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FWIW a golden cross today appeared on the ERHE stock chart. Its significance on a double zero stock is up for debate.
What's not debatable is the 8K 's effect on the stock which has cardioverted ERHE back to life. It is still sick ,but breathing.
Anyone willing to speculate about what a deal for EEZ block 4 would do for the stock?
Good luck,
Farrell
We are both speculating because we do not have data from the trial yet,but the Lancet study should be similar to the Brilacidin for Covid in many ways.
https://www.thelancet.com/action/showFullTableHTML?isHtml=true&tableId=tbl1&pii=S1473-3099%2821%2900485-0
From the Lancet study you can see general trends which should be similar to the brilacidin for covid study:
Average age was about..... 64
Males were more affected than females..... greater than 2 to 1
Coexisting conditions ....73 percent had 1 to 3 coexisting medical problems
Take another look at the numbers from the Lancet trial:
Obesity 278 (34%) 138 (34%) 140 (34%)
Chronic cardiac disease 229 (28%) 111 (27%) 118 (28%)
Diabetes 217 (26%) 104 (26%) 113 (27%)
Chronic pulmonary disease 146 (18%) 71 (17%) 75 (18%)
Chronic kidney disease stage 1 to 3 51 (6%) 19 (5%) 32 (8%)
Auto-inflammatory disease 41 (5%) 17 (4%) 24 (6%)
Malignant haemopathy 35 (5%) 16 (4%) 19 (5%)
Chronic neurological disorder including dementia 34 (4%) 18 (4%) 16 (4%)
Mild liver disease 30 (4%) 15 (4%) 15 (4%)
Active malignant neoplasm 28 (3%) 13 (3%) 15 (4%)
Transplantation 11 (1%) 2 (<1%) 9 (2%)
Asplenia 4 (<1%) 1 (<1%) 3 (1%)
AIDS/HIV not on ART
Those are obviously serious coexisting conditions.
It is clear patients with significant but stable medical problems were included in the Lancet trial.
Another point is the coexisting conditions in the predominantly Russian study population should be much higher in the western Europeans in the Lancet study. The average life expectancy in Russia is 72.6 years Belgium is 81.6 years.Russians are in poorer health.
The Lancet study data suggests most people in the brilacidin study will also have coexisting conditions.It is also clear in the brilacidin trial patients with many medical conditions will not be excluded if they are medically stable. Managing the coexisting conditions is inherent to the trial.
GLTA,
Farrell
If this isn't seriously ill, what is?
From your post:
"Inclusion criteria...
Currently hospitalized and requiring medical care for COVID-19.
Moderate OR severe COVID-19, defined by respiratory function at screening, as below:
Moderate, meets at least one of the following criteria:
Peripheral oxygen saturation SpO2 > 93% on room air;
Respiratory rate ≥ 20 to < 30 breaths per minute.
Severe, meets at least one of the following criteria:
Peripheral oxygen saturation SpO2 ≤ 93% on room air OR arterial oxygen partial pressure (PaO2) / fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=0.133kPa) [corrective formulation should be used for higher altitude regions (over 1000m)];
Respiratory rate ≥ 30 breaths per minute"
...most were older with significant comorbities."
Patients with mild to moderate renal and hepatic disease were allowed in the trial even though they are at risk of becoming worse with Covid 19.
Hypertensive patients with controlled BP on medication were allowed in the trial.
Only patients with severe uncontrolled hypertension are excluded:
"Hypertensive urgency (e.g., SBP >220 mmHg or DBP >120 mmHg) or hypertensive emergency within the last 72 hours..."
In other words stroke level hypertension was excluded
No exclusion listed for the following:
cancer patients, heart disease, asthma, Chronic obstructive pulmonary disease, epilepsy,diabetes, AIDS not requiring treatment,neurologic disorders,dementia, hematologic disorders, gastrointestinal disorders and most other chronic disorders which were well controlled.
