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THE CYTOKINE STORM OF SEVERE INFLUENZA AND DEVELOPMENT OF IMMUNOMODULATORY THERAPY —— Severe influenza remains unusual in its virulence for humans. Complications or ultimately death arising from these infections are often associated with hyperinduction of proinflammatory cytokine production, which is also known as ‘cytokine storm'. For this disease, it has been proposed that immunomodulatory therapy may improve the outcome, with or without the combination of antiviral agents.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4711683/
On Tuesday at the Disease Control and Prevention Summit, I will be presenting the first evidence that ZYESAMI blocks the cytokine storm in a randomized controlled trial of patients with COVID-19 respiratory failure.
https://www.linkedin.com/posts/jonathanjavitt_disease-prevention-and-control-summit-america-activity-6822037749109940224-NYjs
HEPATITIS B
According to current statistics, hepatitis B is the most common infectious disease in the world, affecting some 2 billion people -- that's more than one-quarter of the world's population. This disease, which is characterized by an inflammation of the liver that leads to jaundice, nausea, and fatigue, can lead to long-term complications such as cirrhosis of the liver or even liver cancer. The concern is primarily for those who carry the chronic form of the disease, which is estimated to be about 350 million people.
https://www.fool.com/investing/general/2013/12/29/the-5-most-common-infectious-diseases.aspx
VASOACTIVE INTESTINAL PEPTIDE (VIP) has recently been shown to bind to human lymphocytes and modulate immune functions. The ability of VIP in restoring natural killer (NK) cell activity depressed by hepatitis B surface antigen (HBsAg) has been investigated in the present research.
https://pubmed.ncbi.nlm.nih.gov/1418317/
The global hepatitis therapeutics market size was estimated at USD 21.9 billion in 2019 and is expected to reach USD 22.5 billion in 2020.
https://www.grandviewresearch.com/industry-analysis/hepatitis-therapeutics-market
CARDIOVASCULAR DISEASE
Studies from around the world link heart disease to poverty. Low neighborhood income and education were associated with higher risk factors. Poor diet, lack of exercise and limited (or no) access to a specialist were all factors related to poverty, though to contribute to heart disease.
https://en.wikipedia.org/wiki/Diseases_of_poverty
The presence and SIGNIFICANT CARDIOVASCULAR EFFECTS of VIP in the heart suggests that this peptide is important in the regulation of coronary blood flow, cardiac contraction, and heart rate. Current investigations are defining the physiological role of VIP in the regulation of cardiovascular function.
https://pubmed.ncbi.nlm.nih.gov/11121793/
The global cardiovascular drugs market is expected to grow from $87.79 billion in 2020 to $92.41 billion in 2021 at a compound annual growth rate (CAGR) of 5.3%.
https://www.globenewswire.com/en/news-release/2021/05/17/2230401/28124/en/Insights-on-the-87-Billion-Cardiovascular-Drugs-Global-Market-to-2030-Identify-Growth-Segments-for-Investment.html
In conclusion, our findings strengthen the antiretroviral potential of VIP and PACAP and point to new therapeutic approaches to control the progression of HIV-1 infection.
https://www.frontiersin.org/articles/10.3389/fimmu.2018.01336/full
The global HIV-1 therapeutics market is expected to reach a value of USD 15.8 billion by 2025, growing at a CAGR of 1.4%. According to a new report by Grand View Research, Inc., HIV continues to be one of the most challenging public health issues worldwide.
