Brilacidin can absolutely be developed as a prophylactic in addition to a therapeutic. PolyMedix was developing a prophylactic product called PolyCide® for, among other uses, antimicrobial sutures. Here's a quote from a 2011 article (PolyMedix Presents Data Showing Antimicrobial Activity of Sutures Containing PolyCide):

IPIX is not pursuing brilacidin as a prophylactic. I don't fault them at all. I would be doing the same thing. IPIX is all-in on brilacidin as a therapeutic.

These figures are from the paper previously published in viruses. The "(E)" has to do with how the cells are pretreated before the virus is introduced. It's explained there.

In vitro data presented at ASV 2021 for Alphavirus and Bunyavirus used brilacidin at a concentration of 20µm and included pretreatment of the virus with brilacidin. The concentration of 20µm converts to a dose >1.5 mg/kg (almost 2X the highest single dose used in the ABSSSI P2 trial) while the pretreatment improves the potency of brilacidin. Both this dose and pretreatment of brilacidin are not possible when using brilacidin as a therapeutic in the real world. This is PoC stuff, and I know that investors were not the intended audience, but I was hoping for something to come out of it that would apply to the real world and move the share price.

2 slides seem to be missing from the deck. The slides are numbered 1-21 but there are 19 slides in the PDF. Slide 6 or 7 and 13 are not included.

E-trade is showing 150 sold at $0.29.

bid/ask at 9:09 am is $0.25 / $0.275
NITE on both sides

Hidradenitis Suppurativa from IPIX’s 2015 10-K:

There was no mention of it in subsequent 10-Ks.

Yes, you're correct. I saw that after I posted and edited my post.

I edited my post.

Here's a press release from 2017:

Innovation Pharmaceuticals Phase 2b Psoriasis Study On-Track for Completion in December 2017; Company a Sponsor at Upcoming Symposium on Hidradenitis Suppurativa

I doubt it's still ongoing since there's no mention of ongoing work with brilacidin for Hidradenitis Suppurativa in the recent IPIX 10-Ks. If it's true, it would be a pleasant surprise.

I should have made it clear in my post that I was responding to this part of Hugon’s post:

My opinion is that a shareholder, or potential shareholder, should be more interested in how the company is going to commercialize their product than the mechanics of a clinical trial, whether results are planned to be submitted for peer-reviewed publication, or the timing of when an oral presentation would be published. More importantly, the CEO of the company should have more important things to do with their time than respond to message board themes.

I was disappointed with the Shareholder Alert. I thought we were at a point where the CEO might have something substantial to convey rather what, in my opinion, is litter.

Polymedix received at least 15 research grants or contracts, including several from the Army, for research on “novel defensin-mimetic antimicrobial compounds” (PMX-30063, brilacidin, was their most promising compound). Didn't work out for them. Here's my post from a couple weeks ago:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164656331

I think it's a positive if IPIX is able to get research funding, but it doesn't guarantee anything.

I agree with your comments on the Shareholder Alert. I was hoping the next communication from IPIX would be substantial. This Shareholder Alert is a disappointment imo. For example,

Why does IPIX need to remind shareholders how a double-blind trial is run?

Is planning to submit for a peer-review publication really that notable to shareholders? I know they're few and far between, but who decides whether to buy, hold, or sell shares of IPIX based on this?

And why does IPIX need to toss in "the day after" for the oral presentation? Why can't they just post it the day after and not crow in advance? That would be more impactful imo.

I was expecting more substance and less clutter.

The results would be “good” if brilacidin shows a significant reduction from baseline of the SARS-CoV-2 viral load with minimal TRAEs. This “good” result after IPIX presentations at ASV 2021 (July 19-23) and MHSRS (August 23-26) showing that brilacidin inhibits other viruses in vitro would be very positive imo.

The results would be “great” if brilacidin is also able to improve the primary or secondary outcomes.

You can read the lease extension here: Response to SEC inquiry about Form 10-K for year ended June 30, 2013, Filed September 30, 2013

The lease extension is the 2nd to last page. Paragraph 2 covers the automatic extension for 5 years. The lease extension was signed by Menon on behalf of Cellceutix Corp on August 30, 2013.

Menon and others at CTIX didn’t read the lease extension when it was signed in August 2013 and Leo Ehrlich didn’t read the lease extension when he provided it to the SEC in March 2014.

This document also contains information about the UPenn licenses and patents that CTIX inherited from the Polymedix bankruptcy which is important dd for IPIX investors.