Most of the rest of the exclusions are easily understandable
Individuals on ventilators and ECMO are excluded
Requiring systemic anti-infective therapy for suspected or confirmed active bacterial/fungal/viral systemic infection other than COVID-19.
Any serious medical or psychiatric condition or test abnormality(ies) that, in the investigator's judgment, puts the participant at significant risk, could confound the study results, or may interfere significantly with the subject's safe participation in and completion of the study.
Pregnancy or breast-feeding, or positive urine or serum pregnancy test in a pre-dose assessment.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception throughout the study and for up to 30 days after stopping treatment.
This study of other antiviral Covid treatments was discussed recently on the board. It is a good example of patients allowed in covid clinical trials:
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00485-0/fulltext#coronavirus-linkback-header
Obesity 278 (34%) 138 (34%) 140 (34%)
Chronic cardiac disease 229 (28%) 111 (27%) 118 (28%)
Diabetes 217 (26%) 104 (26%) 113 (27%)
Chronic pulmonary disease 146 (18%) 71 (17%) 75 (18%)
Chronic kidney disease stage 1 to 3 51 (6%) 19 (5%) 32 (8%)
Auto-inflammatory disease 41 (5%) 17 (4%) 24 (6%)
Malignant haemopathy 35 (5%) 16 (4%) 19 (5%)
Chronic neurological disorder including dementia 34 (4%) 18 (4%) 16 (4%)
Mild liver disease 30 (4%) 15 (4%) 15 (4%)
Active malignant neoplasm 28 (3%) 13 (3%) 15 (4%)
Transplantation 11 (1%) 2 (<1%) 9 (2%)
Asplenia 4 (<1%) 1 (<1%) 3 (1%)
AIDS/HIV not on ART
Most moderately to severe covid patiets are older and many have other significant disease.
GLTA,
Farrell
One of the most common problems in foreign clinical trials are computer issues. Each hospital computer software may be different, all the data has to be converted to the software system used by the CRO or data managers. The conversion can be very time consuming.
Another issue is incomplete data. All the patients in the trial were seriously ill most were older with significant comorbities. It was important for the medical staff to manage their problems whether it was ischemic heart disease, liver and kidney problems,cancer. emphysema,asthma etc. That may mean a test may not have been done in the needed time frame or it was done but not recorded. Remember the primary responsibility for the hospital and its medical staff is to care for each individual patient ,the study will always be second.
Covid infections in chronically ill patients can not be treated like they are stamping out identical car parts,they are all going to be different and require individual intensive medical
attention to their pre existing as well as the acquired medical problems from Covid.
The other issue is IPIX is a small company with limited resources. It is not going to be able to complete a study the same way Gilead or Regeneron can.
The good news is we are getting closer to receiving the data.
I am looking forward to reviewing the final result.
Good luck,
Farrell
Thanks for posting. This article is very important.
This study and its sister study showed none of the drugs studied, Remdesivir,lopinavir/ritonavir, lopinavir/ritonavir–IFN–ß-1a [–IFN–ß-1a is an interferon} and hydroxychloroquine had a significant benefit against moderate to severe Covid19.
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00485-0/fulltext#coronavirus-linkback-header
https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(21)00259-7/fulltext
At this point over 18 months after the beginning of the Covid 19 epidemic we do not have a proven antiviral for patients with moderate to severe Covid 19.
In addition vaccinations have shown their limitations. While it is clear vaccines limit severe illness and death , it is also clear the break through infections mean the vaccinated can not only become sick and die ,but can further spread Covid. The goal of having herd immunity from vaccines is now more difficult to obtain.
Plus the CDC is being criticized for not making the complications of Covid and the vaccines available to the public or others in the health care system.Many suggest looking to England and Israel for more insight into the delta variant surge and vaccinations.
https://www.washingtonpost.com/health/2021/08/18/cdc-data-delay-delta-variant/
https://www.cnbc.com/2021/08/12/herd-immunity-is-mythical-with-the-covid-delta-variant-experts-say.html
It is not surprising the government is focusing on antiviral research.
https://www.hhs.gov/about/news/2021/06/17/biden-administration-invest-3-billion-american-rescue-plan-as-part-covid-19-antiviral-development-strategy.html
Hopefully Brilacidin's phase 2 study will show it is effective against Covid 19.