https://www.grandviewresearch.com/press-release/global-human-immunodeficiency-virus-hiv-1-therapeutics-market
Scientific explanation of the AMAZING inner workings of Zyesami (TM)
I finally went through the last S1 which was practically a duplicate from the one on June 25 aside from some details on shares. What I do want to share with all investors of both $nrxp and $Rlftf is an excerpt that clearly provides a detailed timeline of the regulatory interactions with fda. This should shut down any baseless rumors by self-proclaimed fact checkers and all caps sniper that Javitt and/or rlf withheld info that the eua was denied. Please see below. This is directly from the path to regulatory approval section in either of the last 2 S1s submitted by nrxp:
———
“In September 2020, we opened a Pre-EUA file with FDA and requested a narrow EUA only to treat patients who were already allowed under the Expanded Access Protocol granted by FDA in July 2020 but whose hospitals could not implement the administrative requirements of the Expanded Access Program. The FDA notified us in December 2020 that EUA could only be granted upon submission of randomized, placebo-controlled data and stated that such data would be reviewed “promptly” upon submission. In a subsequent communication in January 2021, the FDA advised us that review of complete efficacy and safety data would be required for an EUA determination.
At one month following “last visit,” we reported that the pre-specified primary endpoint was met and advised the public that it planned to file for EUA. We also shared this information with the FDA under the open Pre-EUA file.
Over the 8 weeks following “last visit,” the combined research team reviewed via electronic and manual means approximately 53,909 individual case report forms and verified them against source data (i.e. electronic medical records and physician reports) by study monitors. 1185 Treatment Emergent Adverse Event reports were analyzed and 180 Serious Adverse Events were investigated in detail by medical monitors, each requiring a detailed narrative. 5988 concurrent medication reports were evaluated to detect possible Adverse Events. Over the next two weeks all findings were reviewed with the individual site Principal Investigators and each signed off on the accuracy of the case reports. The database was formally locked on May 7, 2021.
On May 31, 2021, we filed for EUA with the FDA for ZYESAMI, thereby delivering a regulatory file delineating safety and efficacy data of an investigational drug within 3 months of last visit in a clinical trial. Although there can be no assurance that the FDA will conclude that ZYESAMI meets or exceeds the EUA standard of “may be effective” in the treatment of COVID-19, we are hopeful that the FDA will grant EUA to ZYESAMI.” ~ LA, from Y@h00 RLFTF finance conversations
Vasoactive intestinal peptide receptor - 1 deficiency causes an increase in the frequency of antibiotic producing bacteria in mouse fecal samples ——— New antibiotic discovery is critical because bacteria are becoming resistant to currently prescribed antibiotics. A mammalian gut peptide, vasoactive intestinal peptide (VIP), is highly expressed in the gut and possess antimicrobial activity. VIP binds two receptors, designated VPAC1 and VPAC2, and deficiency in all three have been shown to cause significant gut microbiota dysbiosis. We hypothesized that mice deficient for VIP signaling would be good candidates for exploring the existence of novel antibiotic-producing bacteria (APB).
https://www.jimmunol.org/content/198/1_Supplement/216.17
Vasoactive intestinal peptide (VIP) is crucial for gastrointestinal tract (GIT) health. VIP sustains GIT homeostasis through maintenance of the intestinal epithelial barrier and acts as a potent anti-inflammatory mediator that contributes to gut bacterial tolerance. Based on these biological functions by VIP, we hypothesized that its deficiency would alter gut microbial ecology. To this end, fecal samples from male and female VIP+/+, VIP+/–, and VIP–/– littermates (n = 47) were collected and 16S rRNA sequencing was conducted. Our data revealed significant changes in bacterial composition, biodiversity, and weight loss from VIP–/– mice compared to VIP+/+ and VIP+/– littermates, irrespective of sex. The gut bacteria compositional changes observed in VIP–/– mice was consistent with gut microbial structure changes reported for certain inflammatory and autoimmune disorders. Moreover, predicted functional changes by PICRUSt software suggested an energy surplus within the altered microbiota from VIP–/– mice. These data support that VIP plays an important role in maintaining microbiota balance, biodiversity, and GIT function, and its genetic removal results in significant gut microbiota restructuring and weight loss.
