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Good point. Michigan was one of the most restrictive states for mitigation and closings. Now they are suffering a recurrence of Covid now that the variants/mutations are spreading.
Glta Farrell
Brilacidin for Oral Mucositis
"Summary of Topline Results from the Placebo-Controlled Phase 2 Trial
· Brilacidin met primary endpoint of reduced incidence of severe OM experienced by patients during radiation therapy.
· Incidence of severe OM in Modified Intent to Treat (mITT) Population: Brilacidin 42.9%, Placebo 60.0%.
· Incidence of severe OM in Per Protocol (PP) Population: Brilacidin 36.8%, Placebo 60.0%.
· Trial results support continued and expedited development of Brilacidin-OM."
"None of the SAEs were classified by the Investigator as related to Brilacidin."
http://www.ipharminc.com/press-release/2017/12/11/innovation-pharmaceuticals-reports-positive-topline-results-from-phase-2-placebo-controlled-trial-of-brilacidin-for-the-prevention-of-oral-mucositis-in-head-and-neck-cancer-patients
Comparative graph of Brilacidin for oral mucositis:
http://www.ipharminc.com/new-blog/2018/9/24/brilacidin-for-oral-mucositis-at-a-glance-comparative-data-presentation-with-other-investigational-om-drugs
Many of the reported SAEs and AEs are a result of 1 Oral Mucositis 2 Radiation 3 Chemotherapy and 4 the head and neck cancer 5 the patients underlying medical disorders
Some of the reported AE an SAE's in both the treated and placebo group include Radiation skin damage, White cell decrease, febrile neutropenia, catheter site cellulitis, atrial fib, embolism and a variety of oral complaints consistent with oral mucositis.
When you review the AE and SAE's critically few can be blamed on the Brilacidin Sachets.
These are extremely ill patients receiving toxic chemotherapy and radiation which results in debilitating ulceration and irritation of the oral cavity which makes it difficult to eat or swallow to the point where they can not maintain their hydration,weight or continue their treatments. Many require gastric tubes for survival.
GLTA,
Farrell
The Sputnik vaccine is still generating controversy. Link below summarizes some of the concerns which may prove to be minor. Apparently it is the same viral vector technology used by Johnson and Johnson and AstraZenica which both have had there share of concern.
https://www.dw.com/en/is-sputnik-v-vaccine-safe/a-57219314
GLTA, Farrell
"capacity to produce... tons"
It is interesting the Chinese are interested in the manufacture of Brilacidin. The Chinese are probably already making Brilacidin in bulk,and this company wants to get in on the production of a chemical intermediary for the rest of the world which recognizes patent rights.
Thanks for posting... a very intriguing find
"We have our own industry park and our capabilities include rapid initial scale-up and custom synthesis with the capacity to produce up to tons. We supply 4,6-Pyrimidine dicarboxylic acid (CAS NO. 16490-02-1) with high quality which is an intermediate for Brilacidin."
Good luck,Farrell
The 4,6-Pyrimidine dicarboxylic acid is an intermediate compound used in the production of Brilacidin.step c below
c) adding the compound of Formula II and pyrimidine-4,6-dicarboxylic acid in presence of N-(3-dimethylaminopropyl)-N'-ethylcarbodiirnide hydrochloride pyridine to form a compound of Formula III
The biochemists in the group may find it easier to follow process of assembly with the graphs listed in the link to the patent. Preceding this in the patent is a detailed outline of the immunologic properties of Brilacidin which has not been published.
