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Innovation Pharmaceuticals’ Brilacidin Inhibits Novel Coronavirus (COVID-19) by Almost 90% at the Lowest Concentration Tested to Date in a Human Lung Cell Line
Company Considering Conducting In Vitro Testing Combining Brilacidin with Remdesivir™
July 20, 2020 07:30 ET | Source: Innovation Pharmaceuticals Inc.
WAKEFIELD, Mass., July 20, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, reports today receiving new data from ongoing laboratory testing being conducted at a U.S. Regional Biocontainment Laboratory (RBL). The data is helping to inform the planned Phase 2 clinical trial of Brilacidin for COVID-19, targeted to commence in Q4 2020.
Recently released in vitro data showed Brilacidin exhibited a potent inhibitory effect on SARS-CoV-2, the novel coronavirus responsible for COVID-19, in a human lung epithelial cell line—reducing viral load by 95 percent and 97 percent at two efficacious concentrations tested, compared to control (DMSO).
The new data, using the same assay method, reveal Brilacidin exhibited a similarly potent inhibitory effect against SARS-CoV-2 at an even lower concentration in the same human lung epithelial cell line. Brilacidin achieved approximately 90 percent inhibition of SARS-CoV-2 at a drug concentration that was one-half lower than previously tested. The lowest concentration of Brilacidin used in RBL testing to date is well below the clinically-achievable concentration based on the pharmacokinetics observed in the Company’s Phase 2b clinical trial of Brilacidin in Acute Bacterial Skin and Skin Structure Infections.
Additional RBL testing will assess Brilacidin’s inhibition against SARS-CoV-2 in the human lung epithelial cell line at even lower concentrations to allow for accurate determination of Brilacidin IC50 and IC90 values—the drug concentration at which 50 percent and 90 percent of the virus is inhibited. IC90 rather than IC50 values are considered valuable measures of drug potency as they are more likely to reflect in vitro results translating to comparable results in humans.
Brilacidin/Remdesivir™
To put the new RBL testing results in additional context, an article published in Nature showed that Gilead Sciences’ Remdesivir™ achieved 50 percent inhibition against SARS-CoV-2, in a time-of-addition experiment, at a concentration of 3.7 µM in Vero (animal) cells. Remdesivir™ has received attention worldwide as one of the few effective therapies for treating COVID-19, gaining varying levels of authorized use in the U.S., E.U., U.K., India, Singapore, Japan, and Australia.
In the RBL assay (which included Brilacidin pre-incubated with virus), Brilacidin exhibited approximately 90 percent inhibition against SARS-CoV-2 at a concentration similar to that of Remdesivir™, which again reported 50 percent inhibition of the coronavirus. The Brilacidin inhibition assay was tested in a human lung epithelial cell line, with Remdesivir™ tested in Vero cells. The RBL data also supports Brilacidin showing an ability to inhibit viral entry into cells, a highly desirable mechanism of action as it is the first step in the infection process enabling viruses to be targeted outside the cell, whereas Remdesivir™ impacts viral replication only after the host cell has been infected.
The Company believes that Brilacidin and Remdesivir™, tested in combination, may generate even greater antiviral potency. RBL staff and the Company are considering conducting in vitro experiments to assess such potential synergistic effects. No assurances are made or implied that such combination studies will be conducted.
More detailed data, based on the ongoing antiviral testing being conducted at the RBL, is planned to be submitted for peer-review publication.
For researchers and institutions interested in collaborating on Brilacidin for COVID-19, please send inquiries to: covid19@ipharminc.com
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 an established safety and efficacy database on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Ongoing laboratory testing conducted at a U.S. Regional Biocontainment Laboratory (RBL), and at a Public Health Research Institute (PHRI), supports Brilacidin’s antiviral ability to safely inhibit SARS-CoV-2 in both human and animal cell lines. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Additional pre-clinical and clinical data support Brilacidin’s potential to inhibit 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. These data collectively support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—anti-COVID-19 therapeutic candidate.
$IPIX Now that is Great News this Monday Morning. If I am truthful only thing I am not liking is why are we waiting until Q4. Get the production going lets get in earlier. Not for my pockets sake but rather to help knock this virus down that is affection so many and taking lives.
Company must have some sort of indication ruling will be soon and positive. They made that statement within the body of the 10Q recently filed.
They expect normal trading by Fiscal End 2020 which is less than 1 1/2 months away.
Chickens on Standby.
Never said it wasn't filed on time I was pointing out that all ID filings come with that verbiage for PFR is allowed within the 21 days and it is SOP on all ID ruling nothing "Incorrect" about anything I posted. Stop Twisting for sake of argument.
Any and all decisions ordered by the Judges at SEC are put in with that language allowing for the Petitions to be filed by either Aggrieved party. It is SOP on all rulings. All have the same 21 days to enter the Petition For Review. No matter which case is on the docket and ruled on.
Seems some are missing the point the Judge would have ruled to Revoke had the company not Cured all the missing filings. They in fact did so in Conjunction with the SEC's own Corporate Finance Division who accepted the Filings and amendments and considered the company's previous deficiencies rectified. Additionally the company has filed on or before the required dates on all Q's and K's to date.
