Rec finished accum & now holding CTIX. I come here daily, listen more than I talk, and am grateful beyond measure for everyone's contributions.
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Todays news isn’t as “out there” as you’d think.. I’ve no PR in my email, nor does it appear in Apples Reuter’s stock ticker, nor is there even a headline on IPIX website. Not sure how everyone caught wind of 3rd MTA, but there could well be quite a large contingent of people like me, apparently living under an info-blocking rock.
No, it’s the more ignoble explanation. Government is just like that car that knows you’re waiting on it’s parking spot.
Wonder if anyone’s taken Alpha Sigma’s pulse since March, or if there’s a foul smell emanating from beneath their door.
Good thing FDA is feeling so magnanimous isn’t it? With our better safety/efficacy profile, logic insists Brilacidin gets retroactive approval for emergency use.. right? I know, it’s starting to get a little deep in here.
Remdesivir took the starring role in this Weekend at Bernie’s redux, (with a little help from its friends, Fauci, et al). They’ve gotta work fast, though. Thing’s liable to attract blow flies. I wouldn’t put it past them to brew up 9 parts Brilacidin to 1 part Remdesivir and call it “Remdesivir Plus”. To be fair, every good drug has its inert ingredients.
I’ve never seen a drug afforded so many do-overs in the arena of public opinion. I’m sure it’s a fine drug, and may be an exceptional drug in combo therapy, but this breathless fawning I see in media defies logic.
Kevzara is a MAB from Sanofi/Regeneron which entered the Covid trial arena. Sought to control IL-6 by blocking IL-6 receptors just as it does for the treatment of Rheumatoid Arthritis. Trial ended with some benefit to ARD patients but little benefit to mild cases. Brilacidin data presented for OM states the following with regard to IL-6:
Immunomodulatory activity of brilacidin
HDPs are a key component of the innate immune system and have multiple modes of action: immunomodulatory, anti-inflammatory, and rapid microbial killing.
Radiation and/or chemotherapy results in oxidative stress and an inflammatory response in oral mucosa which leads to activation of transcription factors and signal transduction pathways, including NF-?B and p53. mRNA levels of TNF-a and IL-1ß in oral mucosal tissue correlates with severity of mucosal injury. NF-kB activation induces inflammatory cytokines, e.g., IL-6, IL-1ß, TNF-a, that affect mucosal integrity. These pro-inflammatory cytokines initiate an inflammatory cascade leading to activation of matrix metalloproteinases (MMPs) and Monocyte Chemoattractant Protein-1 (MCP-1) that further damages tissue. Ulceration develops and creates portals for bacterial entry and colonization. https://www.escmid.org/escmid_publications/escmid_elibrary/material/?mid=25748
When China steals your IP, that’s when you know you’ve got a product with promise, a la Remdesivir.. Even the Chinese got catfished by that one lol
If tests prove efficacy in human tissue with the known safety profile, it’ll be a blitz play for Brilacidin by far bigger powers than us shareholders. Leo, fists still clenching our patents, will be trampled like Chip Diller. Whether it’ll all be sorted in the end doesn’t concern me. My nails stay short because we could just as easily get pink slipped like Remdesivir, only without the Mulligans.
Oh I can tell you what Fauci will say- Fauci has a Radio Shack endless loop cassette just like Teddy Ruxpin. They power him up, call lights, camera, action! “There is no [and there will be no] effective treatment for Covid-19. The world may never get back to what it considers normal”. His mouth will even move with the audio. The press just can’t get enough of him. He’s like a Kardashian, only less useful.
Can you imagine the security risks being faced by any lab which is in possession of and is charged with giving the thumbs-up or thumbs-down to every potential anti-Covid drug compound in the world? Corporate espionage/sabotage, National espionage or sabotage.. any one of the short list of compounds is worth not billions, but trillions to nations upon confirmation of efficacy. If those white coated jokers are actually rattling around somewhere inside those labs, they, their cultures (and their chain of custody) had better be (1) honest beyond reproach and (2) under heavy armed guard.