GLTA,
Farrell
https://patents.google.com/patent/WO2016133733A1/en
DETAILED DESCRIPTION OF THE INVENTION
The starting materials, which are required to prepare the compound brilacidin and the pharmaceutically acceptable salts thereof, are commercially available in bulk. The compound brilacidin and the salts are prepared by
a) reacting (R)-(-)-N-Boc-3-pyrrolidinol with 2-chloro-5-(trifluoromethyl)-l ,3- dinitrobenzene in the presence of potassium ter-butoxide to form a compound having Formula I
Figure imgf000012_0001
I;
b) reacting the compound of Formula I with an alcohol and a transition metal catalyst in the presence of hydrogen to form a com ound of Formula II
Figure imgf000012_0002
?;
c) adding the compound of Formula II and pyrimidine-4,6-dicarboxylic acid in presence of N-(3-dimethylaminopropyl)-N'-ethylcarbodiirnide hydrochloride pyridine to form a compound of Formula III
Figure imgf000012_0003
in;
d) reacting the compound of Formula III with 5-(carbobenzoxyamino)valeric acid to form a compound of Formula IV
Figure imgf000012_0004
e) reducing the resultant compound of formula IV in the presence of an alcohol, a transition metal catalyst, and hydrogen to afford formula V
Figure imgf000013_0001
V;
f) reacting the resultant compound of V with di-N-Boc pyrazole in the presence of base to provide compound of formula VI ;
Figure imgf000013_0002
VI; and
deprotecting the compound of Formula VI using acid to produce PMX-30063 (brilacidin); and, if desired, preparing a pharmaceutically acceptable salt.
Brilacidin's competition is continuing to fade. An antiviral against Covid 19 is a needed part of any treatment regimen.
Brilacidin may prove to be the best hope for moderate to severe Covid19.
Hopefully we can receive some help to push this trial through.
GLTA Farrell
Ridgeback and Merck halt molnupiravir trial for Covid 19 hospitalized patients.
In addition to announcing the withdrawal of its vaccine and CD24Fc, Merck has also announced Ridgeback and Merck are halting Covid 19 trials for hospitalized patients with oral molnupiravir.
"Early study results on hospitalized patients found that the treatment is unlikely to reduce hospitalization stays and deaths, the companies said Thursday.
Merck said testing found that the drug, called molnupiravir, inhibits replication of the virus. But the trial of people who weren’t hospitalized was too small to show that the drug reduced clinical symptoms during their early treatment, Merck said.
Another surprise Merck announcement today reverses previous optimistic reports of molnupiravirs results for Covid19.
Brilacidin's competitors are dropping like flies.
Farrell
https://www.wsj.com/articles/merck-partner-halt-covid-19-treatment-trial-for-hospitalized-patients-11618483561
You never know, maybe Merck has had a heart to heart talk with Leo about Brilacidin and decided to send up the white flag.
Wouldn't that be something!
Farrell
It is a stunning turn. Merck after spending over 425 million dollars to acquire CD24Fc, it was pressing the FDA for approval a few weeks ago.
https://www.merck.com/news/merck-to-acquire-oncoimmune/
Its initial FDA application was met with skepticism as the FDA ask for more information to answer questions regarding its apparent outstanding initial FDA trials.
https://www.fiercebiotech.com/biotech/fda-tells-merck-told-to-show-more-data-for-its-oncoimmune-covid-drug-as-eua-pushed-back
Merck had even reach an agreement with the FDA to manufacture the drug.
https://www.merck.com/news/merck-announces-supply-agreement-with-u-s-government-for-initial-doses-of-investigational-biological-therapy-for-the-treatment-of-patients-with-severe-and-critical-covid-19/
Now they have withdrawn the drug. Wow how quickly things turn.
http://wearegeneralnews.com/merck-ends-development-of-covid-drug-it-acquired-from-oncoimmune/
GLTA Frrell
It is really not a fair question:
"There was no suggestion at all in the October release announcement of a "planned interim analysis" that the review to be conducted would be limited to safety or that it would be for the purpose of determining whether the initial dosage regimen could be extended. None. So I thought it a fair question."
You know as well as anyone the October PR was before the FDA review. The FDA guided the protocol for the phase 2 Brilacidin study fo Covid19.
Pretending the company some how misguided shareholders is misleading... at best.
Good day,
Farrell
Linked below is a whistle blower lawsuit which claims the CDC, NIAID, and Dr Fauci illegally exchanged data with the Wuhan lab and others including Moderna.
