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Obviously the FDA does not share your concerns. I'll stay with their opinion rather than message board conjecture.
GO IPIX
Well jv for what it's worth, if I were knee deep in final negotiations with a partner, I wouldn't let you know where I was either.
GO IPIX
You're both lightweights. Lol
Phoenix you're right. It's now sunny, 75 degrees with a slight breeze. After this afternoon's hike with my family and my brother, the sun will set, bummer, but hey it all happens again tomorrow and the next day and the next day.
GO IPIX
Yep those idiots are on fire.
Just look around, it won't take long, they're everywhere. Better yet, just listen.
JH, with the legal short position being increased by over 50 percent in the last half of November, today's news is not what they wanted hear, so the negativity flame must now be turned way up. Both transparent as well as funny.
GO IPIX - stay the course
FDA Grants IND Approval for Phase 2 Clinical Trial of Innovation Pharmaceuticals’ Brilacidin for Treating COVID-19
Brilacidin’s potent in vitro inhibition of the Washington and Italian strains of SARS-CoV-2 support its potential to inhibit emerging coronavirus mutations (variants), such as those in the United Kingdom, Denmark and South Africa
120-patient trial to be conducted at U.S. and international clinical sites
Primary endpoint time to sustained recovery through Day 29
WAKEFIELD, MA – December 21, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company developing Brilacidin, a Host Defense Protein (HDP) mimetic representing a new class of drug with antiviral, anti-inflammatory and anti-bacterial properties, is pleased to announce that the U.S. Food and Drug Administrations (FDA) has approved the Company’s Investigational New Drug (IND) application to proceed with initiation of a Phase 2 clinical trial of Brilacidin in hospitalized patients with COVID-19.
Brilacidin has been shown in vitro to be effective against different SARS-CoV-2 strains (Washington and Italian), as well as multiple human coronaviruses, making it less likely to be affected by emerging mutations (in the United Kingdom, Denmark and South Africa) and further differentiating the drug from other COVID-19 treatments in development today.
With its unique HDP mimetic properties, Brilacidin has potential to exert antiviral activity across SARS-CoV-2 variants. The sudden emergence of highly contagious new variants of the coronavirus illuminates the urgent need for drugs, like Brilacidin, with a different mechanism of action from current antivirals to get this resilient virus under control.
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, multi-national, multi-center study expected to enroll approximately 120 patients with moderate-to-severe COVID-19. 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. The Company will now complete site initiation visits and contracts to add additional clinical sites to the study.
“It’s clear from comments of infectious disease experts like Dr. Anthony Fauci and recent news reports on emerging COVID-19 variants that we are not out of the woods yet with the coronavirus, by any stretch of the imagination. Even with vaccines starting to be rolled-out, it is going to be many more months for them to reach the masses and potentially years before vaccines are available worldwide,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “There is now and will be into the foreseeable future a real need for new therapeutics to treat people who contract the infection. We have great hopes Brilacidin will emerge as a novel therapeutic to help fight the global pandemic.”
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for 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. Laboratory 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-1ß, TNF-a 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 fight 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.
Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
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
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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. 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 historical 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 juridictions; 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 and 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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A fabulously well placed bet by DJT. Moderna's vaccine was formulated by the weekend after the genetic sequence of the virus was made available last February.
6 million doses of Moderna's vaccine will be shipped next week which is great news. I will miss this type of insight over the next four years while the old bloated political beauracy plods along.
This is pure bullshit and you know it.
CONCLUSIONS
Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19. Some benefit or harm cannot be ruled out, however, because the confidence intervals for efficacy comparisons were wide. (Funded by Genentech; ClinicalTrials.gov number, NCT04356937. opens in new tab.)
There ya go!
I doubt that and so do you. See the real story on this noteworthy front line Dr.
https://fox40jackson.com/headlines/dr-qanta-ahmed-coronavirus-a-tribute-to-patients-and-their-families-from-an-icu-in-new-york/
Cyber I understand what your saying, but at $2,500 per treatment, Gilead in treating only 2 million more patients, will take in an additional $5,000,000,000 way before they even consider partnering with IPIX.
Like I said, they'll go it alone until they can't. Please don't get me wrong, I would love to see a lucrative partnership sooner rather than later, but after seeing how IPIX has struggled on its own to get this far, I along with all long-time shareholders and IPIX Management, wouldn't want anything else except an exceptional deal that reflects the true value of the B platform.
Gilead will hold on to the entire pie as long as they can. Remdesivir is their billion dollar baby and they will never give in, unless of course they have to. JMO
Short interest(legal) down 1.1M as of 10/15. Over 2M taken of the table in the last two months. The silence is scaring somebody. Personally, I like it.