These bloated agencies are given way too much prominence in the matter. You’d think they were working feverishly, around the clock to develop a cure, when in actuality, they routinely produce nothing (less than nothing if you factor in the cost of their existence). Biotechs have already done all the scientific heavy lifting, and they’ve financed it not with oceanic sized grants, but with penny shares in in a volatile market, fighting competitors, paid saboteurs, dilution, trial failures, a smug and implacable FDA and lawsuits. I see BARDA just as I see the CDC, the FDA, and increasingly, the RBLs: as little more than DMV employees in lab coats.. not to besmirch DMV employees. I’d like to see just one media outlet camped out on the steps of just one RBL, prepared to ask just one useful question to one knowledgeable person therein. It’s mind-numbing- There is only one thing in all the world that matters right now, and it occurs to no one the world over, to ask about it: Show us the leaderboard! Progress report? WTF RBLs? No.. they give us more Fauci.. which we need like tits on a bull.
I can think of one sticky this could replace
"Alarmed as COVID Patients' Blood Thickened, New York Doctors Try new Treatments" By Jonathan Allen Reuters. I wondered when this was going to be mentioned. One of the strongest indicators in diagnosing Covid 19 has been the elevated levels of D-dimer protein fragments in the blood. In another source article, which Im sure I received through Endpoints, D-dimer is off the charts, "a four-fold increase" is observed in Covid patients. I'm well in over my head when it comes to protein fragments involved in blood clotting, but I wonder if this is a byproduct of cytokine, IL expression, and something which would respond favorably to the anti-inflammatory moa we're trying to impart to the thick-headed powers that be with Brilacidin
The prevailing mentality is, when a cure is developed, it will come from a celebrity like Gilead. The same hubris and denial brought down the Detroit auto industry, even as Japan swooped in and ate their lunch. Until the scales fall from their eyes, media will report things as they wish them to be.
post the link if you can
alpha sigma has ROFR for gastro intestinal indications, and we’ve argued whether they have any claim against Oral Mucositis, but I cannot see them having any claim against an off-label use for Covid-19.
There’s nothing IPIX can bring to a partnership other than our IP. We have no production facility, no R&D, no distribution network. That said, the only logical prospect I see is BP buying our IP outright
FDA can’t find its pants in the morning
If we were above the radar, China might’ve preemptively patented Brilacidin
The Pygmalion effect, or Rosenthal effect, refers to the phenomenon in which the greater the expectation placed upon someone or something, the better they perform. See: self-fulfilling prophesy. I’ve seen it with “certain” NFL players, whom, like Remdesivir, people attempt to will into greatness even as the empirical data falls short
Who is our Brilacidin compounder? Dr Reddys Labs? Evonic? Someone else?
Remdesivir smelled fishy from the start of all this
This is significant. Recon on both fronts.
Some updated perspective on the crowded Covid trial field as published in JAMA network.com,
April 13, 2020
Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19)
A Review
James M. Sanders, PhD, PharmD1,2; Marguerite L. Monogue, PharmD1,2; Tomasz Z. Jodlowski, PharmD3; et al
“Ongoing Clinical Trials
The search terms COVID OR coronavirus OR SARS-COV-2 on ClinicalTrials.gov resulted in 351 active trials, with 291 trials specific to COVID-19 as of April 2, 2020. Of these 291 trials, approximately 109 trials (including those not yet recruiting, recruiting, active, or completed) included pharmacological therapy for the treatment of COVID-19 in adult patients. Of these 109 trials, 82 are interventional studies, with 29 placebo-controlled trials. Per description of the studies, there are 11 phase 4, 36 phase 3, 36 phase 2, and 4 phase 1 trials. Twenty-two trials were not categorized by phase or not applicable.”
Excellent point. Much similarity between 1918/19 h1n1 and Sars-CoV-2 in that they’re zoonotic. Both my great grandparents, mid 20’s died within 7 days of each other in the 1918 wave in Republic KS, leaving my grandad, age 6 and his baby sister orphans. He used the same rose given to him at his father’s burial to lay on his mother’s casket one week later. I wish they had therapies and antivirals such as Tamiflu back then. Both then and today, with a novel virus, we really don’t have any option except an end-of-pipeline approach. No vaccine can be brewed up on demand, we just don’t have that efficiency model. I can’t see any sensible approach to CoV19 or similar pathologies other than an effective treatment once exposure has been reasonably established or disease has been diagnosed. It’s infinitely easier and less economically devastating to treat 1.5 million than to vaccinate and quarantine 350 million.