https://www.frontiersin.org/articles/10.3389/fmicb.2019.02689/full
Moreover, VIP could upregulate the expression of occludin in the ileum mucosa compared with the ETEC K88 group. Colon and caecum content bacterial richness and diversity were lower for pigs in the ETEC group than the unchallenged groups. These results demonstrate that VIP is beneficial for the maturation of the intestinal mucosal immune system and elicited local immunomodulatory activities. The TLR2/4-MyD88 mediated NF-?B and MAPK signaling pathway may be critical to the mechanism underlying the modulatory effect of VIP on intestinal mucosal immune function and bacterial community.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0104183
Selbyville, Delaware, May 20, 2021 (GLOBE NEWSWIRE) -- According to estimates by seasoned analysts, global antibiotics market size was valued at USD 40.85 billion in 2020, and is anticipated to register 4.6% CAGR over 2021-2027, subsequently accruing USD 55.96 billion by the forecast period end.May 20, 2021
https://www.globenewswire.com/en/news-release/2021/05/20/2233145/0/en/Global-antibiotics-market-valuation-to-reach-USD-55-96-billion-by-2027.html
In the recent SEC filing Javitt mentions that they plan on applying for Breakthrough therapy designation. It’s essentially the next step from Fast track after preliminary data is submitted in order to expedite drug development and full approval for a life saving drug. ———
After reading a bit on it I found this little nugget on the FAQ. ———
Does a sponsor have to request breakthrough therapy designation in order to be considered for the designation? ———
A sponsor needs to submit a request for breakthrough therapy designation in order to be considered for the designation. In some cases, FDA may suggest that the sponsor consider submitting a request for breakthrough therapy designation if: (1) after reviewing submitted data and information (including preliminary clinical evidence), FDA thinks the drug development program may meet the criteria for breakthrough therapy designation, and (2) the remaining drug development program can benefit from the designation. ———
We know they met with FDA before filing for EUA. We can’t say for certain if FDA suggested that we apply for breakthrough therapy designation but we can infer it was most likely discussed. ———
If the FDA suggested it we fit the criteria and timing perfectly. I can’t see how the FDA would suggest Breakthrough while denying EUA. All the pieces are coming together. ~ from Kpags, Y@h00 finance conversations
Vasoactive intestinal peptide (VIP), a neuropeptide that is produced by lymphoid as well as neural cells, exerts a wide spectrum of immunological functions, controlling the homeostasis of the immune system through different receptors expressed in various immunocompetent cells.
https://pubmed.ncbi.nlm.nih.gov/11862320/
Serious infections increase the risk of life-threatening conditions such as deep vein thrombosis (DVT), a blood clot that can form in deep veins, and pulmonary embolisms (PE), a condition where an artery in the lung becomes blocked by a blood clot. These conditions affect 1 in 1000 adults and lead to approximately 200,000-300,000 deaths per year.
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Her team is establishing a link between infection, thrombosis and changes in the bone marrow programming of immune cells and working on understanding the interplay between the immune system and thrombosis to help identify new, non-blood thinning techniques for preventing and treating DVT in the future.
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My current work, like many surgeons, was the result of observing human suffering. During the 2009-2010 H1N1 influenza outbreak, I spent much time in the surgical intensive care unit caring for young individuals, some in their 20s and 30s, with severe pulmonary disease requiring advanced life support. We noticed that a large number of these patients developed severe venous clotting, leading to a very high mortality. Blood thinners helped us decrease the risk of death but led to a host of other bleeding complications for these ill patients.
https://labblog.uofmhealth.org/lab-report/investigating-immune-systems-connection-to-blood-clots
The global anticoagulants market was valued at $24,265 million in 2017, and is expected to reach $43,427 million by 2025, growing at a CAGR of 7.5% from 2018 to 2025.
