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Sent: Fri Jan 29 2021 4:09:00 PM ESTBusinessWire, GlobeNewswire and PR Newswire News
Innovation Pharmaceuticals Inc IPIX:OTCQB
Innovation Pharmaceuticals' Phase 2 Clinical Trial of Brilacidin for Treating COVID-19 Scheduled to Begin Next Week
GlobeNewswire
4:05 PM ET
-- Brilacidin treatment unlikely to be impacted by coronavirus variants, such as those originating in the U.K., South Africa and Brazil, and spreading worldwide, due to its ability to attack the virus directly
Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, announces today that the Company's Phase 2 clinical trial of Brilacidin for treating COVID-19 is scheduled to begin next week.
The Phase 2 randomized, placebo-controlled clinical trial is to include approximately 120 hospitalized patients with moderate-to-severe COVID-19. Two intra venous treatment arms are to be enrolled--active and placebo, with ~60 patients per arm. The trial's primary endpoint is time to sustained recovery through Day 29 based on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale. Other endpoints include: in-hospital outcomes, all-cause mortality, measurement of inflammation-related biomarkers, changes to SARS-CoV-2 viral load, and other key measures.
The Company believes Brilacidin holds tremendous promise to help address the global pandemic, particularly given the emergence of contagious and virulent coronavirus variants. Data increasingly are showing these variants can significantly lessen the effectiveness of COVID-19 treatments and vaccines. For example, a Phase 2b trial in South Africa showed the Novavax vaccine was less than 50 percent effective against a new coronavirus variant originally identified in that country.
A key differentiating aspect of Brilacidin's antiviral mechanism of action is its ability to attack the coronavirus directly by disrupting viral membrane integrity. This suggests Brilacidin would be less prone to resistance developing due to viral mutations. Brilacidin already has been shown to inhibit the Washington and Italian strains of the coronavirus and multiple strains of endemic human coronaviruses (H-CoVs), with additional laboratory testing of Brilacidin planned against new coronavirus variants.
The Company looks forward to the start of its clinical trial to further evaluate Brilacidin's COVID-19 treatment potential. Novel therapeutics with broad-spectrum anti-coronavirus properties are, and will continue to be, much-needed as the world confronts the coronavirus pandemic and prepares for the likelihood of future viral pandemics.
Brilacidin and COVID-19
Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) f or other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Pre-clinical testing at independent laboratories supports Brilacidin's antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin antiviral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin's inhibition of IL-6, IL-1B, TNF-α and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin's robust antimicrobial properties might also help to fi ght secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3-in-1 combination--antiviral, immuno/anti-inflammatory, and antimicrobial--COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. A preprint supporting Brilacidin's COVID-19 treatment potential can be downloaded at the link below.
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full
Global COVID-19 Cases and Mortality
An online tool tracking COVID-19 cases and mortality, both in the U.S. and globally, can be found on the Company's website ( http://www.ipharminc.com), and at the following link:
https://ipixcovid19tracker.com/
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at: http://www.ipharminc.com/email-alerts/
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019, who have recently initiated a Phase 1 study with their formulation. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Brilacidin, based on promising in vitro antiviral activity against SARS-CoV-2, is being evaluated as a potential treatment for COVID-19. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other coronaviruses, as well as obtaining government regulatory approvals to commence clinical testing. Other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of histor ical fact. These statements involve risks but not limited to risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the US and other jurisdictions; that prior test results may not be replicated in future studies and trials, uncertainties and assumptions that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company's need for, and the availability of, substantial capital in the future to fund its operations an d research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company's licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com
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So if you guys saw it this morning I sure missed it. Didn't hit my email till after close.
All good. IPIX is by far not my only stock.
And I just checked MY email for an alert from IPIX, NADA. This emails was from TD Ameritrade, but we know how lame the brokerages are getting taking care of retail. Maybe they sat on it all day.
So yeah, this is new to me.
Cheers, see IPIX over the $ soon.
IMO
News hit as I was posting. Very well done Leo!!!
http://www.ipharminc.com/press-release/2021/1/29/innovation-pharmaceuticals-phase-2-clinical-trial-of-brilacidin-for-treating-covid-19-scheduled-to-begin-next-week
Message in reply to:
Friday, 01/29/21 04:10:22 PM
News in 20 minutes? Or before open on Monday? Let's see it LEO!!!!
News in 20 minutes? Or before open on Monday? Let's see it LEO!!!!
LII's came back. Crazy. $IPIX IS ROCKIN!!!
