Dr Poland's latest video 8/20/2021

I listened to the whole video. Dr Poland was advocating vaccines social distancing and masks. He gave documentation for his advice. The reason I did not emphasize that is because it was expected.

Everyone should review his comments if they are unvaccinated or if they know someone unvaccinated. It is the best documented review of mitigation, masking and vaccines available.

What is very obvious to anyone who listened is he only mentioned break through infections in passing with no mention of the risk of death and hospitalization in the vaccinated. He did mention the English data, but again no mention of their documented break through infections with the hospitalizations and death.

He did mention the excellent work Dr Andrew Pollard did at Oxford as well as the REACT study, but he did not mention Dr Pollard's conclusion that herd immunity is not possible with the vaccinated becoming infected at high levels.

https://www.medicalnewstoday.com/articles/has-the-delta-variant-of-sars-cov-2-made-herd-immunity-impossible

At the 54 minute mark, Dr Poland, the world renown vaccinologist at the Mayo clinic for over 30 year, consultant to many vaccine companies and who is working on a Covid vaccine himself was asked a simple question.

" What is the end Game for Covid "

Dr Poland's answer, " there is no end game"

Wow... silence after the absolute and humbling veracity of his comment.

I quickly paraphrased his following comments...which are even more damning:

"There is no end game...variants will continue to develop to become more resistant to vaccines...infections spread... situation gets worse...herd immunity can never develop without world wide universal vaccines...never ending mutations and resistant variants...then after Covid 3,4,5,6...after untold deaths... virus devolves into endemic influenza like yearly or seasonal infection"

He could have been describing the black plague in the middle ages.

"minute 105 Antibody dependent enhancement {ADE} can develop as a complication of every variant and every vaccine."

At this point in the pandemic if vaccines hold very little hope for ending the pandemic the importance of therapeutics has to move to the front, does it not?

GLTA,

Farrell

Mayo clinic Covid 19 pod cast

minute 54

Dr Poland, what is the end game for Covid?

Paraphrasing:

There is no end game...variants will continue to develop to become more resistant to vaccines...infections spread... situation gets worse...herd immunity can never develop without world wide universal vaccines...never ending mutations and resistant variants...then after Covid 3,4,5,6...after untold deaths... virus devolves into endemic influenza like yearly or seasonal infection

minute 105 Antibody dependent enhancement {ADE} can develop as a complication of every variant and every vaccine.

Great review of vaccines and delta variant

Therapeutics are needed to break the cycle of resistant, more deadly variants. Hopefully Brilacidin will be the answer because the worlds expert on vaccines, Dr Gregory Poland ,feels in the end vaccines can not over come covid.

GLTA, Farrell

It is too soon to make the assumption we have reached a peak.
The peak will come, but the delta infections are very regional. I think it is more likely states with high infection rates will improve and less affected states will become worse. Unfortunately states with high vaccination rates are not going to be immune from delta.

Delta infection rates are going to be significant for some time.We will know the outcome the next few weeks.

JMO

GLTA,Farrell

Thanks for posting through link about SI!

GLTA,

Farrell

New CDC study....... confirms delta variant infections are increasing in vaccinated patients:

"The research shows vaccine effectiveness was 91% before the dominance of the delta variant, and it has since dropped to 66%."

"What we were making an attempt to determine out is: is this Delta, or is this waning effectiveness?” Dr. Fowlkes explained. “Our conclusion is that we just can’t truly inform.”

“We’re not getting the word out enough that people who have been vaccinated are not protected as much as they think. They need to mask up, they need to do everything they can. Make believe that there wasn't a vaccine..."


"Those who ended up hospitalized in spite of vaccination had been also older, on normal, than the unvaccinated who ended up hospitalized. The death rate among the vaccinated was reduced: .2 per cent, as opposed with .6 per cent between the unvaccinated. The median age at loss of life was also increased among the the vaccinated, at 78, in comparison with a median age of 63 among the the unvaccinated.

“We really wanted to let people know that we were seeing a decline in the effectiveness of the vaccine in protection against any infection, symptomatic or asymptomatic, since the Delta variant became dominant,” Dr. Fowlkes said."

