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Thanks for the thoughtful post, Farrell. My faith in Leo is not gone, but it has lessened as time has past.
"JMO I am very optimistic IPIX will receive government funding.
As per the PR, Mr Ehrlich is working to accomplish that goal.
Glta, Farrel"
Is it accurate to believe that you made these recommendations to Leo in a call or email? Or you got this from the PR? It would be heartening to believe that Leo would communicate with you. The board has been full of discussions of nasal and injection (and other) treatment modalities augmenting IV for a couple of years. It would be good to see those options being pursued, though I am not really expecting that.
Uhh, right you are. Leo was too cheap to have developed a pre-hospital or prophylaxis treatment. As noted, maybe he was advised that there could be no practical development of a vaccine, patch, inhalant or pill that fit the bill, and just decided not to inform his stock holders. Who knows? TIAB had the last laugh, ok, not a belly laugh as it appears he also lost his azz, big time.
"And I have voiced this opinion personally to Leo!!!"
What was his response? And why do you think he communicates with you, but has shut off a number of other longs? Fwiw I don't blame him for the Prurisol failure, he gave it a good shot. I blame him for lots else including the covid sham. But I'm still modestly hopeful for good things to result from the AlfaSigma IBD test.
And, I know it is a real long shot, but Leo could still try and use B for ABSSSI if he could pop for a shot in addition to the IV. There is so much need for new antibiotics it seems a almost a crime not to follow up. All for 34 million or someone, anyone, interested to buy in. And B works in this and no doubt other antibiotic applications as we have gone over before. Can make you almost scream.
Yeah, but we got good tips for serving at weddings and funerals.
I'd like that too, even something, anything re kevetrin.
The world moves on, and some still await info re rehashing a failed covid test.
February 24, 2022
FDA Authorizes Bebtelovimab for Mild to Moderate COVID-19 Treatment
Brian Park, PharmD
intravenous antibiotics
Lilly will supply up to 600,000 doses of bebtelovimab to the US government. Credit: Thinkstock.
The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab for the treatment of mild to moderate COVID-19 in patients 12 years of age and older weighing at least 40kg with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
Bebtelovimab is a recombinant neutralizing human IgG1? monoclonal antibody that works by binding to the spike protein of SARS-CoV-2. The EUA was supported by data from the phase 2 BLAZE-4 trial (ClinicalTrials.gov Identifier: NCT04634409), which evaluated the efficacy and safety of bebtelovimab in nonhospitalized patients with mild to moderate COVID-19. Patients received a single IV infusion of bebtelovimab 175mg alone or together with bamlanivimab 700mg and etesevimab 1400mg.
Among 380 low-risk patients enrolled in the placebo-controlled portion of the trial, treatment with bebtelovimab resulted in a reduction in time to sustained symptom resolution compared with placebo. The median time to sustained symptom resolution was 7 days (95% CI, 6-8) for patients treated with bamlanivimab, etesevimab, and bebtelovimab together (P =.289) and 6 days (95% CI, 5-7) for patients treated with bebtelovimab alone (P =.003), compared with 8 days (95% CI, 7-9) for patients treated with placebo. There was also a reduction in viral load observed on day 5 after treatment compared with placebo.
In the randomized, open-label portion of the trial, 150 high-risk patients were treated with a single infusion of bebtelovimab alone or together with etesevimab and bamlanivimab. The proportion of patients with COVID-19 related hospitalization or death by any cause was assessed by day 29. Results showed events occurred in 2 patients treated with the combination of bamlanivimab, etesevimab, and bebtelovimab and in 3 patients treated with bebtelovimab alone. One patient treated with bebtelovimab alone died on day 34. The median time to sustained symptom resolution was 7 days for patients treated with bebtelovimab alone.
In the nonrandomized, open-label portion of the trial, 176 high-risk patients were treated with a single infusion of bamlanivimab, etesevimab, and bebtelovimab. The proportion of patients with COVID-19 related hospitalization or death by any cause was assessed by day 29. Events occurred in 3 patients with no deaths reported. The median time to sustained symptom resolution was 8 days.