GLTA,
Farrell
At that point IPIX is on to Ulcerative Colitis which I am very excited about. The phase 2 study of Brilacidin for Ulcerative Proctitis was fantastic even though the number of patients was small.
The Oral Mucosiditis phase 3 study is planned for 2022.
"Additional work tied to starting, in 2022, a planned Phase 3 study of Brilacidin in Oral Mucositis is also in progress. We aim to maintain momentum across our clinical programs.”
IPIX has announced the stage 2 Ulcerative Colitis oral Brilacidin study should start in the next few months:
"Development work related to the formulation and manufacture of Brilacidin in capsule form is underway to support our Phase 2 trial in Ulcerative Colitis planned to commence this year."
In addition Alfasigma is making plans to study Brilacidin for Ulcerative Proctitis:
"Also in the pipeline, Alfasigma S.p.A. (“Alfasigma”)—the licensee of worldwide rights to develop, manufacture and commercialize rectally-administered Brilacidin for treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS)—notified the Company, in April, of its intentions to commence, in 2021, a Phase 2 multinational clinical trial of Brilacidin for UP/UPS. Alfasigma has placed an order with the Company for Brilacidin drug substance needed for the trial, which the Company is in the process of supplying. Per the licensing agreement, Innovation Pharma is eligible to receive $24 million in upfront and milestone p2022ayments, and a 6 percent royalty (net sales), upon the successful marketing of Brilacidin for UP/UPS."
http://www.ipharminc.com/press-release/2021/5/13/innovation-pharma-files-form-10-q-patient-enrollment-in-phase-2-clinical-trial-of-brilacidin-for-covid-19-tops-70-percent
GLTA Farrell
Synergy between Remdesivir and Brilacidin was predicted in the antiviral in vitro studies. Phase 2 confirmation of the synergy would be terrific.
Unfortunately it is likely only a few patients treated in the US received Remdesivir. The SOC antiviral in Russia is most likely Favipiravir.
Hopefully Brilacidin's anti-inflammatory effects will reduce pulmonary and other complications in the patients who are more ill.
We will see when the full results are reported.
GLTA Farrell
The point of the trial is to see if Brilacidin + SOC is superior to SOC alone.
We should know the result very soon.
Glta,
Farrell
Do you really believe your statement?
"Where’s the “independent testing”? The only “independent” thing I see is that a lab technician at GMU (probably a student) did the bench work. IPIX was involved in the rest."
George Mason is one of the 12 facilities in the country which has a BSL research lab. They do viral research for a variety of indications for government, private and corporate entities. They are one of the few BSL labs with a background in doing research on defensins and human defense proteins.
https://cidr.science.gmu.edu/
The following description reflects the sophistication of research performed at George Mason BSL
https://www.niaid.nih.gov/research/george-mason-regional-biocontainment-lab
https://cidr.science.gmu.edu/research-and-facilities/research-services/
If you have concerns about George Mason's integrity you should contact the university or the NIAID.
GLTA Farrell
Scored some at .227 ;more stink bids are in place.
All I can say is thank you so much to the individuals that are selling.
Data lock soon???
GLTA, Farrell
More proof therapeutics needed for corona virus infection #2
Washington understands vaccines are not protecting the public or providing herd immunity as hoped. Their political futures require action to halt the pandemic.
Washington announces a new plan to fight viral pandemics. Biden will present the American Pandemic Preparedness Plan tomorrow night.
https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf
GLTA Farrell
From the presentation. Therapeutics highlights:
2. Therapeutics
Goal: Have a range of therapeutics suitable for any virus family, available before a pandemic
or readily created during a pandemic.