GLTA,

Farrell

https://biologicalce.com/vaccines-prevented-fewer-infections-as-delta-emerged-researchers-find/

https://www.usatoday.com/story/news/health/2021/08/24/covid-vaccine-efficacy-delta-variant-cdc-study-los-angeles/5578703001/

Thanks for pointing that out. I took the vaccine because my occupation and other factors put me in one of the highest risks for developing serious complications from Covid. In addition I was concerned I could develop Covid and pass it to an immediate family member who is taking chemotherapy for leukemia. I have no regrets about taking the vaccine and I have encouraged everyone in a high risk group to take the vaccine.

You posted the link to my post today about increased risk of illness and death in the vaccinated now that the delta variant has become widespread.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165551263

My intent was not to discourage anyone from receiving the vaccine,but to point out the current vaccines are not as effective as we had hoped. I believe everyone should stay current with the Covid data as it will continue to change with each variant.

It is important to be aware of the changes in the vaccine effectiveness. Many individuals are not aware of the increased risked of the delta variant and this lack of awareness is contributing to the surge in delta infections, complications and deaths. See my post 136337.

The decreased effectiveness of the vaccines against the delta variant is the reason for the new recommendations of distancing, masks and booster shots.

The primary reason I made the post above on the IPIX board is because Brilacidin has the potential to be an important therapeutic against Covid and all the variants, a pancorona virus treatment. It should be obvious to anyone reviewing the data of the current status of the Covid 19 pandemic and the treatment of Covid19 that an effective antiviral against Covid 19 would be invaluable.

We should know the results of the Phase2 study soon.

Good luck to all,

Farrell

I'll drink to that! Hopefully we will be drinking 25 year old Pappy Van Winkle.

https://www.wine-searcher.com/find/old+rip+van+winkel+25+straight+bourbon+whisky+kentucky+usa/1/usa-ky-y

Woodford Reserve is very good, too.

Good luck,Farell

New Covid cases in the US are at a record high. The daily deaths yesterday were 2677, record high was 4460 in Jan 21 2021.

Delta cases and deaths are still increasing with the delta variant surge.

https://coronavirus.jhu.edu/region/united-states

I agree an antiviral therapeutic is needed. The Vaccines are not working as well as hoped.

Herd immunity is unlikely with vaccinated individuals catching the virus at high levels with high viral loads; spreading the virus to unvaccinated as well as the vaccinated.

https://www.cnbc.com/2021/08/12/herd-immunity-is-mythical-with-the-covid-delta-variant-experts-say.html

GLTA, Farrell

Good for you!

GLTA, Farrell

It is a great question. I have researched the old Polymedix data a number of times; and I have never found Brilacidin's blood brain barrier penetration documented.

Perhaps someone else can find it.

I did find this:

"Defensins are small, cationic, cyclic peptides that are abundantly stored in granules of neutrophils. Defensins non-specifically interact with membranes by forming weakly ion-selective pores. Here we demonstrate immunolocalization of defensin-secreting cells in human brain. Defensins, secreted by activated granulocytes, apparently are not prevented by the blood-brain barrier (BBB) from diffusing across cerebral endothelium to penetrate...

This may not apply to Brilacidin,but Brilacidin is a small, cationic definsin mimetic.

GLTA Farrell

Why did you wait so long to be vaccinated?

Farrell

should be:

Your post is still a reasonable future prediction.

Keep posting what you see in your crystal ball.

GLTA, Farrell

Your post still outlines a reasonable as a future projection.

Keep posting what you see in your crystal ball.

GLTA, Farrell

Those are the pre delta stats. The delta stats show more vaccinated hospitalizations and deaths. The CDC will announce new stats next week.

"Breakthrough infections accounted for 12 percent to 24 percent of Covid-related hospitalizations in the states, The Times found. The number of deaths was small, so the proportion among vaccinated people is too variable to be useful, although it does appear to be higher than the C.D.C. estimate of 0.5 percent."

https://www.nytimes.com/2021/08/17/health/covid-vaccinated-infections.html

Delta vaccinated patients are experiencing more hospitalization and deaths than expected.

My local hospital has reported has delta infections split 50-50 between the vaccinated and unvaccinated. The equal distribution extends to hospitalizations, ICU beds and deaths. About 48% in our area are vaccinated. Looking at data like that, how effective are the current vaccines? Almost all the local vaccinated received M-RNA vaccines. Of course local hospital data will vary and our stats in the vaccinated are higher than expected.

The unexpected increase in hospitalizations and death in vaccinated with the delta variant infection is consistent with the Israeli and English data.