BLAZE-4 was conducted prior to the emergence of the Omicron variant; no patients in the study were infected with virus of the Omicron lineage or sublineages. However, nonclinical viral neutralization data showed that bebtelovimab retained full neutralizing activity against Omicron and all other known variants of interest and concern, including BA.2.
The most common adverse reactions reported with bebtelovimab were infusion-related reactions (0.3%), pruritus (0.3%), and rash (0.8%). Treatment with bebtelovimab may also be associated with serious hypersensitivity reactions, including anaphylaxis.
The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. Bebtelovimab should be administered as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. The product is supplied as a 175mg/2mL single-dose vial.
The health care provider fact sheet for bebtelovimab can be found here.
References
Lilly’s bebtelovimab receives Emergency Use Authorization for the treatment of mild-to-moderate COVID-19. News release. Eli Lilly and Company. February 11, 2022. Accessed February 14, 2022. https://www.prnewswire.com/news-releases/lillys-bebtelovimab-receives-emergency-use-authorization-for-the-treatment-of-mild-to-moderate-covid-19-301480923.html
Coronavirus (COVID-19) update: FDA authorizes new monoclonal antibody for treatment of COVID-19 that retains activity against Omicron variant. News release. US Food and Drug Administration. February 11, 2022. Accessed February 14, 2022. https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-new-monoclonal-antibody-for-treatment-of-covid-19-that-retains-activity-against-omicron-variant-301480912.html
AbCellera-discovered antibody, bebtelovimab, receives U.S. FDA Emergency Use Authorization for the treatment of mild-to-moderate COVID-19. News release. AbCellera. February 11, 2022. Accessed February 14, 2022. https://www.businesswire.com/news/home/20220211005524/en/AbCellera-Discovered-Antibody-Bebtelovimab-Receives-U.S.-FDA-Emergency-Use-Authorization-for-the-Treatment-of-Mild-to-Moderate-COVID-19
Bebtelovimab fact sheet for health care providers. Accessed February 14, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-factsheet-hcp.pdf
This article originally appeared on MPR
Oops, found another old fed friend who is an IPIX investor. I took off their names. They are IPIX believers/hopers, or so it seems.
"Richard ... Jr RN-BC, CCM, CNLCP, NHDP-BC
1st degree connection1st
Pres - H....... & Associates, Inc /Team Commander at DHHS/ASPR/OEM/NDMS (National Disaster Medical System)
11h
Phase 2 in play from what I have read. Hi old friend!
Like
Reply
See profile for F.... Status is reachable
F....
1st degree connection1st
Retired March 3, 2014
12h
I read that phase 2 testing has started. Hope this drug proves to be effective since ulcerative cholitis seems to be on the increase.
Like
I still never got a response from my LinkedIn question or my emails to AlfaSigma regarding what is the status of the B for IBD test. No surprise there. But I did get a response from an old work buddy, while on the LinkedIn site, who also invests in IPIX and feels the Ph2 is underway. He's not on this message board as far as I can tell. I kind of hate to add participating in LinkedIn to all the other IPIX time wasters I indulge in. It looks to be kind of addictive. I sure wish others here would be on the site too, unless they are, and have kept mum about it.
https://www.biospace.com/article/alfasigma-usa-reintroduces-ibs-c-drug-zelnorm-to-u-s-market/
Scroll down to find the quote. I reproduced it below:
Alfasigma USA Reintroduces IBS-C Drug Zelnorm to U.S. Market
Published: Sep 12, 2019 By Alex Keown
Approximately 75% of the people in the United States who suffer from irritable bowel syndrome with constipation are women. While there are a number of treatment options available, many patients are dissatisfied with them due to lack of efficacy or side effects.
But now, an older and trusted drug for IBS-C has returned to the market in the U.S. In August, Alfasigma USA, the American branch of Italy-based Alfasigma based in New Jersey, secured the rights to Zelnorm, which was recently re-approved by the U.S. Food and Drug Administration for the treatment of IBS-C. Bryan Downey, chief executive officer of Alfasigma USA, told BioSpace in an exclusive interview that Zelnorm is the company’s “first toe in the water” as a U.S. pharmaceutical company.
