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We don't know what we don't know
Who said he was "forced." Who said the shares wasn't paid for? Even if they were not, How much money did Leo need to pay versus surrendering them?
There are many ways one could interpret this information, but I am content to take Leo at his word that this is a personal tax situation. Apparently, Leo found the option to surrender these shares to be superior to whatever other options he had.
And for those who do not take Leo's word...let the wild speculation begin.
Message in reply to:
I saw that, but why would he be forced to involuntarily forfeit his shares?
My edit may have occurred after you composed your post. Here it is again:
The shares were fully paid for, right?
Per your link: "Forfeiture of shares refers to the situation where the allotment of shares is cancelled for the shareholders due to non-payment of any installments."
Forfeiture and Surrender of Shares Can Be Related
Difference between Forfeiture and Surrender of Shares
https://byjus.com/commerce/difference-between-forfeiture-and-surrender-of-shares/
Happy Holidays to all. One must also remember that while Jesus' government took his life, IPIX's government, by way of free research, is giving it new life.
Message in reply to:
Merry Christmas and blessings to all. Hope everyone has a prosperous year. As we celebrate Jesus and his birth, one must remember he also rose from the dead. Perhaps IPIX can too.
Hound.
Brilacidin is being evaluated for PROPHYLAXIS not CURATIVE
Published 30 June 2022
SitTight: You Might Find Post #393523 Of Interest
NIAID Developing COVID Nasal/Oral Combo-Therapy Using Brilacidin/Remdesivir?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170011799
Antibiotics boosted with new targeted delivery system
IPIX's Speediest And Most Lucrative Path To Market
And that route is through NIAID developing Brilacidin through a P2 COVID, thereby positioning IPIX to negotiate a licensing agreement with Gilead Sciences for a combo-prophylactic COVID therapeutic that showed very-high efficacy in pre-clinical testing.
IPIX doesn't have any money for the clinical development of its pipeline. Military development agreements call for potential partners/collaborators to have some skin (money) in the game as well. Here's their "business" page:
https://usamriid.health.mil/businessopspage.htm
IPIX needs NIAID's "freebies" but not necessarily Remdesivir:
"Brilacidin exhibited a statistically significant (p<0.0001) and potent inhibitory effect on SARS-CoV-2, the novel coronavirus responsible for COVID-19, in a human lung epithelial cell line—reducing viral load by 95 percent and by 97 percent, compared to control, at two therapeutic concentrations tested."
http://www.ipharminc.com/press-release/2020/6/17/innovation-pharmaceuticals-brilacidin-inhibits-sars-cov-2-covid-19-by-97-percent-in-a-human-lung-cell-line
In human lung epithelial cell line experiments performed at the RBL, Brilacidin in combination with Remdesivir, compared to Remdesivir-only treated conditions, showed a statistically significant and synergistic inhibition of SARS-CoV-2. Of particular note, overall viral load was reduced by 99.85 percent in one combination experiment, with remaining virus dropping to near undetectable levels."
http://www.ipharminc.com/press-release/2020/9/15/laboratory-testing-of-brilacidin-for-covid-19-in-combination-with-remdesivir-reduces-viral-load-by-nearly-100-percent
Remdesivir doesn't bring much in the way of efficacy , but Gilead does in other ways :
"For emerging biopharma firms, licensing options can equal a boon to the business when cash runways are short and financing options run thin. Theoretically, small biotechs benefit from their licensing partner’s development and manufacturing assets, regulatory and clinical trials know-how, brand reputation, and sales force." https://www.bioprocessonline.com/doc/the-compounded-risk-of-early-stage-biopharma-licensing-deals-0001
Remdesivir is the hospitalized standard of care COVID treatment that is losing relevance due to decreased hospitalizations. Remdesivir sales, $5B in 2021, are expected to fall to $2B in 2022. THAT'S A THREE BILLION DOLLAR DROP IN SALES IN ONE YEAR. Eye-poppin' as this might sound it wasn't totally unexpected by Gilead:
"Gilead believes that as the pandemic shifts into an endemic stage and as antiviral pills become more readily available that hospitalizations will decline, limiting the need for Veklury."
https://www.fiercepharma.com/pharma/gilead-credits-veklury-s-strong-sales-to-omicron-s-surge-antiviral-pulled-1-4-billion-q4
So, for Gilead, Brilacidin represents an opportunity to halt Remdesivir's retreat toward irrevelence as a late-stage COVID therapeutic as well as its plummeting sales and regain its prominence as a prophylactic, combo-therapy for COVID.