Precisely. You hit on the one topic that not one researcher, politician, epidemiologist or otherwise rational thinking person has asked! What is the similarity between the cytokine storm a minority of patients exhibit vs mild to no symptoms other patients exhibit, and the heightened, self-destructive immune responses we see with lupus, rheumatoid arthritis, multiple sclerosis, type1 Diabetes, food intolerances, et al? I personally suspect much of this is the result of this knee-jerk reliance upon immune system modulation with vaccinations and their associated adjuvants for every disease, both worthy and unworthy of prophylaxis, over a measured response allowing the natural biological development of antibodies to take place in the manner which evolved so perfectly for hundreds of thousand of years. Over use of antibiotics has created MRSAs, and overuse of vaccines has created f’d up immune systems that toss and twitch in Tourette’s-like fashion, until they go postal. Exceptions obviously exist, dependent upon virulence profile, patient comorbidities and such, but the public’s outcry for a blanket application of vaccines is steeped in ignorance, when the outcry should be for MORE THERAPIES - TARGETED THERAPIES focused on that population minority whose immune systems go into cascade effect. I’ve become cynical enough to realize stupid is incurable, so I’m perfectly amenable to calling Brilacidin a “vaccine” if I can profit from doing so, but try as I might, I won’t do so without an eye roll.
Cant tell whether Pfizer is a possible suitor or even knows we exist..
Endpoints News
April 9, 2020 06:52 AM EDT
Updated 09:51 AM
Coronavirus
Covid-19 roundup: Pfizer hustling up millions of doses of vaccine — details $748M BioNTech deal; CDC tweaks stance on controversial malaria drugs
Pfizer and BioNTech are ready to outline the details of their ambitious alliance on a Covid-19 mRNA vaccine for the world.
Their plan now is to start human trials in a matter of days, while ramping up manufacturing for a global market well ahead of the first readout. And the German mRNA company — largely owned by the billionaire Struengmann brothers — is getting a big upfront to go with the collaboration.
The pharma giant is providing the biotech $185 million in cash, including an equity investment of $113 million. Then there’s $563 million in milestones. They plan to jointly commercialize the vaccine around the planet, with Fosun taking China per their separate pact with BioNTech.
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The clinical trial supplies of the vaccine will be provided by BioNTech’s existing manufacturing facility, leaving the partners to start immediately building out enough manufacturing capacity to provide “millions” of doses before the end of this year and “hundreds of millions” by next year. All of that investment is “at risk” — a bet that their jab can end the outbreak.
Pfizer, meanwhile, is also beginning testing soon on a new Covid-19 drug for mild to moderate cases. The company tells the Wall Street Journal that the therapy has the potential to stop the virus from replicating. And they also plan to study their rheumatoid arthritis drug Xeljanz against the virus, part of a multi-prong effort to combat Covid-19.
First up, though, is mRNA.
A group of mRNA companies are taking a shot at producing new vaccines in record time. That group includes BioNTech, CureVac and Moderna in the US. Their technology, while yet to produce an approved product, holds the promise of swift identification of the antigens needed to come up with an effective way to spur immune resistance to the coronavirus.
If it works, it will revolutionize pandemic preparedness efforts. The whole world is watching what happens next. — John Carroll
CDC tweaks guidance on controversial coronavirus meds — report
The European Medicines Agency has cautioned against using the pair of malaria drugs — chloroquine and hydroxychloroquine — outside of clinical trials or national emergency use programs for coronavirus patients, citing the potential for serious side-effects at high doses or when used in combination with other drugs.