Originally a Novartis medication, Zelnorm, a serotonin-4 (5-HT4) receptor agonist, was first approved in 2002 as the first prescription medication for IBS-C. But, in 2007, the drug was removed from the market due to cardiovascular concerns. After multiple safety studies were conducted, the FDA reapproved Zelnorm for the market in March for women under 65 years of age with IBS-C, which is characterized by frequent abdominal pain and altered bowel habits with predominant constipation. In June, Alfasigma USA acquired Zelnorm and relaunched the medication.
Downey, who came over to Alfasigma two years ago from Sanofi, said his team has been “carrying the information” about Zelnorm’s availability to doctors and are re-confirming with them the updated safety profiles. Dr. John Kincaid, head of medical affairs at Alfasigma USA, said the safety trials showed that less than .01% of patients who received the drug in clinical trials had a major cardiovascular problem. There was also no major Major Adverse Cardiovascular Events (MACE) in the data from patients without the preexisting cardiovascular events or risk factors, he added.
It was that new safety data, as well as the name recognition for Zelnorm that, in part, drew Alfasigma to the medication. Downey said when he heard Zelnorm was now available, he became excited.
“Everyone knew the drug. It was the first of its kind in this space,” he said. “We conducted our own marketing research and the recognition for it was still high. It has a unique mechanism of action in the IBSC patients and there’s not another product like it. It fit their ambitions nicely,” he said.
Downey added that with IBS-C patients, there’s still an unmet need as many patients are not happy with their treatment options and Zelnorm could provide the relief they need. He expressed confidence that the re-introduced Zelnorm will do well in the space despite new drugs that have been developed, such as Ardelyx’s Tenapanor, which could be approved by the FDA this week.
“There’s a lot of noise from other products, which is a great thing for patients,” Downey said. “The newer drugs have a different mechanism of action and focus and we will point to that.”
As Alfasigma USA moves forward with Zelnorm, Downey said the company is expanding its pipeline in order to grow its presence in the pharmaceutical space. In July, the company licensed Brilacidin from Innovation Pharmaceuticals for more than $24 million. Alfasigma will develop Brilacidin for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis. The company is also working with Theravance Biopharma to develop velusetrag for gastroparesis. Downey said he anticipates 2023 or 2024 for the first significant news out of those assets. The company is also working with Salix Pharmaceuticals to develop a reformulation of Xifaxin as a treatment for Crohn’s disease.
As Alfasigma USA firms up its position in the U.S. pharma landscape, Downey said the company will maintain a concentration on gastroenterology and is focused on how their long-term strategy will benefit that focus.
“We have a very long view of the future. Our vision is set out at least 10 years in the future,” Downey said. “We are moving at a right pace with a passion for pharmaceuticals and doing the right thing for patients.”
Email this
Hmm, no pressure on this one.
Let me hunt around, it was posted by the company in an earlier posting, as I recall. I picked it up a week or so ago.
Zandant, I wouldn't cross it off yet. If the AlfaSigma testing is successful only good things can come of it. There are other potentials, I won't mention as they've been hashed and rehashed over and over, but are real none the less. Though they dwindle with time, as we all know.
I have no idea what that means, and have not been able to find out anything. Other than a brief conversation (I previously reported) with office staff who hung up before I could ask more. The lady who said something to the effect that "The covid affected everything." Interesting, Leo won't answer emails, and neither will AlfaSigma. I do believe that the tests are proceeding, no real reason to believe they will not. Do you recall an earlier company summary that mentioned 2023 or 2024 as the study's completion?
Just went on one of the AlfaSigma LinkedIn sites and asked if anyone knows the status of the testing of Brilacidin for IBD. I emailed the company a few times and have received no response. If I get anything of course I'll share. Maybe Leo has some info he is willing to share? He doesn't answer my email or calls. Guess I got him angry for keeping asking about the Prurisol data, among other things.
Or there is no new staff, just salary boosts for the two already on board.