TD Ameritrade blocking my LII for IPIX, shorts (of whatever kind) ARE IN TROUBLE!!!!
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Brokerages are getting more and more out of control!!!!!!!!!!!!!
2.76 support here, who's ready for round 2? Well, maybe 2.60's then.
13:41:06 .2050 25,000 LET's see more of these!!!
Go $IPIX!!
Shares getting munched right between the bid/ask .203 x .205.
a few 10K's and below.
News this afternoon?
Everyone has their own rules for OTC plays.
Good luck!!
1.48 for me, this puppy should push up nicely imo.
GLTU!!
Up gap fills around 2.70.
https://finviz.com/quote.ashx?t=sngx
I'm on the .20's. Where's our news???!!
IPIX daily
Seriously, nothing pretty there. Need trial start news.
Chart starting to set up imo. See if it can get back over $3 and hold over it. Might take a few trading days but I'm starting to like what I see.
Weekly Obviously needs more time.
BLRX daily Some of my indicators showing possible reversal coming.
I get it. It's not just the group you guys mentioned. Robinhoods too.
Maybe they'll pick up on IPIX when our COVID trial starts.
I'm looking to see IPIX set up for another squeeze. News should come and squeeze this before the chart even has a chance to be ready.
This board is for IPIX, not all the other (scam) plays that manipulate on air.
"They've" been trying to discourage anyone the could and can out of investor shares of IPIX for quite some time too.
Volatility and this and that play into IPIX as well, but, "THEY" still try to keep shares to themselves and accumulate what they can until Leo actually pulls through.
I picked up a few this morning myself. IMO this isn't the end of a market reset / consolidation. This is just the beginning.
SOME bio's handle a bear market better than others, we'll see how this puppy hangs in there.
Would love to see a PR saying it has already begun.
Though I have my doubts as well.
Let's not be disappointed. LET'S GO LEO!!!!!!!!!!!!!!!!!
Have to agree. Had to get through a bunch of bs just to get to this...
Our COVID-19 drug candidates successfully entered core safety pharmacology studies required prior to any human clinical trials around October/November, 2019. These studies have now been completed and we are anticipating the report from the external CRO shortly.
Where's the beef? Why not just post the data? I was mentioning this with another group wondering why this company isn't on the otc yet.
Anyway, anything could happen.
Building for FDA approval here...
https://finance.yahoo.com/news/soligenix-poised-announce-us-commercialization-133000323.html
Hey there Farmmarket1! Guess it's been a bit since we've seen the potential in the same play!
Next few months should be good for this one. And yes, a very nice up gap to fill here. The market volatility under the new administration may take a few days to reveal but as we know the market does this quickly and I'm very well positioned to take advantage. But I've also been accumulating here.
Best to you and yours and Happy new Year!!
2021.... GO FOR IT!!!
They did announce a couple presentations coming up. WEBCAST should be posted soon for playback.
https://www.soligenix.com/
Yes, me as well. They should present at ASCO later this year. And everywhere else.
Here's the link. Looks like FDA approval on the way.
https://sqps.onstreamsecure.com/origin/enliven/players/Soligenix.html
Was just thinking the same thing. Tic Toc!!!!
I'll be "slapping that ask" when we finally see trial kickoff!!!
Waiting patiently.
$IPIX
https://clinicaltrials.gov/ct2/results?cond=&term=brilacidin&cntry=&state=&city=&dist=
Message in reply to:
'Time awareness' doesn't make sense when you keep telling your investors 'any day now' for the last several months.
I think he/ipix totally knows what he/it is doing. Wash, rinse, repeat
For those offering words of 'calm down' 'stop whining'...etc....stop saying things like 'stink bid' and instead say 'slap that ask.'
This strawman is asking for the snakeoil salesmen to step up the rhetoric to believable instead of hoop dream.
Nothing to do but sit back and wait on news that propels this on up.
Message in reply to:
I wondered a few days ago if the big gap and quick run to .299 wasn’t a reset for the shorts. Maybe. The people planning the attack always have the upper hand since they know when it will happen and know what their goal is. Solid shareholders are sitting around smiling thinking the stock is ready to move. Then, BAM! Back to .18 to cloze a gap?
And maybe it is about to move and the shorts know that. I don’t know how nearly a million shares get traded in an instant going from .25+ all the way to .18. It had to be thirty seconds or less.
Who knows? Go Leo!
Solid opportunity if you were able to be on the trigger. Trial news must be close.