The documents on file with the court for the "Innovation Pharmaceuticals Inc. vs. Cummings Properties, LLC" lawsuit can be accessed using the link and instructions I provided in this post: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164059214

I don't see how IPIX wins this case. Signing documents and making contractual commitments without reading them is not a valid claim.

I'm with you in the opinion that the 60 day phone call should be reassessed unless the DMC has evidence from earlier subjects that there are safety issues at 60 days (unlikely imo).

Lemoncat has posted the FDA's guidance on this issue several times. Here's one of those posts:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164653355

Holy smokes! I didn't see this one coming.

What part of the brilacidin GMU paper can you point us to that would indicate this has any bearing to reality at all?

You don't like mRNA vaccines, that's fine, but c'mon JTFM.

IPIX stopped paying the lease with the payment that was due January 2020. This is in the documents filed with the court. They paid the lease for October 2018 through December 2019.

IPIX hired a real estate broker to try to sublet the property (again from the court documents filed with the court). The real estate broker was unable to find someone to sublet and IPIX ended that relationship before filing the lawsuit.

It's pretty remarkable for someone to do this and then file a lawsuit claiming they didn't know the lease had an automatic renewal.

BTW, the lease extension that included the automatic renewal clause was 1 page, 6 paragraphs, and the 2nd paragraph covered the automatic renewal. They didn't read what they signed!

I stated in an earlier post that this lawsuit shows poor judgment on the part of the CEO. It's futile and a waste of company resources.

Very intriguing connecting of dots!

Here's another dot about the DOD and brilacidin in case others don’t already know. Polymedix received at least 15 research grants or contracts, including several from the Army, for research on “novel defensin-mimetic antimicrobial compounds” (PMX-30063, brilacidin, was their most promising compound). Perhaps this past research helped IPIX get interest on brilacidin as an antiviral? I'm unclear as to why IPIX wouldn't have issued a PR on gov't funding.

Here are a couple articles about Polymedix and DOD funding:
Radnor-based Polymedix earns $1.6 million contract to combat biowarfare pathogens
More Army funding for PolyMedix antimicrobial research

Here's a quote from a Polymedix 2012 press release: PolyMedix Reports Second Quarter 2012 Financial Results:

I didn't read through it until just now. Thanks for pointing it out.

Here's an interesting bit, earlier in this thread MinnieM provided a duckduckgo link to help me find the reference. If you go to the link you'll see that "Hungry_Ghost"'s original post is now coming up as the #3 hit! The op is famous!

https://duckduckgo.com/?q=The+European+commission+just+signed+a+agreement+for+1.8+billion+Pfizer+covid+19+shots+to+vaccinate+the+450+million+Europeans+for+the+year+2023.+YES%2C+2023&t=newext&atb=v279-2__&ia=web

That occurred to me. Another possibility, which I have been guilty of myself, is misreading things in a way that reinforces the narrative you want to believe.

I'm most interested in finding out if there's information we're not aware of.

The May deal is old news.

If you go back and look, you'll see that I wrote "Interesting. Please post the link." to the op. It was everyone else chiming in that confused the issue. If we just let "Hungry_Ghost" post the link we might all learn something.

Again, here's the op from "Hungry_Ghost":

The 2nd bullet says it's for 2021 through 2023. And it's the deal from May which is old news.

I don't think I'm misreading the original post from "Hungry_Ghost". It's very specific:

The op says it was "just signed" and repeats the fact that this is for 2023.

That is definitely not it. The op was quite clear that it was 1.8 billion doses from Pfizer for 2023.

Thanks for the links anyways. Maybe someone else has the link. Here's the original post from "Hungry_Ghost":

Those are from May and for vaccines purchased from 2021 through 2023. I'd like the link the op referenced:

Seems definitive to me. The poster "Hungry_Ghost" should have a link.

Interesting. Please post the link.

Has anyone heard of proxalutamide being developed by Kintor Pharmaceutical Ltd? I hadn't heard about it until this morning. Come to find out they have five Phase 3 clinical trials for COVID. This is the kind of competition that exists for IPIX.

One of their trials completed recently: Proxalutamide Treatment for Hospitalized COVID-19 Patients (Phase 3)
Study had 645 participants and was done in Brazil. The study start date was February 1, 2021 and results were posted June 23, 2021. The drug is administered as a pill. Study has results posted so you can dig into the outcomes, SAEs, etc. The last outcome date was 28 days -- no 60 day phone call for these guys.