"I don't think so. One of the good findings about the B-OM, B-UC, and B-UP trials is that high doses of B can be delivered throughout the digestive tract with negligible absorption into the blood stream. B in the blood stream is where the side effects start to show up."
Guess we can both both make lots of points. However, with Leo at the helm, what we see are discussions, and little fruitful action.
"In which case I think AS would stop development of the inferior UP delivery system."
You mean the enema that AS is using in its test? Of course a pill would be better, but that just does not exist yet, as we have seen; an injection would probably be even better (at least re development, I would think), unless Leo has reason to believe it would not be, and we have not been informed. As a side note I just reviewed various AS sites to find updates re IPIX. Found none, but did see that their 2021 estimates were for completed tests of B by 2023 or 2024. And that was before the covid issues in N. Italy. I must have missed that the first time around. I agree with Minnie's previous post re a purchase by AS of IPIX after a successful IBD test would be a great outcome for IPIX. And they do have right of first refusal. Time marches on, Leo and Jane get their coin, we get the enema (you know that one had to come up).
"Initial feasibility work to formulate Brilacidin for potential prophylactic use via inhaled delivery, to leverage Brilacidin’s unique virucidal and blocking antiviral properties, also is underway"
If Leo were not so hesitant to spend money he would have paid for an injectable treatment option. He didn't, so he lowered the chances that the covid study would have been successful. This also lowers the chances that any future anti-viral and anti-biotic uses will occur. There will always be problems with an inhalable treatment option, though it will be a decent addition when and if it ever comes. I took the chance and did not sell on the coivd pop, just wish I would have paid more attention to the tells, the major one being, imo, when there was no mass medial attention on the successful companionate use examples (Since there were none). Would have been a buck or two stock easily, probably more. So yes, I am down on Leo and his salary.
Leo and Jane.
That's one way to look at it. But, if any of the products or potential products were successful, Kevetrin, B for OM, ABSSSI, other antibiotic or viral uses then it would have been money well spent. If not, if none of the potential products are real, what are we longs doing here, except subsidizing Leo and his friend?
I'm afraid that's just crazy talk :o)
Yes it is, but it's all I can come up with.
There is another option. Leo could borrow some money, and at least try and see if any bank or other financial institution thought IPIX credit worthy. IPIX might have a small lab that develops alternatives to the cumbersome IV method, tries other things including wide-scoped invitro research, seeks and relates to university and other federal research possibilities, and even finishes some tests. Borrow a bit more, in other words like a real company, not just a shell company with a million dollar payroll. Take risks. Right now IPIX is mainly a safe way for the IPIX shareholders to subsidize a salary for Leo and a friend's stock forays.
"Some will greatly disagree with my assessment. We will see who is right when the complete trial data is released. Though the secondary data may be limited in efficacy due to the low dosage I believe the Compassionate Use data will affirm B was effective according to many markers seen in the CU patients such that it should be continued to be studied for further investigation and use at much higher dosing."
Wouldn't it have been wiser to have developed an alternative to an IV and caught non-institutionalized patients who were less damaged?
"Pill form Brilacidin some day."
Too many complexities except in narrow, IBD-related circumstances, discussed here many times. An injection, on the other hand, would be more flexible. That Leo has not spent the time/money to accomplish this key treatment mode is one of the reasons that I have lost most of my remaining feelings regarding his competence.
Great post grump. Many thinks from a dispirited, degenerate gambler/investor.
'"Innovation management is engaged in discussions potentially to acquire rights to new pipeline assets, as well as to enter into new licensing agreements". Go Leo!
"Collaborative work with NIH and other researchers on Brilacidin’s broad-spectrum antiviral properties is ongoing and generating promising data, with future updates planned".'
If smoke and mirrors were pps we'd all be in a better place. It's gotten so I really hate to see this 20021 "factoid" updated for 2022. It is so far from successful Ph 3 tests that many of us on this board will have died even if there were approved products. And many kids or grandkids reviewing our files will say, '"Jeez" how could Gramps or Grammie have bought into this POS, (or words to that effect.). Have you got a calculator, what is 600,000 shares worth at .0052?' Ok, there is still a chance but it grows dimmer each day.
