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The Technology 202: Study finds sites that mislead, not flat-out lie, attract record share of Facebook engagements
By Cristiano Lima
Tech newsletter reporter
Today at 9:14 a.m. EDT
https://www.washingtonpost.com/politics/2021/08/24/technology-202-study-finds-sites-that-mislead-not-flat-out-lie-attract-record-share-facebook-engagements/
BPTH up 24% on clearance of IND for leukemia drug
Bio-Path Holdings Announces Clearance of Investigational New Drug Application for BP1002 in Refractory/Relapsed Acute Myeloid Leukemia Patients
•
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Bio-Path Holdings, Inc.
Tue, August 24, 2021, 4:00 AM
Phase 1/ 1b Clinical Trial to Evaluate Ability of BP1002, Targeting Bcl-2 Protein, to Treat Refractory/Relapsed AML Patients
HOUSTON, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the Investigational New Drug (IND) application for BP1002 (liposomal Bcl-2), the Company’s second drug candidate, for an initial Phase 1/ 1b clinical trial that will evaluate the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients.
“AML patients that fail frontline venetoclax-based therapy have very poor prognosis with a median overall survival of less than three months and a novel treatment modality is urgently needed for such patients. Preclinical studies indicate that the BP1002 and decitabine combination is effective against venetoclax-resistant cell lines, suggesting that the BP1002 and decitabine combination therapy may provide benefits to patients who have relapsed from venetoclax-based treatment,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.
By targeting Bcl-2 at the DNA level rather than the protein, BP1002 might overcome and prevent some of the mechanisms of resistance that affect venetoclax. The current standard of care for patients with AML not eligible for intensive chemotherapy is venetoclax, an oral Bcl-2 inhibitor that targets the BH3 domain of the Bcl-2 protein, in combination with a hypomethylating agent or with low-dose cytarabine. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with AML. Preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and its benign safety profile should enable BP1002 combination therapy with approved agents, such as decitabine.
“We are excited to move into these advanced clinical studies and look forward to generating data that not only support the DNAbilize platform but bring us one step closer to bringing these potentially lifesaving drugs to patients,” said Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board.
The Phase 1/1b clinical trial is anticipated to be conducted at several leading cancer centers in the United States, including the Weill Medical College of Cornell University, The University of Texas MD Anderson Cancer Center and the Georgia Cancer Center.
Initially, a total of six evaluable patients are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study will commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.
Gail J. Roboz, M.D., will serve as Principal Investigator for the Phase 1/1b trial. Dr. Roboz is professor of medicine and director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University and the New York-Presbyterian Hospital in New York City.
The IND review process was performed by the FDA’s Office of Oncologic Diseases, Division of Hematologic Malignancies and involved a comprehensive review of data submitted by the Company covering pre-clinical studies, safety, chemistry, manufacturing and controls, and the protocol for the Phase 1/1b clinical trial.
About Bio-Path Holdings, Inc.
Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous transfusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for the treatment of blood cancers and is in the process of filing an IND for a Phase 1 clinical trial for solid tumors. The Company’s second product BP1002, which targets the Bcl-2 protein, is being evaluated for the treatment of blood cancers and solid tumors, including lymphoma and acute myeloid leukemia. In addition, an IND is expected to be filed for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide developed by Bio-Path as a specific inhibitor of STAT3, in late 2021 or 2022.
For more information, please visit the Company's website at http://www.biopathholdings.com.
Bladerunner
Some governmental agencies lie more than others. Look at what happened in Afghanistan... our military and intelligences agencies continually lied and wildly exaggerated our successes there for 20 yrs. There was some progress made as far as women's rights and education however no amount of U.S. military hubris or prowess could overcome the corruption and incompetence of the Afghan gov't, military and police and the lack of nationalistic identity and will of the Afghan people. The worst lies are the lies we tell ourselves and in Afghanistan it could not be more relevant.
I believe our health agencies (NIH, FDA, CDC) are generally reliable and truthful however mistakes and incompetence happen occasionally. Fortunately there is a system of peer reviewed studies and data that must be published and scrutinized prior to any agency decisions that keeps them in check. The scientific community outside the NIH has far more expertise than those inside. I believe the scientific community generally agrees with FDA and CDC decisions and actions however there are occasional disagreements...i.e. Biogen's aducanumab approval & Fauci's mask controversy.
I believe Fauci's statements on masks were misleading and confusing however the controversy is overblown IMO. Fauci should have stuck to the science instead of trying to manipulate people's attitudes and reactions to the pandemic. The CDC's response in the initial weeks was thoroughly bungled IMO.
I view the health agencies as similar to the FAA. In the early days plane crashes were common place however over the years after many air disasters, lessons were learned and regulations were implemented to correct mistakes by the aviation industry in the manufacture and operation of air planes. The NIH, FDA and CDC have followed a similar track. They're not perfect but much better than the past.
Corporations lie occasionally but there is so much oversight and so many regulations that lies are the exception rather than the rule. Occasionally a Theranos(Elizabeth Holmes) or Nikola(Trevor Milton) will come along however with whistleblower laws and the diligence of the shorts the truth will eventually come out. The biggest lies by corporations by far are those propagated through advertising.
The media is by far the biggest source of lies and misinformation IMO. There are 2 parts to what I mean by "media". There is mainstream media and social media. Both are protected by the 1st Amendment which gives them almost free reign to say whatever they want. Because mainstream media is supported by advertisers and in many cases has shareholders, there is much more pressure and incentive for TV, radio and print publications to be honest with their viewers. But some mainstream media have figured out that lying is good for ratings which allows them to jack up their advertising rates. Fox, OAN and Newsmax are examples of going overboard on that business model and now may end up paying billions to Dominion. Lies are protected speech however lies that result in economic harm or loss of revenues and/or profits can be remedied through the courts.
Social media is the wild card and a much bigger propagator of lies and misinformation than mainstream media...no contest. It's all about eyeballs and mouse clicks. It's a tough problem but I support Twitter, Facebook and Youtube for trying to get a handle on what are obviously outright lies and misinformation about COVID. the 2020 election etc. As public businesses they have the right to police their customers. Some may call it censorship but what people forget is that the 1st amendment only protects individuals from government or state censorship and the social media companies are well within their rights to take such actions as they see fit. The social media companies are not restricting anyone's speech. People still have the right to say whatever they want...they just don't have the right to use a megaphone.
The link below is a pretty good resource I use to check the political bias and factual accuracy of mainstream media. It's a good tool that helps me sort out what may be fact or fiction which is sometimes hard to tell.
It's a good starting point...
https://mediabiasfactcheck.com/
>>> Pfizer Agrees to Buy Cancer Biotech Trillium Therapeutics at a 200% Premium
Barron's
By Josh Nathan-Kazis
Aug. 23, 2021
https://www.barrons.com/articles/pfizer-trillium-acquisition-cancer-51629726947?siteid=yhoof2
Pfizer acquisition values Trillum at $2.3 million. Company sees "blockbuster potential" for its cancer treatments.
Pfizer said early Monday that it had agreed to purchase cancer-focused biotech Trillium Therapeutics for $2.3 billion in cash, or $18.50 a share, a 118% premium over the stock’s average price over the past 60 days, and a 208.8% premium over its Friday closing price of $6.09.
Pfizer (ticker: PFE) has previously signaled interest in the company, and in September made a $25 million investment in Trillum (TRIL). A Pfizer executive sits on its scientific advisory board.
Trillium’s lead drug candidates, known as TTI-622 and TTI-621, block a molecule known as CD47, and are being tested in various types of cancer.
Shares of Trillium were up 187.6%, to $17.52, in Monday morning trading. Pfizer shares were up 3.5%. Shares of other Covid-19 vaccine makers were also rising after the U.S. Food and Drug Administration gave full approval to Pfizer’s Covid-19 vaccine on Monday.
“The proposed acquisition of Trillium builds on our strong track record of leadership in Oncology, enhancing our hematology portfolio as we strive to improve outcomes for people living with blood cancers around the globe,” said Pfizer Oncology global president and general manager Andy Schmeltz, in a statement out early Monday.
In a presentation posted Monday, Pfizer called TTI-622 and TTI-621 “potential best-in-class” compounds, and said they would diversify the company’s oncology pipeline, and could be used in combination with other Pfizer therapeutics. The drugs block a signal that cancerous tumors use to evade the body’s innate immune system.
The company said that the drugs have “blockbuster revenue potential” in the 2026-to-2030 time frame.
The more than 200% premium Pfizer is paying over Trillium’s Friday closing price raised some eyebrows early Monday. According to a database of biotech acquisitions maintained by the website BiopharmaDive, it is the third-largest percentage premium paid for any biotech firm since 2018. As of Friday, Trillium shares were down 58.6% so far this year, and 39.2% over the past 12 months. Of the seven analysts tracked by FactSet who cover the stock, all had Buy or Overweight ratings.
In a note out Monday, Bernstein analyst Ronny Gal wrote that Pfizer has lots of cash to spend. “Pfizer is now sitting in a position where it generates very large amounts of cash, with the need to place it to shore up post-Covid growth,” he wrote. Bernstein said that buying a company to acquire a drug that targets CD47 “is not very imaginative,” but “offers a solid risk reward.”