The suit outlines in great detail the irregularities in the relationship between Wuhan, North Carolina, NIAID and Dr Fauci
https://f.hubspotusercontent10.net/hubfs/8079569/The%20FauciCOVID-19%20Dossier.pdf
https://www.linkedin.com/pulse/evidence-towards-antitrust-lawsuit-against-cdc-fauci-et-lehrman/
Another report from 2016 of the North Carolina lab producing a virus similar to COVID 19 with the heads of the Wuhan Lab ( Zhengli-Li Shi} and Noth Carolina lab (Ralph Baric} as co authors.
https://www.nature.com/articles/nm.3985
" Using the SARS-CoV reverse genetics system2, we generated and characterized a chimeric virus expressing the spike of bat coronavirus SHC014 in a mouse-adapted SARS-CoV backbone. The results indicate that group 2b viruses encoding the SHC014 spike in a wild-type backbone can efficiently use multiple orthologs of the SARS receptor human angiotensin converting enzyme II (ACE2), replicate efficiently in primary human airway cells and achieve in vitro titers equivalent to epidemic strains of SARS-CoV. Additionally, in vivo experiments demonstrate replication of the chimeric virus in mouse lung with notable pathogenesis."
Farrell
Dr Ralph Baric is a professor at the University of North Carolina. He has been described as a leading expert in coronavirus research.
https://sph.unc.edu/adv_profile/ralph-s-baric-phd/
He has been criticized for performing "gain of function" experiments on cornavirus where the viral genome is manipulated to add additional "function".
https://www.wral.com/coronavirus/controversial-virus-research-seen-both-as-groundbreaking-reckless/19098107/
https://www.nature.com/news/engineered-bat-virus-stirs-debate-over-risky-research-%201.18787
https://www.the-scientist.com/news-opinion/lab-made-coronavirus-triggers-debate-34502
Below is a report of some of his research describing the gain in function by genetic manipulation of Coronvirus and attempts to study vaccines against the lab created viruses.
https://www.med.unc.edu/orfeome/wp-content/uploads/sites/609/2018/03/a-sars-like-cluster-of-circulating-bat-coronaviruses-shows-potential-for-human-emergence.pdf
"We report the in vitro reconstruction and biological character-ization, using reverse genetics and synthetic-genome design, of aninfectious clone of BtCoV HKU5 (icBtCoV HKU5) containing theectodomain from the SARS spike (S) protein (BtCoV HKU5-SE).We show that BtCoV HKU5-SE replicated efficiently and demon-strate that a small molecule inhibitor targeting 3CLpro effectivelyinhibited BtCoV HKU5-SE and MERS-CoV replication in cellculture. In addition, we report that BtCoV HKU5-SE replicated tohigh titers in both young and aged mice but did not cause life-threatening disease. Virus replication and disease were dependenton the presence of the mouse angiotensin-converting enzyme 2(ACE2) receptor, and immunohistochemistry staining demon-strated the presence of viral antigen in epithelial cells lining thesmall airways and alveoli."
The risky research was stopped temporarily in 2014:
https://www.npr.org/sections/health-shots/2014/11/07/361219361/how-a-tilt-toward-safety-stopped-a-scientists-virus-research
The NIH may have provided funding for the Wuhan lab:
https://thediplomat.com/2020/05/why-would-the-us-have-funded-the-controversial-wuhan-lab/
There is speculation that cooperation between the North Carolina labs and the Wuhan labs led to the final development of Covid 19.
The government denies these claims and others that Dr Fauci assisted the cooperation between the American and Chinese labs.They also state the Covid19 virus occurred naturally without genetic manipulation.
https://www.statesman.com/story/news/politics/politifact/2021/02/09/covid-dr-anthony-fauci-did-not-fund-research-tied-creation/4450338001/
GLTA,Farrell
Please sticky at top. Post of the month if not the year.Thanks for posting.
Good luck to all,
Farrell
Aarthi Narayanan1 was the lead researcher and author for the first Brilacidin publication in, Viruses.
Dr Narayanan should be well known to her peers as she has dozens of publications related to viral research including several for Covid19 and Alpha viruses. My guess is she would be invited to make the Brilacidin presentation at the conference.
https://scholar.google.com/scholar?start=30&q=%22Aarthi+Narayanan%22&hl=en&as_sdt=0,18
Your negativity is unwarranted. The presentation will publicize Brilacidin to some of the leading virologists in the world at a time where viral research has been the focus of the scientific, government and medical communities.