The fact the vaccinated population is having more illness and deaths with the delta variant is why the Israelis are giving boosters to its entire population and the US is giving boosters to the immunocompromised; and many believe the US will soon give booster vaccines to everyone.

https://www.sciencemag.org/news/2021/08/grim-warning-israel-vaccination-blunts-does-not-defeat-delta

The latest English data is even more grim:

"The data shared by PHE also showed that of the confirmed delta cases that ended up hospitalized since July 19, 55.1% of the 1,467 were unvaccinated, while 34.9% had received both doses of the vaccine."

https://www.forbes.com/sites/jemimamcevoy/2021/08/06/fully-vaccinated-may-transmit-delta-just-as-easily-and-new-variant-shows-signs-of-vaccine-evasion-early-uk-research-suggests/?sh=1d15f0301ac5

The world needs an effective antiviral therapeutic. I would be happy if Brilacidin proves to be effective in the next couple of weeks.

GLTA, Farrell

It's canceled.

https://militaryhealthinstitute.org/events/2021-military-health-system-research-symposium-save-the-date/

GLTA Farrell

Thanks for posting.

Glta,
Farrell

No.. next they will review the data case by case and site by site looking to confirm the data reported.

"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."

http://www.ipharminc.com/press-release/2021/8/12/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

GLTA, Farrell

Side by side comparison of the Phase 2 Brilacidin for Covid Clinical trial March report to the August update shows:

1. enrollment: 120 patients anticipated.... 120 actual

if any patients dropped out they were replaced...{IMO good news}

2.They scrubbed the Louisiana site

3. Minor language changes to designate study completion

GLTA, Farrell

I am sorry to hear of her passing. My condolences to her family and friends.

Farrell

We will see more volume with the data lock .

Even more with the phase 2 results. Good or bad.

"The developer of the AstraZeneca shot says the Delta variant has made herd immunity impossible because vaccinated people can still transmit the virus."

GLTA,

Farrell


https://news.yahoo.com/developer-astrazeneca-shot-says-delta-114837457.html

I afraid it is bad news for us. The Israeli and English delta variant data suggest the vaccines do not work as well as had been hoped plus we have many more unvaccinated here in the US compared to Israel and England. The unvaccinated are likely to have more severe infections, hospitalizations and death.

In addition we know the vaccinated can become infected at a relatively high rate even though they may have milder symptoms as a whole they are contagious with a high viral load; the Israeli experience indicates the vaccinated patients greater than 50 age are at risk for severe infections, pulmonary failure and death.

Unfortunately the delta variant experience in Israel and England is projecting a bleak picture here in the US for the next few weeks.The rising US Covid delta hospitalization rates and increasing ICU usage has already begun.

GLTA Farrell

Israel begins Pfizer boosters due to breakthrough infections.What if that does not work? Horrifying news.

When reviewing the statistics remember Israel's population is smaller than North Carolina's which has suffered about 3000 case per day the last few days

GLTA Farrell

"Almost 80 per cent of the adult {Israeli} population has been fully vaccinated, one of the highest rates in the world, but more than 6,000 people tested positive for Covid-19 on Monday, according to the health ministry. Nearly 650 people were in hospital and 400 of them were in serious condition, it said, without indicating how many had already been vaccinated."

"Just under 5 per cent of coronavirus tests were coming back positive, in a sign that the nation was in the midst of a major Covid increase, warned Salman Zarka, the government’s coronavirus tsar. Israel was at “a critical point for our health, for our lives and for our economy”, he said."

"Now, with studies showing the efficacy of the vaccine fading among the over-60s, some of whom received their first shots as early as December, health authorities have taken the lead in administering booster injections."

"Israel did not wait for the US Food and Drug Administration to approve boosters of the Pfizer vaccine, instead administering third shots to about 2,000 immunocompromised people weeks ago before extending it to all those over 60 on August 1. As many as 600,000 older Israelis have now received a third shot, which could soon be offered to the over-50s too."

"But the rapid pace of new infections makes it likely that new restrictions will have to be imposed, he said."

https://www.ft.com/content/9e06cb33-38a1-4efe-859e-95008c85a623

Thanks for sharing. The article and your comments add clarity to the discussion.

GLTA,Farrell

Below is a summary of an article from the New England Journal of Medicine:

"Antibodies induced by currently available mRNA vaccines can still neutralize the Delta and Kappa variants of the SARS-CoV-2 virus, but do so at a reduced potency, according to a report published in the New England Journal of Medicine.

