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I'm looking forward to seeing the secondary endpoints when it comes to the number of ventilators being used in each group. I'm hoping to see B+R requiring fewer patients going on ventilators. If secondary shows nothing then I will continue to accumulate for B-OM.
I’m pretty sure they have three days to release news.. just think of the dealings with BPs and government that could be happening right if they’re holding good to great results.
Go IPIX
Could be a part of the FDA "fast-tracked" designation which allows communication throughout the process.
WRONG! it didn't sink to .06 it hit .05. I know this cause I was able to buy a nice chunk that I'm still holding onto and not selling any of them until we're 10.00 plus a share.
Still seeing manipulation on level 2. Shorts will regret this @ 9:29:12 a buy of 96,030 printed as a sell.
They won’t be dumping they’ll be holding for partnerships and eventually buyouts.
News out
Innovation Pharma Surpasses 50 Percent Enrollment in Phase 2 Clinical Trial of Brilacidin for COVID-19
Innovation Pharma Surpasses 50 Percent Enrollment in Phase 2 Clinical Trial of Brilacidin for COVID-19
• >60 patients have been randomized in the Company’s ~120-patient Phase 2 COVID-19 clinical trial
• With COVID-19 cases rising worldwide as the coronavirus continues to mutate, the need is greater than ever to develop novel broad spectrum antivirals of the future
WAKEFIELD, MA – April 28, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced that enrollment has surpassed 50 percent of the total targeted number of randomized trial participants (~n=120) in its double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897).
Brilacidin is the only non-peptidic defensin-mimetic drug candidate in the world currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19. Additionally, Brilacidin has shown potent inhibition in vitro against different strains of coronaviruses and alphaviruses (with lab testing against other virus families also underway), supporting Brilacidin’s potential to be developed as a broad spectrum antiviral.
“Achieving over 50 percent trial enrollment represents an important milestone as we advance Brilacidin for treatment of COVID-19,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “We are hopeful Brilacidin will emerge not only as an effective COVID-19 therapeutic, but also as a desperately needed broad spectrum antiviral. With the world experiencing a record number of new COVID-19 cases, including nearly 1 million new infections in India across a 3-day period, we remain dedicated to bringing to market a novel antiviral to help ease patient suffering. We look forward to completing our COVID-19 clinical trial and releasing topline results.”
Linked below are recent articles published in the journal Nature. Both reinforce the need for developing novel antiviral drugs, such as Brilacidin, to help address the current COVID-19 crisis, as well as to be prepared to confront future pandemics.
• Funders, now is the time to invest big in COVID drugs (nature.com): Vaccine development has been a resounding success. But the medicine cabinet should have been better stocked.
• The race for antiviral drugs to beat COVID — and the next pandemic (nature.com): Despite dire warnings, a stockpile of ready compounds to fight viral pandemics was sorely lacking. Can drugmakers finally do the right thing?
About Brilacidin and COVID-19
Innovation Pharma is developing Brilacidin for COVID-19 under Fast Track designation from the U.S. Food and Drug Administration (FDA), and currently is enrolling patients in a Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897). Upon recently completing a scheduled review of interim safety data from the trial, an independent Data Monitoring Committee (DMC) recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, which may maximize therapeutic benefits and provide a comparison with 5-day remdesivir (Veklury™), currently the only FDA-approved treatment for COVID-19. The annual global antiviral drug market is estimated to reach $44 billion by 2026.
Do some research and you’ll see the being vaccinated doesn’t mean you’ll get it again. Bril will be a major player if positive results on PH2 and EUA is given. There’s nothing you can say that will stop it from happening. Let’s let the science speak for it’s self.
Go IPIX!
Agreed, I also like to point out the AEs for the placebo....it’s water!! Bril is SAFE for humans and anyone pushing a false narrative that it’s not should be taken with a grain of salt. Know what you own as our time to shine is coming.
We view it differently then. I see the B-UP arm as an indication that IPIX was okay with not getting a massive upfront payment. What I find massive value in is the cost savings at them fronting the cost for any research & trials. In the agreement all findings will be shared with IPIX which could potentially be used to support other indications of Bril. 10s of millions of dollars were saved with this deal. Don’t forget there’s a clause in there too that IPIX can yank the indication for B-UP if progress isn’t made. I also scratch any trials other than cancer or covid related off as hospitals around the would came to a halt.