I missed that yesterday, thanks for sharing!
http://www.ipharminc.com/new-blog/2021/1/20/the-rise-of-coronavirus-variants-early-signs-of-immune-escape
Message in reply to:
Shareholder Alert: Rise of Coronavirus Variants
Innovation Pharmaceuticals (IPIX) posted today an update to its website, linked below, discussing the emergence of new coronavirus variants, which are raising concerns among scientists and public health officials worldwide. Early data suggests these variants might lessen vaccine efficacy and potentially even escape the body’s immune response.
http://www.ipharminc.com/new-blog/2021/1/20/the-rise-of-coronavirus-variants-early-signs-of-immune-escape
This worrisome situation illustrates a large, and likely prolonged, unmet need for COVID-19 therapeutics to supplement the use of vaccines, as the coronavirus continues to evolve and adapt. Innovation will be initiating a Phase 2, randomized, placebo-controlled clinical trial, enrolling hospitalized patients with moderate-to-severe COVID-19, to further evaluate Brilacidin’s COVID-19 treatment potential.
This is just getting started. First at bat, Leo.
Cruisin. Picking up some nice momentum.
GO #$IPIX
Trial launch news coming soon!
CertainlyPLENTY of interest in IPIX for trial kickoff. Looking forward to seeing the list of trial sites!!!!
PR's will be flowin!!
Message in reply to:
Gap filled - double bottom already printed
The ball is in IPIXs court. If they can deliver over the next two weeks, some of us nit pickers will be gone (cause the stock will have finally rallied again)
Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track Designation.
https://ih.advfn.com/stock-market/USOTC/innovation-pharmaceuticals-qb-IPIX/stock-news/84105469/current-report-filing-8-k
Looking forward to seeing him as our primary investigator. And certainly the presentation in front of big pharma when Brilacidin proves itself here in phase 2 for COVID.
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He happens to know and respect a guy named Dr. DeGrado
https://profiles.ucsf.edu/william.degrado
https://profiles.ucsf.edu/davida.kessler
This appointment by the Biden administration feels like a last warning shot across the bow of shorts, naked or otherwise.
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
I'm not sure when the request was made but we do know that we're on track for trial kickoff. As I see it there is no mention of manufacturing (or requirements) in the fast track literature that I've found. But if I remember correctly, manufacturing for both trials (inside US and OCUNUS Has already produced ample brilacidin.
IPIX is ready to rock-N-Roll!!
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
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Fast track also means that manufacturing and distribution has already been worked out, so in that way, yes, there are agreements in place.
Message in reply to:
Fast track also means that manufacturing and distribution has already been worked out, so in that way, yes, there are agreements in place.
LXRX hit $9.40, I was able to do a few intraday trades along the way. That was exciting.
IPIX brilacidin COVID fast track news.
IBIO consolidated nicely, see what's next for that one.
Accumulating on GALT It may just be me but I think it's been setting up for a bit.
Happy Friday!!!
Nice volume on COVID brilacidin fast track news. Investors know what they're buying into here.
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farrell90 next PR should be to announce the human clinical trial sites.
don't agree. He will not announce clinical trial sites other than maybe number of patients that were jabbed.
December presentation
https://investor.galectintherapeutics.com/static-files/e02430e7-e6f8-4b46-b174-461df8d85a84
Last 10-Q
https://www.sec.gov/ix?doc=/Archives/edgar/data/1133416/000119312520288500/d204131d10q.htm
They could be close to partnership. More data soon as well imo.
Started accumulating.
LXRX NEWS Lexicon Pharmaceuticals Provides Regulatory Update on Sotagliflozin in Heart Failure
https://finance.yahoo.com/news/lexicon-pharmaceuticals-provides-regulatory-sotagliflozin-130000096.html
Made a few nice round trips on this puppy!! Keeping a handful for sure.
INPX News: Inpixon Wins IoT Sensor Company of the Year Award
https://finance.yahoo.com/news/inpixon-wins-iot-sensor-company-143000709.html
Slow and steady wins the race.
There really was no reason for it to gap like it did. I called the squeeze yesterday from 1.26, so it needs to reset imo. Walked away this morning with some nice green.
Tuesday, 01/12/21 08:34:57 AM
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160853371
Tuesday, January 12, 2021 3:37:22 PM
https://investorshub.advfn.com/boards/read_msgs.aspx?board_id=18104&NextStart=4278&BatchSize=10
Sometimes you just have to lock in the green when it's there. I will tell you that I started adding back in today @ 1.67 and will add in the 1.40's if it looks to bottom.
Filled the gap. Still needs to test in the 1.40's imo. Shorty made out on the gap & trap that's for sure.