The Delta variant, first identified in India and previously known as B.1.617.2, is now dominant in the United States. The Kappa variant, previously B.1.617.1, was also first identified in India.

Compared with the Washington strain that arrived in the United States last year, vaccine-induced antibodies are 2.9 times less able to neutralize Delta and 6.8 fold less able to neutralize Kappa. Still, researchers concluded that the antibodies induced by mRNA vaccines will be strong enough in many people and protective immunity is “most likely retained” against Delta and Kappa."

http://news.emory.edu/stories/2021/07/coronavirus_delta_kappa_vs_vaccine_antibodies/index.html

The real answer is we are not likely to know which is the best path for previously infected for some time. The current reports often conflict.

You have to agree the Delta variant is less responsive to antibody based therapies, Monoclonal antibodies, convalescent sera and vaccines than previous Covid viruses.

The most disturbing information is the break through infections seen in Israel and England where so many vaccinated individuals were hospitalized and died. Obviously the vaccinations are safer than the primary infections and confer lower hospitalization and death rates. Why is it the vaccines do not provide better protection?

Currently we do not have an adequate explanation for these illnesses. Is it because the vaccines lose potency with time.Obviously the variant mutations change the S protein structure and change its antigenic profile. Individuals differ in their immune responses. Does innate immunity produce a better T cell response?

This article discusses T cell immunity in vaccinated and in patients previously infected, but it also made this observation

"The ratio of serum virus neutralization GMT to recombinant RBD-binding IgG GMC is lower after immunization with BNT162b1 than after infection with SARS-CoV-2. As noted previously, this difference may be attributed, in part, to BNT162b1 eliciting antibodies that bind epitopes that are exposed on the RNA-encoded RBD immunogen but buried and inaccessible in the spikes of SARS-CoV-2 virions, differentially increasing RBD-binding IgG GMCs after immunization. In addition, infection with SARS-CoV-2 might elicit neutralizing antibodies that recognize epitopes that are exposed on virions and located outside the RBD, differentially increasing the serum neutralizing GMT after infection29,30.

https://www.nature.com/articles/s41586-020-2814-7

Good luck,

Farrell

It would make sense if IPIX made 2 billion a quarter. 8 billion a year opens a lot of doors.

Of course that seems impossible now just as it did for BioNTech in January of 2020.

GLTA Farrell

BioNTech is quite a company. Their primary source of income is from the Covid Vaccine, but they are involved in 80 clinical trials, many involve therapeutic vaccines against cancer.

https://clinicaltrials.gov/ct2/results?cond=&term=biontech&cntry=&state=&city=&dist=

If IPIX Brilacidin proves to be equally successful it would be interesting to see if they could expand the research on synthetic defensin mimetics. It is my understanding IPIX controls all the technical information and computer programs to make compounds similar to Brilacidin.

Perhaps they could merge with DeGrado's company,Pliant Therapeutics and engage some of the original Polymedixs researchers.

https://pliantrx.com/team/bill-degrado-ph-d/

I doubt that makes much business sense , but it would be great to develop new drugs with the background laid by Polymedixs.

GLTA Farrell

Israel, a highly vaccinated country,data shows 700 greater effect against delta with natural immunity than vaccine which was predominately Pfizer.


“With a total of 835,792 Israelis known to have recovered from the virus, the 72 instances of reinfection amount to 0.0086% of people who were already infected with COVID.

“By contrast, Israelis who were vaccinated were 6.72 times more likely to get infected after the shot than after natural infection, with over 3,000 of the 5,193,499, or 0.0578%, of Israelis who were vaccinated getting infected in the latest wave.”

With over 60% of their respective populations now fully vaccinated, Israel and the U.K. are perfect case studies demonstrating that vaccines are not playing the predominant role in slowing down the viral spread. If you compare all of the European countries by recent cases per million to vaccination rates, you will find zero correlation, and in fact, eastern European countries with low vaccination rates seem to have fewer cases.

https://newsrescue.com/delta-variant-natural-immunity-700-greater-protection-than-shot-data-from-israeli-govt-shows/

I looked for the royalty agreement and found the documents but the amounts were x'ed out. BioNtech's revenue was $2 billion the 1st quarter of 2021 up 7294.95%.

GLTA, Farrell

There exists conflicting research on this point, but I think Rand is right.