The continuing problem has been alluded to so many times. Leo gets paid as does his "1 person staff" and we get warmed over PRs that sound nice, but that are really predicting good results in vivo testing that we have not even seen (not worth much in themselves) and so very far away from product status. Bright dreams of broad spectrum anti-viral and anti- biotic uses are just that, dreams. So far. You'd think Leo would try harder with all of the shares he owns, guess he and his friend/staff are happy at the million or so they get annually for not sure what.
From the Guardian--
Lockdowns do not harm health more than Covid, say researchers
Little evidence that social restrictions during the pandemic have added to rates of death and ill-health
Coronavirus – latest updates
See all our coronavirus coverage
Doctors meet ambulances arriving with patients at the Whitechapel hospital in East London
Doctors meet ambulances arriving with patients at the Whitechapel hospital in East London Photograph: Mark Thomas/REX/Shutterstock
Natalie Grover, Science correspondent
@NatalieGrover
Tue 20 Jul 2021 02.00 EDT
Since early in the coronavirus pandemic, critics of unprecedented lockdown measures seen worldwide have argued that these interventions cause more harm than the disease itself. But an analysis of global health data suggests there is little evidence to support the idea that the cure is worse than the disease.
The analysis, published in the journal BMJ Global Health, considered claims that lockdowns cause more health harms than Covid-19 by examining their impacts on measures including death rates, routine health services and mental health.
As part of their study, researchers examined existing evidence, including on countries which imposed heavy restrictions with few Covid cases to assess whether the intervention was triggering excess mortality, said author Prof Gavin Yamey, from the Duke Global Health Institute at Duke University.
What were some of the collateral effects of lockdowns?
David Spiegelhalter
Read more
One key study they examined is called the World Mortality Dataset, an international dataset of all-cause mortality from 94 countries, the researchers found that countries such as New Zealand and Australia experienced no excess mortality last year. In contrast, places with few Covid restrictions such as Brazil, Sweden, Russia and at times parts of the US had large numbers of excess deaths over the course of the pandemic.
“It is … one of the most compelling pieces of evidence to support the notion that the cure was not worse than the disease,” said Yamey. “It does seem that countries that acted quickly and aggressively often had fewer deaths than in previous years. The study showed that lockdown may have reduced annual mortality by up to 6% from eliminating flu transmission alone.”
The excess-mortality data could not rule out harms caused by lockdown or conclude whether lockdowns have a net benefit, however, especially given very high excess mortality in many nations that did pursue such strategies such as the UK, the researchers wrote.
Another avenue of inquiry was healthcare services. Although data suggests a clear reduction in attendance for vital non-Covid health services during lockdowns, overwhelmed health services or a high perceived risk of infection at health facilities would also disincentives people from accessing care, the researchers suggested. “With current evidence, it is simply not possible to support either causal assertion adequately,” they concluded.
The relationship between mental health and lockdowns is often highlighted but the link between large-scale Covid outbreaks and depression and anxiety is often overlooked, the researchers noted. “Missing school clearly affects children’s mental health, but so does losing a loved one to Covid-19.”
Yes, lockdown was bad for mental health. Not to do it would have been worse
Dirk Richter
Read more
The paper, which does not include economic considerations, argues that it is likely that lockdowns have negative effects. However, “the fact that there are no locations anywhere in the world where a lockdown without large numbers of Covid cases was associated with large numbers of excess deaths shows quite convincingly that the interventions themselves cannot be worse than large Covid outbreaks, at least in the short term”.
Dr Dean Burnett, honorary research associate at Cardiff University, who was not involved in the analysis, said the study suggests many problems attributed to lockdowns cannot be easily distinguished from those caused by the pandemic itself.
“The main takeaway is that ‘deciding’ between lockdown or pandemic is a very flawed premise,” he said. “The pandemic exists, whether there’s a lockdown or not. While lockdown may have a number of negative consequences for mental health, there’s little or no evidence to say that these consequences are any worse than what we’d see in the same situation in the absence of lockdown. It’s far more likely that the opposite would be true.”