Consider that:
"...the global COVID-19 Therapeutics market size was valued at US$ 10.2
Billion in 2021, and it is expected to reach US$ 25.6 Billion in 2030, record
a promising CAGR of 10.7% from 2021 to 2030."
https://www.bloomberg.com/press-releases/2022-01-18/global-covid-19-therapeutics-market-worth-14-6-billion-by-2022-exclusive-report-by-insightace-analytic#:~:text=Business-,Global%20COVID%2D19%20Therapeutics%20Market%20worth%20%2414.6%20billion%20by%202022,Exclusive%20Report%20by%20InsightAce%20Analytic
Remdesivir's 2021 sales ($5B) were 50% of the 2021 global COVID-19 Therapeutics market size. This was at the height of Remdesivir's reign as the late-stage go to therapeutic for hospitalized COVID patients. Well, as Gilead knows, late-stage COVID therapeutics are no longer where the action (money) is. The COVID area of unmet need is for an early-phase, prophylactic, COVID-19 therapeutic.
Little more then two years ago NIAID, IPIX, and Gilead learned of the synergism between Brilacidin and Remdesivir in pre-clinical testing that suggested very-high efficacy against COVID by this "dynamic duo."
NIAID is IPIX's ONLY option for advancing B-COVID with no money. The military has a cost-sharing business plan and the anti-fungal research seems to just be gaining a head of steam.
Gilead is the "dream" licensee for Brilacidin considering their expertise in obtaining FDA-EUA and FDA approval for Remdesivir as well as the reasons mentioned above.
Gilead is aware that pre-clinical testing and market projections suggest, with a Brilacidin license, Remdesivir could, once again, rake in billion$, only this time as a COVID early-phase, combo-prophylactic therapeutic.
Gilead's infrastructure has demonstrated, via Remdesivir, that it can ramp up billion$ of dollars in sales within months of FDA approval. Even if IPIX has negotiated 10% of net sales (what I consider to be a low percentage) this could produce hundreds of millions in annual revenue for IPIX.
These kind of contracts can take a year or more to negotiate. I believe Gilead and IPIX have been negotiating for months already. It defies money and logic that they wouldn't be.
What I envision is NIAID formulating a drug comprised of Brilacidin/Remdesivir and conducting a phase 2 with same. I believe IPIX and Gilead will have a negotiated agreement by the end of phase 2 or shortly thereafter. I believe Gilead will further develop this combo-therapy through FDA approval.
In the end, NIAID will have the early-stage, prophylactic COVID therapeutic it was seeking for government purchase, distribution and stockpile. Gilead will make billion$ in sales, halting Remdesivir's sales decline and, thereby, resulting in hundreds of millions of dollars in licensing revenue for IPIX.
Two Comments That Bode Well For IPIX's Future
“It is a remarkable feature of Brilacidin that it can potentiate multiple antifungals, in different pathogenic fungi, including hard-to-treat species. New antifungal combination strategies are urgently needed due to a scarcity of novel agents, alongside emerging resistance in the clinical setting,” commented Gustavo Henrique Goldman, Professor of Molecular Biology, University of São Paulo, Brasil, and a Chief Editor for Frontiers in Fungal Biology, a peer-reviewed journal dedicated to the study of mycology. “Another notable finding from our research is that Brilacidin shows exceptional potency of its own as a monotherapy against C. neoformans, a particularly problematic fungus. We look forward to broadening our planned studies of Brilacidin’s antifungal properties.”
https://mailchi.mp/ipharminc/innovation-pharmaceuticals-announces-publication-of-scientific-article-on-the-antifungal-activity-of-brilacidin?e=d6a81bdb11
"Across multiple cell lines and under different testing conditions, research showed Brilacidin inhibited viral replication in a statistically significant manner in encephalitic [enveloped] alphaviruses,...
The in vitro evaluation of Brilacidin’s antiviral activity was expanded to Echovirus, a non-enveloped picornavirus, to assess Brilacidin’s effect on early viral entry in contrast to its ability to disrupt the lipid membranes of enveloped viruses. Brilacidin was shown to inhibit Echovirus, suggesting Brilacidin possesses additional antiviral mechanisms beyond its ability to directly impact viral envelopes.
Collectively, these data support Brilacidin’s potential to be developed as a broad-spectrum antiviral."
http://www.ipharminc.com/press-release/2022/9/14/new-in-vitro-data-supporting-the-broad-spectrum-antiviral-activity-of-innovation-pharmaceuticals-brilacidin-presented-at-2022-military-health-system-research-symposium
Brilacidin's Synergy With Other Drugs Continue To Impress
(1) "Brilacidin plus CAS [owned by Merck] cleared infection in the lungs by almost 95 percent, compared to ~50 percent when each compound was administered individually."