Trust me if covid results are positive. Than pan coronavirus alone are multiple trials that will need to be tackled on top of the other indications we have planned.
We have enough on our plate right now. It’s now up to bril to flex its muscles.
Go IPIX.
There you go again kitty cat... 420k plus royalties plus they cover the cost of potential 10s of million dollars of research/trial cost. It's a good deal for their first one so IPIX and focus on the many other avenues the Bril can tackle.
You're undervaluing the B-OM market.
From the November 13th PR 2019
A safe and effective drug to prevent—or even reduce the duration of SOM—has the potential to fill a large void in supportive cancer care and capture a substantial new market, an annual global commercial opportunity estimated to range between $500 million and $2.5 billion.
Oh please tell me more about this "Super" fast track designation the FDA has kept hidden from the medical community? Does that mean we're super fast-tracked status after we get EUA with rems?
Hope you sense my sarcasm in the above statement to your comment.
FDA has grated IPIX fast track designation and now its time for Bril to shine and prove with results on the PH2 trial. They've given us the pathway and now it's up to the IPIX team to come through with the results.
That's common sense that pathway would need to happen. If Ph2 results are good/great you can bet that GSK and others will be partnering or trying to buy us out. Money won't be an issue for much longer as long as the results come through. I invest in the future and based on past trials with Bril and the GMU research along with FDA fast track I'm feeling pretty dang good with my decision. Buying more every chance I get.
That's good news for us since therapeutics will be coming in that actually work It allows us to continue to accumulate at a massive discount to build & hold hundreds of thousands of shares. In reality, I believe were the bottom of the 8 with bases loaded and Mark McGwire is up with bases loaded and the pitcher is a 15-year-old boy who throws underhand. Good Ph2 results with Rems and EUA will transform this into a whole different company. I have not and will not be taking any vaccine that isn't FDA approved or transcribes the mRNA. I'll pass
U.S. calls for pause on Johnson & Johnson's COVID-19 vaccine
https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-va/u-s-calls-for-pause-on-johnson-johnsons-covid-19-vaccine-idUSKBN2C01BC
Previous post translated:
The active ingredient brilacidin from Innovation Pharmaceuticals can prevent SARS-CoV-2 from multiplying in cell cultures . It inhibits molecules such as interleukins and tumor necrosis factor alpha, which contribute significantly to stimulating an inflammatory reaction. It is currently being tested in a Phase II study with hospitalized Covid-19 patients. Not only does it have antiviral and anti-inflammatory effects, but it also stops bacteria from multiplying. It was shown as a mouth rinse in a phase II study with patients who had developed inflammation in the oral cavity (oral mucositis) as part of chemotherapy. The FDA granted brilacidin Fast Track statusto accelerate the development and testing of the active ingredient.
I hope not. IMO we need revenue of a possible successful ph3 Bril-OM marketed drug then focus on bringing the other Ph2 drugs up through development. Ph3 OM would be quick vs Ph2 then PH3 UC trial.
All comes down to financials. I agree If the war chest is packed then all indications are moved forward.
IMO your 1.3 patients a day is off now due to recruiting sites coming online. When you originally posted this assumption of run rates was before the last update of sites beginning recruiting. FDA doesn’t update their stats daily either nor do we know if there’s a influx or decrease in patients trial sign up.
All comes down to financials vs dilution. IPIX could have sold shares into market but we would’ve been at a significantly higher OS then we are now. I know any type of Cancer trials are not cheap and estimate we would’ve needed 9-14mil to run it and at that time we didn’t have that in the bank. B-OM would be the fastest way to market after Covid. Other similar OM ph3 trials have been ran with less than 700 patients.
Ph3 by far the biggest and most costly phase of any drug development and I truly believe if PH2 covid comes through with positive results the flood gates from BPs and FDA will open. They just want the results first to back up this new never before in market drug that will change the Therpy landscape.
I believe ipix will be busy signing deals with BP and FDA if results are positive. Bril has not failed one PH1 or PH2 clinical trial throughout the multiple indications it’s tackled.
The way I see it is that Leo has two paths once positive ph2 covid is released. (Assuming EUA is given)
1) Become a licensing/partnership to big pharma.