Meanwhile, in the middle of March, President Trump reportedly personally pressed federal health officials to make the malaria drugs available to treat the new coronavirus. Soon after, the FDA cited limited in-vitro and anecdotal clinical data to endorse the emergency use of the two therapies to treat malaria and lupus among other disorders for Covid-19 when clinical trials are not available, or participation is not feasible.
Now, the CDC has walked into the controversy. According to a report by Reuters, the agency hastily removed from its website atypical guidance informing doctors on how to prescribe hydroxychloroquine and chloroquine. Initially, the CDC webpage, titled Information for Clinicians on Therapeutic Options for Patients with COVID-19, said: “Although optimal dosing and duration of hydroxychloroquine for treatment of COVID-19 are unknown, some U.S. clinicians have reported anecdotally” several ways to prescribe the drugs to treat Covid-19.
A few tiny trials out of France and China have so far yielded inconclusive evidence on the use of the drugs in patients with Covid-19. The studies and the data that emanated from them is not peer-reviewed.
“Why would CDC be publishing anecdotes?” asked Lynn Goldman, dean of the Milken Institute School of Public Health at George Washington University, in conversation with the wire agency.
On Wednesday, the CDC website read: “There are no drugs or other therapeutics approved by the US Food and Drug Administration to prevent or treat COVID-19.” The truncated guidance also said “hydroxychloroquine and chloroquine are under investigation in clinical trials” for use in coronavirus patients.
Trump has been touting the pair of drugs as Covid-19 treatments for weeks now, despite caution from his own scientific advisors, including infectious disease expert and NIAID chief Anthony Fauci who has insisted that there is no strong scientific proof backing their efficacy against Covid-19.
Cowen analyst Yaron Werber, in a note on Wednesday, suggested that given the existing (limited) data on hydroxychloroquine (HCQ), the potential for its use will likely be as a prophylactic agent.
“(B)ased on all available data, HCQ is unlikely to significantly improve clinical outcomes for hospitalized patients with COVID-19…we would likely already be aware if HCQ was having a robust effect given its wide use throughout China, Italy and the U.S. thus far,” he wrote. “The role for HCQ in post-exposure prophylaxis appears more promising with many clinical trials currently investigating this concept. The drug has shown effectiveness in viral clearance in vitro and may provide benefit if viral replication is impaired in the very early stages of illness, before the systemic inflammatory cascade takes hold.” — Natalie Grover
Boston hospitals assemble a small Covid-19 study in the front lines of the Covid-19 war
A flu antiviral from Japan that was rushed into use in China to help fight the first outbreak of Covid-19 will now be featured in a small US study — right in one of the central fronts of the outbreak.
Brigham and Women’s Hospital, Massachusetts General Hospital and the University of Massachusetts Medical School have begun collaborating on a Phase II study of favipiravir that will recruit 50 patients suffering from coronavirus, according to its manufacturer, Fujifilm.
This small trial comes a little more than a week after Fujifilm launched a more ambitious Phase III in Japan.
Favipiravir — sold as Avigan in Japan since its initial approval in 2014 — attracted a lot of attention in China during the peak of its fight against the new virus. The Chinese adopted it after a pair of small studies. And it’s helped shed some additional luster on Gilead’s remdesivir, which many believe will work better using the same mechanism of action.
As far as the data we’ve seen so far, though, it’s all still a crapshoot.
The drug inhibits RNA polymerase necessary for influenza virus replication, which could be useful in the Covid-19 war. The jury, though, is still very much out over how effective it may be or whether it can be more than a marginal treatment against a fast-spreading virus. — John Carroll
Biotechs broaden the spectrum of anti-inflammatory drugs thrown against Covid-19
With the FDA signalling a willingness to wave a broad spectrum of Covid-19 therapies into the clinic, two biotechs are pitching in their pipeline stars to tame the inflammation often responsible for devastating patients.
Biohaven has the green light to begin testing intranasal vazegepant — its CGRP receptor antagonist designed for acute migraines — in pulmonary complications of the viral infection. “This pandemic is a call to action for our entire industry,” CEO Vlad Coric said, and Biohaven with researchers at Thomas Jefferson University to develop the protocol.
