conscious.
   
   “The first four patients who were intubated, two were extubated. One of them self-extubated, and became alert,” said Nader Pourhassan, the CEO of CytoDyn.
   
   Now the two patients are out of the ICU.
   
   Pourhassan said when he heard the results he had to stop what he was doing.
   
   “And cried for about five minutes. It was very, very emotional,” Pourhassan said.
   
   He said studies show that in the U.S., 85 percent of COVID-19 patients who end up needing ventilators will die.
   
   But the patients who’ve gotten shots of this drug have shown strong results.
   
   “All eight patients we’ve analyzed so far -- the first eight patients -- saw immunological benefits. The FDA immediately allowed us to have a phase two randomized trial. We are initiating that today,” Pourhassan said on Friday.
   
   He said the results were even seen in COVID patients who only got the shots three days, though it takes two weeks for full effect.
   
   The drug is already used for treating HIV and breast cancer. AGC Biologics has been manufacturing the key molecule for almost four years, and says it’s ready to ramp up production to treat coronavirus patients if needed.
   
   “Our urgency level couldn’t be higher. It’s every day, seven days a week,” said Mark Womack, the chief business officer of AGC Biologics.
   
   For people sick with COVID, when the virus reaches your lungs, your immune system starts attacking there -- causing more inflammation, which can stimulate the immune system to attack the lungs further.
   
   It’s a vicious cycle called a “cytokine storm” and your lungs can fill with fluid, and then you can’t breathe.
   
   The drug leronlimab basically boosts your immune system and calms the acute inflammation in the lungs that prevents people from breathing.
   
   CytoDyn said FDA also cleared them to try treating less seriously ill patients to see if the drug will stop the virus from reaching advanced stages.
   
   “We’re hoping we can save millions of lives,” Pourhassan said.
3. nb 4 april 2020 20:59

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   afwachten, wel hoopvol voor de zieke mens
4. [verwijderd] 4 april 2020 23:03

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   Trump snapt er nog steeds niets van...
   
   Hydroxychloroquine, wie gelooft daar nu nog in!!
   
   fc
   
   China and Oregon send ventilators to New York as Trump touts unproven Covid-19 'cure'
   
   Andrew Cuomo says state has acquired more ventilators as apex of coronavirus outbreak nears in the state, while Trump promotes malaria drug
   
   Billionaires working with the Chinese government have facilitated ventilator donations to New York to treat patients with Covid-19, as the pandemic accelerates toward a peak in the worst-hit US state.
   
   As New York governor Andrew Cuomo announced the news, as well as the loan of ventilators by the state of Oregon, Donald Trump again promoted an unproven malaria drug as treatment for Covid-19.
   
   Cuomo said he had obtained 1,000 ventilators from the Chinese government with the help of billionaires Joseph and Clara Tsai and Alibaba founder Jack Ma. Oregon had loaned New York another 140, he said.
   
   “We’re not yet at the apex,” said Cuomo, who described the crescendo of cases to come as “the number one point of engagement of the enemy”.
   
   Current projections put the peak of the pandemic in New York anywhere between four and 14 days away. Officials hope physical distancing imposed across the state will slow the spread of the disease, and forestall the possibility of running out of ventilators and hospital beds.
   
   Cuomo admitted he hoped to see the apex soon, so the experience would soon end. The pandemic, “stresses this country, this state, in a way nothing else has frankly in my lifetime”, he said.
   
   Cuomo put the New York case load at 113,704 and the death toll at 3,565, most in New York City but with nearly 1,000 deaths in other parts of the state. At lunchtime on Saturday, researchers at Johns Hopkins University in Maryland put the national toll at nearly 279,000 cases and 7,170 deaths.
   
   Cuomo’s briefing from the New York state capital, Albany, offered another contrast in leadership between the governor and the president. While Cuomo’s briefings convey alarming statistics, his frank descriptions of shortages and personal struggles have been praised across the country.
   
   On Saturday, Cuomo said the state had a signed contract for 17,000 ventilators, which he was later told could not be filled because many had already been purchased by China.
   
   At nearly the same time, Trump retweeted an article about hydroxychloroquine, a treatment for malaria. Some researchers believe the drug shows promise as a possible treatment for Covid-19 but so far studies lack control groups and are therefore treated as anecdotal. There is no known therapeutic for Covid-19, and no vaccine.
   