https://www.alliedmarketresearch.com/anticoagulant-drugs-market
I’m sorry for your loss and share your hope that this drug, Zyesami (TM), will soon be given EUA and approval by FDA. The info comes 4 to 5 decades of VIP studies published in the WWW. Best
THE MULTIPLE SCLEROSIS DRUGS MARKET SIZE
The global multiple sclerosis drugs market size was USD 26.05 billion in 2020. The global impact of the COVID-19 has been unprecedented and staggering, with multiple sclerosis drugs witnessing a moderate negative demand shock across all regions amid the pandemic. Based on our analysis, the global market exhibited a growth rate of 4.2% in the year 2020, which is lower as compared to the previous years. The market value is USD 27.38 billion in 2021 and is expected to reach USD 41.99 billion in 2028 at a CAGR of 6.3% in the 2021-2028 period. The sudden rise in CAGR is attributable to the market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.
https://www.fortunebusinessinsights.com/industry-reports/multiple-sclerosis-drugs-market-100386
AMAZING NEUROPEPTIDE!!
VIP prevents experimental multiple sclerosis by downregulating both inflammatory and autoimmune components of the disease
https://pubmed.ncbi.nlm.nih.gov/16888178/
Experimental models of multiple sclerosis
https://pubmed.ncbi.nlm.nih.gov/17607184/
Kingsbolt, you are truly fortunate to have beat that cancer! Best to you and family. I hope we can have Zyesami (TM) developed into immunotherapies that will prevent/defeat disease/cancer. Zyesami (TM) for homeostasis!! ———
Homeostasis is any self-regulating process by which an organism tends to maintain stability while adjusting to conditions that are best for its survival. If homeostasis is successful, life continues; if it's unsuccessful, it results in a disaster or death of the organism.~ Britannica
https://byjus.com/biology/homeostasis/
Vasoactive intestinal peptide (VIP) is crucial for gastrointestinal tract (GIT) health. VIP sustains GIT homeostasis through maintenance of the intestinal epithelial barrier and acts as a potent anti-inflammatory mediator that contributes to gut bacterial tolerance.
https://www.frontiersin.org/articles/10.3389/fmicb.2019.02689/full#h1
NOT IF WE CAN HELP IT…
Pancreatic ductal adenocarcinoma (PDAC) is projected to become the second leading cause of cancer related death in the U.S. by 2030.
https://www.jimmunol.org/content/202/1_Supplement/70.8
In cancer, immune checkpoint pathways are often activated to inhibit the nascent anti-tumor immune response. Immune checkpoint therapies act by blocking or stimulating these pathways and enhance the body's immunological activity against tumors.
https://jhoonline.biomedcentral.com/articles/10.1186/s13045-018-0582-8
In summary, we have identified that VIP signaling is a novel and targetable immune checkpoint pathway in PDAC, which when inhibited in combination with checkpoint inhibitors, significantly improves treatment response in mouse PDAC models. As the VIP sequence is conserved across different species including mouse and human, and since we have observed VIPR antagonists stimulate proliferation of human T cells, there is an increased potential for clinical translation of VIPR antagonists in the treatment of human PDAC.
https://cancerres.aacrjournals.org/content/80/16_Supplement/5571
NRx Pharmaceuticals and Nephron Pharmaceuticals believe that the mechanism by which aviptadil rapidly degrades in solution has been identified and formulation, manufacturing, and container closure innovations have been developed to counter this degradation. As of June 15, 2021, NRx Pharmaceuticals has initiated GMP manufacturing of ZYESAMI™ and anticipates a long-term stable formulation that will have the potential to be stockpiled should ZYESAMI™ be deemed safe and effective by the FDA.