“We suspect that Trillium, realizing that staying competitive…would require large company resources, was a realistic seller,” Gal wrote.
The acquisition must be approved by Trillium shareholders.
Pfizer stock is up 32.4% this year as of the close of the market on Friday. It trades at 13.2 times earnings expected over the next 12 months, according to FactSet, slightly above its five-year average of 12.4 times earnings.
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>>> Steve Kirsch On COVID Early Treatment and Censorship
>>> Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19
November 12, 2020
https://jamanetwork.com/journals/jama/fullarticle/2773108
A Randomized Clinical Trial
Eric J. Lenze, MD1; Caline Mattar, MD2; Charles F. Zorumski, MD1; et alAngela Stevens, BA1; Julie Schweiger1; Ginger E. Nicol, MD1; J. Philip Miller, AB3; Lei Yang, MPH, MSIS1; Michael Yingling, MS1; Michael S. Avidan, MBBCh4; Angela M. Reiersen, MD, MPE1
Author Affiliations Article Information
JAMA. 2020;324(22):2292-2300. doi:10.1001/jama.2020.22760
Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19
Key Points
Question
Does fluvoxamine, a selective serotonin reuptake inhibitor and s-1 receptor agonist, prevent clinical deterioration in outpatients with acute coronavirus disease 2019 (COVID-19)?
Findings In this randomized trial that included 152 adult outpatients with confirmed COVID-19 and symptom onset within 7 days, clinical deterioration occurred in 0 patients treated with fluvoxamine vs 6 (8.3%) patients treated with placebo over 15 days, a difference that was statistically significant.
Meaning In this preliminary study, adult outpatients with symptomatic COVID-19 treated with fluvoxamine, compared with placebo, had a lower likelihood of clinical deterioration over 15 days; however, determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.
Abstract
Importance Coronavirus disease 2019 (COVID-19) may lead to serious illness as a result of an excessive immune response. Fluvoxamine may prevent clinical deterioration by stimulating the s-1 receptor, which regulates cytokine production.
Objective
To determine whether fluvoxamine, given during mild COVID-19 illness, prevents clinical deterioration and decreases the severity of disease.
Design, Setting, and Participants
Double-blind, randomized, fully remote (contactless) clinical trial of fluvoxamine vs placebo. Participants were community-living, nonhospitalized adults with confirmed severe acute respiratory syndrome coronavirus 2 infection, with COVID-19 symptom onset within 7 days and oxygen saturation of 92% or greater. One hundred fifty-two participants were enrolled from the St Louis metropolitan area (Missouri and Illinois) from April 10, 2020, to August 5, 2020. The final date of follow-up was September 19, 2020.
Interventions
Participants were randomly assigned to receive 100 mg of fluvoxamine (n?=?80) or placebo (n?=?72) 3 times daily for 15 days.
Main Outcomes and Measures
The primary outcome was clinical deterioration within 15 days of randomization defined by meeting both criteria of (1) shortness of breath or hospitalization for shortness of breath or pneumonia and (2) oxygen saturation less than 92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.
Results
Of 152 patients who were randomized (mean [SD] age, 46 [13] years; 109 [72%] women), 115 (76%) completed the trial. Clinical deterioration occurred in 0 of 80 patients in the fluvoxamine group and in 6 of 72 patients in the placebo group (absolute difference, 8.7% [95% CI, 1.8%-16.4%] from survival analysis; log-rank P?=?.009). The fluvoxamine group had 1 serious adverse event and 11 other adverse events, whereas the placebo group had 6 serious adverse events and 12 other adverse events.
Conclusions and Relevance
In this preliminary study of adult outpatients with symptomatic COVID-19, patients treated with fluvoxamine, compared with placebo, had a lower likelihood of clinical deterioration over 15 days. However, the study is limited by a small sample size and short follow-up duration, and determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.
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Biocqr, You're getting paid, right?
Nobody reads this board anyway, so how about buzzing off.
Fact Check-COVID-19 vaccines are not ‘cytotoxic’
Fact Check-COVID-19 vaccines are not ‘cytotoxic’
Spike Proteins
McCullough is a lying, discredited nutjob....
https://en.wikipedia.org/wiki/Peter_A._McCullough
>>> Peter McCullough, MD testifies to Texas Senate HHS Committee
>>> Spike protein is very dangerous, it's cytotoxic (Robert Malone, Steve Kirsch, Bret Weinstein)
You throw around the terms 'lies and misinformation' pretty freely. Lies and misinformation (propaganda) have historically been the purview of the government, media, and big corporations. If you don't realize that fact then you might want to crack open a world history book.
But this discussion is going nowhere, so how about letting me use my 15 daily posts in a more productive manner? Thankyou.
True. However it's against my nature to let obvious lies and misinformation to go unchallenged especially when lives are at stake.
Ban me if you want but I strongly urge you to more diligent with your postings and consider the possible consequences of someone making a bad health decision that could lead to serious illness or death based on misinformation you post.
This is not a game.
Biocqr, No one is forcing you to read this board.
The point is that many people won't believe or trust ANY of the statistics or info coming from the government, media, corporations. They never will, and for good logical reasons - because these sources routinely lie about everything. Get it?
What statistics do you not believe?
The number of COVID cases?
The severity of COVID?
The number of deaths caused by COVID?
The number and severity of side effects of vaccines?
Why would you believe any of the stats you're posting?
What give YOUR sources credibility?
Biocqr, Statistics need to be based on accurate and honest numbers. Lots of people will never trust the official numbers because they come from sources that have habitually lied in the past (government, big pharma, media). So why should they be believed now? It's just simple logic.
'Falsus in uno, falsus in omnibus' -- the legal principle that a witness who testifies falsely about one matter is not credible to testify about any matter
>>> The Vaccinated Are Worried and Scientists Don’t Have Answers
Bloomberg
By Kristen V Brown and Rebecca Torrence
August 22, 2021
https://www.bloomberg.com/news/articles/2021-08-21/science-can-t-keep-up-with-virus-creating-worry-for-vaccinated?srnd=premium
Anecdotes signal surprising number of infections in vaccinated
Officials must formulate plans despite a dearth of hard data
Anecdotes tell us what the data can’t: Vaccinated people appear to be getting the coronavirus at a surprisingly high rate. But exactly how often isn’t clear, nor is it certain how likely they are to spread the virus to others.
Though it is evident vaccination still provides powerful protection against the virus, there’s growing concern that vaccinated people may be more vulnerable to serious illness than previously thought.
There’s a dearth of scientific studies with concrete answers, leaving public policy makers and corporate executives to formulate plans based on fragmented information. While some are renewing mask mandates or delaying office reopenings, others cite the lack of clarity to justify staying the course. It can all feel like a mess.
“We have to be humble about what we do know and what we don’t know,” said Tom Frieden, a former director of the Centers for Disease Control and Prevention and the head of the nonprofit Resolve to Save Lives. “There are a few things we can say definitively. One is that this is a hard question to address.”
Absent clear public health messaging, vaccinated people are left confused about how to protect themselves. Just how vulnerable they are is a key variable not just for public health officials trying to figure out, say, when booster shots might be needed, but also to inform decisions about whether to roll back reopenings amid a new wave of the virus. On a smaller scale, the unknowns have left music lovers unsure if it’s OK to see a concert and prompted a fresh round of hang-wringing among parents pondering what school is going to look like.
In lieu of answers, what has emerged is a host of case studies providing somewhat different pictures of breakthrough infections. Variables including when the surveys were conducted, whether the delta variant was present, how much of the population was vaccinated and even what the weather was like at the time make it hard to compare results and suss out patterns. It’s difficult to know which data might ultimately carry more heft.
“It’s quite clear that we have more breakthroughs now,” said Monica Gandhi, an infectious disease expert at the University of California, San Francisco. “We all know someone who has had one. But we don’t have great clinical data.”
One of the best known outbreaks among vaccinated people occurred in the small beach town of Provincetown, Massachusetts, as thousands of vaccinated and unvaccinated alike gathered on dance floors and at house parties over the Fourth of July weekend to celebrate the holiday -- and what seemed like a turning point in the pandemic. About three-fourths of the 469 infections were among vaccinated people.
Authors of a CDC case study said this might mean that they were just as likely to transmit Covid-19 as the unvaccinated. Even so, they cautioned, as more people are vaccinated, it’s natural that they would also account for a larger share of Covid-19 infections and this one study was not sufficient to draw any conclusions. The incident prompted the CDC to reverse a recommendation it had issued just a few weeks earlier and once again urge the vaccinated to mask up in certain settings.
Still, the particular details of that cluster of cases may have made that outbreak especially bad, according to Gandhi.
“The rate of mild symptomatic outbreaks in this population was higher because of a lot of indoor activity (including intimacy), rain that weekend, not much outside time and mixture of people with different vaccination status,” she said in an email.