The press will cover this conference with great interest for any reports of possible therapeutic treatments for Covid19.
The presentation is an acknowledgement of Brilacidin's activity against Covid19 and it is a big deal.
GLTA,
Farrell
I agree, but I doubt Remdesivir will be part of the protocol. My guess is we will see a step wise protocol in the patients with significant but early pulmonary involvement.Hopefully Brilacidin will prove to be the antiviral of choice with Dexamethasone and anti coagulants added as the disease progresses.
So far the many other anti-inflammatories and antivirals seem to be only weakly effective, but they may prove to be effective in subsets of the very ill patients. eg leronlimab, tocilizumab etc
Merck and Oncoimmune's GVH drug, CD24Fc, had impressive results , but the FDA is requiring additional testing. Dexamethasone is going to be difficult to replace.
The treatment regimen needs an effective antiviral. A combination of antivirals with different complementary mechanisms of action may be necessary, but Brilacidin is the only virucidal, anti-capsid drug being studied and it may have 2 other antiviral MOA's plus the anti-inflammatory and antibiotic properties.
We should know more soon as the Phase 2 Brilacidin study is reported.
https://www.fiercebiotech.com/biotech/fda-tells-merck-told-to-show-more-data-for-its-oncoimmune-covid-drug-as-eua-pushed-back
GLTA, Farrell
Variants continue to spread in the US accounting for 27% of new cases. New variant outbreaks now in Michigan and Florida.
Brilacidin seems to be needed now more than ever.
GLTA,
Farrell
From the NYT 4/3
https://www.nytimes.com/2021/04/03/health/coronavirus-variants-vaccines.html?action=click&module=RelatedLinks&pgtype=Article&action=click&module=RelatedLinks&pgtype=Article
"Even as vaccines were authorized late last year, illuminating a path to the pandemic’s end, variants were trouncing Britain, South Africa and Brazil. New variants have continued to pop up — in California one week, in New York and Oregon the next. As they take root, these new versions of the coronavirus threaten to postpone an end to the pandemic.
At the moment, most vaccines appear to be effective against the variants. But public health officials are deeply worried that future iterations of the virus may be more resistant to the immune response, requiring Americans to queue up for regular rounds of booster shots or even new vaccines..."
"“We don’t have evolution on our side,” said Devi Sridhar, a professor of public health at the University of Edinburgh in Scotland. “This pathogen seems to always be changing in a way that makes it harder for us to suppress.”
"Health officials acknowledge an urgent need to track these new viruses as they crawl across the United States. Already, B.1.1.7, the highly contagious variant that walloped Britain and is wreaking havoc in continental Europe, is rising exponentially in the United States.
Limited genetic testing has turned up more than 12,500 cases, many in Florida and Michigan. As of March 13, the variant accounted for about 27 percent of new cases nationwide, up from just 1 percent in early February."
“We didn’t quite anticipate how quickly it was going to occur.”
"A variant is of concern only if it is more contagious, causes more severe disease, or blunts the immune response. The variants identified in Britain, South Africa, Brazil and California all fit the criteria.
B.1.1.7, the first to come to widespread attention, is about 60 percent more contagious and 67 percent more deadly than the original form of the virus, according to the most recent estimates.
The variant is no different from the original in how it spreads, but infected people seem to carry more of the virus and for longer, said Katrina Lythgoe, an evolutionary biologist at the University of Oxford. “You’re more infectious for more days,” she said.
So contagious is B.1.1.7 that Britain succeeded in driving down infections only after nearly three months of strict stay-at-home orders, plus an aggressive vaccination program. Even so, cases fell much more slowly than they did during a similar lockdown in March and April."
Poland’s rate of daily new cases has quintupled since mid-February, forcing the closure of most public venues. Germany’s has doubled, triggering a ban on nighttime gatherings in Berlin.
In France, where B.1.1.7 is causing three-quarters of new infections, some hospitals have had to move coronavirus patients to Belgium to free up beds. Roughly as many people are dying each day from Covid-19 in Europe as were this time a year ago.