From the filing today. ~Kpags, Y@h00 finance conversations
The immune system is the collective army of a trillion white blood cells, the bone marrow, antibodies and the thymus gland that identifies and then destroys the millions of microbes (bacteria, viruses, parasites, fungi) that penetrate our bodies every day. This system also needs to eliminate 500 to 10,000 of our own cells that have become genetically abnormal or cancerous. ———
Central to the immune system are the lymphocytes which include the T-cells, B-cells and NK cells. These cells are able to identify and destroy almost every intruder or infected/cancerous cell in the body. NK cells are of particular importance because they are able to work more or less independently, without special instructions from the immune system, to recognize and destroy many types of cancerous cells. ———
They are therefore considered the body’s first line of defense against cancer.~ canceractive
https://pubmed.ncbi.nlm.nih.gov/1311995/
VASOACTIVE INTESTINAL PEPTIDE AND REGULATORY T-CELL INDUCTION: A NEW MECHANISM AND THERAPEUTIC POTENTIAL FOR IMMUNE HOMEOSTASIS
https://pubmed.ncbi.nlm.nih.gov/17467339/
T cells are a part of the immune system that focuses on specific foreign particles. Rather than generically attack any antigens, T cells circulate until they encounter their specific antigen. As such, T cells play a critical part in immunity to foreign substances.
https://www.news-medical.net/health/What-are-T-Cells.aspx
WE’VE FINALLY ARRIVED: ZYESAMI
These studies indicate that altered VIP concentration can have significant consequences in terms of health and disease. In addition, the protective effects of VIP from tissue damage associated with inflammatory processes described in the lung also may be applicable to other pathological conditions such as rheumatoid arthritis, anaphylaxis, and the swelling and edema seen in the brain following head trauma. While VIP degrades rapidly, synthetic VIP-like drugs may be developed that interact with VIP receptors and have similar protective effects. Synthetic VIP-like agents also may be useful in treating neuroendocrine disorders associated with dysregulation of the hypothalamic-pituitary-adrenal axis, and pituitary release of prolactin.
https://pubmed.ncbi.nlm.nih.gov/8790778/
VIP RESTORES NATURAL KILLER CELL ACTIVITY DEPRESSED BY HEPATITIS B SURFACE ANTIGEN
https://pubmed.ncbi.nlm.nih.gov/1418317/
Natural killer (NK) cells are effector lymphocytes of the innate immune system that control several types of tumors and microbial infections by limiting their spread and subsequent tissue damage.
https://www.nature.com/articles/ni1582
NK CELLS WITH ADAPTIVE IMMUNE CELL PROPERTIES ———
Classically, NK cells are regarded as members of the innate immune system, but recent studies have elucidated that NK cells can display both adaptive and memory-like phenotypes. Antigen-specific NK cell memory was first described in T and B cell deficient mice displaying hapten-specific contact hypersensitivity (CHS) in skin cells after adoptive transfer of NK cells from a previously sensitized donor (O'Leary et al., 2006).
https://www.frontiersin.org/articles/10.3389/fcimb.2020.00231/full
POTENTIAL TO BECOME TIL and/or ONCOLOGY IMMUNOTHERAPEUTIC???
FDA IS LIKELY LOOKING AT THE DOTTED I’s AND CROSSED T’s.
“My view is that Dr JJ wants EUA as badly as anyone! So he will take his time dotting his I's and crossing his T's to ensure a high probability of success on his 2nd EUA attempt. I'm betting that he (and BRPA and GEM) are all collectively smart/wise enough to not let a business quarrel with RLFTF result in an insurmountable impasse to EUA. After all, money talks.
Once EUA is accomplished then I (and I think JJ thinks too) foresee a flood gate of opportunities coming down the pipe. So EUA is really where the priority should be at this juncture. So I am willing to wait and be patient. JMHO.” ~ PennyWorld
I HOPE WE CROSS THE “NEW BEGINNING” LINE FIRST.
Vasoactive intestinal peptide stimulates immunoglobulin production and growth of human B cells
https://pubmed.ncbi.nlm.nih.gov/1311995/
Immunoglobulins, also known as antibodies, are glycoprotein molecules produced by plasma cells (white blood cells). They act as a critical part of the immune response by specifically recognizing and binding to particular antigens, such as bacteria or viruses, and aiding in their destruction.
https://www.thermofisher.com/us/en/home/life-science/antibodies/antibodies-learning-center/antibodies-resource-library/antibody-methods/introduction-immunoglobulins.html
B cells are a type of lymphocyte that are responsible for the humoral immunity component of the adaptive immune system. These white blood cells produce antibodies, which play a key part in immunity.
https://www.akadeum.com/b-cell/
Michael’s son began searching for survivor stories and read about a Florida doctor who recovered after treatment with an experimental drug known now as ZYESAMI.