A newly released, far larger CDC case study of infections in New York state, meanwhile, found that the number of breakthrough infections has steadily ticked up since May, accounting for almost 4% of cases by mid-July. Those researchers cautioned that factors such as easing public health restrictions and the rise of the highly contagious delta variant might impact the results.
Yet another CDC case study, in Colorado, found that the breakthrough infection rate in one county, Mesa, was significantly higher than the rest of the state, at 7% versus about 5%. The report suggested it was perhaps because the delta variant was circulating more widely there, but also noted the ages of patients in Mesa and the lower vaccination rate may have played a role.
Research out of Israel seems to back the idea that protection from severe disease wanes in the months after inoculation, and more recently, that breakthrough cases may eventually lead to an uptick in hospitalizations. The information is preliminary and severe breakthrough cases are still rare, but it bolsters the case that some people will need booster shots in coming months.
Case studies and data from some states in the U.S. have similarly shown an increase in breakthrough cases over time. But with the delta variant also on the rise, it’s difficult to tell whether waning immunity to any type of coronavirus infection is to blame, or if the vaccinations are particularly ineffective against the delta variant. It could be both, of course. Changing behavior among vaccinated people could be a factor, too, as they return to social gatherings and travel and dining indoors.
All that said, some facts are well established at this point. Vaccinated people infected with the virus are much less likely to need to go to the hospital, much less likely to need intubation and much less likely to die from the illness. There’s no doubt that vaccines provide significant protection. But a large proportion of the nation -- almost 30% of U.S. adults -- have not been vaccinated, a fact that has conspired with the highly contagious delta variant to push the country into a new wave of outbreaks.
“The big picture here is that the vaccines are working and the reason for the spike in the U.S. is we have too little vaccine uptake,” Frieden said.
To a certain extent, breakthrough cases of any virus are expected. In clinical trials, no Covid vaccine was 100% effective -- even the best vaccines never are. The more the virus is in circulation, the greater the risk of breakthrough cases. It’s also common for some aspects of viral immunity to naturally wane over time.
For the time being, there are simply more questions than answers. Are breakthrough infections ticking up because of the delta variant, waning immunity or a return to normal life? Are vaccinated people more vulnerable to severe illness than previously thought? Just how common are breakthrough infections? It’s anyone’s guess.
“It is generally the case that we have to make public health decisions based on imperfect data,” Frieden said. “But there is just a lot we don’t know.”
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You are 1.8X more likely to die from a fall from stairs, 2X more likely to die from a fire, 28X more likely to die from a car accident and 44X more likely to die from accidental poisoning than myocarditis or pericarditis occurrence after the 2nd dose of an mRNA vaccine.
The odds are 1 in 232,283 (.000430%) of myocarditis or pericarditis occurrence after the 2nd dose of an mRNA vaccine.
U.S. review of possible link between Moderna vaccine and uncommon side effect delays adolescent approval
https://www.washingtonpost.com/health/2021/08/19/moderna-vaccine-myocarditis/
Cases of VITT and Myocarditis associated with COVID vaccines are very rare and have been mild. No cases of VITT associated with Pfizer and only 3 cases connected to Moderna.
There is not a drug or vaccine on the planet that doesn't have some risk or side effect.
It is unrealistic and foolish to have a zero tolerance for risk before you would take a drug or vaccine that could reduce a much, much higher risk of serious illness or death.
The odds of contracting VITT or Myocarditis are infinitesimally small. The odds of contacting COVID are magnitudes higher. COVID can lead to long term complications or death. You are far more likely to suffer blood clots in the brain or heart inflammation from a COVID infection than from a vaccine.
from your link...
Dr. Peter McCullough on the suppression of Covid therapeutic drugs -
>>> Immunocontraception -
https://en.wikipedia.org/wiki/Immunocontraception
Immunocontraception is the use of an animal's immune system to prevent it from fertilizing offspring. Contraceptives of this type are not currently available for human use.
Typically immunocontraception involves the administration of a vaccine that induces an adaptive immune response which causes an animal to become temporarily infertile. Contraceptive vaccines have been used in numerous settings for the control of wildlife populations.[1] However, experts in the field believe that major innovations are required before immunocontraception can become a practical form of contraception for human beings.[2]
Thus far immunocontraception has focused on mammals exclusively. There are several targets in mammalian sexual reproduction for immune inhibition. They can be organized into three categories.[3]
Gamete production
Organisms that undergo sexual reproduction must first produce gametes, cells which have half the typical number of chromosomes of the species. Often immunity that prevents gamete production also inhibits secondary sexual characteristics and so has effects similar to castration.[4][5]
Gamete function
After gametes are produced in sexual reproduction, two gametes must combine during fertilization to form a zygote, which again has the full typical number of chromosomes of the species. Methods that target gamete function prevent this fertilization from occurring and are true contraceptives.
Gamete outcome
Shortly after fertilization a zygote develops into a multicellular embryo that in turn develops into a larger organism. In placental mammals this process of gestation occurs inside the reproductive system of the mother of the embryo. Immunity that targets gamete outcome induces abortion of an embryo while it is within its mother's reproductive system.[6][7]
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Vaccine Associated Disease Enhancement (VADE) -
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164865094
Polio vaccine contaminated with cancer virus -
>>> Vaccine contamination with SV40
https://en.wikipedia.org/wiki/Vaccine_contamination_with_SV40
From Wikipedia, the free encyclopedia
Vaccine contamination with Simian vacuolating virus 40, known as SV40 occurred in the United States and other countries between 1955 and 1961.
SV40 is a virus found in monkeys and humans, which has the potential to cause cancer, in animals and humans.[1] Soon after its discovery, SV40 was identified in early batches of the oral form of the polio vaccine. The vaccines in which SV40 was found, were produced between 1955 and 1961 by Lederle (now a subsidiary of Wyeth). The contamination may have been in the original seed strain (coded SOM) or in the substrate—primary kidney cells from infected monkeys used to grow the vaccine virus during production.
Both the Sabin vaccine (oral, live virus) and the Salk vaccine (injectable, killed virus) were affected; the technique used to inactivate the polio virus in the Salk vaccine, by means of formaldehyde, did not reliably kill SV40. The contaminated vaccine continued to be distributed to the public through 1963.[2][3]
It was difficult to detect small quantities of virus until the advent of polymerase chain reaction; since then, stored samples of vaccine made after 1962 have tested negative for SV40. In 1997, Herbert Ratner of Oak Park, Illinois, gave some vials of 1955 Salk vaccine to researcher Michele Carbone.[4] Ratner, the Health Commissioner of Oak Park at the time the Salk vaccine was introduced, had kept these vials of vaccine in a refrigerator for over forty years.[5][better source needed] Upon testing this vaccine, Carbone discovered that it contained not only the SV40 strain already known to have been in the Salk vaccine (containing two 72-bp enhancers) but also the same slow-growing SV40 strain currently found in some malignant tumors and lymphomas (containing one 72-bp enhancer).[6] It is unknown how widespread the virus was among humans before the 1950s, though one study found that 12% of a sample of German medical students in 1952 – prior to the advent of the vaccines – had SV40 antibodies.[7]
An analysis presented at the Vaccine Cell Substrate Conference in 2004[8][medical citation needed] suggested that vaccines used in the former Soviet bloc countries, China, Japan, and Africa, could have been contaminated up to 1980, meaning that hundreds of millions more could have been exposed to the virus unknowingly.
Population level studies show no evidence of any increase in cancer incidence as a result of exposure,[9] though SV40 has been extensively studied.[10] A thirty-five year followup found no excess of the cancers commonly associated with SV40.[11]
References
Schipani, Vanessa (24 Apr 2018). "Did the Polio Vaccine Cause Cancer?". Factcheck.org. Retrieved 4 Mar 2020.
CDC website https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html Accessed 1 November 20166
Study Is Unsure on Tainted Polio Vaccine's Cancer Role. Denise Grady. New York Times. October 23, 2002 https://www.nytimes.com/2002/10/23/us/study-is-unsure-on-tainted-polio-vaccine-s-cancer-role.html Accessed 1 November 2016
Ferber, Dan (2002). "Virology. Monkey virus link to cancer grows stronger". Science. 296 (5570): 1012–1015. doi:10.1126/science.296.5570.1012. PMID 12004103. S2CID 32723346.
Bookchin, Debbie; Schumacher, Jim (2004). The Virus and the Vaccine. St. Martin's Press. pp. 226–28. ISBN 978-0-312-27872-4.
Rizzo, Paola; Di Resta, Ilaria; Powers, Amy; Ratner, Herbert; Carbone, Michele (1999). "Unique Strains of SV40 in Commercial Poliovaccines from 1955 Not Readily Identifiable with Current Testing for SV40 Infection". Cancer Research. 59 (24): 6103–8. PMID 10626798.
Martini, F; Corallini, A; Balatti, V; Sabbioni, S; Pancaldi, C; Tognon, M (9 July 2007). "Simian virus 40 in humans". Infectious Agents and Cancer. 2: 13. doi:10.1186/1750-9378-2-13. PMC 1941725. PMID 17620119.
Bookchin, Debbie (7 July 2004). "Vaccine scandal revives cancer fear". New Scientist.
