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George h: This should partly answer your question.
www.sciencealert.com/not-all-viruses-are-bad-for-you-here-are-some-that-can-have-a-protective-effect/amp
The CDC recommended a minimum of $3 billion upwards to $6 billion. Trump started at requesting $1.8 billion. Caronavirus pandemic should not be a partisan issue and should definitely not undergo austerity screening.
BU has a BSL Level 4 lab. Level 4 is the highest level of safety for biohazards. They can work with Ebola and Chikungunya in level 4 labs.
http://www.bu.edu/articles/2017/neidl-bsl-4-lab-approved/
One has to know the difference between a vaccine and an anti-inflammatory to prove that point. Vaccines stimulate the immune system to prevent infections. Anti-inflammatories treat infections and immunal responses.
Brilacidin treating a Coronavirus infection is not at all the same as Coronavirus vaccine preventing the disease.
That’s simply not true. A Carona virus vaccine is at least 12 months away and more probably another 2 years. In spite of claims, no one will have a vaccine ready in the next 12 months.
“ Common Stock - Class A, $0.0001 par value, 600,000,000 shares and 300,000,000 shares authorized, as of December 31, 2019 and June 30, 2019, respectively, 219,211,111 shares and 202,860,141 shares issued as of December 31, 2019 and June 30, 2019, respectively, 218,551,663 shares and 202,631,923 shares outstanding as of December 31, 2019 and June 30, 2019, respectively.”
You are correct. In spite of claims by many over the course of the above time frame, less than 16 million shares were issued during the 6 months from June to December.
It appears that much of caronavirus damage is due to cytokinetic storms among other severe immuno-responses to infection. COVID-19 damage, like SARS and MERS, is mostly centered on swelling of the alveoli which blocks oxygen and carbon dioxide transmission. If Brilacidin should work as a treatment against infections, it’s likely to be the anti-inflammatory properties rather than antiviral. Since an effective vaccine is likely 2 or more years away, simply suppressing immune response might limit damage.
Also, there are no grants available for anti influenzas that aren’t already glommed onto by Big Pharma and very well-connected startups.
Doesn’t AS have the right to first refusal in their contract? So, yes, I think you are right.
It answers where Brilacidin is released. The pills deliver at or after the ileocecal junction (rising colon). It then would treat the entire colon. Brilacidin then likely treats everything else to the anus. The pills should also be useful in replacing the enema treatment.
Of course, it will need proof in Phase 2.
Not everyone on Humira is so fortunate:
“ Humira Warnings
Humira carries a black-box warning because it can affect your immune system and reduce your ability to fight infections.
Some people who have taken the drug have developed serious or life-threatening infections, including tuberculosis (TB).”
“Numbness or tingling
Vision problems
Weakness in your legs
Chest pain
Shortness of breath
New joint pain
Hives
Itching
Swelling of the face, feet, ankles, or lower legs
Rash on your cheeks or arms that gets worse in the sun
Trouble breathing or swallowing
Fever, sore throat, chills, and other signs of infection
Unusual bruising or bleeding
Pale skin
Dizziness
Red, scaly patches or raised, pus-filled bumps”
https://www.everydayhealth.com/drugs/humira
Have you a different experience?
“Common Side Effects of Remicade (Infliximab):
Stomach and chest pain.
Chills.
Cough, runny nose, sneezing.
Respiratory infections, such as sinus infections and sore throat.
Dizziness or fainting.
Fatigue or weakness.
Difficulty breathing (shortness of breath)
Tightness in the chest.”
No need for couching with “do you expect” or “is it the hope of.” The way Brilacidin works, since there is almost no systemic absorption, the drug after release at the distal end of the small intestine and before the large intestine will treat everything from that point through the colon and to the anus. While the target is the colon, the “timed release” only has to happen near the ileocecum valve. Of course, the colon itself is a huge target.
Yes, previous trials have already shown this. That’s why the IPIX trial size is so few subjects. The primary outcome is simply to show that Brilacidin can also be delivered to targeted areas of the colon. IMO, slam dunk trial.