2) Get Bril to as many end of Ph2 ready for Ph3 drugs and sell the entire company.
3) covid Ph2 fails and he was to do some hard diluting of shares to finance Bril-OM.
If 1 or 2 happens we’ll be into double digit territory.
I think Leo is a smart man and might have learned some lessons and is hoping for 1 or 2 to happen but is using this prepare just in case 3 happens. I was happy seeing that we were at 14million in the bank last quarterly report.
This is of course with Alfasigma silently pushing Bril along in the indications it’s licensed out.
Hope for the best but plan for the worst
Go IPIX.
The realization of a great drug working like Bril will come after results are published after the trial and EUA is given in use with Rems a few months later. Bril will slap COVID in the face along with the medical world in a whole new class of therapy drug and multiple future indications. This isn't your typical repurposed drug here. That's one reason FDA & other BPs want to see the data first before throwing 10s of millions behind us.
Covid is just the tip as I see OM being pushed through a fast Ph3 soon after an injection of cash from a future partner after positive results of PH2. There are many BP's waiting to see the results and leo/CT/FDA/RBL has and will provide the data to backup Bril.
The original COVID line I'm not worried about based on the RBL in-depth depth testing. We'll see results but as COVID mutates this is what everyone will be looking for is a therapy that can handle the whole spectrum. I saw that one of the vaccines protects only 10% based on the South African stain. I feel confident enough in bril reporting positive Ph2 that I'm betting the house on it.
Go IPIX
Another reason why I'm happy they're running trials in Russia is below taken from their PR.
According to Russian news agency Tass, nearly 1,500 coronavirus mutations have been discovered in Russia, a country where seven sites are currently enrolling patients in the Company’s COVID-19 clinical trial.
If Bril succeeds in Russia then it has a higher probability it came into contact with an aggressive form of COVID-19 and decimated it. This should put the naysayers to rest and share price sent to orbit. Bril the penicillin of our time.
Finally Lemoncat your future price projections are creeping up the correct way. Once you start looking at the potential other indications and it will really blow your mind and price projections. I believe with each passing trial that Bril shows provides us more info on the drug which raises the probability of the drug succeeding in future trials. all we need is a good PH2 and the money will flow which will give us the final backing we need and we're off to the races.
Go IPIX
Ph2 results will come when they come and I'm expecting them to prove yet again Bril is a monster and fights against COVID (along with other indications that we already know). NO I don't care about Prurisol. Prurisol was years ago and patent rights were given back after it failed. It's a dead horse but you and others continue to bring it up years later. It didn't work so it's not worth the companies time or money.
Go IPIX!
Fully agree that both FDA and IPIX had to agree to taking on all mutations. I think it speaks volumes on the known strength of Bril.
RBL Data: Bril is a beast and crushes the variant X,Y, and Z
FDA to IPIX: (reviews RBL testing) Dang IPIX you really do have something special here. Let’s run it against all spectrum of Covid. We’ll hand you fast track and key an eye on the trial.
IPIX: heck ya we’ve known that Bril is a beast and it can handle it and when it does be ready for our EUA application soon after the trial is complete
Nothing wrong with the company and Leo is our largest shareholder. Out of anyone he knows what we have and knows where this is going. Longs will have a major payoff. The 150ft California redwood once was a seed sprouting. It takes time..go have a juice box block the constant manipulation of soft bashing and watch IPIX grow into a monster over time.
GLTAL’s
Still accumulating
Bonne chance for us riding a wave many of us will only experience one in a lifetime. Bril is the Penicillin of our time.
Everyone has a plan which is good but since I was discussing the EUA being used you might have to sell at 6-8 or even more Frenchy. Not saying that's a bad thing right? When the news hits and if it's what I believe it is then it will scream past 5 bucks. 4-6 months for potential high positive Ph2 results and EUA authorization.
OH, that's weird... I wonder what EUA stands for and what it means for a drug. Guess I'll have to look that up when I pull off my tin foil hat. I'm well aware of what the company is currently trading at but if you were paying attention you would see we were talking about future projections Enstine.
Last time I checked BP's invest/buyout small companies based on the potential of the drug being marketed and revenue income. If you really think 5 dollars is the sweet number then there's no point in this discussion. We'll have to agree to disagree.