For too long, government officials disregarded the threat. “Case plateaus can hide the emergence of new variants,” said Carl Pearson, a research fellow at the London School of Hygiene and Tropical Medicine. “And the higher those plateaus are, the worse the problem is.”
In the United States, coronavirus infections began a rapid decline in January, soon prompting many state leaders to reopen businesses and ease restrictions. But scientists repeatedly warned that the drop would not last. After the rate bottomed out at about 55,000 cases and 1,500 deaths per day in mid-March, some states — notably Michigan — began seeing an uptick.
Since then, the national numbers have steadily risen. As of Saturday, the daily count was up to nearly 69,000, and the weekly average was 19 percent higher than the figure two weeks earlier.
Even when cases were falling, researchers questioned the notion that vaccinations were the reason. Millions of Americans are immunized every day, but even now only 31 percent have received a single dose of a vaccine, and just 17 percent of the population have full protection, leaving a vast majority susceptible.
“The fact is that we’re still in a position now where we don’t have enough vaccinated people,” said Kristian Andersen, a virologist at the Scripps Research in San Diego. “And if we, like Texas, say we’re done with Covid-19, B.1.1.7 will come in and remind us that we are not right. I have no doubt about it.”
“I still don’t think we’re out of the woods,” Dr. Cobey said, referring to the country at large. “If we don’t have another wave this spring, then I’m going to be really, really worried about the fall.”
"While most vaccines are effective against B.1.1.7, researchers are increasingly concerned about other variants that contain a mutation called E484K. (Scientists often refer to it, appropriately, as “Eek.”)
This mutation has evolved independently in many variants worldwide, suggesting that it offers the virus a powerful survival advantage.
In laboratory studies, the Pfizer-BioNTech and Moderna vaccines seem to be slightly less effective against B.1.351, the variant identified in South Africa. That variant contains the Eek mutation, which seems to enable the virus to partly sidestep the body’s immune response. The vaccines made by Johnson & Johnson, AstraZeneca and Novavax were even less potent against B.1.351.
“I think for the next year or two, E484K will be the most concerning” mutation, said Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Research Center in Seattle.
The mutation slightly alters the so-called spike protein sitting on the surface of the coronavirus, making it just a bit harder for antibodies to latch on and destroy the invader.
The good news is that the virus seems to have just a few survival tricks in its bag, and that makes it easier for scientists to find and block those defenses. “I’m feeling pretty good about the fact that there aren’t that many choices,” said Michel Nussenzweig, an immunologist at Rockefeller University in New York.
The Eek mutation seems to be the virus’s primary defense against the immune system. Researchers in South Africa recently reported that a new vaccine directed against B.1.351 ought to fend off all other variants, as well.
Pfizer, BioNTech and Moderna already are testing newly designed booster shots against B.1.351 that should work against any variants known to blunt the immune response.
Instead of a new vaccine against variants, however, it may be just as effective for Americans to receive a third dose of the Pfizer-BioNtech or Moderna vaccines in six months to a year, said Dr. Anthony S. Fauci, head of the National Institute of Allergy and Infectious disease."
Thanks for posting. My guess is a PR will be coming soon. Perhaps an interim report and update.
GLTA,
Farrell
Great video which I will share with my friends.
GLTA,
Farrell
Thanks for putting the SRO designation in context.
Here is more. Evidently the FDA expects IPIX may have pharmaceutical sales, a regulated product, or operations in fields regulated by the FDA.
"HHS Supplemental Standards of Ethical Conduct formally defines SRO as “an organization for which the sales of products regulated by the Food and Drug Administration (FDA) constitute ten percent or more of annual gross sales in the organization's previous fiscal year; where an organization does not have a record of sales of FDA-regulated products, it will be deemed to be significantly regulated if its operations are predominately in fields regulated by FDA, or if its research, development, or other business activities are reasonably expected to result in the development of products that are regulated by FDA." See 5 C.F.R. § 5501.101(c)(2)."
Another step along the path. The FDA ia aware of Brilacidin for Covid19 and is watching its clinical trial and development.
GLTA,
Farrell
https://www.fda.gov/about-fda/ethics/significantly-regulated-organizations-sros
I had to laugh when you posted the CDYD volume chart; since it is down about 50% from its high YTD. Most of the volume spike was bailing out after its catastrophic FDA Covid study.