Similarly, San Diego-based CalciMedica has permission to study whether its small molecule drug — which inhibits calcium release-activated calcium (CRAC) channels — can keep patients with severe pneumonia from going on ventilators.
Once they provided data from their Phase II pancreatitis trial involving patients with systemic inflammation and hypoxia, as well as animal data suggesting CM4620-IE has protective effects on lung injury, the FDA approved their IND in less than 10 days, CMO Sudarshan Hebbar told Endpoints News.
The trial will start small with plans to recruit 60 patients between Regions Hospital in St. Paul, Minnesota and Henry Ford Hospital in Detroit. Patients will be randomized to receive drug or placebo in a 2:1 ratio. — A
If Brilacidin demonstrates significant viral sensitivity in current human cell tests, together with its established safety values, I’m not even fleetingly entertaining delusions of Phase III anything- the whole notion of which is a construct of a regulatory agency that has proven itself arbitrary, ineffectual and less than irrelevant in times of pandemic. I’m looking for total buyout by a BP who knows all the secret handshakes. I’m looking for cash and stock conversion, and so should be Leo! Hopefully Brilacidin won’t be outright commandeered from us under war powers act under the premise of “Ipix doesn’t have the wherewithal to manage this intellectual property in the expeditious manner circumstances dictate”
Exactly. We still have Wuhan Corona Virus 20 and 21 coming soon. Good to have a broad spectrum product on hand that remained off the worlds radar throughout its development. What an incredible miracle that Shanghai and Beijing are the only two places on planet earth devoid of a single case, despite their proximity to the epicenter.. surely our miracle drug can compete with theirs lol
I cannot imagine any reason why Brilacidin could not be nebulized. We successfully lyophilized Brilacidin, which along with lending it excellent storability, presumably allows it to be put into suspension for a variety of administration methods
How many have died from Hydroxychloroquine adverse effect or drug interaction? It’s statistically impossible that there are none, though I can assure you their attending would chalk the BP crash or the cardiac arrest to death by Covid.
There are MANY CoV patients you CAN’T administer Hydroxychloroquine to. The drug interaction list is a freaking mile long! Retinal damage, Heart arrhythmia, precipitous drops in BP... On a side note, Celgene is dragging Thalidomide out of hell’s back room.. Brilacidin should be among the headlines of obvious alternatives; short molecule, “easy-to-manufacture”, established safety profile.. only in Opposite World does science and capital beat a path to the electric shock when the cheese is at arms length
FDA might as well give deference to the DMV on matters of national urgency. At least the DMV possesses total uniformity in the course of being useless.
Yes! Useful information! May God bless you richly! I don’t know why, but I simply couldn’t find diddly on this.
Question of the month! Production Capacities, Production Lead and Ramp-up timelines, availability of components, Locations and Identities of secure domestic Manufacturing/Compounding Facilities, Production Commitments secured to date and From Whom. Financial Incentives for pharmaceutical manufacturers to produce compounds as directed, regardless of that compound’s corporate ownership, Role of War Powers Act as it pertains to above. If just ONE reporter during these daily press briefings could deviate from their short list of simple-minded questions and ask these, my boiling urge to throw each of them through the nearest unopened window would rapidly diminish.
Whom among our fine politicians and policy makers is currently afflicted with Corona virus? Surely the number is growing. Might do well to drop their respective offices a line inquiring as to what is impeding availability of Brilacidin and other anti-Covid compounds even as Europe is expediting compassionate use.
Leo telephoned me once, just as the Mako debacle was unfolding, in answer to a question I’d left on voice message. We spoke mostly about that topic. He exists. He isn’t exactly the sentimental type, either. I’d say he’s matter-of-fact, strictly business, and rather dry in personality. In my opinion, he lacks all the necessary charisma of a con artist.. but he exists.
Retail is always the last to get news. You can take that to the bank.
Dr Oz now telling his audience what we all knew two weeks ago: About 1/2 CoV19 pts suffer Intestinal symptoms prior to the onset of the hyped respiratory symptoms AND those present this way tend to afflict more seriously. Could there possibly be a louder clarion call for Brilacidin CoV?