A preprint of their paper has been posted: Efficacy of Proxalutamide in Hospitalized COVID-19 Patients: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Clinical Trial.

Takeaway from the preprint:

 
People were throwing around potential revenue numbers for brilacidin. Does this drug have any impact on brilacidin's revenue potential?

"If the only TRAEs were paraesthesia and hypertension at 3 days, yes, they probably go approval to raise to 5 days."

You’re saying the DMC would know that 14 out of 15 subjects experienced TRAEs under the 3 day dosing regime yet would decide to extend their discomfort (perhaps even amplify it) by an additional 2 days without even knowing whether the drug is having any benefit? That sounds downright cruel. Again, they have no idea whether the drug is having any benefit.

I agree that if the drug showed benefit the ends might justify the means, but remember the DMC has no idea whether the drug is working or not.

And I think it's possible that using additional medications to manage the TRAEs runs the risk of compromising the clinical trial.

Here's the relevant part from the IPIX PR of April 5 (Innovation Pharma Completes Interim Safety Data Review—DMC Approves Increased Dosing Frequency in Phase 2 Clinical Trial of Brilacidin in Hospitalized COVID-19 Patients):

I read through the section you identified (and 4.4.1.2. Monitoring for Safety) and didn't see anything that changed my opinion. Perhaps I missed it.

My point was that if the dose was equal to the 3-day regimen from the ABSSSI Phase 2B, we would expect that 14 of the 15 subjects who received brilacidin would experience a TRAE. With that information and no efficacy data, would the DMC be likely to recommend that the dose be increased to 5 days (an increase of 66%)? My conclusion is that they would not. They might do it if they knew the drug was having a benefit, but at the time they are making their decision they don't know.

Are you suggesting that if the DMC reviewed data on the first 30 subjects (25%) and 14 of the 15 subjects who received brilacidin reported TRAEs on a 3-day dosing regimen that they would then authorize an increase to a 5-day dosing regimen? (14 of 15 subjects having TRAEs = 93% TRAEs which is in line with the 3-day dosing TRAEs of 92.5% from the ABSSSI Phase 2B) The DMC has no visibility on efficacy. Unlike your example, they have no idea "if it proves effective." The DMC is looking at safety only.

That’s impossible in my opinion. The conclusion I draw is that the dose being used in the COVID trial must be lower than the dose used in the 3-day dosing regimen in the ABSSSI Phase 2B trial. Only a lower dose would present a safety profile that would justify the DMC increasing the dosing from 3 to 5 days. And based upon my reading of the GMU data for brilacidin without preincubation, that low dose will have a modest therapeutic effect, perhaps even sub-therapeutic as another poster suggested.

The brilacidin COVID trial excludes subjects “Requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) at the time of randomization.” I agree that the mortality rate of those on ventilators is terrible, but I think you’ve gotten twisted up in trying to justify the use of brilacidin. “1/500+ or 1/2 chance of dying. I'll take the Brilacidin.” is dramatic nonsense imo.

Here's the safety information from the ABSSSI Phase 2B trial:

The total TRAEs for subjects administered brilacidin was between 79.2% and 92.5% of the subjects. Where the ABSSSI Phase 2B trial did better was in the number of subjects who discontinued brilacidin. In the ABSSSI Phase 2B trial 6 subjects discontinued (Polymedix was 9).

The 3-day dosing regime in the ABSSSI Phase 2B trial was 0.6 mg/kg day 1 followed by 0.3 mg/kg days 2 and 3. This 3-day dosing regime had 92.5% TRAEs and 26.4% had hypertension issues.

My opinion is that they are using a lower dose in the COVID clinical trial if they were able to increase the dose from 3 to 5 days. Based upon the GMU paper data without preincubation, that lower dose probably has modest antiviral effect.

“Yes Completely False:”????

You overlooked the “Brilacidin (PMX-30063) Antibiotic Fact Sheet” put out by Polymedix.

Between 70.6% and 96.6% of the subjects treated with brilacidin had TRAEs. Some had SAEs. Some had SAEs of hypertension.

You can find the fact sheet on the Wikipedia page for brilacidin. It is footnote #2.

Part of my skepticism about the success of brilacidin in the ongoing trial is that a safe dose of brilacidin is a low dose. The fact that the dosing was increased from 3 to 5 days reinforced my opinion that the dose being used was significantly lower than what was given by either Polymedix or CTIX in their Phase 2 trials. That low dose coupled with my reading of the GMU paper showing the modest antiviral effects of brilacidin without preincubation (preincubation is where briliacidin and the virus are combined for 1 hour before being introduced to the cells -- impossible to do in the real world) suggests to me that the low/safe dose being used will have little therapeutic effect.