(2) "Brilacidin in combination with Remdesivir, compared to Remdesivir-only treated conditions, showed a statistically significant and synergistic inhibition of SARS-CoV-2. Of particular note, overall viral load was reduced by 99.85 percent in one combination experiment, with remaining virus dropping to near undetectable levels."
(1) " Caspofungin sales were estimated to be $414 million in 2021..."
(4) "Gilead reported $1.4 billion in sales for Veklury in the fourth quarter of 2021, a decrease of about 30 percent from the same quarter in 2020. However, full-year revenue for Veklury hit $5.6 billion in 2021, a 98 percent jump from 2020 revenue.
Gilead said Veklury sales closely align with COVID-19 hospitalization trends in the U.S. The drugmaker said it expects hospitalization rates to fall in 2022 but is still projecting $2 billion in Veklury sales this year.
The FDA approved Veklury for use in all hospitalized COVID-19 patients 12 and older in October 2020. On Jan. 21, the agency authorized use of the drug in nonhospitalized patients with mild to moderate COVID-19 who have a high risk of their cases becoming severe."
(1) "global antifungal drugs market estimated at $14.8 billion in 2021 and expected to reach $20.5 billion by 2030."
(3) " The global antiviral drugs market size is expected to reach USD 60.0 billion by 2028..."
(1) https://mailchi.mp/ipharminc/innovation-pharmaceuticals-announces-publication-of-scientific-article-on-the-antifungal-activity-of-brilacidin?e=d6a81bdb11
(2) http://www.ipharminc.com/press-release/2020/9/15/laboratory-testing-of-brilacidin-for-covid-19-in-combination-with-remdesivir-reduces-viral-load-by-nearly-100-percent
(3) https://www.bloomberg.com/news/articles/2022-08-02/gilead-boosts-sales-forecast-on-demand-for-covid-19-drug
(4) https://www.beckershospitalreview.com/pharmacy/gilead-saw-5-6b-in-remdesivir-sales-last-year.html
Merck could use Brilacidin to help it maintain market dominance in the global caspofungin market, while Gilead Sciences could use Brilacidn to reverse the projected sales decline of Veklury (Remdesivir).
Factoring in the 2020 global antibiotic market size of $40B and the projected market sizes of $60B and $20B for the antiviral and antifungal markets, respectively, by 2030 Brilacidin could be addressing markets with an aggregate value in excess of $120B.
Brilacidin is clearly on the radar of medical researchers worldwide and they're giving Leo and/or his proxies plenty to discuss/negotiate with BP, however, IMO, selling IPIX is not on the table. You don't sell the goose that lays gold eggs...you sell the eggs.
Don't know if you saw this post?
Important Distinctions Between NIAID And The Military (MHSRS)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169815484
But, if you didn't you'll probably find it germane to Farrell's post and if you did it might be worth another look.
NIAID Developing COVID Nasal/Oral Combo-Therapy Using Brilacidin/Remdesivir?
In September 2020, NIAID, Gilead Sciences and IPIX learned that Remdesivir and Brilacidin are, together, a more powerful inhibitor of COVID than either of the two as standalone therapies:
"In human lung epithelial cell line experiments performed at the RBL, Brilacidin in combination with Remdesivir, compared to Remdesivir-only treated conditions, showed a statistically significant and synergistic inhibition of SARS-CoV-2. Of particular note, overall viral load was reduced by 99.85 percent in one combination experiment, with remaining virus dropping to near undetectable levels.
Brilacidin appears to have primarily an extracellular mechanism of action, by disrupting viral integrity and blocking viral entry. In contrast, Remdesivir—currently authorized by the FDA for emergency use against COVID-19—has an intracellular mechanism of action, affecting viral replication post-infection. Exhibiting different but synergistic antiviral properties, these two drugs may be an especially potent drug combination in treating COVID-19."
http://www.ipharminc.com/press-release/2020/9/15/laboratory-testing-of-brilacidin-for-covid-19-in-combination-with-remdesivir-reduces-viral-load-by-nearly-100-percent
The findings of this NIAID-sponsored, GMU study was published in February 2021 and the study authors stated:
"A desirable outcome for any potential COVID-19 therapeutic will be its ability to synergize with existing COVID-19 treatments, particularly if the mechanisms of action of the synergistic treatments can impact more than one step of the viral lifecycle. Such combinations are more likely to elicit an additive response while also reducing the likelihood of viral resistance developing...