NIH/National Cancer Institute (2004-08-25). "Studies Find No Evidence That Simian Virus 40 Is Related To Human Cancer". Science Daily.
Hilleman MR (1998). "Discovery of simian virus 40 (SV40) and its relationship to poliomyelitis virus vaccines". Dev Biol Stand. 94: 183–90. PMID 9776239.
Carroll-Pankhurst, C; Engels, EA; Strickler, HD; Goedert, JJ; Wagner, J; Mortimer EA Jr. (November 2001). "Thirty-five year mortality following receipt of SV40- contaminated polio vaccine during the neonatal period". Br J Cancer. 85 (9): 1295–7. doi:10.1054/bjoc.2001.2065. PMC 2375249. PMID 11720463.
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Pfizer - >>> Legal issues
https://en.wikipedia.org/wiki/Pfizer#Controversy
Aggressive pharmaceutical marketing
See also: List of largest pharmaceutical settlements and Franklin v. Parke-Davis
Pfizer has been accused of aggressive pharmaceutical marketing.[147][148][149]
Illegal marketing of gabapentin for off-label uses
In 1993, the Food and Drug Administration (FDA) approved gabapentin only for treatment of seizures. Warner–Lambert, which merged with Pfizer in 2000, used continuing medical education and medical research, sponsored articles about the drug for the medical literature, and alleged suppression of unfavorable study results, to promote gabapentin. Within five years, the drug was being widely used for off-label uses such as treatment of pain and psychiatric conditions. Warner–Lambert admitted to violating FDA regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses.[150] In 2004, the company paid $430 million in one of the largest settlements to resolve criminal and civil health care liability charges. It was the first off-label promotion case successfully brought under the False Claims Act.[151] A Cochrane review concluded that gabapentin is ineffective in migraine prophylaxis.[152] The American Academy of Neurology rates it as having unproven efficacy, while the Canadian Headache Society and the European Federation of Neurological Societies rate its use as being supported by moderate and low-quality evidence.[153]
Illegal marketing of Bextra
In September 2009, Pfizer pleaded guilty to the illegal marketing of arthritis drug valdecoxib (Bextra) and agreed to a $2.3 billion settlement, the largest health care fraud settlement at that time. Pfizer promoted the sale of the drug for several uses and dosages that the Food and Drug Administration specifically declined to approve due to safety concerns. The drug was pulled from the market in 2005.[154][155] It was Pfizer's fourth such settlement in a decade.[156][157][158] The payment included $1.3 billion in criminal penalties for felony violations of the Federal Food, Drug, and Cosmetic Act, and $1.0 billion to settle allegations it had illegally promoted the drugs for uses that were not approved by the Food and Drug Administration (FDA) leading to violations under the False Claims Act as reimbursements were requested from Federal and State programs. The criminal fine was the largest ever assessed in the United States to date.[155][156][157][158] Pfizer entered a corporate integrity agreement with the Office of Inspector General that required it to make substantial structural reforms within the company, and publish to its website its post approval commitments and a searchable database of all payments to physicians made by the company.[159]
Termination of Peter Rost
Peter Rost was vice president in charge of the endocrinology division at Pharmacia before its acquisition by Pfizer. During that time he raised concerns internally about kickbacks and off-label marketing of Genotropin, Pharmacia's human growth hormone drug. Pfizer reported the Pharmacia marketing practices to the FDA and Department of Justice; Rost was unaware of this and filed an FCA lawsuit against Pfizer. Pfizer kept him employed, but isolated him until the FCA suit was unsealed in 2005. The Justice Department declined to intervene, and Pfizer fired him, and he filed a wrongful termination suit against Pfizer. Pfizer won a summary dismissal of the case, with the court ruling that the evidence showed Pfizer had decided to fire Rost prior to learning of his whistleblower activities.[160][161]
Illegal marketing of Rapamune
A "whistleblower suit" was filed in 2005 against Wyeth, which was acquired by Pfizer in 2009, alleging that the company illegally marketed sirolimus (Rapamune) for off-label uses, targeted specific doctors and medical facilities to increase sales of Rapamune, tried to get transplant patients to change from their transplant drugs to Rapamune, and specifically targeted African-Americans. According to the whistleblowers, Wyeth also provided doctors and hospitals that prescribed the drug with kickbacks such as grants, donations, and other money.[162] In 2013, the company pleaded guilty to criminal mis-branding violations under the Federal Food, Drug, and Cosmetic Act. By August 2014, it had paid $491 million in civil and criminal penalties related to Rapamune.[163]
Illegal marketing
In June 2010, health insurance network Blue Cross Blue Shield (BCBS) filed a lawsuit against Pfizer for allegedly illegally marketing drugs Bextra, Geodon and Lyrica. BCBS alleged that Pfizer used kickbacks and wrongly persuaded doctors to prescribe the drugs.[164][165] According to the lawsuit, Pfizer handed out 'misleading' materials on off-label uses, sent over 5,000 doctors on trips to the Caribbean or around the United States, and paid them $2,000 honoraria in return for listening to lectures about Bextra.[166][167] Despite Pfizer's claims that "the company's intent was pure" in fostering a legal exchange of information among doctors, an internal marketing plan revealed that Pfizer intended to train physicians "to serve as public relations spokespeople."[168] The case was settled in 2014 for $325 million.[169] Fearing that Pfizer is "too big to fail" and that prosecuting the company would result in disruptions to Medicare and Medicaid, federal prosecutors instead charged a subsidiary of a subsidiary of a subsidiary of Pfizer, which is "nothing more than a shell company whose only function is to plead guilty."[168]
Removal of ads after unflattering article
According to Harper's Magazine publisher John R. MacArthur, Pfizer withdrew "between $400,000 and a million dollars" worth of ads from Harper's Magazine following an unflattering article on depression medication.[170]
Quigley Company asbestos
The Quigley Company, which sold asbestos-containing insulation products until the early 1970s, was acquired by Pfizer in 1968. In June 2013, asbestos victims and Pfizer negotiated a settlement that required Pfizer to pay a total of $964 million: $430 million to 80% of existing plaintiffs and place an additional $535 million into a settlement trust that will compensate future plaintiffs as well as the remaining 20% of plaintiffs with claims against Pfizer and Quigley. Of that $535 million, $405 million is in a 40-year note from Pfizer, while $100 million is from insurance policies.[171]
Shiley defective heart valves
Pfizer purchased Shiley in 1979, at the onset of its Convexo-Concave valve ordeal, involving the Bjork–Shiley valve. Approximately 500 people died when defective heart valves fractured and, in 1994, Pfizer agreed to pay $10.75 million to settle claims by the United States Department of Justice that the company lied to get approval for the valves.[172]
Firing of employee that filed suit
A federal lawsuit was filed by a scientist claiming she got an infection by a genetically modified lentivirus while working for Pfizer, resulting in intermittent paralysis.[173] A judge dismissed the case citing a lack of evidence that the illness was caused by the virus but the jury ruled that by firing the employee, Pfizer violated laws protecting freedom of speech and whistleblowers and awarded her $1.37 million.[174]
Celebrex intellectual property
Brigham Young University (BYU) said a professor of chemistry, Dr. Daniel L. Simmons, discovered an enzyme in the 1990s that led towards development of Celebrex. BYU was originally seeking a 15% royalty on sales, equating to $9.7 billion. A research agreement had been made between BYU and Monsanto, whose pharmaceutical business was later acquired by Pfizer, to develop a better aspirin. The enzyme Dr. Simmons claims to have discovered would induce pain and inflammation while causing gastrointestinal problems and Celebrex is used to reduce those issues. A six-year battle ensued because BYU claimed that Pfizer did not give Dr. Simmons credit or compensation, while Pfizer claimed that it had met all obligations regarding the Monsanto agreement. In May 2012, Pfizer settled the allegations, agreeing to pay $450 million.[175]
Nigeria Trovafloxacin lawsuit
Main article: Abdullahi v. Pfizer, Inc.
In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives and personnel from a contract research organization (CRO) traveled to Kano to set up a clinical trial and administer an experimental antibiotic, trovafloxacin, to approximately 200 children.[176] Local Kano officials reported that more than fifty children died in the experiment, while many others developed mental and physical deformities.[177] The nature and frequency of both fatalities and other adverse outcomes were similar to those historically found among pediatric patients treated for meningitis in sub-Saharan Africa.[178] In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment.[179] According to Democracy Now!, "[r]esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug."[180] The lawsuits also accused Pfizer of using the outbreak to perform unapproved human testing, as well as allegedly under-dosing a control group being treated with traditional antibiotics in order to skew the results of the trial in favor of Trovan. Nigerian medical personnel as well as at least one Pfizer physician said the trial was conducted without regulatory approval.[181][182]
In 2007, Pfizer published a Statement of Defense letter.[183] The letter stated that the drug's oral form was safer and easier to administer, that Trovan had been used safely in more than five thousand Americans prior to the Nigerian trial, that mortality in the patients treated by Pfizer was lower than that observed historically in African meningitis epidemics, and that no unusual side effects, unrelated to meningitis, were observed after four weeks.