I’ve read some other posters commenting about the probability of success being a coin flip or a roll of the dice. I think the probability of success in the clinical trial is <5%. That does not mean this is a bad time to own the stock. The near future could be positive since there are a couple good PR opportunities coming up that could cause the share price to pop given the depressed share price/valuation, massive cash flooding the market, and abundance of uninformed investors.

The article promotes early treatment with fluvoxamine and ivermectin. Here are a couple quotes from the article:

I didn't see where it highlighting the desperate need for brilacidin, indirect or otherwise.

It sounds almost as if you doubt that COVID can be detected at all.

That’s pretty far from your original argument about the inability to compare the % of positives before and after the vaccine became widely available.

The technology for PCR testing is about 35 years old and is a ubiquitous laboratory tool. The COVID test was created last year because it tests COVID. Can’t add much to that.

Things are getting back to normal where I live. Today I’m going out to register for a booth at our local street fair. That fair was cancelled last year because of COVID.

In general I thought CTIX overhyped the results and minimized the TRAEs. At that point in time there were several compounds in the works including kevetrin, the one that brought me to CTIX. I do remember sending an email to the CEO when I received this communication: Cellceutix to President Obama: We Have the Tools and Will Rise Up to the Challenge to Prevent Antibiotic Resistant Bacteria Becoming a Serious Threat to Public Health. My message to him was simple: He would do better for shareholders to underpromise and overdeliver rather than the other way around.

Obviously, he didn't take my advice. I expect IPIX will send out PRs over the next several months that hopefully will move the share price.

I was never a buy-and-hold investor in CTIX/IPIX. My original interest was kevetrin and that looks to be the most viable compound imo. There was some promising research published in Oct '20 on kevetrin:Kevetrin induces apoptosis in TP53 wild-type and mutant acute myeloid leukemia cells. This was independent research without the funding and conflicts of interest of the GMU research that seems to have been ignored. Even the PR done by IPIX was weak imo. I don't think IPIX knew the paper was being published. Menon was credited as author, so he knew, but I guess he wasn't telling anyone at IPIX.

The near future could be positive imo since there are a couple good PR opportunities coming up. I’ve made no secret of my skepticism of brilacidin performing well in the ongoing trial, but that is offset by the depressed share price/valuation, massive cash flooding the market, and abundance of uninformed speculators.

"The threshold doesn’t pertain to deciding whether the test is positive or not." Referring to the PCR threshold of 28 cycles.

You can read the full article here: Story Twists Facts on Diagnosing Breakthrough COVID-19 Cases

A surprisingly bold statement from the CDC: “. . . nearly every death due to Covid-19 is particularly tragic, because nearly every death, especially among adults, due to Covid-19 is at this point entirely preventable."

You can read the full article here: Nearly every new Covid-19 death is now entirely preventable, CDC director says

Brilacidin is on the RAPS list. Information on brilacidin was last updated on April 9th.

I agree that any investor in IPIX should review this list carefully and be knowledgeable about the competitive landscape.

I wrote this morning:

An investor also needs to consider the number of other therapeutics in the market and coming to market in the near future. It’s a tough pull for brilacidin imo.

Article was posted earlier this morning. Not likely to need brilacidin:

https://www.yahoo.com/news/almost-4-000-fully-vaccinated-062303297.html

It’s flawed logic to assume that brilacidin would be purchased by countries that cannot afford to vaccinate their populations (third world countries). If a country can’t afford $25 to vaccinate they are unlikely to be a viable market for a costly drug like brilacidin with a complicated method of delivery.

As to vaccinations . . . I think it’s a lack of historical knowledge to suggest that the rate of vaccination is slow. Vaccinating 2.4 billion people in 6 months is nothing short of astounding. And don’t forget that the people being vaccinated first are those most susceptible to COVID.

We all know that the antiviral market is huge, but it was also huge when brilacidin was developed by Polymedix. Why wasn’t brilacidin developed as an antiviral by Polymedix?

The usefulness of a vaccine isn’t that you don’t get the virus at all, but rather that when you do get the virus your immune system is prepared to fight it off. That’s basic stuff. In fact, the article says that, “. . . most of the new cases among vaccinated persons are mild . . . .”

Nothing is 100% so there will always be a need for therapeutics, but that need appears to be modest based upon the number and efficacy of the vaccines and the rates at which they are being administered.