By combining remdesivir with brilacidin, a two-pronged strategy of inhibiting viral entry and viral RNA synthesis might be successfully leveraged to most effectively control progression of SARS-CoV-2 infection. The opportunity that combination treatments with brilacidin could potentially offer in treating COVID-19 requires further exploration, and in vivo animal studies are in planning stages."
https://www.mdpi.com/1999-4915/13/2/271/htm
Sars-Cov-2, Omicron subvariants b.4 and b.5, is a major NIAID pathogen of concern and while Brilacidin shows much promise as a broad-spectrum, antiviral for coronaviruses, the synergism between Brilacidin and Remdesivir, relative to inhibiting Sars-Cov-2, is so potent that NIAID, IMO, must have felt compelled to investigate this combo-therapy against this pathogen that they have specifically prioritized and targeted:
" As part of the APP, NIAID will establish Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern. The centers will initially focus on novel, oral antivirals for SARS-CoV-2 and other coronaviruses and will expand to other pathogens of pandemic concern in future years."----December 2021
https://www.niaid.nih.gov/sites/default/files/pandemic-preparedness-plan.pdf
In January 2022, Gilead announced it was:
"... developing its own oral drug—a remdesivir prodrug dubbed GS-5245—which can quickly turn into remdesivir inside the body. A phase 1 trial of the drug is now underway, O’Day said in a Friday statement. A previous study found a prodrug of remdesivir was effective at neutralizing coronavirus in ferrets, blocking virus replication and preventing transmission to other animals." (1)
Given Gilead's knowledge of the synergy between Remdesivir and Brilacidin, I found this comment by Gilead;s chief medical officer to be quite interesting:
" Gilead Sciences Chief Medical Officer Merdad Parsey, M.D., Ph.D., said drug combinations could be the future of COVID-19 treatment to address potential drug resistance." (1)
Just to recap:
Sep 2020 - NIAID and Gilead learn of powerful synergy between Brilacidin and Remdesivir
Dec 2021 - NIAID, via APP, planning combo invivo-studies involving Brilacidin
Jan 2022 - Gilead announces phase one clinical trial for ORAL Remdesivir
In the aggregate, all of this suggest to me that NIAID and Gilead are working to develop a combo-therapy for Sars-Cov-2 utilizing Brilacidin and Remdesivir.
From a COVID prophylaxis perspective, NIAID and Gilead appear to be thinking that a Bri/Rem combo-therapy is the way to go, or, as Gilead's chief medical officer put it:
“We’re going to need multiple mechanisms out there to be able to treat [COVID-19] outpatients."
(1) https://www.fiercepharma.com/pharma/gilead-expands-veklury-fda-approval-non-hospitalized-covid-19-patients-oral-version-heads-to
As to the original question that prefaced this post...I believe the answer is YES.
B-COVID Is Both Pathogen-Specific And Has Broad-Spectrum Activity
Therapeutics
NIAID will continue to support basic, translational, and clinical research efforts to identify promising targets for intervention and generate novel therapeutics that are both pathogen-specific and have broad-spectrum activity. Leveraging earlier successful partnerships (as for HIV drug development) and continuing the collaborative interactions that were established in response to the COVID-19 pandemic, NIAID will engage pharmaceutical companies to share libraries, medicinal chemistry, and drug development expertise to accelerate internal efforts to ensure the most promising drug candidates progress rapidly into clinical use.
Small Molecule/Antivirals
The Pandemic Preparedness Plan will respond to the pressing need for safe and effective therapeutics by building sustainable platforms for targeted drug discovery through the development of small molecules and antivirals that may be useful against a wide range or class of pathogens of concern. NIAID will evaluate and advance new drug candidates to the stage of being late Phase 2-ready.
https://www.niaid.nih.gov/sites/default/files/pandemic-preparedness-plan.pdf
B-COVID Meeting NIAID'S Criteria For Development As Antiviral
Small Molecule/Antivirals
"NIAID will evaluate and advance new drug candidates to the stage of being late Phase 2-ready. One existing program through which NIAID will develop safe and effective antivirals is the Antiviral Program for Pandemics (APP). The APP will focus on antivirals that directly act against viral targets
As part of the APP, NIAID will establish Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern. The centers will initially focus on novel, oral antivirals for SARS-CoV-2 and other coronaviruses [***] ..."
https://www.niaid.nih.gov/sites/default/files/pandemic-preparedness-plan.pdf
"
https://www.ipharminc.com/press-release/2022/6/23/innovation-pharmaceuticals-reports-brilacidin-inhibits-omicron-delta-gamma-and-alpha-sars-cov-2-variants-based-on-in-vitro-testing-by-nihniaid-sponsored-and-rutgers-university-researchers
" [**] If a patient started study treatment within fewer than 7 days of onset of COVID-19 symptoms, patients in the Brilacidin 5-dose group achieved sustained recovery more quickly compared to the pooled placebo group (p=0.03). For this patient population, early treatment with Brilacidin from onset of symptoms appeared to have a potential positive impact on time to sustained recovery (the study’s primary endpoint), suggesting cases that can be treated close to initial onset of disease may be an attractive population to target for Brilacidin treatment.