You are trying too hard. We will find out what the truth is when the Brilacidin for Covid trial is soon completed.
Good luck,relax and be happy,
Farrell
I disagree, the IBD trial has the potential to be very successful.
The early trials have been successful and it is a unique treatment with a very large market. See CallmeCrazy's post353005
Ipix rightfully postponed it due to Covid16, but it will be restarted soon. IPIX has the funds to begin the first phase 2 trials of oral Brilacidin for Ulcerative Colitis and we will see that whether Brilacidin is successful against Covid19 or not.
Another point is clear to those paying attention; Leo's frugal management is the only reason we may benefit from Brilacin for Covid19 and IBD.
JMO, Farrell
BTW ... The capitalization key is on the left side of the keyboard.
Great post.
I agree IPIX prioritized Brilacidin for Covid19. As you pointed out with the market size as well as the critical need for a good anti Covid antiviral plus the outstanding pre clinical studies it is the right path for the company.
Glta,Farrell
IPIX first announced the pancoronavirus research in 06/2020:
"Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announces today the Company and researchers at a U.S. Regional Biocontainment Laboratory (RBL) are collaborating on a federal grant application to be submitted this week"
"The proposed research aims to evaluate Brilacidin as a potential pan-coronavirus therapeutic, for treating SARS-CoV-2, SARS-CoV-1 and MERS-CoV, including extending the current in vitro testing of Brilacidin to in vivo testing. Longer-term objectives include potentially performing additional research to develop Brilacidin as a broad-spectrum antiviral, with possible application beyond coronaviruses, e.g., treating other viruses, such as encephalitic alphaviruses and filoviruses."
"The ongoing Brilacidin anti-SARS-CoV-2 research being conducted at the RBL is separate from the ongoing research being performed at a Public Health Research Institute (PHRI). The lead researchers at both the RBL and at the PHRI have informed the Company they plan to submit their findings, separately, upon completion of in vitro testing, for peer-review publication."
WAKEFIELD, Mass., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces additional independent preliminary laboratory research suggests Brilacidin, the Company’s flagship defensin mimetic, has the potential to treat other endemic human coronaviruses (H-CoVs), such as those causing common colds, and not just SARS-CoV-2, the novel coronavirus responsible for the ongoing global COVID-19 pandemic.
Research shows Brilacidin exerted potent in vitro inhibition of multiple strains of H-CoVs. On completion of testing, the H-CoV findings are expected to be submitted for peer-review publication. The Company is evaluating these data alongside previously obtained SARS-CoV-2 data, strategizing with its scientific advisors and consultants, to develop Brilacidin as a “pan-coronavirus” therapeutic...
The Company is planning to conduct additional in vitro and in vivo Brilacidin studies on multiple coronaviruses, to further inform the drug’s anti-coronavirus properties and prepare for potential future clinical testing.
My guess is this in vitro studies should be done soon. The in vivo animal studies may take longer. I would expect the labs would also be studying the coronavirus mutations. I am looking forward to seeing another Brilacidin publication.
GLTA'
Farrell
https://www.globenewswire.com/news-release/2020/11/30/2136611/0/en/Innovation-Pharmaceuticals-COVID-19-Clinical-Trial-to-Support-Additional-Development-of-Brilacidin-as-a-Pan-Coronavirus-Therapeutic.html
https://www.globenewswire.com/news-release/2020/06/11/2046799/0/en/Innovation-Pharmaceuticals-Collaborating-with-Regional-Biocontainment-Lab-on-Grant-Application-to-Research-Brilacidin-as-a-Pan-Coronavirus-Therapeutic.html
If I am seriously ill with Covid19 and go elsewhere there is almost a 100% chance of receiving Remdesivir which has been shown to have next to no effect on mortality or Covid complications.
Plus, we know Rememdesivir has been shown to have the potential to have hepatotoxicity since the current dose is close to the safe theraputic index...a ratio that compares the blood concentration at which a drug becomes toxic and the concentration at which the drug is effective.
The hepatotoxicity was first described in the Ebola studies and is now being reported in Covid 19 patients being treated with Remdesivir.