News, ”On Friday, we received notice that analysis of the gamma scintigraphy images and plasma pharmacokinetic samples are ongoing from our Phase 1 trial investigating the use of delayed targeted release tablets for colonic delivery of Brilacidin in healthy volunteers. The analysis of gamma scintigraphy images from the study is critical to best evaluate the delivery of Brilacidin directly to the colon. We believe that targeted delivery to the colon is part-and-parcel to the potential future success of Brilacidin as a new oral inflammatory bowel disease drug. We are pleased to inform our shareholders that we expect to release topline results from the trial later this week.”
Is IPIX finally I he right medical need at the right place is me?
With the pipeline for new antibiotics slowing to a trickle and bankruptcies driving pharmaceutical companies from the field, the World Health Organization on Friday issued a fresh warning about the global threat of drug resistant infections.
Some 700,000 people die each year because medicines that once cured their conditions are no long effective. Yet the vast majority of the 60 new antimicrobial products in development worldwide are variations on existing therapies, and only a handful target the most dangerous drug-resistant infections, the agency said in a report.
“We urgently need research and development,” said Sarah Paulin, technical officer of Antimicrobial Resistance and Innovation at the W.H.O. and an author of two reports on the subject issued Friday. “We still have a window of opportunity but we need to ensure there is investment now so we don’t run out of options for future generations.”
Without government intervention, the United Nations estimates that resistant infections could kill 10 million people annually by 2050 and prompt an economic slowdown to rival the global financial crisis of 2008. ...
Read more:
https://www.nytimes.com/2020/01/17/health/antibiotics-resistance-new-drugs.html?algo=identity&fellback=false&imp_id=159677160&imp_id=774396978&action=click&module=Science%20%20Technology&pgtype=Homepage
It may still take a year or two to find out. In the meantime, watch the development of human testing for anti-inflammatory properties for IBD.
As much as I would like to say yes, B is the panacea of all human ailments, no, it is not effective against viruses. Fungi, maybe, prion, unlikely, viral, definitely not, but bacterial, absolutely, and inflammatory, oh yes. Viral diseases often result in secondary infections, so yes to treatment of inflammatory and bacteria infections following viral respiratory infections.
Yes, of course. They received permission to do a small bridge study in early 2020, didnt they?
Not gone. Still here. News is the pipeline continues to progress. News is antibiotic resistant strains are emerging exactly as predicted 5 years ago. News is developmental biopharma bankruptcies are stifling new therapies during the rise of antibiotic resistance. News is IPIX continues to prove both its platforms and its resistance to those forces working against it. I’m still here.
Not ready for CT. Needs to be up a little (or a lot) more before his alert triggers.
If short sales are 77%, then can’t be but a few sellers. 77% of buyers are picking up shares at or near bid with sellers providing only 23% of the shares.
Nice little update. Was it fluffy? Yeah, a little. But, it did outline where the company is on its IBD pill with a timeline confirmation for December safety and time release/ targeting data. Just good to get that. I would have liked to have gotten those .09s from midday, but wasn’t ready for the dip. I like the close, though. All in all, neither good nor bad; just daily IPIX, for years now.
Oh, bullshit. Raising money means selling shares, no matter how it’s structured. Only a partnership is better, though still usually dilutive.
Issuing shares, selling shares, is better than not issuing and selling shares. Is it good? I think most would say no. But, it’s better to raise money than not to raise money. Increasing the AS with the approval of shareholders is better than running out of shares whence funding, or just raising the AS an telling us to lump it like so many other OTC in its history. Leo is still following reporting requirements.
Why would I ask Leo? Wouldn’t that be insider info? Oh, not if it’s already reported.
Is there anything we are looking for this week or next? Any anticipated announcements?
Ho hum? Ho hum? The treatment was 100% effective in all cases. Someone bring up the slide deck. They are working on a number of approaches including increased retention through foams, jells, etc. The spectacular results came from nothing more than water, if I remember correctly.
The patents for Brilacidin will be extended by reformulation into time release, targeting capsule/pill, or through reformulation for oral use (viscosity adjustments) and possibly enema delivery (if oral delivery targeting the lower bowel and colon is not practical or efficient. I’m not worried about patent expiration.
Efficacy: the ability to produce a desired or intended result.
The primary outcome and therefore measure of efficacy for the phase 1 trial was modulation of the gene controlling apoptosis. Kevetrin was shown to be effective in modulating that gene. Whether or not it was effective in controlling or treating late stage cancers is what you refer to and were part of secondary outcomes (if I recall correctly).
“Yams”? All this time I thought it was “hot tamales.”