https://www.ipharminc.com/press-release/2022/3/7/innovation-pharmaceuticals-reports-additional-findings-based-on-review-of-brilacidin-phase-2-covid-19-trial-results-and-compassionate-use-cases
" [***] Brilacidin has now been tested in vitro in seven SARS-CoV-2 strains (Omicron, Delta, Gamma, Alpha, Italian, Washington, Wuhan) and three human coronavirus (H-CoV) strains (OC43, 229E, and NL63), in addition to MERS-CoV and SARS-CoV-1. Brilacidin has consistently inhibited all coronaviruses tested,..."
https://www.ipharminc.com/press-release/2022/6/23/innovation-pharmaceuticals-reports-brilacidin-inhibits-omicron-delta-gamma-and-alpha-sars-cov-2-variants-based-on-in-vitro-testing-by-nihniaid-sponsored-and-rutgers-university-researchers
Feds Interest in B-COVID is prophylaxis NOT moderate-to-severe
No Doubt - FEDS Will Help/Develop Brilacidin As Antiviral
2022 MHSRS POSTER SESSIONS BY TOPIC AREA - 09/14/2022
POSTER SESSION 3
Wednesday, 14 September 2022
1000 – 1200
Poster Set-up: Beginning at 0900
Presenters at Posters: 1000 – 1200
Poster Take-down: By 1400
Development of New Front Line Therapies to Prevent & Treat Endemic Viral Diseases (non SARS CoV-2)
https://mhsrs.amedd.army.mil/SiteCollectionDocuments/2022_MHSRS_Poster_Sessions.pdf
Abstract provided below.
Introduction: Acutely infectious viruses, including those transmissible by the respiratory and aerosol routes, pose critical threats to the warfighter and the civilian population. Aerosol-transmissible pathogens, such as bunyaviruses (Rift Valley fever virus [RVFV]), and alphaviruses (Venezuelan Equine Encephalitis Virus [VEEV], Eastern Equine Encephalitis Virus [EEEV]), have a broad range of host tropism, retain high rates of infectivity as aerosols, attain high viral load in the host over short periods, cause damage to the blood-brain barrier (BBB), impact neurological integrity and are likely to contribute to organ damage due to extreme inflammation. These viruses pose nontrivial challenges to the warfighter because no FDA-approved therapeutics or vaccines are currently available that can be rapidly scaled up, field-deployed, and thus potentially mitigate the harmful consequences of inflammation in addition to decreasing viral load. The long-term neurological sequelae that can ensue from these acute viral infections, especially by the aerosol route, can lead to a life-long health burden for the warfighter. These pathogens are also naturally transmitted by mosquito vectors. They are known to cause zoonotic diseases in animals and affect humans annually in the United States and other parts of the world. This situation could further drive mutations, leading to infectious spillover events between species. There is an urgent, unmet need for broad-spectrum intervention strategies that can ideally control the disease manifestations in the host and the spread of disease as a prophylactic countermeasure. Our ongoing studies with brilacidin, a host defense peptide (HDP)-based mimetic, have successfully demonstrated that brilacidin can interfere with viral integrity and exert an antiviral effect in vitro against candidate alphaviruses and bunyavirus. Furthermore, early indications support the potential of brilacidin to also act in an anti-inflammatory capacity by its impact on inflammatory cytokine expression.
Methods: Appropriate cell lines (Vero cells, U87MG cells, HSAE cells, Huh7, and HepG2 cells) were infected with RVFV (MP-12 strain), VEEV (TC-83 and TrD strains) and SINV +/- brilacidin. Culture supernatants and nucleic acid lysates were quantified for extracellular and intracellular viral load and impact on infectivity by plaque and qRT-PCR assays. The effect of brilacidin on cell viability and lack of toxicity were ascertained by CellTiter Glo assay. The effect of treatment on inflammatory events was quantified by a combination of PCR (gene expression) and ELISA (protein expression). Early studies involving cell biological mechanisms have involved transmission electron microscopy of virus distribution in infected cells +/- brilacidin.