In June 2010, the US Supreme Court rejected Pfizer's appeal against a ruling allowing lawsuits by the Nigerian families to proceed.[184]
In December 2010, a United States diplomatic cables leak was released by WikiLeaks indicating that Pfizer hired investigators to find evidence of corruption against Nigerian attorney general Aondoakaa to persuade him to drop legal action.[185] The Washington Post reporter Joe Stephens, who helped break the story in 2000, called these actions "dangerously close to blackmail".[180] In response, the company released a press statement describing the allegations as "preposterous" and saying that it acted in good faith.[186] Aondoakka, who had allegedly demanded bribes from Pfizer in return for a settlement of the case,[187] was declared unfit for office and had his U.S. visa revoked in association with corruption charges in 2010.[188][189]
The lawsuits were eventually settled out of court. Pfizer committed to paying 35 million USD "to compensate the families of children in the study", another 30 million USD to "support healthcare initiatives in Kano", and 10 million to cover legal costs. Payouts began in 2011.[190]
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>>> Dr. Robert Malone - State of the Science (Aug 2021) -
>>> The Noble Lies of COVID-19
Do we want public health officials to report facts and uncertainties transparently? Or do we want them to shape information to influence the public to take specific actions?
Slate
BY KERRINGTON POWELL AND VINAY PRASAD
JULY 28, 2021
https://slate.com/technology/2021/07/noble-lies-covid-fauci-cdc-masks.html
In March 2020, as the pandemic began, Anthony Fauci, the chief medical adviser to the president of the United States, explained in a 60 Minutes interview that he felt community use of masks was unnecessary. A few months later, he argued that his statements were not meant to imply that he felt the data to justify the use of cloth masks was insufficient. Rather, he said, had he endorsed mask wearing (of any kind), mass panic would ensue and lead to a surgical and N95 mask shortage among health care workers, who needed the masks more. Yet, emails from a Freedom of Information Act request revealed that Fauci privately gave the same advice—against mask use—suggesting it was not merely his outward stance to the broader public.
Although some have claimed that the evidence changed substantively in the early weeks of March, our assessment of the literature does not concur. We believe the evidence at the time of Fauci’s 60 Minutes interview was largely similar to that in April 2020. Thus, there are two ways to consider Fauci’s statement. One possibility is, as he says, that his initial statement was dishonest but motivated to avoid a run on masks needed by health care workers. The other is that he believed his initial statements were accurate, and he subsequently decided to advocate for cloth masks to divert attention from surgical or N95 masks, or to provide a sense of hope and control to a fearful and anxious public.
Additional evidence suggests that the second interpretation may be more accurate. In a lengthy commentary from July 2020, COVID expert Michael Osterholm wrote in detail about the continued scientific uncertainty regarding masks—even as he expressed support for their widespread public use as one measure among many. But Fauci’s reversal, which came at a time of political polarization, contributed to the evolution of masks from a basic, precautionary mitigation strategy to a badge of political allegiance. President Donald Trump was reluctant to wear a mask and justified his behavior by referring to Fauci’s comments from the 60 Minutes interview. The controversy continued into the presidential debates, with Trump mocking Joe Biden for donning the “biggest mask” he’d ever seen.
One thing is beyond a doubt, however: One of those two statements did not accurately reflect the evidence as Fauci saw it. Such high-profile mixed messages in a short time frame, without substantive new data to justify the change, generated confusion and a backlash from politicians, other experts, and the general public.
When experts or agencies deliver information to the public that they consider possibly or definitively false to further a larger, often well-meaning agenda, they are telling what is called a noble lie. Although the teller’s intentions may be pure—for example, a feeling of urgency that behavioral change is needed among the lay public—the consequences can undermine not only those intentions but also public trust in experts and science. During the first year of COVID-19, leaders were faced with an unknown disease amid a politically sensitive election in the era of social media, and the preconditions for noble lies became especially fertile. Not surprisingly, we witnessed several examples. More than anything, these examples illustrate the destructive potential of such lies.
Later in 2020, Fauci participated in a second noble lie. In December, he explained in a phone interview with then–New York Times reporter Donald McNeil that he had been moving the target estimate for herd immunity based in part on emerging studies. But he also said:
When polls said only about half of all Americans would take a vaccine, I was saying herd immunity would take 70 to 75 percent. Then, when newer surveys said 60 percent or more would take it, I thought, “I can nudge this up a bit,” so I went to 80, 85.
In his own words, he “nudged” his target range for herd immunity to promote vaccine uptake. Even though his comments were made to influence public actions to get more people vaccinated (a noble effort), the central dilemma remains: Do we want public health officials to report facts and uncertainties transparently? Or do we want them to shape information, via nudges, to influence the public to take specific actions? The former fosters an open and honest dialogue with the public to facilitate democratic policymaking. The second subverts the very idea of a democracy and implies that those who set the rules or shape the media narrative are justified in depriving the public of information that they may consider or value differently.
Aside from whether it’s right to tell noble lies in the service of eliciting socially beneficial behavior, there is also the question of efficacy. Experts on infectious diseases are not necessarily experts on social behavior. Even if we accept Fauci’s claim that he downplayed the importance of wearing masks because he didn’t want to unleash a run on masks, we might wonder how he knew that his noble lie would be more effective than simply being honest and explaining to people why it was important to assure an adequate supply of masks for medical workers.
With the arrival of vaccines in early 2021, the potential for such deliberately misleading messages to backfire became more obvious. Key opinion leaders, agencies, and the Centers for Disease Control and Prevention all articulated some version of “once you are vaccinated, nothing changes,” implying that experts did not know if it was safe to relax precautions and restrictions, such as mask wearing or social distancing, after immunization. But the stance was immediately called into question by others, including epidemiologists, who pointed to the high efficacy of the vaccines and suggested that some, but not all, social distancing measures could be relaxed in certain circumstances. Ultimately, the “no change” message, which may have been intended to discourage mass gatherings or out of a fear that unvaccinated people would lie about their vaccination status, may itself have been harmful: Surveys find that interest in vaccination increases if people are told that it means they can stop masking.
The fourth noble lie from government agencies and/or officials occurred more recently. On June 4, using data from February to March, the agency made the case that hospitalizations were rising in adolescents. It tweeted, “The report shows the importance of #COVID19 vaccination for adolescents.” That tweet spurred a great deal of media attention and concern. It was true that hospitalization rates had risen. However, at the time of the press coverage, hospitalization rates in this age group had already fallen again. Numerous commenters immediately pointed out that the “rise” in hospitalization statistic promoted by the CDC was out of date the moment it was highlighted and raised questions about why the CDC would promote a dated statistic, when the organization had access to up-to-date information.
This obvious error was compounded weeks later during a meeting of the Advisory Committee on Immunization Practices. The committee met to discuss what we knew and did not know about heart inflammation, or myocarditis, that had been linked to mRNA vaccination, and most notable in young men who received the vaccine. During the course of the meeting, representatives of the CDC showed a model that claimed that vaccination of young adults was preferable to the disease itself.
There were, however, several concerns with this model. First, it used rates of community SARS-CoV-2 spread that again were out of date. By the time of the meeting, the rates were lower, meaning the benefits of vaccination would be reduced, but the harms remain the same. Second, it did not consider the risks separately for boys and girls, who appear to have substantially different risk of myocarditis (much higher in boys). Third, it did not consider any middle ground positions, such as only receiving one dose of the vaccine, which provides much of the benefit with far lower myocarditis risk. Instead, the CDC presented zero or two doses as the only options. Fourth, the modeling did not consider natural immunity—i.e., the vaccine’s risk to kids who already recovered from COVID-19 might be the same, but the benefits far lower (as these children have some natural immunity). Finally, the model did not consider the fact that young adults with preexisting medical conditions and those who are otherwise well might have different risk benefit profiles, as the former account for a disproportionate number of COVID-19 hospitalizations.
Together, these are all information choices made by government agencies and/or officials about vaccination of young adults. Amplifying out-of-date statistics and building a model to support vaccination that has questionable assumptions work to support rapid deployment of two doses of mRNA to all healthy kids aged 12 to 17. That may be the CDC’s policy pursuit, and one we are sympathetic to. However, distorting evidence to achieve this result is a form of a noble lie. Accurately reporting current risks to adolescents, and exploring other dosing possibilities, is part of the unbiased scientific exploration of data.
We worry that vaccine policy among supporters of vaccines is increasingly anchored to the irrational views of those who oppose them—by always pursuing the opposite. Exaggerating the risk of the virus in the moment and failing to explore middle ground positions appear to be the antithesis of the anti-vax movement, which is an extremist effort to refuse vaccination. This seems a reflexive attempt to vaccinate at all costs—by creating fear in the public (despite falling adolescent rates) and pushing the notion that two doses of mRNA at the current dose level or nothing at all are the only two choices—a logical error called the fallacy of the excluded middle.