   The US federal government’s response to the outbreak has been defined by bungled testing, poor coordination, low stockpiles and planning failures. Federal failure to intervene in supply chains has led to bidding wars for masks and other personal protective equipment, governors have said.
   
   etc.
   
   www.theguardian.com/world/2020/apr/04...
5. [verwijderd] 4 april 2020 23:53

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   Van de Yahoo MB geplukt (poster Lyndon 4/4 - 23:30 uur)
   
   Vergelijk tussen Remdesivir en Leronlimab
   
   CYDY and GILD are like David & Goliath in the fight against COVID-19. Gilead"s Remdesivir works as an antiviral drug and has shown some benefit in treatment of Ebola, SARS & MERS but mortality rate reduction was not impressive. Remdesivir trial for COVID-19 started much earlier than Leronlimab's P2 trial for mild to moderate COVID infection. These 2 drugs/therapies more likely will be the first treatments for COVID-19 not to include Hydroxychloroquine & Chloroquine which are currently being used but not proven yet in RDB study. To emphasize, my discussion here will be focused between Leronlimab & Remdesivir.
   
   Remdesivir P3 trials (3 total being conducted by US investigators, not including trial conducted by Chinese investigators) involves total of 1440 (440 + 600 + 400) subjects in multiple countries with COVID-19 infection. You can find link for trials here: www.cdc.gov/coronavirus/2019-ncov/hcp...
   Trials have started enrolling from mid Feb 2020 to mid March 2020. For each trial, investigators can review on day 15 after 1st dose in first 100 patients to see if there is significant response or difference from placebo or SOC (supportive at this time). The DSMB can stop trial at any stage for benefit or futility reason. Since we are already in April (4/4/20), the trials if enrollment is brisk (which I expect) more likely should have reached the 1st 100 patients for review. With an urgent need for a treatment on a blossoming pandemic, not one trial for Remdesivir have so far shown an impressive interim result to stop such trial. We might more likely have to wait for the full completion of trial to see final results.
   
   In Leronlimab's case, enrollment just started in last 3-10 days for both P2 trials (mild-moderate & severe infection). Both are RDB trials with n=75 & n=342. Primary end point for severe trial is mortality at 14 days after initial dose. I expect Leronlimab trials to come up first with results sooner than Remdesivir. For the first 4 of 10 severe patients under EIND, there was already significant improvement within 3 days after getting 1 dose as reported by Dr. NP & Dr. Patterson. Two got extubated and all had significant improvement in immunologic response by day 3. I will not be surprised that interim assessment by investigators after 1 week of 1st dose can be significantly positive such that trial can be stopped. It will be unethical to let the placebo patients who are not responding or getting worse not be given Leronlimab if already proven significantly effective for treating COVID-19 infection. I hope this is the case as there are tens of thousand patients who will need the treatment urgently.
   I expect this coming week will be full of news & updates on Leronlimab trials and EIND patients (10).
   
   To add on, Remdesivir is given IV with recommended 10 day treatment while Leronlimab is SC given weekly. The convenience of SC injection and weekly regimen and possible impact on lowering mortality or ventilator need favors Leronlimab over Remdesivir.
6. [verwijderd] 5 april 2020 17:20

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   Nieuws van gisteren, maar 10 van de 10 doodzieke patiënten van de IC.
   
   www.youtube.com/watch?feature=youtu.b...
   
   En nog steeds haalt het de grote pers niet. Alleen de conservatieve New York Post heeft vrijdag wat gepubliceerd. Alle andere bladen hullen zich in stilte...
   
   fc
7. Sub!et 5 april 2020 18:30

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   Stel je voor dat Roche, J&J, Pfizer zo'n toevalligheid hadden ontdekt . Zij hebben wel vriendjes in de media om zo'n nieuws te verspreiden.
   De dag van vandaag wordt ALLES gemanipuleerd.
   Het is misschien naïef te denken dat de grote boys het zomaar uit handen gaan geven.
   De oplossing vinden zal een enorme impact hebben en wie wil die pluim niet op zijn hoed steken.
   Het is nog maar getest op 10 personen.
   Een gedegen argument als excuus, bij de concurrentie ,om het te weerhouden.
   Nog nooit heeft een medicijn, zonder al die Fase1, Fase2,...
   trappen , zoiets teweeg kunnen brengen.
   De uitgestelde uitzending door Fox is niet toevallig (Fox doet NIKS toevallig).
   Kan zijn om tijd te winnen voor ander speler.
   Of de druk wordt te groot om CytoDyn te negeren en er onderhandeld wordt,
   op welk niveau dan ook......
   Heel gunstig voor allen zou zijn, dat ze gewoon nog een paar dagen extra nemen om goed voorbereid te zijn voor de "take off".
   