(2.1) Inhibiting key viral functions. Develop inhibitors that target essential viral functions, such as cell
entry and replication, for any human viruses within a family or subfamily. (Effective inhibitors of this
type have been developed for HIV and Hepatitis C.) Viral inhibitors would be valuable for treatment and
prevention in both pandemic response and ordinary times (for example, to treat shingles or virally-
caused meningitis). Promising approaches to develop anti-viral therapeutics include: (i) broadly-acting,
small-molecule therapeutics against key viral functions, in advance of a pandemic and (ii) programmable
RNA-based therapeutics targeted against specific viruses, for use during a pandemic.
Funding
2. Therapeutics $11.8
2.1 Develop antivirals that inhibit key proteins for viral families, and evaluate in clinical
trials against relevant diseases
2.3 Develop host-specific therapeutics and immunomodulators, and evaluate in clinical
2.1) Inhibiting key viral functions. Develop inhibitors that target essential viral functions, such as cell
entry and replication, for any human viruses within a family or subfamily. (Effective inhibitors of this
type have been developed for HIV and Hepatitis C.) Viral inhibitors would be valuable for treatment and
prevention in both pandemic response and ordinary times (for example, to treat shingles or virally-
caused meningitis). Promising approaches to develop anti-viral therapeutics include:
• Develop broadly-acting small-molecule therapeutics against key viral functions, in advance of
a pandemic. Development of small-molecule therapeutics against viral proteins, such as
polymerases or proteases, is a well-established approach — involving high-throughput screening
using in vitro or cellular systems to identify molecules, chemical optimization to produce lead
molecules, preclinical testing, and clinical testing. Because the approach is too slow to enable
creation of new therapeutics in the midst of a pandemic, it is necessary to identify and test
broadly-acting therapeutics against viral families in advance of a pandemic. The goal would be to
develop therapeutics that are effective across a broad spectrum of viruses within a viral family
or across multiple viral families.
2.3) Controlling counterproductive patient responses to infection. Develop and characterize new
therapeutics that limit damage from infectious diseases caused by over-or under-active responses of the
human body to infection.
• Develop therapeutics to modulate responses by the immune, circulatory, and other organ
systems to viral infection. Modulators of the immune system—such as dexamethasone and
tocilizumab, which act through distinct mechanisms—were found to reduce mortality among
the sickest COVID-19 patients. Therapeutics targeting the respiratory system or the circulatory
system would be useful for treatment of pneumonia or blood clotting symptoms in both
ordinary times and during pandemic response.
More proof therapeutics needed for corona virus infection
Up to date delta corona virus cases in England.
Vaccinations: up to 89% for 1 80% for 2
Deaths: at a 4 month high 191 per day
Hospitalizations: at a 4 month high 933 per day
See Graphs at:
https://coronavirus.data.gov.uk/
UK summary
The official UK government website for data and insights on coronavirus (COVID-19).
See the simple summary for the UK.
Vaccinations
People vaccinated
Up to and including 7 September 2021
Percentage of population aged 16+
88.9%
1st dose
80.3%
2nd dose
People tested positive
Latest data provided on 8 September 2021
Daily
38,975
Last 7 days
272,475
arrow 36,196 (15.3%)
Rate per 100,000 people: 377.4
Graph - click for more details
All cases data
Deaths
Deaths within 28 days of positive test
Latest data provided on 8 September 2021
Daily
191
Last 7 days
932
arrow 193 (26.1%)
Rate per 100,000 people: 1.2
All deaths data
Healthcare
Patients admitted
Latest data provided on 4 September 2021
Daily
933
Last 7 days
6,730
arrow 205 (3.1%)
Graph - click for more details
Could you supply a link for your assertion that Covid vaccines are associated with ADE?
GLTA Farrell
I could not find the 226 billion documented ,but I did find this program announced a few months ago:
https://ncats.nih.gov/antivirals
Interesting some of the viruses of interest named were the ones reported in the recent GMU research of Brilacidin's antiviral effects.