Noble lies—small untruths—yield unpredictable outcomes. Nietzsche once wrote, “Not that you lied to me, but that I no longer believe you, has shaken me.” Public health messaging is predicated on trust, which overcomes the enormous complexity of the scientific literature, creating an opportunity to communicate initiatives effectively. Still, violation of this trust renders the communication unreliable. When trust is shattered, messaging is no longer clear and straightforward, and instead results in the audience trying to reverse-engineer the statement based on their view of the speaker’s intent. Simply put, noble lies can rob confidence from the public, leading to confusion, a loss of credibility, conspiracy theories, and obfuscated policy.
Noble lies are a trap. We cannot predict the public’s behavior, and loss of trust is devastating. The general population is far too skeptical to blindly follow the advice of experts, and far too intelligent to be easily duped.
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>>> Studies look at clotting, myocarditis tied to COVID-19 vaccines
Center for Infectious Disease Research and Policy
by Lianna Matt McLernon
Aug 10, 2021
https://www.cidrap.umn.edu/news-perspective/2021/08/studies-look-clotting-myocarditis-tied-covid-19-vaccines
Two studies published by JAMA Cardiology today discuss adverse effects associated with COVID-19 vaccines. The first describes vaccine-induced immune thrombotic thrombocytopenia with cerebral venous sinus thrombosis (VITT with CVST) linked to the AstraZeneca/Oxford and Johnson & Johnson vaccines. The second is a case series looking at 15 adolescents who experienced myocarditis after receiving the Pfizer/BioNTech vaccine.
Despite these risks, both research teams continue to advocate for COVID-19 vaccines as the health risks from the virus are far greater than those linked to the vaccine. For instance, the VITT study researchers say that CVST risk from COVID-19 infection is 60- to 230-fold higher than the risk derived from COVID-19 vaccination.
No current strategies to avoid VITT
Both the AstraZeneca and Johnson & Johnson COVID-19 vaccines have regulatory warnings about VITT now, and data have shown that women under 60 years old appear to be at a higher risk. Symptoms include intracranial pressure, shortness of breath, lethargy, back pain, abdominal pain, spot bleeding under the skin, and leg or arm weakness, as well as positive test results for heparin-induced thrombocytopenia (HIT). Onset occurs a median of 8 or 10 days after receiving the Johnson & Johnson or AstraZeneca COVID-19 vaccine, respectively.
CVST, one of the worst manifestations of VITT, happens when clots form in the brain and major dural sinuses. While the average 30-day mortality is 6%, about 10% of patients have permanent neurological issues 1 year later.
No current strategies exist to avoid VITT, but interim recommendations include first-line therapy with non-heparin anticoagulants and intravenous immunoglobulins (IVIG), plus second-line steroids. Platelet transfusions can be given if the patient has or is at high risk for serious bleeding, but the researchers emphasize that routine platelet transfusions are associated with a 5-fold increase in mortality, probably because they are the source of platelet factor 4. Healthcare providers should also avoid aspirin.
"The mechanism of development of the prothrombotic state and its association with the vaccine are still only partially known, because multiple converging prothrombotic pathways may be involved in the pathogenesis," the researchers write.
Although both AstraZeneca's and Johnson & Johnson's adenovirus-based COVID-19 vaccines have been connected with VITT, the syndrome seems to occur at four times the frequency with the AstraZeneca vaccine, according to the researchers. As for the mRNA COVID-19 vaccines, no instances have been recorded with the Pfizer vaccine, but three cases have been connected to Moderna.
"Adverse events like VITT, while uncommon, have been described despite vaccination remaining the most essential component in the fight against the COVID-19 pandemic. While it seems logical to consider the use of types of vaccines (eg, mRNA-based administration) in individuals at high risk, treatment should consist of therapeutic anticoagulation mostly with nonheparin products and IVIG," the researchers write.
Myocarditis appears to mostly resolve
Pfizer's COVID-19 vaccine is more associated with myocarditis, or heart inflammation, with crude analysis showing greater risk for males ages 12 to 17, according to the authors of the case series. To examine the outcomes, they looked at 15 children admitted to Boston Children's Hospital from May 1 to Jul 15 for vaccine-associated myocarditis. All but one patient was male, and the median age was 15 (children 12 to 17 are eligible for Pfizer's vaccine). None had prior, known COVID-19 infection, although one did have reactive antibodies.
Symptom onset began 1 to 6 days post-vaccine (14 cases occurred after the second dose). The whole cohort experienced chest pain, but other common symptoms were fever (10), weakness (8), and headache (6). Troponin levels were also elevated at admission (median, 0.25 nanograms per milliliter compared with 0.1) and continued increasing 0.1 to 2.3 days after admission.
Overall, 13 patients presented with myocarditis via cardiac magnetic resonance imaging. Three had decreased left ventricular ejection fraction, and five had abnormal global longitudinal or circumferential strain. Still, no patients needed intensive care unit (ICU) admission, and hospitalization stay was a median of 2 days.
At a median of 1 to 13 days after discharge, four patients still had symptoms (fatigue, 3; chest pain, 1). Troponin was mildly elevated in three patients, and one patient had nonsustained ventricular tachycardia. One of the asymptomatic cases had persistent borderline low left ventricular systolic function.
The researchers conclude, "In this case series, in short-term follow-up, patients were mildly affected. The long-term risks associated with postvaccination myocarditis remain unknown. Larger studies with longer follow-up are needed to inform recommendations for COVID-19 vaccination in this population."
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This is false....
gfp927z...this is total BS!
Blood clotting is NOT associated with either the Pfizer or Moderna vaccine...
Blade, Blood clotting from the vaccines doesn't sound too great either. I also wonder about the long term side effects of these vaccines. No long term safety studies were done, and there is credible evidence out there that the vaccines don't work as designed -- 1) the spike protein cleaves off the cell and bioaccumulates in the brain and other organs, and 2) the spike protein itself is cytotoxic. These vaccines are experimental, have a completely new mechanism, and were rushed through at warp speed without the usual safety studies. No regular drug would ever be allowed to get to market like this. I'll remain skeptical.
One thing we should be demanding is that bio weapons research be ended worldwide, and the BSL-4 labs be shut down. Otherwise the same thing, or worse, will happen again. Technically there has been a ban on bioweapon development for decades, but they get around it by saying the work is for countermeasures.
I'm also not convinced that Covid wasn't deliberately released (and not by the Chinese). Lots of unanswered questions, and many people distrust government, big corporations, the media, for good reason. If they routinely lie about everything else, why should vaccines be any different? In legal speak - 'false uno, false omnibus'. So I'll remain skeptical.
gfp,
Ivermectin causing poisonings in Mississippi. This is why you and Rickards are killing people with your lies and misinformation.
HEALTH 08/20/2021 11:58 pm ET Updated 5 hours ago
Mississippi Poison Calls Soar As Vaccine Skeptics Turn To Livestock Drug For COVID-19
“You wouldn’t get your chemotherapy at a feed store,” warned a state health official. Livestock anti-parasite medication ivermectin can be deadly to humans.
headshot
By Mary Papenfuss
Mississippi health officials are pleading with state residents not to take a livestock drug to treat COVID-19 as calls to poison control centers soar.
Fearful Mississipians skeptical of the safety of vaccinations are shockingly turning instead to swallowing ivermectin — generally used to eradicate or prevent parasites in livestock.
“Do not use ivermectin products made for animals,” Mississippi’s Health Department flatly stated in a Facebook post Friday. “Animal doses are not safe for humans.”
“I think some people are trying to use it as a [COVID-19] preventative, which I think is really kind of crazy, so please don’t do that,” Mississippi State Health Officer Dr. Thomas Dobbs said at a press briefing Wednesday.
“You wouldn’t get your chemotherapy at a feed store. You wouldn’t treat your pneumonia with your animal’s medication,” he added. “It can be dangerous to get the wrong doses of medication, especially for something that’s meant for a horse or a cow. It’s really important, if people have medical needs, go through your physician or provider.”
Bladerunner
Anyone here interested in CTMX and/or FMTX? Both are trading at 52-week lows, with CTMX trading at cash value.
Bladerunner
>>> Best Biotech ETFs for Q4 2021
ARKG, IDNA, and BBH are the best biotech ETFs for Q4 2021
Investopedia
By NATHAN REIFF
Aug 12, 2021
https://www.investopedia.com/articles/investing/081415/top-3-biotech-etfs.asp?utm_campaign=quote-yahoo&utm_source=yahoo&utm_medium=referral
Biotech companies use or modify biological processes in order to create new pharmaceuticals or therapies. Some of the most prominent biotech companies include Vertex Pharmaceuticals Inc. (VRTX) and Regeneron Pharmaceuticals Inc. (REGN).
KEY TAKEAWAYS
The biotech sector underperformed the broader market over the past year.
The biotech ETFs with the best one-year trailing total return are ARKG, IDNA, and BBH.
The top holding of ARKG is Teladoc Health Inc., and the top holding of IDNA and BBH is Moderna Inc.
Investing in the biotech sector can be risky. The scientific and regulatory issues involved with gaining approval from the U.S. Food and Drug Administration (FDA) can be substantial, making it risky and difficult to predict what biotech stocks will outperform.1 One of the easiest ways to invest in the sector is through biotech exchange-traded funds (ETFs). These funds have holdings in a large array of biotech companies, offering investors a well-diversified portfolio in one easy-to-execute trade.