“I looked into it, we weren't gonna just jump on the bandwagon with some kind of quack thing,” Lori shared.
In order to get access to the therapy, the DiDonato’s physician had to ask the drug company to allow compassionate use.
https://wgem.com/2021/06/24/zyesami-investigational-drug-for-covid/
The immune system is the collective army of a trillion white blood cells, the bone marrow, antibodies and the thymus gland that identifies and then destroys the millions of microbes (bacteria, viruses, parasites, fungi) that penetrate our bodies every day. This system also needs to eliminate 500 to 10,000 of our own cells that have become genetically abnormal or cancerous.
Central to the immune system are the lymphocytes which include the T-cells, B-cells and NK cells. These cells are able to identify and destroy almost every intruder or infected/cancerous cell in the body. NK cells are of particular importance because they are able to work more or less independently, without special instructions from the immune system, to recognize and destroy many types of cancerous cells.
They are therefore considered the body’s first line of defense against cancer.~cancer active
Yesterday I posted about prior EUA approval time frames. I just found this today.
On May 28th, 2021 Humanigen Submitted Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19. Their application is based upon positive results from a trial. They have not received feedback yet.
Aviptadil was submitted May 31st. No news yet either.
Given they filed only 3 days apart presents an interesting situation. If news on Humanigen comes out first you can bet that Aviptadil news will be right behind them. That truly will be your last best time to add either RLFTF or NXRP if you have any dry powder. But don't hesitate, as we will not be the only ones that have this figured out.~ rk, Y@h00 finance conversations
A variant of the Covid-19 virus known as the Delta variant, first identified in India, is spreading rapidly in some regions and on track to become the dominant virus strain globally, health experts warn.
https://www.cnn.com/videos/world/2021/06/21/delta-variant-covid-19-coronavirus-holmes-pkg-intl-hnk-vpx.cnn
Yet the CDC only briefly mentioned one group that should remain cautious, even if they’re fully vaccinated: those who are immunocompromised.
These are people whose immune systems don’t mount a strong — or sometimes any — response to potential invaders, which already leaves them more vulnerable to infection and illness, including COVID-19.
Adding to the problem is that COVID-19 vaccines may not provide as much protection for some who are immunocompromised compared to the general population.
“The limited data that we have creates significant concerns that vaccines against COVID-19 may not be as effective in immunosuppressed patients,” says Daniel Kaul, M.D., director of the Transplant Infectious Disease Service at Michigan Medicine.
https://healthblog.uofmhealth.org/wellness-prevention/if-im-immunocompromised-should-i-keep-wearing-my-mask-once-im-vaccinated
Ms Pegs1, I would like to think EUA by next week and approval by October 2021, all in our LIVING YEARS!!
Elllk, remember these words, “infection in immunocompromised persons”. VIP seems to up-regulate production of B cells, T cells, the cancer Natural Killer cells and orchestrate counterattack of disease threats in the human body. The amazing NEUROPEPTIDE!!