“IPIX shares, get em while they’re hot.” Harkens back to the days when Bollinger had a primitive finance show on NY cable where he pumped hot penny stocks ready to explode. Nearly all of them did.
“Prior estimates for the cost to develop one new (cancer) drug span from $320.0 million to $2.7 billion.”
“In a widely publicized analysis from the Tufts Center for the Study of Drug Development, the authors estimate $2.7 billion (inflation adjusted for 2017 US dollars) is needed to bring a single drug to the US market.”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5710275/
$30 million is nothing in real costs for cancer drug development. And yet, it’s a lot of money not just to those of us who don’t have $30 million.
Thanks for setting me straight.
Compassionate use requires there to be efficacy signals for a disease. Currently there are no Kevetrin data (that I know of) for pancreatic cancer.
Ginsberg is lucky enough to be on the same platinum medical care plan as Congress, senators, White House cabinet and POTUS. Her cancer was detected early enough that the only effective treatment available could be applied, pancreas resection. The vast majority of pancreatic cancers are detected only after the pancreas stops working sufficiently and there are no tissues left not cancerous. In fact, by the time it’s detected it is already late stage and has already metastasized.
Kevetrin as a treatment will likely need to be adjusted to target the pancreas by combination, turning the molecule into a chimera, or direct injection (ouch). In any case, until there is efficacy signals and a clear strategy for treatment course, it’s unlikely to be used as a treatment of last resort for PC. At the point of compassionate use, most authorities see late stage PC as untreatable.
There is currently 3D printer stem cell technology that creates and grows small replacement organs. This is likely the only effective PC treatment in the next 2 decades. But, it takes several months to grow even a small organ and PC patients usually have less than 6 months
No. It’s my position that no one knows the size of the upfront except the principles involved. It’s my position that AS policy is not to make public the amount of upfront payments.
Exactly.
“SS....Well now then.....You just posted proof that the material event was the Licensing of the UP/UPS indications to Alfasigma. So that has been reported and truly was a "material event", IMO.”
Sorry, but I don’t see anything there that states Leo has to report cash not yet received. As LR pointed out, Leo has determined the upfront money is nonmaterial after disclosing terms of the agreement. Payments deemed nonmaterial need not be reported until received.
Back at you, cite the regulation that says Leo has to report cash or any payments before they are received. You can’t. Leo is only obligated to report the amounts after payment.
The UC/Crohns trial will most likely be similar to the previous IBD trial—proof of concept, small trial, about 20 patients. The cost could range from $3 million to $7 million. That would include drug preparations and pharmacy start up as well as paying for PI, Coordinator and clinical space, plus all testing including multiple xoscopy exams, blood tests and MRIs. One can speculate on the term ”substantial” from there.
It’s not material until IPIX receives it. Until then, he only has to disclose that there is an agreement and upfront payment. His obligation, as you put it, is neither ethical or fiduciary. It is merely regulatory.
“Are you saying that the 2b will be used to determine medium AND dosage, using multiple cohorts of both? (Or would they select a medium without any formal clinical testing to determine their relative effectiveness?) How many patients might a P2 require given those variables?”
Dosage and safety isn’t an issue since there is almost no absorption. For those 18 patients, efficacy and safety are already well established. Really, it’s just a matter of tweaking dosage and exposure to see if efficacy can be maximized. As for medium and delivery, there are well-established emulgents that require minimal testing. It’s really just a matter of picking the most convenient and easily applied, and then running with that. As for patients, I would think fewer than 300, perhaps as few as 100 if the plan is a phase 3. I would think that AS is in a position to argue safety sufficient to allow Phase 2/3 in Europe. Far less likely that same approval in the US.
Yes, there seems to be a corresponding B concentration and retention, but there is also a signal for increased concentration and efficacy. Cohort C approached 100% no RB more quickly than either of the other cohorts. However, 3rd week results give me pause as C drops back to 20% no RB from 60% the week before. Don’t know what that means. Just the same, no RB in 100% of subjects at week 7 for both B and C cohorts should mean accelerated trials. Again, AS is in a position to argue successfully for a BTD.
To your last question, I think it’s less of an issue than one might think. We are talking about retention enemas, which have been around for decades, if not centuries. We aren’t talking about time release capsules targeting specific regions of the upper and lower gastrointestinal tracts.