There are 10 biotech ETFs that trade in the U.S., excluding inverse and leveraged ETFs as well as funds with less than $50 million in assets under management (AUM). The biotech sector, as measured by the Nasdaq Biotechnology Index, has underperformed the broader market with a total return of 28.0% over the past 12 months compared to the S&P 500's total return of 34.0%, as of Aug. 10, 2021.2 The best-performing biotech ETF, based on performance over the past year, is the ARK Genomic Revolution ETF (ARKG). We examine the top three best biotech ETFs below. All numbers are as of Aug. 10, 2021.3
ARK Genomic Revolution ETF (ARKG)
Performance over One-Year: 46.2%
Expense Ratio: 0.75%
Annual Dividend Yield: 0.91%
Three-Month Average Daily Volume: 2,939,797
Assets Under Management: $8.9 billion
Inception Date: Oct. 31, 2014
Issuer: ARK
ARKG is an actively managed ETF focused on companies expected to benefit from technologies and scientific developments in genomics that could extend and enhance the quality of human and other life. The fund provides exposure to companies engaged in gene editing, therapeutics, stem cells, and bioinformatics and holds approximately 60 growth stocks of various market capitalizations.4
ARKG's top three holdings include Teladoc Health Inc. (TDOC), a provider of tele-healthcare services; Pacific Biosciences of California Inc. (PACB), a maker of systems for gene sequencing; and Fate Therapeutics Inc. (FATE), a biopharmaceutical company developing immunotherapies for cancer.5
iShares Genomics Immunology and Healthcare ETF (IDNA)
Performance over One-Year: 39.5%
Expense Ratio: 0.47%
Annual Dividend Yield: 0.16%
Three-Month Average Daily Volume: 62,820
Assets Under Management: $359.2 million
Inception Date: June 11, 2019
Issuer: BlackRock Financial Management
IDNA is a multi-cap blended fund that tracks the NYSE FactSet Global Genomics and Immuno Biopharma Index, which is made up of companies that may benefit from long-term growth and innovation in genomics, immunology, and bioengineering. The fund invests in companies from both developed and emerging markets, although the large majority of its holdings are domiciled in the U.S. or Germany.6
IDNA's top holdings include Moderna Inc. (MRNA), a pharmaceutical and biotechnology company specialized in vaccine technologies based on messenger RNA; Intellia Therapeutics Inc. (NTLA), a biotechnology company focused on CRISPR gene-editing technology; and sponsored American depositary receipts (ADRs) of BioNTech SE (BNTX), a German biotechnology company that manufactures immunotherapies.7
VanEck Vectors Biotech ETF (BBH)
Performance over One-Year: 35.2%
Expense Ratio: 0.35%
Annual Dividend Yield: 0.28%
Three-Month Average Daily Volume: 15,785
Assets Under Management: $629.3 million
Inception Date: Dec. 20, 2011
Issuer: VanEck
BBH tracks the MVIS U.S. Listed Biotech 25 Index, an index of companies involved in the development and production, sales, and marketing of therapies based on genetic analysis and diagnostic equipment. The fund is highly concentrated in a few names, with the top 10 of its 24 holdings accounting for more than 60% of all invested assets.8
BBH's top holdings include Moderna Inc.; Amgen Inc. (AMGN), a biopharmaceutical company focused on treating serious illnesses and hard to cure diseases; and sponsored ADRs of BioNTech SE.9
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Thank you. Good luck if you do choose to invest.
You're assuming approval will be automatic. Even so...the label will be key and it could disappoint or be misinterpreted.
see...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165316601
Jim Rickards on Covid vaccines - >>> Tyranny
BY JAMES RICKARDS
AUGUST 17, 2021
Tyranny
I’d like to stop writing about COVID, but I can’t because it has such strong economic implications, which can’t be separated. And I’m afraid policies will be enacted that will only make things worse.
We all know the Delta variant of the COVID virus (SARS-CoV-2) is spreading rapidly in the U.S. and Australia. Major outbreaks have also hit India and Brazil.
What has received less attention is the fact that the Delta variant is now also spreading in China. That’s ironic because the virus started in China at the Wuhan Institute of Virology.
While the virus spread around the world, China quickly eliminated the spread inside China itself. Now, the virus has come full circle and is back in China in a new, more virulent form.
There’s a huge difference in how China approaches the virus from a public health perspective compared to the U.S., Japan or Europe. China’s lockdowns are far more extreme.
Why China Enforces Extreme Lockdowns
China will quickly identify an outbreak and cut off all car, train and air services to the affected area. China will also quickly shut down major ports and distribution centers if even a single case appears.
China knows that the spread of the virus is a threat to the legitimacy of the Chinese Communist Party. China cares more about Party loyalty and Party survival than it does about economic growth.
China is now imposing extreme measures, including canceling many domestic flights, closing ports and restricting vacation travel. China’s economy was already slowing before this new wave of the virus. Given China’s more extreme forms of COVID control, their economy will slow even further.
That’s bad news for China – and bad news for the world. Global growth will slow noticeably in the months ahead, partly because of the extreme nature of China’s lockdown approach.
That’s a prime example of how the virus and the economy are closely linked.
But how much do we really know about COVID? Can you really trust what the health authorities are telling you?
Science vs. Anti-Science
The essence of science is debate. One scientist will propose a hypothesis, which is then tested with experimentation. If the data from the experiment tends to confirm the hypothesis, it gains acceptance in a wider professional audience.
If the data tends to refute the hypothesis, it can be abandoned in favor of another new hypothesis. If the data are unclear, the experiments can continue. At the same time, other professionals can question the hypothesis or propose their own.
Different experts may question the experiments or challenge the interpretation of experimental data.
All of these ideas and results are published in peer-reviewed academic journals. The debate goes on until some consensus is reached. But even then, the consensus may last only until some even better view comes along. And, so it goes.
Anyone who says that the science on a particular topic is “settled” knows nothing about science because true science is never settled. It evolves. Just ask Newton, Einstein and Niels Bohr. They were three of the giants of science, yet each one revolutionized the work of their predecessors.
Unfortunately, none of the rules of real science seem to apply anymore. The “science” surrounding the COVID pandemic has been politicized, distorted, squashed and lied about to the point that citizens don’t trust their public officials – nor should they.
Censorship
One of the reasons the per capita rate of infection and fatality in Sub-Saharan Africa has been so much lower than was expected at the start of the pandemic is because Africans routinely take hydroxychloroquine to prevent malaria.
Hydroxychloroquine is cheap and safe and seems to have excellent prophylactic properties against the COVID virus. Likewise, the drug Ivermectin, which is also cheap and safe, has had fantastic results in helping to mitigate a severe outbreak of the Delta variant of the virus in India.
In India, Ivermectin may have stopped COVID dead in its tracks. 61 studies incorporating about 23,000 people revealed as much as a 96% reduction in death by taking Ivermectin.
Why have you not heard more about the role of hydroxychloroquine in Africa? Why have you not heard more about the role of Ivermectin in India? Why are both drugs not being more widely utilized to fight COVID?
The answer is that Big Tech and Big Media have banned any discussion. If you type the word hydroxychloroquine on Twitter, your tweet will be shadow-banned, or your account will be shut down. If you post something about Ivermectin on Facebook, you’ll be slapped with a “misinformation” warning label or worse.
The main TV networks – ABC, NBC and CBS (and the leading newspapers) – won’t report on these drugs and others. The news is being censored with a view to forcing vaccination with the experimental gene modification treatments from Moderna and Pfizer.
I don’t want to sound like a conspiracy theorist, but you have to ask yourself why positive news about cheap, effective therapeutics is being suppressed.
It never hurts to follow the money. It’s all about billions of dollars for Big Pharma and creating a nation that lives in fear.
Who Cares What the Science Says?
Unfortunately, the pandemic will go on because the vaccines don’t work well and wear off quickly. And, that means economic growth will continue to face headwinds. The pandemic could be mitigated with some cheap generic drugs. But it won’t be because of censorship and simple greed.
But that’s not stopping bureaucrats and politicians from demanding universal vaccination.
The COVID-19 vaccine mandate train keeps rolling down the tracks. The Biden administration said several months ago that there would be no national vaccine mandate. In the narrow technical sense, no federal mandate applicable to all citizens has been issued.
But, the spirit of Biden’s promise is now in shreds.
Instead of a single nationwide mandate, Biden has issued a large number of separate mandates to specific groups and encouraged private businesses and institutions to do likewise. The result has been practically the same as a national vaccine requirement.
The vaccine is now required for all federal officials and all government contractors. It is required for all military forces. It is required at most major universities for students returning to class. Major businesses such as Walmart, Amazon, Facebook and others require the vaccine for some or all of their employees.
Similar vaccine requirements have been imposed at the state and municipal level and by school districts, teachers’ unions and non-government organizations. Still, there are pockets of the population where the mandates don’t apply, and some individuals have been able to maintain their freedom of action.