GO IPIX
Absolutely agree CMC. According to the study linked below the median cost of drug development is 985M.
The amount spent on B by IPIX is probably a fraction of what's been incurred by the RBLs.
https://www.biospace.com/article/median-cost-of-bringing-a-new-drug-to-market-985-million/
By living in the USA, you live in the freeest country on earth. Free to wear a mask or not. Is there really any wonder to the USA numbers. I think not.
GO IPIX
Oldprof I couldn't agree more. Menon should have exited after the Aruda fiasco. Truth be told, Menon merely licensed all of the previous compounds in Cellceutix's portfolio. Why he chose to screw Aruda is beyond me.
I agree. You know there's a lot of number crunching going on right now at Gilead and whoever else realizes what B really is.
GO IPIX - stay the course
03/08/20 12:39:27 PM
Re: None 0
Post #
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I can't imagine that Dr William DeGrado is sitting on his hands while this virus is starting to sweep across the globe. Did the second MTA which cited shipping B to a major University actually cover sending B back to Dr DeGrado at UCSF. I can only wonder.
I'm not wondering any more.
GO IPIX - stay the course
The fact that the legal shorting of IPIX has recently risen 200 percent, clearly means that there's a strong bias toward failure.
It will take a seminal event to shake this out. You can choose what that might be. A buy out, a reverse merger, a successful trial and approval or something else that management executes.
Unless you're willing to wait for this to happen, your money is better invested elsewhere.
Personally, I do not have a problem with waiting. I do have a strong expectation of eventual success.
GO IPIX - stay the course
RBL continues with extremely positive results, company secures more financing and the negative comments explode.
Must be some kind of correlation. Not sure exactly what it is or why. LOL
GO IPIX
Evans out, Menon out, Bertolino out, that leaves Ehrlich with B in hand at the White House doorstep. I like it.
Not exactly. In this order: Evans wanted money. Evans wanted a reverse split. Evans got canned. Evans settled. The rest is motion picture history.
GO IPIX - stay the course -reverse split never
GO IPIX - stay the course
Not bad for a one-legged man in an ass kicking contest
Exactly. Nothing to see here, move on. Right.
This could only be true if the morons live with or visit Grandma and Grandpa. But then again, there's no fixing stupid.
Not bad for a one legged man in an ass kicking contest.
GO IPIX - stay the course
Market Moving.
Realistically, would the announcement as framed within the article about a therapeutic from a top 5 large pharma move the market. I can't see it. On the other hand, would such an announcement for a study done by Federal labs on a drug that showed a 97 percent kill rate from a very little company be Market Moving, absolutely.
Merck is hoping that's not the last antibiotic blockbuster in its portfolio."
With even Zerbaxa failing to achieve anything close to Merck's blockbuster expectations, saving face must be extremely difficult for the original execs behind the Cubist deal, if anyone of them is left.
Lastly, one of the first things Merck did after the Cubist purchase was get rid of Cubist's entire R&D staff putting 120 scientists out of work.
As I've posted previously, big pharma doesn't show enough interest in developing antibiotics, no matter how much the world might need them. Lip service for sure, real commitment, not so much.
Although the claim of defeating antibiotic resistance may well be true, it's never been proven.
With Merck's folly of acquiring Cubist at a cost of over 9 billion dollars, it's no wonder that they, nor seemingly any other big pharma, is willing to invest in another unproven antibiotic platform, regardless of how promising it might be.
The resurrection of P has about as much of a chance as Mennon returning to IPIX. Slim to none.
The mask issue wasn't politicized unless you consider the government's concern for first responders being a political call. At the beginning, there just weren't enough masks. The unspoken fear was that there wouldn't be availability for those providing the care. Americans proved what they would do if masks were cited as necessary. I'm sure that there's still plenty of toilet paper in personal stock piles. AIMO.
Sapien I agree, but I also expect more of the same, that is trading up past where it should go. The last PR on June 17 resulted in two things. Based on that release, the sp went from 28 to 43 the next day. As we now know, the added increase to 65 was a play. Just more of the usual, until it isn't.
If that's the case, let's start "banging the table" again:)
GO IPIX
TD it was good to see it again.
On the way up I'd like 1.58 and then 2.58 and then 3, well you get my jist.
GO IPIX - stay the course
I like the sound of 58. Well that's just me:)
Agreed.
Innovation Pharmaceuticals Collaborating with Regional Biocontainment Lab on Grant Application to Research Brilacidin as a Pan-Coronavirus Therapeutic
Barda is not the only source of funding and it all might just end up pissing off several other pharmas outside of the RBL/IPIX submission.
GO IPIX - stay the course
Absolute nonsense. Good luck today.
GO IPIX - stay the course