   Tot we nieuws hebben blijft het gissen, hopen, stressend surfen op de golfjes,
   My 2 cents
8. [verwijderd] 5 april 2020 18:53

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   Natuurlijk, alles is politiek gedreven en BP zal zo lang mogelijk proberen CytoDyn in de schaduw te laten staan. Daarnaast heb je ook nog het gedoe tussen de republikeinen en democraten. Democratisch NY wil Trump het liefst laten sneuvelen op Covid-19. Terecht ook, de ziekenzorg in de USA is bagger.
   
   Covid-19 is bijvangst, het gaat om HIV en vooral kanker. Dat is pas echt de markt!!
   
   Het goede nieuws is dat de patiënten worden behandeld met Leronlimab, terwijl we hier zitten te wachten :). En Leronlimab is zo krachtig, het zal naar buiten komen. Ik verwacht dat iedere dag de komende week er wel wat nieuws naar buiten sijpelt.
   
   Nog even voor beleggers die een positie overwegen, het is Pink sheet, OTC, dus hoog risico beleggen. Niet geschikt voor "nervous nellies", de koers kan 30% naar beneden en vervolgens weer 30% omhoog. Er zitten 0.08% instituten in (dus nul), en dat zegt genoeg denk ik.
   
   fc
9. [verwijderd] 5 april 2020 20:42

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   Nog een poging om CytoDyn de voet dwars te zetten? Het zal alleen niet helpen...
   
   Hun Remdesivir lijkt niet veel te doen tegen Covid-19. Ze doen hun best om hun rommel (gratis) te slijten en zich in de kijker te wurmen.
   
   Leronlimab doet niet aan gratis weggeven na de trials. Is niet nodig: een werkend middel is geld waard!
   
   fc
   
   Gilead to Donate Experimental Coronavirus Drug Remdesivir
   
   5 april 2020 01:31 CEST Updated on 5 april 2020 02:47 CEST
   
   Gilead Sciences Inc. said it’s donating 1.5 million doses of its experimental anti-coronavirus drug remdesivir, which could treat 140,000 patients.
   
   The drug will be offered for compassionate use, expanded access and clinical trials, and will treat patients with severe symptoms, Chairman and Chief Executive Officer Daniel O’Day said in an open letter. The company is also boosting its supply of remdesivir to more than 500,000 treatment courses by October, and to more than 1 million by the end the year. Production time has also been accelerated to six months from one year, he said.
   
   “While we are working with the utmost sense of urgency on the immediate needs before us, we are also looking forward,” he said. “Over the next weeks and months, we will be able to further increase our supplies of remdesivir as raw materials with long lead times become available for manufacture.”
   
   The drugmaker said last week it’s switching to “expanded access” from a “compassionate use” program under which remdesivir was given. The move will accelerate its emergency use for multiple severely ill patients. More than 1,700 patients have been treated through these programs, O’Day said in the letter on Saturday.
   
   A World Health Organization panel said in January that remdesivir was considered to be the most promising therapeutic candidate based on its broad antiviral spectrum, and existing data based on human and animal studies. The medication was developed initially for Ebola and studied in patients in Eastern Congo.
   
   Multiple clinical trials are investigating the drug’s effects in Covid-19 patients in China and elsewhere.
   
   www.bloomberg.com/news/articles/2020-...
10. [verwijderd] 6 april 2020 00:38

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    Andrew Cuomo, gouverneur van New York doet een update.
    
    www.youtube.com/watch?v=4VoqvS1wtP4
    
    De laatste minuut is het leukst, maar voor beleggers CytoDyn is 34:14 het belangrijkst, uiteraard indirect genoemd.
    
    Daarnaast op de BBC een transcript van de "hoogtepunten" van de speech:
    www.bbc.com/news/world-us-canada-5217...
    
    Situatie met ventilators wordt kritisch op dinsdag/woensdag. Trial met Leronlimab komt precies op tijd!
    
    fc
11. Sub!et 6 april 2020 12:03

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    CytoDyn Inc. has just released the following news:
    
    First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency IND and Two Patients Have Already Extubated
12. Sub!et 6 april 2020 12:56

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    Interpreteren jullie het als dezelfde twee patiënten van vorige week of twee nieuwe patiënten van de vijf die net zijn geïnjecteerd?
13. [verwijderd] 6 april 2020 13:05

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    quote:

    CentProcent schreef op 6 april 2020 12:56:

    Interpreteren jullie het als dezelfde twee patiënten van vorige week of twee nieuwe patiënten van de vijf die net zijn geïnjecteerd?