In addition to SARS-CoV-2, NCATS’ activities will address other viruses within the scope of the APP that represent known threats because of their pandemic potential. The table below shows virus families/orders and examples of viruses that the APP may target.
Viral Family/Order Example Viruses
Coronaviridae SARS-CoV, MERS-CoV, SARS-CoV-2
Bunyavirales Rift Valley fever, Hantavirus, Crimean-Congo hemorrhagic fever
Filoviridae Ebola, Marburg
Flaviviridae Yellow fever, Dengue, Zika
Paramyxoviridae Hendra, Nipah
Picornaviridae Enterovirus D68
Togaviridae Chikungunya
From post 366725
Bunyavirus infections are the causative agent in a number of serious human diseases.
Pneumonitis
-Hantavirus has a mortality rate of 35%
https://www.ecdc.europa.eu/en/hantavirus-infection/facts
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3840873/
Hemorrhagic fever
-Rift valley fever
https://www.cdc.gov/vhf/rvf/about.html
-Lassa fever
https://www.who.int/health-topics/lassa-fever#tab=tab_1
Severe fever with thrombocytopenia syndrome (SFTS}
https://www.nature.com/articles/s12276-021-00610-1
Encephalitis
-California and LaCross encephalitis
https://emedicine.medscape.com/article/234159-overview
-Crimea-congo encephalitis
https://www.who.int/news-room/fact-sheets/detail/crimean-congo-haemorrhagic-fever
Brilacidin is also reported to be effective in some alpha viruses.
Alpha viral diseases include Togaviridae. Virus, chickungunya; Ross River; Mayaro; , O'nyong-nyong; Sindbis; eastern equine encephalitis; Venezuelan equine encephalitis.
GLTA Farrell
Assuming the phase 2 study of Brilacidin confirms its safety and efficacy against Covid 19 and an EUA is released at the interim report of the phase 3 study or before my guess is the timing would be similar to Regeneron's experience which was about 9 mos between its EUA for treatment of mild disease and approval for prophylaxsis.You can add as many months as you think it will take to obtain an EUA to the 9 mos.
I would expect it to be studied for prophylaxsis in high risk adults on exposure, after a positive covid test and at the onset of symptoms.
Regeneron's EUA for treatment of mild covid was approved on
11/21/2020. Its approval for prophylaxsis was on 7/30/2021.
GLTA, Farrell
https://www.healio.com/news/infectious-disease/20210730/fda-authorizes-regeneron-antibody-cocktail-for-postexposure-prophylaxis-of-covid19
https://www.healio.com/news/infectious-disease/20210804/regeneron-cocktail-shows-promise-as-postexposure-prophylaxis-for-covid19
Latest CDC projections of delta variant surge plus graphs.
This week’s national ensemble predicts that the number of newly reported COVID-19 deaths will likely increase over the next 4 weeks, with 5,100 to 17,700 new deaths likely reported in the week ending September 18,
https://www.cdc.gov/coronavirus/2019-ncov/science/forecasting/forecasting-us.html
GLTA Farrell
All the earlier studies show it is not absorbed orally. It is possible to formulate some IV or IM meds into oral medications or IM depo injections If the phase 2 or 3 leads to and EUA I would like for them to begin that research.
Below is an article describing how peptides formulated for diabetes were converted to an oral form.
https://cen.acs.org/pharmaceuticals/biologics/oral-form-blockbuster-diabetes-drug-has-arrived/97/web/2019/12
GLTA,Farrell
The company,Innovation Pharmaceuticals, has expressed an interest in making an inhaler for pulmonary diseases which would likely include Covid. Hopefully, the inhaler for Covid could be given prophetically either at exposure or the on the beginning of symptoms.
GLTA, Farrell
The government needs to redouble its efforts to fund therapeutic research. More and more of the leading experts have expressed an opinion that herd immunity is not possible with current vaccines.
And, many predicted increasingly resistant, dangerous variants.
GLTA, Farrell
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
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.