Results: Our studies to query any potential cytotoxicity and quantify CC50 values for brilacidin have indicated that the compound is very well tolerated by a wide breadth of cell lines, including those of neuronal origin. The CC50 values for brilacidin in some representative cell types are Veros: 64.90 µM U87MGs >100 µM, HSAECs: 61.32 µM, Huh7s: 12.03 µM, HepG2s: 153.3 µM. Studies that queried the antiviral activities of brilacidin were also tailored to address the mechanism of action and target validation. For candidate alphaviruses and bunyavirus, the following treatment conditions were assessed: pre-treatment only (Pre), pre-treatment + post-treatment (Pre+Post), virus-incubation only (Virus), pre-treatment + virus-incubation + post-treatment (Pre + V + Post). For VEEV, our data demonstrated that in both Vero cells and U87MG astrocytes, the Pre + V + Post-treatment strategy resulted in >1 log reduction of infectious virus in the culture supernatant. For SINV, an old-world alphavirus, we noticed a higher inhibitory impact on the viral load (> 2 logs) than what was observed in the case of new world alphaviruses. For RVFV, the Pre + V + Post-treatment produced the highest antiviral outcome with a decrease in viral load of >2.5 logs. Ongoing studies are focused on obtaining the inhibition profile for EEEV in astrocytes and microglial cells. Our overall assessment of brilacidin targets suggests that brilacidin exerts an impact on the virion integrity directly for several viruses. However, the sensitivity to brilacidin differs for different viruses (SARS-CoV-2>RVFV>VEEV). Brilacidin appears to exert its greatest antiviral effect when the virus is directly exposed to brilacidin. Quantification of anti-inflammatory activities in VEEV infection by ELISA demonstrated a decrease in IL-1b and IL-6 levels when treated with brilacidin. Early assessments of virus distribution in TC-83-infected cells by electron microscopy suggest potentially lower intracellular viral load upon treatment. Assessment of innate immune activities included quantification of interferon-gamma expression by PCR in the context of RVFV infection, which did not indicate a statistically significant change in IFN-ß at the gene expression level. Additional ongoing studies focus on assessing brilacidin treatment on a broader array of inflammation-associated genes. The impact of brilacidin on the maintenance of BBB integrity in the context of endothelial cells will also be investigated.
Conclusions: The observations that we continue to make in experiments involving brilacidin in the context of acutely infectious viruses support the idea of brilacidin functioning in a broad-spectrum capacity as an antiviral compound. Several lines of evidence suggest that brilacidin may affect virion integrity and hence impact viral entry, thus positioning it well as a broad-spectrum prophylactic countermeasure solution. The observations about anti-inflammatory activities indicate that intracellular events are also modulated by brilacidin treatment that exerts a combined protective effect by decreasing viral and inflammatory load. Brilacidin has also undergone several clinical studies for multiple indications, using different routes of administration, and has a known safety profile in humans.
Learning objectives:
1. To understand the broad-spectrum potential of brilacidin against aerosol-transmissible acute viruses.
2. To evaluate the mechanism(s) of antiviral activities of brilacidin against enveloped viruses.
3. To ascertain the anti-inflammatory potential of brilacidin in the context of acute virus infections.
https://www.ipharminc.com/new-events-and-presentations/2022/8/8/2022-military-health-system-research-symposium
New York declares 'state of emergency' as polio continues to spread
The Triple Threat of Polio, Monkeypox, and SARS-CoV-2
COVID-19 Will Likely Be With Us Forever.
COVID-19 Responsible For Brilacidin's Potentially Bright Antiviral Future
Feb. 18, 2020 - As COVID-19 was beginning a full-scale invasion of America, bringing with it a significant threat to human life, IPIX reported:
U.S. Pandemic Preparedness [Therapeutic] Plan For Upcoming Year
FIRST ANNUAL REPORT ON AMERICAN PANDEMIC PREPAREDNESS PLAN
NIAID Has Done Drug Approval via "Animal Studies"
This Is Exactly The Point I've Been Making
NIAID To Try "B" As Broad- Spectrum Anti-Coronavirus Prophylactic
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169745581
More Inducements For NIAID/IPIX B-COVID Prophylactic Clinical Trial
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169763983
Both NIAID and the Military are interested/investigating Brilacidin as a prophylactic-antiviral for use against their pathogens of concern.
Message in reply to:
The anti-viral focus has changed I think to prophylactic.
Important Distinctions Between NIAID And The Military (MHSRS)
The distinction is that NIAID will pay Brilacidn's early antiviral development costs and the military will share ALL B-AV development costs with IPIX.
More Inducements For NIAID/IPIX B-COVID Prophylactic Clinical Trial
NIAID To Try "B" As Broad- Spectrum Anti-Coronavirus Prophylactic
This is my opinion based on a substantial amount of evidence.
In 2020, George Mason University reported in their testing of Brilacidin:
" Brilacidin’s ability to disrupt viral integrity and block viral entry indicates it has the added potential to prevent infection, upon appropriate formulation, as a prophylactic."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169609082
"University of Arizona and University of California-San Francisco scientists characterized the antiviral activity of Brilacidin against multiple endemic human coronaviruses (HCoVs), including HCoV-OC43, HCoV-229E, HCoV-NL63, and SARS-CoV-2, in human cell lines...