    Het staat in één zin vermeld, dus twee van de nieuwe vijf patiënten. Daarnaast, de eerste 10 patiënten waren afgelopen vrijdag al van de ventilator/ICU.
    
    fc
    
    First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency IND and Two Patients Have Already Extubated
    
    Fifteen (15) severely ill COVID-19 patients have been treated under an EIND; 7-day results from the first four patients are available and are very promising; 7-day results for the first 10 patients will be available this week
    
    VANCOUVER, Washington, April 06, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the first two COVID-19 patients have been treated with leronlimab under the Company’s Phase 2 randomized clinical trial, which is for patients with mild-to-moderate indications. The Company anticipates that enrollment of more patients will accelerate this week at multiple clinical sites.
    
    In addition, the Company’s investigational new drug, leronlimab, has now been administered to 15 severely ill COVID-19 patients at four hospitals, 10 patients treated at a leading medical center in the New York City area and five patients at three other hospitals, all under an emergency investigational new drug (EIND), which were granted by the U.S. Food and Drug Administration (FDA) for each individual patient.
    
    CytoDyn also anticipates initiating its other COVID-19 trial this week. This trial is a Phase 2b/3 for severely ill COVID-19 patients and is for 342 patients, double-blinded with a 2:1 ratio (drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks, with the primary endpoint being the mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients following two weeks of leronlimab therapy.
    
    Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, “We are encouraged by the positive results demonstrated with leronlimab in the New York patients. Our team is working hard to distribute leronlimab to multiple clinical sites to initiate therapy in patients with severe COVID-19 disease. While every patient is experiencing different comorbidities, we are seeing similar clinical responses, which we believe is a reflection of leronlimab’s mechanism of action.”
    
    Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, said, “Our partnership with the New York medical team and now other hospitals has been exemplary. We are collaborating in every aspect to deliver leronlimab to patients in order to provide proof of concept as soon as possible. The outstanding coordination among the physicians, the hospital administrators, the FDA, and our team, will hopefully help mitigate the deleterious effects from this pandemic should we prove leronlimab as a solution. The lead physician in New York is a true medical hero, who deserves to be recognized for his contribution to humanity in the pandemic of COVID-19. We are very hopeful of sending the day three and day seven results of the first ten EIND patients to the FDA by the end of this week.”
14. [verwijderd] 6 april 2020 13:12

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    quote:

    FatCool schreef op 5 april 2020 18:53:

    Nog even voor beleggers die een positie overwegen, het is Pink sheet, OTC, dus hoog risico beleggen. Niet geschikt voor "nervous nellies", de koers kan 30% naar beneden en vervolgens weer 30% omhoog. Er zitten 0.08% instituten in (dus nul), en dat zegt genoeg denk ik.

    Voor de waaghalzen die mee willen doen, spring er niet bij de opening onmiddellijk in!
    
    Wacht één a twee uurtjes tot de prijs wat stabieler is, want ik verwacht een sterke stijging bij opening en dan gaan winstnemingen de koers wel weer drukken. Dan op het "laagste" punt erin.
    
    JMHO!
    
    fc
15. Sub!et 6 april 2020 13:53

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    Voor de waaghalzen die mee willen doen, spring er niet bij de opening onmiddellijk in!
    zoals in
    Stuttgart bij opening 2,9€ v
    momenteel 2,68€
16. Sub!et 6 april 2020 15:25

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    Pre market
    
    IMMU up 145% on ending phase 3 study early for TNBC due to astonishing results as recommended by independent ,Data Safety Monitoring Committee .
    
17. Sub!et 6 april 2020 21:24

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    www.youtube.com/watch?v=hjcn-5m4nYs
    
    Uitzending van Proactive
    
    CytoDyn Inc treats two coronavirus patients in Phase 2 trial
    •6 apr. 2020
    CytoDyn Inc (OTCQB:CYDY) CEO Nader Pourhassan and diagnostic advisor to the group Dr Bruce Patterson tell Proactive the company has enrolled and begun treating the first two patients in its Phase 2 trial of leronlimab for people with mild-to-moderate coronavirus symptoms.
    
    Pourhassan says the company expects enrollment to accelerate this week at multiple clinical sites, while separately, 15 severely ill coronavius patients have been treated with leronlimab so far, primarily in New York.
18. [verwijderd] 6 april 2020 23:10

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    quote:

    CentProcent schreef op 6 april 2020 13:53:

    Voor de waaghalzen die mee willen doen, spring er niet bij de opening onmiddellijk in!
    zoals in
    Stuttgart bij opening 2,9€ v
    momenteel 2,68€
    

    Plukje gekocht eod.
19. Sub!et 7 april 2020 12:08

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    April 07, 2020 6:00am EDT
    
    CytoDyn Collaborating with U.K.’s Department of Health to Provide Emergency Access to Leronlimab for Severe and Critically Ill COVID-19 Patients
    
20. [verwijderd] 7 april 2020 13:31

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    Voor Boris?