GLTA Farrell

Remdesivir was given an EUA at the interim report of its Phase 3 study. That's my best guess for Brilacin.

It could be sooner if the Phase 2 shows outstanding results, acing all the primary and secondary outcomes with absolute safety.

The other factor is the status of the pandemic. If the Delta virus outbreak continues to accelerate or if vaccine resistant or more deadly variants appear, Brilacidin could be pushed up to the drug of choice.

JMHO Farrell

Good point. It is a tremendous undertaking to manufacture ,distribute, market and sell a new drug flawlessly.

It is hard to imagine IPIX making the right personnel and business structural changes quickly enough to satisfy the demand of a new successful Covid drug. The key would be to find the pharmaceutical company to enter into a partnership or licensing agreement.

An example of a Covid pharmaceutical start up small partnering with a big Pharma for the reasons outlined above would be the Pfizer Bionet deal:

" Pfizer and BioNTech to jointly develop COVID-19 vaccine, initially in the United States and Europe, and scale-up manufacturing capacity to support global supply
Potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval by regulatory authorities, and then rapidly scale up capacity to produce hundreds of millions of doses in 2021.
BioNTech will contribute multiple mRNA vaccine candidates as part of its BNT162 COVID-19 vaccine program, which are expected to enter human testing in April 2020
Pfizer will contribute its leading global vaccine clinical research and development, regulatory, manufacturing and distribution infrastructure and capabilities
BioNTech will receive an upfront payment of $185 million, including an equity investment of approximately $113 million, and be eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million."

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-further-details-collaboration

If Brilacidin proves to be successful in the clinical trials the terms above are likely too conservative. Brilaciidin would be in a stage 3 trial with an EUA after the interim report at the earliest.

Good luck to all,

Farrell

Nice review. At this point IPIX should continue on its prudent course of carefully and thoughtfully engaging the FDA. An example of aggressive promotion drawing the ire of the FDA can be seen with Cytodyn.

The FDA's letter to Cytodyn was a warning to all pharma companies.

https://www.fda.gov/drugs/drug-safety-and-availability/statement-leronlimab

The fallout from the FDA slap down continues to plague the company. Last week Cytodyn received subpoenas from the SEC and DOJ regarding Leronlimab's promotion.

https://seekingalpha.com/news/3724193-cytodyn-receives-sec-doj-subpoenas-related-to-leronlimab-as-a-covid-19-treatment

The above is addition to lawsuits from class action attorneys and shareholders.

https://www.fiercebiotech.com/biotech/cytodyn-shares-plummet-after-being-accused-by-fda-cherry-picking-covid-19-data

https://www.cnbc.com/2021/07/24/large-shareholder-group-calls-for-a-board-overhaul-at-pharma-company-cytodyn.html

GLTA Farrell

Doomsday variant may be closer than you think. Brilacidin needed now.

https://www.newsweek.com/2021/08/13/doomsday-covid-variant-worse-delta-lambda-may-coming-scientists-say-1615874.html

Leo needs to hire the attorneys who wrote this contract.

Thanks for posting.

Farrell

Unbelievable. the CDC just blunders from one mistake to the next. The British Delta peak has past ,but they reported a reinfection rate of 40% .

The CDC thinks its OK to have over 100 million vaccinated people, many who believe they can not be reinfected and can not possibly spread the disease, not understand that there is a significant risk of reinfection and subsequent contagion.

GLTA Farrell

https://www.forbes.com/sites/joshuacohen/2021...it-matter/

There is a control SOC group with 60 pts and a treatment group of 60 pts with the SOC +Brilacidin.

THE FDA and others felt the study without SOC treatment for both groups was unethical. The Phase 3 study may have direct comparisons.

ACTI-6, a large trial with multiple repurposed drugs, has begun. It is possible Brilacidin will be a part of a future similar study if the phase 2 study is possible.

https://www.nih.gov/news-events/news-releases/large-clinical-trial-study-repurposed-drugs-treat-covid-19-symptoms.



GLTA Farrell

An enormous need exists for an effective Covid antiviral infections.

GLTA Farrell

The protocol does not call for the testing of mutations/variants. The delta variant became the dominant variant during the trial so many patients probably had the delta variant.

https://www.nytimes.com/2021/06/18/world/europe/coronavirus-russia-delta-moscow.html.

GLTA Farrell