Mechanistic studies revealed Brilacidin exerts antiviral activity by interfering with viral attachment to host cells by binding to heparan sulfate proteoglycans (HSPGs). HSPGs are important co-receptors through which different viruses gain entry into host cells, thus providing an attractive target for the development of broad-spectrum antivirals. Beyond exhibiting this blocking property, Brilacidin was also shown to target viral proteins directly, acting through a virucidal property. This dual antiviral mechanism of action suggests Brilacidin may be well-suited for prophylactic development and less likely to be subject to drug resistance.
http://www.ipharminc.com/press-release/2022/3/15/innovation-pharmaceuticals-announces-publication-of-peer-review-article-in-the-journal-of-medical-virology-on-anti-coronavirus-properties-of-brilacidin
And completing the trifecta:
"Researchers at Rutgers University have also shown Brilacidin inhibited in vitro the Gamma (P.1) and Alpha (B.1.1.7) variants of SARS-CoV-2.
Brilacidin has now been tested in vitro in seven SARS-CoV-2 strains (Omicron, Delta, Gamma, Alpha, Italian, Washington, Wuhan) and three human coronavirus (H-CoV) strains (OC43, 229E, and NL63), in addition to MERS-CoV and SARS-CoV-1. Brilacidin has consistently inhibited all coronaviruses tested..."
http://www.ipharminc.com/press-release/2022/6/23/innovation-pharmaceuticals-reports-brilacidin-inhibits-omicron-delta-gamma-and-alpha-sars-cov-2-variants-based-on-in-vitro-testing-by-nihniaid-sponsored-and-rutgers-university-researchers
Even Brilacidin's COVID-19, phase 2, that many considered a failure, provided support for Brilacidin's potential as a broad-based, anti-coronavirus prophylactic.
"If a patient started study treatment within fewer than 7 days of onset of COVID-19 symptoms, patients in the Brilacidin 5-dose group achieved sustained recovery more quickly compared to the pooled placebo group (p=0.03). For this patient population, early treatment with Brilacidin from onset of symptoms appeared to have a potential positive impact on time to sustained recovery (the study’s primary endpoint), suggesting cases that can be treated close to initial onset of disease may be an attractive population to target for Brilacidin treatment"
https://www.ipharminc.com/press-release/2022/3/7/innovation-pharmaceuticals-reports-additional-findings-based-on-review-of-brilacidin-phase-2-covid-19-trial-results-and-compassionate-use-cases
The potential for Brilacidin as a broad-spectrum, anti-coronavirus prophylactic has been demonstrated in three university's testing (in vitro) and one COVID-19 phase 2 study (in vivo).
The "Omicron" variant of COVID-19 is still a pathogen of major concern for NIAID.
"The Omicron was first detected in November 2021 and has become the most dominant strain of COVID-19...The majority of people likely infected with the omicron variant of COVID-19 were unaware, according to a study from a medical center in Los Angeles, Calif...Our study findings add to evidence that undiagnosed infections can increase transmission of the virus."
https://www.npr.org/2022/08/19/1118402942/omicron-variant-unaware-covid-research-study?fbclid=IwAR0592RVoGEQ9A4qGiZvhLDi6oDYUyKMKNPLv8F9x0GAOQwkI2-U9YAlny4
And just in case you were thinking there's no more "gold in them-thar COVID hills:
"According to the latest market intelligence research report by InsightAce
Analytic, the global COVID-19 Therapeutics market size was valued at US$ 10.2
Billion in 2021, and it is expected to reach US$ 25.6 Billion in 2030, record
a promising CAGR of 10.7% from 2021 to 2030."
https://www.bloomberg.com/press-releases/2022-01-18/global-covid-19-therapeutics-market-worth-14-6-billion-by-2022-exclusive-report-by-insightace-analytic
Testing at 3 universities (in vitro) and B's COVID P-2 (in vivo), all indicate that B-AV's "blocking" attribute indicate it is well-suited for the role of broad-spectrum, anti-coronavirus prophylactic. B's COVID P-2 went a long way in helping researchers to see that B's role, at least insofar as COVID is concerned, is probably preventing COVID from entering the body and NOT eradicating COVID after it has built-up a strong position in the body.
The data suggest that prophylactic B-COVID will keep the virus/variant out of the body and that COVID may not be able to created a "Trojan Horse" (mutation) to get around it.
I believe NIAID will, ultimately, conduct many clinical trials, researching Brilacidin's antiviral attributes against many viral families, but, given the immediate threat still posed by COVID/Omicron and data suggesting B's ability to inhibit this virus, I think NIAID will conduct this B-COVID prophylactic trial first.