Get Vaxxed or Live Like a Leper
Those pockets are the next targets of the vaccine pushers. Since some cannot be forced to take the vaccine, the latest tactic is to make their lives as miserable as possible until they agree to do so voluntarily. These tactics include being banned from indoor dining, concerts, sporting events, plays, movies and other social activities.
A new reign of terror being imposed on those who refuse to go along with the vaccine orthodoxy. Among the most chilling recommendations are requirements “mandating vaccines for interstate travel” and reducing Medicare payments to the unvaccinated who get COVID.
There are many legitimate reasons not to take the vaccine, including those who have already had COVID (about 35 million people with stronger antibodies than the vaccine itself produces), religious reasons, and serious doubts about side-effects and permanent changes to individual DNA genomes because of the vaccine.
None of that matters to the bureaucrats. The vaccine is being imposed whether you like it or not. Those who don’t get vaxxed will be forced into the basement of a two-tiered society and be denied access to public spaces and social interaction.
Your choice is to get vaxxed or be treated like a leper.
Regards,
Jim Rickards
for The Daily Reckoning
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$IBIO iBio, Inc. is a biotechnology company, which engages in the development and manufacture of biotherapeutics. Its pipeline include idiopathic pulmonary fibrosis, systemic sclerosis, and scleroderma.
$IBIO iBio, Inc.“iBio is a global leader in plant-based biologics manufacturing. Its FastPharming System® combines vertical farming, automated hydroponics, and novel glycosylation technologies to rapidly deliver high-quality monoclonal antibodies, vaccines, bioinks and other proteins. iBio is developing proprietary products which include biopharmaceuticals for the treatment of cancers, as well as fibrotic and infectious diseases. The Company’s subsidiary, iBio CDMO LLC, provides FastPharming Contract Development and Manufacturing Services along with Glycaneering Development Services™ for advanced recombinant protein design. For more information, visit www.ibioinc.com.
https://finance.yahoo.com/news/ibio-reports-successful-preclinical-immunization-211000069.html
Buffett sells drug stocks - >>> Warren Buffett Buys More Consumer Stocks, Sells Drug Stocks, GM
Investor's Business Daily
by GILLIAN RICH
08/17/2021
https://www.investors.com/news/warren-buffett-stocks-buys-sells-berkshire-hathaway-q2-2021-13f/?src=A00220
Warren Buffett revealed more exposure to consumer stocks as Berkshire Hathaway (BRKB) posted a key regulatory filing for the second quarter of 2021 late Monday.
The highly anticipated 13-F showed Buffett added to his positions in grocery chain Kroger (KR) by 21% and high-end furniture retailer RH (RH) by 2%.
Berkshire grew its stake in insurance brokerage Aon (AON) by 7% after buying if for the first time in Q1.
Meanwhile, Buffett sold more shares in drug giants, slashing his Merck (MRK) holdings by 49%, Bristol-Myers Squibb (BMY) by 15%, and AbbVie (ABBV) by 10% after opening those positions in Q3 2020. But he did initiate a stake on Merck spinoff Organon (OGN).
Berkshire also exited its position in biotech Biogen (BIIB) and trimmed its stake in top U.S. automaker General Motors (GM) by 10%. Its Chevron (CVX) stake was cut by 2%.
Kroger shares rallied 2.8% on the stock market today, Merck edged up 0.6%, AbbVie added 0.2%, GM fell 2.9%, RH lost 2%, and Organon added 1%.
Berkshire remained a seller of stocks in Q2, according to its earnings report earlier this month.
Its net stock sales of $1.1 billion in Q2 was down from $3.9 billion in Q1, but it marked the third straight quarter of selling.
Still, the value of Berkshire's overall stock portfolio swelled 8.7% to $293.8 billion by the end of Q2. That was up from $270.4 billion in Q1, as the S&P 500 and Nasdaq hit fresh highs to close out the quarter.
Meanwhile, Berkshire bought $6 billion worth of BRKB stock in Q2. That move cam after it repurchased $6.6 billion in Q1 and a record $27.4 billion in 2020.
Buffet's stock portfolio remains highly concentrated in a handful of companies. In Q2, 69% of its aggregate value was in Apple (AAPL) ($124.3 billion) and Bank of America (BAC) ($42.6 billion). Also, American Express (AXP) ($25.1 billion), and Coca-Cola (KO) ($21.6 billion).
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>>> Organon & Co. (OGN), a science-based pharmaceutical company, develops and delivers health solutions through a portfolio of prescription therapies within women's health, biosimilars, and established brands. Its women's health portfolio comprises contraception and fertility brands, such as Nexplanon/Implanon, a long-acting reversible contraceptive. The company's biosimilars portfolio consists of three immunology products, such as Brenzys, Renflexis, and Hadlima, as well as two oncology products, including Ontruzant and Aybintio in the United States, Canada, Australia, and Ukraine. It also has a portfolio of established brands in cardiovascular, respiratory, dermatology, and non-opioid pain management. The company sells its products primarily to drug wholesalers and retailers, hospitals, government agencies, and managed health care providers, such as health maintenance organizations, pharmacy benefit managers, and other institutions. Organon & Co. was incorporated in 2020 and is based in Jersey City, New Jersey. Organon & Co. operates independently of Merck & Co., Inc. as of June 2, 2021.
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“I'm not holding any bios currently. I'm waiting for RVNC approval then will probably take a position.”
Query for you…why wait for FDA as it relates to Daxi approval? Wouldn’t it me prudent to invest in RVNC now at $26 than wait until it jumps up on news of approval and launch? Is the downside too risky at this juncture? TIA for your time and comments. GLTA
Thanks, that's an interesting group of stocks. I'm also figuring on a market correction before too long. It sounds like the timeline for the Fed's tapering plans may have been accelerated, but on he other hand there is evidence that global growth rates already peaked and are now slowing. China recently had to ease credit, while the US is planning on tightening, so some mixed signals out there.
Fwiw I've mostly been out of stocks for the last month, not wanting to give back those nice 2020/21 gains. The rise of Delta seems ominous, and the stock market looks in need of a decent correction.
I'm not holding any bios currently. I'm waiting for RVNC approval then will probably take a position. I have a feeling the label will be disappointing because of misinterpretation or high expectations and will buy if it sells off. I'm more into tech stocks and currently own FUBU, STEM and TSP.
I also like AMD, ASML, SNAP, UPST, ASAN, CRWD and OPEN. I'm expecting volatility to pick up in the fall...especially if the Fed starts to taper bond purchases which will put a floor on interest rates. That should result in a 5-10% stock market correction.
Yes, good point about 'confirmation bias'.
Btw, Just curious if you have some favorite stocks you are currently following? (bio and/or non bio)
I don't follow the bio sector as closely as before, but still have a few 'on the radar'. Innovation Pharma (IPIX) is one that could start getting more attention soon with their broad spectrum antiviral Brilacidin. Their Covid Phase 2 data should be coming in Sept.
Innovation Pharma - >>> Last Patient Last Visit Completed in Innovation Pharmaceuticals’ Phase 2 Clinical Trial of Brilacidin for COVID-19; Trial Database Undergoing Review in Preparation for Database Lock
Innovation Pharmaceuticals Inc.
August 12, 2021
https://finance.yahoo.com/news/last-patient-last-visit-completed-130000435.html
WAKEFIELD, Mass., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provided additional information regarding the status of its randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897). The Company is developing Brilacidin for treatment of COVID-19 under U.S. FDA Fast Track designation.
Full enrollment in the 120-patient clinical trial was completed in early June 2021. The last patient follow-up visit occurred on July 30, 2021. The subject database remains blinded with the current emphasis on confirmation of all data entered at study sites, as well as completion of source data verification and the necessary checks and reviews by the data management vendor in preparation of database lock.
Following database lock and transfer to the biostatistics vendor, analysis of the unblinded data from the clinical trial will begin to assess Brilacidin’s performance, against placebo, across primary, secondary, and other endpoints. Topline results are anticipated to be available one week after database lock, with full analysis to follow.
“Our team is as excited as anyone to learn the results of our Brilacidin COVID-19 clinical trial. Everything is advancing per industry norms and standards,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “We look forward to sharing Brilacidin topline data in treating COVID-19 as soon as we have it in hand.”
About Brilacidin and COVID-19
Brilacidin is the only non-peptidic defensin-mimetic drug candidate currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19 (see NCT04784897). Brilacidin has shown potent and consistent inhibition in vitro against coronaviruses, alphaviruses and bunyaviruses (with laboratory testing against other viruses also underway), supporting Brilacidin’s potential to be developed as a broad-spectrum antiviral. The annual global antiviral drug market is estimated to reach $44 billion by 2026.
A peer-reviewed article in Viruses supporting Brilacidin’s COVID-19 treatment potential can be accessed at the link below.
Bakovic, A.; Risner, K.; Bhalla, N. (et al). Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. Viruses 2021, 13, 271; https://doi.org/10.3390/v13020271
https://www.mdpi.com/1999-4915/13/2/271/
Two independent Machine Learning studies identified Brilacidin as one of the most promising inhibitors of SARS-CoV-2, the virus responsible for COVID-19, based on Brilacidin’s molecular properties. Click here to learn more.
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases.
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