PULMONARY MUCORMYCOSIS
Pulmonary mucormycosis is relatively uncommon but an important opportunistic fungal infection in immunocompromised persons. The literature on the subject is sparse. We describe a recent case and review the literature to delineate the clinical characteristics of this infection. We searched the MEDLINE database for articles published in the English-language literature since 1970 and carefully analyzed 87 cases. The main risk factors were diabetes mellitus, hematologic cancers, renal insufficiency, and organ transplantation. Several patients had no apparent immune compromise. There was a predilection for involvement of the upper lobes. Air crescent signs on chest x-ray films were predictors of pulmonary hemorrhage and death from hemoptysis. Fiberoptic bronchoscopy was a useful diagnostic method, and histopathologic examination was more sensitive than fungal cultures. The overall survival rate was 44%. Patients treated with a combined medical-surgical approach had a better outcome than patients who did not undergo surgery. Thus, this relatively rare but often fatal disease should be suspected in immunocompromised patients who fail to respond to antibacterial therapy. Early recognition and aggressive management are warranted to maximize chances for cure. Optimal therapy requires systemic antifungal therapy, surgical resection, and, when possible, control of the patient's underlying disease.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/485069
Mucormycosis is a devastating disease most commonly seen in immunosuppressed individuals. It has the propensity to disseminate in humans and cause rhinocerebral, pulmonary, gastrointestinal, and cutaneous infections. This study focuses on cutaneous mucormycosis, incidence, epidemiologic characteristics and mortality in intensive care medicine.
https://www.researchgate.net/publication/278729204_Cutaneous_mucormycosis_in_the_ICU
VIP CAN HELP ———
Vasoactive intestinal peptide (VIP) is widely expressed throughout the cardiopulmonary system and exerts a variety of biological actions, including potent vascular and airway dilatory actions, potent anti-inflammatory actions, improving blood circulation to the heart and lung, and modulation of airway secretions. ~ respiratory research biomedcentral
The covid-19 vaccines in widespread use have emergency authorizations (EUA), not actual approvals, a crucial regulatory distinction that reflects major differences in the level of regulatory scrutiny and certainty about the risk-benefit balance.
https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid-19-vaccine-this-year/
OUTRAGE!!
WASHINGTON — The Food and Drug Administration fast-tracked Biogen’s divisive Alzheimer’s drug Aduhelm, but it’s not going to do the same for amyotrophic lateral sclerosis anytime soon — and ALS advocates are outraged.
https://www.statnews.com/2021/06/11/advocates-blast-fda-for-not-fast-als-alzheimers/
Vasoactive Intestinal Peptide Decreases ß-Amyloid Accumulation and Prevents Brain Atrophy in the 5xFAD Mouse Model of Alzheimer's Disease. J Mol Neurosci.
https://pubmed.ncbi.nlm.nih.gov/30498985/
Who’sJohnGault, after 14 months of trials…more patience
YOU CAN RUN BUT YOU CANNOT HIDE FROM VIP
The real big advantage of Aviptadil is that viral mutations won't damage effectiveness. Vaccines and mAbs are vulnerable to immune escape, what works today might not work tomorrow but Aviptadil carries on.~ SpoEd @Yah00 finance conversations
Recent evidence indicates that vasoactive intestinal peptide (VIP), an anti-inflammatory neuropeptide with therapeutic potential in various immune disorders, participates in maintaining immune tolerance by a novel mechanism of inducing the generation of Treg cells.
https://www.cell.com/trends/molecular-medicine/comments/S1471-4914(07)00067-6
WILL VIP BECOME THE STANDARD OF CARE IN IMMUNOTHERAPY???
When NK cells are activated by VIP, what can NK cells do? How do NK cells do it???
The global cancer immunotherapy market size was estimated at USD 91.0 billion in 2019 and is expected to reach USD 107.3 billion in 2020.
https://www.grandviewresearch.com/industry-analysis/cancer-immunotherapy-market
VIP Restores Natural Killer Cell Activity Depressed by…what viruses???
https://www.liebertpub.com/doi/10.1089/vim.1992.5.195
If VIP switches on NK cell activity then….
Dear Ms Pegs1, I hope so too! Best to you and your family!
Dear Ms Pegs1, if I understood correctly, you will be asking your pulmonologist for Zyesami IV off-label once approved to market 2021, yes? Once Zyesami IV is approved to market, what is to keep Zyesami inhaler from going to market as well …2021? Get that one off-label as well!!! >>>>
The most abundant neuropeptide in the lung is the vasoactive intestinal peptide (VIP), which is a potent muscle relaxant and has therefore been suggested in the therapy of chronic inflammatory lung diseases, including COPD [15,16]. In experimental conditions, VIP has a positive inotropic and chronotropic effect.
https://www.karger.com/Article/Fulltext/439228
ALSO KNOWN AS VIP, THE FINAL MAGIC WAND
IS DR. REICHSTETTER IN THE HOUSE???