Below are several recent reports of Covid19 patients suffering liver damage due to Remdesivir.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7386240/
"Our observation supports previous findings obtained in healthy volunteers (Gilead Sciences, data on file) and COVID-19 patients treated with RDV [4, 5], suggesting this antiviral may cause hepatocellular injury."
In addition Remdesivir has many drug interactions which can limit treatment of other life threatening conditions:
https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa883/5864408
https://www.uptodate.com/contents/image/print?imageKey=EM%2F73326&topicKey=RHEUM%2F1666&source=see_link
Your contention that Brilacidin may have "known Serious Adverse Events" pales to the risk of Remdesivir. If a patients on Brilacidins blood pressure increases it is easily treatable and serious elevations of blood pressure were not demonstrated at the Brilacidin.6mg/kg dose. The tingling sensation has not been shown to be associated with neurologic or other long term complications.
The real question is would you rather have a drug with the potential to have profound effect against the Covid19 or a drug we know has little effect.
I will stand by my post.
My bet is after Brilacidins Phase2 trial there will be many requests across the country for compassionate use of Brilacidin for Covid 19 for the reasons I have outlined.
GLTA Farrell
A few points are undeniable:
-oil price is trending up
-demand for oil is up
-value of oil reserves is up
-ERHC's volume is up
-ERHC's share price is up
Even hedge funds are investing in oil:
https://www.reuters.com/article/us-global-oil-hedgefunds-focus-idUSKBN2A70IM
Good luck,
Farrell
If I get Covid19, I am heading to DuPage co NorthWestern hospital ASAP. I had some family that lived in Carol Stream, but they moved some time ago. I have visited there a number of times, but never to the hospital.
Keep your eyes and ears open.
Good luck to all,
Farrell
Inching up at close ??? may be green today.
GLTA, Farrell
The Northwestern hospital system is participating in a number of Covid 19 studies, but the webpage has not been updated yet to include Brilacidin for Covid19 at the west NW hospital.
Brilacidin continues to progress!
https://www.feinberg.northwestern.edu/sites/covid-19/covid-19-clinical-trials.html
Here is the hospital in the western Chicago suburbs:
https://www.nm.org/locations/central-dupage-hospital?utm_source=yext&utm_medium=gmb+location&utm_campaign=online+listings&y_source=1_ODIyOTgyMi03MTUtbG9jYXRpb24uZ29vZ2xlX3dlYnNpdGVfb3ZlcnJpZGU%3D
Good luck to all,
Farrell
You sound concerned; as if IPIX will not be fairly rewarded if the clinical trial is a big success.
Many would agree an excellent treatment for Covid19 is virtually impossible to value, in fact invaluable.
Earlier you threw $50 million; which is absolutely laughable.
The only context we have is the 1.9 billion Remdesivir brought in last quarter.
If Brilacidin proves to be safe and effective it will make more than Remdesivir.
JMO
GLTA,Farrell
PS do the math...it is astounding
One of the reason health care workers are refusing the vaccine is many have already had Covid 19. They feel they have developed immunity and feel vaccination is unnecessary. I have heard of hospitals where as many as 70% of the interns and resident doctors have already contracted Covid19 and 35-40% of the nurses.
https://khn.org/news/nurses-and-doctors-sick-with-covid-feel-pressured-to-get-back-to-work/
http://publichealth.lacounty.gov/acd/docs/COVID19HCWReport.pdf
GLTA Farrell
Good post.
I am trying to think of something to add to your post and this thread, but the subject seems to have been beaten to death this morning. With that background I think the most constructive point I can make is I am looking forward to seeing positive posts regarding IPIX, Brilacidin and the clinical trials.
GLTA,Farrell
If the phase 2 trials are positive you can expect an expanded compassionate use to be granted like it was for Remdesivir after their phase 2 trial. Many sick Covid patients are still not responding well to current standard of care.
Glta,
Farrell
One fact is undeniable, every dollar the price of oil increases the value of Erhc assets in the EEZ and JDZ . Most analysis are expecting $80 oil in a few mos as the demand continues to rise.