After approval and in short order, I believe B-COVID could become a billion-dollar indication practically overnight, based only on worldwide sales to governments, who will stockpile and distribute.
Message in reply to:
NIAID has a high-degree of interest in Brilacidin and I can't wait to see which direction they move in. Will it be "B" as a COVID prophylactic, broad-spectrum antiviral or possibly something involving monkeypox?
This NIAID Developed Drug Had 2021/Sales of $125M
Tecovirimat/excellent example of NIAID's drug development capability
Before NIAID can do B-AV P-2, they will have to decide what is the best delivery method (pill/tablet/aerosol) for B-AV.
NIAID's Antiviral Program for Pandemics (APP) And Brilacidin
NIAID Continues Financing Brilacidin Antiviral Testing and Research
Leo's strategy, IMO, is to create revenue streams from lesser Brilacidin indications (UP/UPS, B-OM, etc), while saving the multi-billion dollar indications, like UC/CD and B-AV for IPIX to conduct clinical trials on.
Why do you frustrate yourself over information you're not likely to get. Many here don't seem to understand that Leo is executing a long term strategy and that short term investor concerns are not likely to occupy much of his thoughts (as they shouldn't).
If one studies, what I perceive to be, Leo's long term strategy then it should be pretty clear that he's not interested in selling IPIX. Leo is creating future streams of income via Alfasigma, Squalus, B-OM and B-AV. in the hope these income streams will allow him to do bigger things with the more lucrative part of the pipeline.
NO! Leo does not have to "show us the money." I'm content with the FACT that Leo will share whatever info he deems important for us to know (legal considerations aside). Those who don't like it can take their marbles and go home.
In 1997, Apple was selling for less than a dollar and on the verge of bankruptcy. If it happened once it can happen again. As Warren Buffet has said, In the stock market, the impatient investor pays the patient one" (or words close to this effect).
Connecting The Dots in Posts 392079, 392113, & 392123
A chronological timeline:
Feb. 2020 - IPIX's collaboration with NIAID begins with the shipment of Brilacidin to
NIAID funded lab to "evaluate Brilacidin’s potential antiviral and anti-
inflammatory properties in the context of viral infections, including
inhibition of SARS-CoV-2, the virus responsible for COVID-19.
Mechanism of action studies of Brilacidin...are also planned.
Oct. 2020 - IPIX & GMU announce testing results that Brilacidin "potently inhibits"
Sars-Cov-2 and has potential as a prophylactic.
Nov. 2021 - IPIX reports that Brilacidin failed to meet its primary endpoint in a
phase 2 COVID-19 clinical trial BUT Brilacidin showed potential as a
prophylactic
Dec. 2021 - NIAID announces a new 'Pandemic Preparedness Plan' and states
their existing program the 'Antiviral Program for Pandemics' (APP)
"will focus on antivirals that directly act against viral targets,
specifically for RNA viruses. Antivirals of interest will have broad
use in the outpatient setting, reducing viral burden in the early
stages of infection."[/B]
June 2022 IPIX reports NIAID sponsored testing results that show Brilacidin
Inhibits Omicron, Delta, Gamma and Alpha SARS-CoV-2 Variants.
"Related, results from new NIH/NIAID in vitro testing of Brilacidin in
over 20 acutely infectious viruses, and from the Brilacidin Phase 2
COVID-19 clinical trial, are being prepared for publication."
Additionally, "Innovation Pharmaceuticals Announces New Antiviral
Research on Brilacidin in Bunyaviruses and Alphaviruses to be
Presented at the 2022 Military Health System Research Symposium."
Aug. 2022 - Innovation Pharmaceuticals Announces NIH/NIAID-Affiliated
Researchers to Evaluate Brilacidin’s Treatment Potential Against
Monkeypox.
After 2.5 years of testing, with more to come, NIAID, I believe, has already determined Brilacidin's best antiviral role is as a prophylactic and, thus, they are attempting to establish the range of viruses that Brilacidin can inhibit.
I believe the 2022 Military Health System Research Symposium poster actually contains NIAID's intent for Brilacidin in that it " will be part of the Development of New Front Line Therapies to Prevent and Treat Endemic Viral Diseases."
I offer no timeline estimates because, as I've previously stated, the government is running IPX's Brilacidin Antiviral Program and, while I believe they are moving with deliberate speed, I don't know when we'll see the fruits of the past 2.5 years of testing and research, however, I think this collaboration will ultimately yield tens, if not hundreds, of millions of dollars for IPIX. More than enough to finance expensive clinical trials for IPIX's more lucrative indications.
IMO, this partially explains NIAID's interest in Brilacidin
You had to look at the post didn't you? Mission accomplished.
Post # 392079 eom
Why NIAID Is Spending Money To Test B-Antiviral