I do know a positive Ph2 against COVID along with EUA puts us north of 10 dollars a share and I'm willing to take my 230k shares past that. I'll mark this post and revisit it in 4-6 months.
GO IPIX
I'm a buyer anytime under .34 which is currently my average per share. I've picked up more than twice in the last week as that average continues to tighten lower.
YOLO IPIX to the poor house or mansions and I sleep pretty dang good at night knowing the numbers Bril has put down in the past trials. There will always be room for therapies when it comes to Covid
Lemon 5 is way too low. no one in their right mind would take 5 bucks as stated 100s of times but you keep lowballing it like always along with all the FUD slingers that continue to talk to themselves. IPIX and any other smart pharma would be willing to wait since we're in trials right now that your best ROI would be to wait and see the data. pharma wants a proven drug which Bril continues to show and will do in the covid-19 just like their other phase 2 trials. Take Bril fully developed for all current indications and cut that in half and quarter of what Kevetrin might one day get and that's the buyout price. one day this will be bought out and it will be north of 5 bucks by 6 fold your "buyout" price or more.
Of course I would prefer XXX millions to push other indications through though. Pound the table Leo!!:)
I agree multiple BP will be offering XX millions and high royalties for B if/when a EUA is given. I think GSK would want to top all offers to keep the title as SOC in US in house. Only thing is that I wish we had a third testing arm of Bril only vs rems +Bril.
We know Bril alone is safe for humans but never tested with rems in a human before. I have a feeling though GSK nodded to IPIX after seeing the RBL results and FDA agreed. If PH2 knocks it out of that park and EUA is given then the flood gates will open and many of us will be handed financial wealth overnight.
Bril is a race horse and it keeps putting up the numbers time after time. Each indication that it succeeds in raises the chances of the next to work as well. Some one here said months ago it the penicillin of our time and I couldn’t agree more.
I hope after EUA is given with the financial wealth that floods into IPIX Leo pushes for a ph3 Bril-OM. That trial is another sure bet and quickest and easiest path to market approval. Then the rest of the platform for Bril and finish up kevetein pill form formulation. This is of course figuring that someone doesn’t pony up xx billions to buy us once they see the potential of the entire platform working. It’s mind blowing to layout the revenue that could one day be captured with Bril fully developed.
Been in since 2013 so what’s another 1 to 2 years.
If PH2 is a solid win and EUA given to Bril then GSK will have to try to lock it down with a big licensing deal.
Both trials are moving along and our finances are stronger. Just sit back and we’ll hear more in the coming weeks.
As of December 31, 2020, we had approximately $8.2 million in cash compared to $6.0 million of cash as of June 30, 2020, and as of the date of this filing, we have approximately $13.9 million in cash.
Agreed, seeing that we obtained a higher rate of viral load obliteration compared to most of not all vaccines currently and any other therapy was nice to see and just reinforces what we’ve known throughout the years.
What I found extremely promising was that the same of bril needed to destroy Covid is the same amount or even less than what we used in the PH2 successful trial when we beat out the SOC Daptomycin in the ABSSI trial.
A lot of good info in the med journal. All I need to see was this.
The high CC50 (a measure of cytotoxicity) and low IC50 (a measure of potency) val- ues observed for brilacidin in Calu-3 cells—yielding a Selectivity Index (SI) for brilacidin of 426 (CC50 = 241 µM/IC50 = 0.565 µM)—strongly support brilacidin’s treatment poten- tial to achieve positive antiviral outcomes in humans. A vast majority of other drugs being evaluated as potential COVID-19 treatments, including repurposed drugs, have SIs that are much lower than that achieved by brilacidin [70], with most drugs failing to show anti- SARS-CoV-2 potency in the <1 µM range [71]. Of note, the IC50 (0.565 µM) and IC90 (2.63 µM) values for brilacidin observed in the Calu-3 cell line are well below clinically achiev- able concentrations based on pharmacokinetics observed in Phase 2 clinical trials with brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). Applying the in vitro IC50 and IC90 parameter targets to in vivo human plasma concen- tration data, simulated dose regimens for brilacidin are similar to that already tested in clinical trials for ABSSSI and even exceed such targets, thereby further supporting the progression of brilacidin to clinical testing for treatment of COVID-19.
We’re golden
I'll be happy in the winners' circle cause I finally won't be the crazy uncle pounding the table at holiday parties.