This article was amended on 21 July 2021 to clarify that the researchers analyzed existing evidence; a reference to the World Mortality Dataset, which was one of the studies they used, was also added.
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Ok, I'll look it up too. I guess you will. But, the issue still remains, if you want to find out how many died from covid annually in a place, you do the public health excess death way. That will work no matter how many deaths are caused by lock downs (Not too many I think). But, if I am doing that, will you also reread what I wrote and what lots of folks wrote about the excess death method of estimating any disease-caused deaths, that works no matter how many deaths are caused by the lock down. Not sure why that bothers you?
Thanks, great info. Logical, too.
When I say "excess deaths" I mean the deaths that are over the adjusted annual average. I didn't make up the term or define it. What's that got to do with the lockdown? How could the lockdown cause deaths?
"The best covid statistics in my experience are from Israel and the United Kingdom"
Good advice, but isn't it sad that our own CDC isn't the best? I know GB has a national system as does Israel (least I think it does) and do very well. But we are so big, with so many smart folks and so many resources, and spend more than any other nation per capita, twice that of other advanced nations. Guess that just isn't enough. Somewhere we have a problem.
All that you post is true, but slightly off the mark. The best way to determine deaths due to covid is to use the old public health method of excess deaths. Deaths before the virus, deaths after the virus, adjusted by year and by any other serious events. What is left is ascribable to the virus. The Economist magazine usually has a nice discussion each issue or two. With that method the death toll is nearer 1.2 or 1.3 million annually. Public health departments and most small hospitals post numbers that are off. They are traditionally underfunded, understaffed and the issue of what caused the death, covid or another issue is always in play, and always hard to determine. Even smart docs that are not epi trained tend to view the problem as an individual classification issue when the 30,000 foot view is best. Ok, I only took one part of a course in epi, so I am far from an expert, but the Economist has proved its value through the decades. I am not banging on you, you posted legit stuff, but the best stuff is harder to find. Not sure why that is.
"And this talk of Leo being crooked resembles the imaginarium of Dr. Parnassus.
I don't necessarily think Leo is crooked, just shrewdly and successfully self-interested, but also incompetent as a little bio CEO. He is all in the open on his strategy, always has been, imo. Say a lot but provide as little hard evidence as possible, always look to future directions but leave out the ways to pursue actual financing of these direction. When there is enough dilution money begin some actual studies. Keep emphasizing the real treatment potential of some the assets. Keep getting paid.
We could come out of this tail spin and make some great returns, but if the past is any indication of future success, we probably won't, again, imo.
'Apparently "Leo isn’t going anywhere" in spite of that performance'
Wise words.
"generating promising data"
As promising as in vitro data can be. In my view, that's not really saying much but more "slide and test tube successes." Been there, done that. It's like promising to review data from a failed covid test. Love to see the numbers. Still waiting. Leo is in the great position of getting paid nicely to watch his large personal investment. Worked out well so far (except for the investment part), but after all, he is a cpa. Just not much of a manager or science guy, or.....
I can't be positive from whom we caught it, but we really tried to stay away from everyone, I didn't even avail myself of the the open bars with my favorite Scotch on hand. These were the folks that literally came over and hugged us a few times (the only ones) and we later found out they were positive. Did not hear this from or about anyone else. These were honorable folks, truth tellers, you might say. So, that is what I believe. My take is that is certainly easily caught, but distancing yourself from others really does lower, but not eliminate your risk. And of course if vaxed/boosted, the chance of getting really sick is extremely low. If you get sick and are unvaxed/unboosted (and have no compelling reason not to be) you are a danger to yourself and to others and get what you deserve. Sorry, that's how I feel.
I had it last month. Was one of the lucky ones with just a runny nose. We were vaxed, boosted, etc. Got it at a wedding where all were tested for temperatures (kind of a useless thing, really), but had no masks. Our whole family was infected by an an unvaxed person, who spread the wealth to several people. I really didn't want to go, but sometimes you just have to go with the flow.