Glta, Farrell
Commanders Palace is one of our favorites. Great food followed by a nice walk on Magazine st and the Garden district. Enjoy
Controversy regarding Molnupiravir formerly EIDD-2801 now MK-4482
continues:
"This brings us to the controversy around the drug as explained by C&EN (emphasis ours):
" EIDD-2801 has been viewed as a potential competitor to remdesivir, although a contentious one, because similar compounds are mutagenic in animal studies, meaning they produce birth defects. Rick Bright, who was removed from his position as head of the US Biomedical Advanced Research and Development Authority (BARDA) in April, was reluctant to provide funding for the drug for this reason, according to an 89-page whistleblower complaint Bright filed after being fired. Merck’s investment in EIDD-2801 can be seen as a vote of confidence in the compound.
Bright’s concerns began in November 2019, more than one month before China disclosed the first COVID-19 cases in Wuhan — ScienceMag has that story:
Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, notes that his former pharmaceutical company, Pharmasset, abandoned it in 2003 after discovering its mutagenic properties. Schinazi says the small chemical tweaks made to increase the ingredient’s bioavailability and transform it into EIDD-2801 are unlikely to change its mutagenicity. “Thank goodness someone is raising the red flag,” about EIDD-2801, Schinazi says. “You don’t develop a drug that’s mutagenic. Period.”
" Merck’s Research Labs President Roger Perlmutter addressed the lingering questions about the drug’s mutagenic side-effects during the earnings call and explained what the company is doing to address safety concerns, a transcript of which is available at this link.
First of all, for the MK-4482, as you know, the compound is Ames positive. That’s, in a way, not unexpected given its mechanism of action. It is a cytosine analog so that — one could expect to see those kinds of things. The question is, does the compound have mutagenic activity that’s meaningful in mammalian cells and what do we want to do about this. Ordinarily, of course, we don’t want to take mutagens forward into clinical practice, although it has been done where the benefit/risk profile makes sense"
What does it mean to be Ames positive?:
The Ames test is a widely employed method... it is a biological assay to assess the mutagenic potential of chemical compounds.[1] A positive test indicates that the chemical is mutagenic and therefore may act as a carcinogen, because cancer is often linked to mutation. The test serves as a quick and convenient assay to estimate the carcinogenic potential of a compound...
THe positive Ames test and documented birth defects in similar compounds as document by Dr Bright must be thoroughly addressed.
GLTA, Farrell
https://bgr.com/2020/07/31/coronavirus-cure-merck-mk-4482-eidd-2801-rick-bright-controversy/
https://en.wikipedia.org/wiki/Ames_test
Wow what a list. That's a Roladex of Phds It is helplful to have friends in high places.
Go IPIX!
GLTA,Farrell
Strong close on good volume bodes well for the rest of the week.
GTA,Farrell
It is important to remember that many mild BP elevations do not require treatment and the higher levels can be treated easily.
Hypertension was addressed in the Brilacidin clinical trial eligibility criteria:
"-Hypertensive urgency (e.g., SBP >220 mmHg or DBP >120 mmHg) or hypertensive emergency within the last 72 hours, as assessed by the investigator following local guidelines.
-If has a history of hypertension in the last 3 months, must have been receiving appropriate anti-hypertensive therapy in accordance with local guidelines."
GLTA,
Farrell
It has been my observation the hedge fund managers are never shy.
Of course, it reflected badly on him and Ridgeback when Dr Bright stood up to him when his political contacts tried to help him score funds from Barda.
Even though Merck bought a position in Ridgeback, it is Ridgeback controlling the phase 1 and 2 trials, not Merck. How much credibility does Ridgeback have?
Stuart Varney"s and Dr Siegel"s phones must be ringing constantly to tell them the rest of the story. Mr Hedge fund has made a lot of enemies.
Remember. Dr Rick Bright is now on the Biden Coronavirus Advisory Committee
The other point is Dr Rick Bright spent several years early in his career at Emory then the CDC which works closely with Emory. I doubt many at Emory were happy to see Molnupiravir sold to a hedge fund.
Which brings up the question,why the hell would they do that?
The truth is often stranger than fiction.
GLTA Farrell