DESCRIPTION (provided by applicant): Psoriasis is a chronic inflammatory skin disease that to this date is only insufficiently controlled by currently available treatments which can also come with severe, and sometimes life threatening side effects. In this application, we propose to create a new class of biologics drug for the treatment of this debilitating disease. We are proposing to formulate the immunomodulatory neuropeptide vasoactive intestinal peptide (VIP) into a long-acting formulation that will be tested as a drug candidate for the treatment of psoriasis. From preliminary experiments we know that our formulation can be injected subcutaneously (s.c.) which is of advantage for patients with severe disease, and we envision that it can be applied topically for less severe cases. During the Phase I of this project, we propose to synthesize a new batch of drug carrier that we used for the formulation of VIP in preliminary experiments. This formulation has increased in vivo half-life and provides better safety properties compared to unformulated VIP. In the proposed project, we will collect data about bioavailability of VIP after s.c. and topical administration, and, as VIP can decrease the arterial blood pressure, measure the blood pressure in the tail of VIP treated mice after topical administration. Blood pressure data already exists for s.c. administration of our VIP formulation. VIP has been shown to be efficacious in many animal models of chronic inflammatory conditions in which efficacy overlapswith efficacy for psoriasis; however, it has not been tested directly in models of psoriasis. We therefore also propose in this application to test efficacy of our long-acting VIP formulation after s.c. administration and topical application in a mouse model of psoriasis. If Phase I is successful, we are planning to conduct a formal toxicity study during Phase II, further develop the topical formulation and file a investigational new drug application with the FDA at the end of Phase II. PUBLIC HEALTH RELEVANCE: Psoriasis is a debilitating chronic inflammatory skin condition with an immense burden on the economy and, despite treatments advances, is still a largely unmet medical need. This proposal would create a new class of biologics drug that can be administered both by subcutaneous injection and for less severe cases by topical application that has the potential of changing the lives of the patients.
https://www.sbir.gov/sbirsearch/detail/399666
The global psoriasis treatment market size was valued at USD 20.09 billion in 2019 and is projected to reach USD 40.58 billion by 2027, exhibiting a CAGR of 9.2% during the forecast period.
https://www.fortunebusinessinsights.com/industry-reports/psoriasis-treatment-market-100600
Vasoactive Intestinal Peptide Ameliorates Acute Myocarditis and Atherosclerosis by Regulating Inflammatory and Autoimmune Responses
https://www.jimmunol.org/content/200/11/3697
WE MAY HAVE TO CLEAN AFTER VACCINES
https://www.theguardian.com/us-news/2021/jun/11/cdc-covid-vaccines-mrna-heart-inflammation-reports
Congestive cardiac failure has become one of the major health challenges of the 21st century and new therapies are needed to address this problem. The concentration of vasoactive intestinal peptide (VIP) in the heart has been shown to decrease as fibrosis (the pathology leading to heart failure) increases and to become undetectable in end stage cardiomyopathy. We sought to determine whether replenishment of myocardial VIP might treat myocardial fibrosis and therefore represent a new therapeutic target.
https://pubmed.ncbi.nlm.nih.gov/31449808/
OR BETTER YET, GET A GOOD CHUNK OF THEIR MARKET
According to the report published by Allied market Research, the global Vaccines Market was pegged at $32.46 billion in 2019, and is anticipated to hit $54.15 billion by 2027, registering a CAGR of 6.6% from 2020 to 2027.
https://www.globenewswire.com/en/news-release/2021/05/04/2222544/0/en/Vaccines-Market-Size-is-Expected-to-Hit-54-15-Billion-by-2027-Says-Allied-Market-Research.html