If the company was not Current with filings the Petition for Review should be upheld and Final Order against the Company should be entered but THAT IS NOT THE CASE NOW IS IT?
Company is UTD and operating and is not a shell and the Judge was right to determine that an operating Entity with all filings current should not be Revoked or Suspended to protect Investors. Those available Sanctions were not appropriate in this case.
No one is disputing that the OIP points were proven but the Judge ruled as following.
After some reading of the Communications that were going going back and forth between DBMM, SEC Enforcement and the Judge 1 thing is 100% obvious.
SEC Enforcement Lawyers
Samantha a M. Williams
David . Frye
Securities and Exchange Commission
100 F Street, N .E.
Washington, DC 20549-5949
Tel: (202) 551-4061 (Williams)
Email: williamssam@sec.gov
Counsel for the Division of Enforcement
Are total Class A B*#ches. She & He obviously has it out for $DBMM and really has her nose out of joint both prior to decision and after her historic loss.
I would not be surprised if they are the cause of the Petition for Review being buried somewhere.
Even though Corporate Finance at SEC had worked with Company to rectify all filing and language within it she still refused to drop the case and is totally pissed she lost.
1M Bidder @0073 now moved to 0075. Slap it up. 10Q will be filed by Monday maybe AH. But it is coming.
Audits in Pinks are Rare normally the ones looking to uplist would go that way. Or QB etc. Annual 10K's will eventually be audited once company gets to a PPS that warrants Uplisting to QB for now this is the way Pinks work.
$RJDG undervalued at present. Great Revs Great SS. Getting noticed and MM's spreading Bid v Ask shows it is tightly held.
Illiquidity evident. Can move fast on 10Q filing plus news.
Per Company 10Q filing they feel they should return to normal trading by Fiscal 2020 which we are currently 1/2 way through the final Q of so even if I have to wait another 45 days I am OK with that.
Hope they Under Promise and Over Deliver on that statement.
Q's are not Audited Correct the 10K's are! Annual Filing encompass all Q's and those are the Audited Filings.
The filing is not effective until tomorrow.
Correct my apologies Mid August for End of June Q. Too many Tickers LOL. Was looking at a different Stock on a different Fiscal. Thx for the correction.
We may get a glimpse into what is to come AH in the 10Q Due today.
OK Thx Like I said I wasn't sure how to Interpret the Statute for time as it applied to them. But 100% Dec 3rd 2019 was date PFR was taken into the process. So little over 7 months.
OIP was already dismissed. Then The Losers in the SEC put in a Petition for Review on the last day they were legally able to. Dec 3, 2019.
That Petition is being sat on at the Commissioners Office and have not ruled on it to either Allow or just move to Final Order to Dismiss the OIP as has been ordered by Carol Fox Foelak Administrative Law Judge on November 12, 2019.
This is where we sit. About 7.5 months after the petition was received by the Office of the Secretary at the SEC.
I have seen some precedent regarding timeframe to act on PFR's and see 90 days to 120 days for Respondents to act but don't know if that applies to the Bereaved Party (SEC Enforcement) in this case.
Simple Terms $DBMM won the case vs SEC Enforcement and they wanted to appeal it to the commissioners office and thus far they have done Sweet F*%K All.
Time for them to either realize they lost and get over it or also realize their window to act has long since closed.
Also Filing takes effect 7/17 not today.
File Date Effective Date Filing Number Document Type
07/15/2020 07/17/2020 20200785214 Certificate Pursuant to NRS 78.209
It is on OTCM and up top in headlines.
https://www.otcmarkets.com/filing/conv_pdf?id=14271596&guid=eMZFUW2sk9XyK3h
I am no lawyer but SEC is overdue to act per their own guidelines. Someone who is better at reading these things please feel free to interpret.
No I just looked at it it was stamped rcvd Dec 3, 2019 21 days exactly after Initial Decision Finding from Judge.
https://www.sec.gov/litigation/apdocuments/3-17990-event-116.pdf
LP do you have any Idea how long the Commission has to act on the Dec 3/19 petition for review??? Seems as though this process should have been long completed.
And Resume Normal Trading by end of Fiscal 2020 a Quarter 1/2 way done.
$DBMM about to turn up the heat.
OK Thanks $DBMM better be on the agenda!!!!!
You know this or speculating? In any event the company just stated they intent to be resume normal trading by Fiscal end 2020 that is this upcoming Quarter.
Oh I agree they are useless as Tits on a Bull. SEC is not the sharpest knife in the drawer.
Yup so we are waiting on the SEC to stop dragging this on and respect the courts decision.
Tik Tok.
Going forward, there will be an emphasis on investor awareness as soon as the SEC enters a Final Order for the initial decision issued November 12, 2019. DBMM has been current in its filings since July 2018 and are encouraged by the outlook after normal trading has re-commenced which will not occur until Final Order has been issued by the Commission. DBMM intends to make significant strides in aggressively widening its brand exposure using a variety of digital and social channels. There are investors around the globe who understand the digital marketplace and its increasing influence on consumer decisions. DBMM is targeting these new investors in the public market through a global digital and traditional, integrated campaign which will be run by Digital Clarity, with third parties, as required for distribution.
The expectations for fiscal year 2020 remains to return to normal trading following the dismissal of the SEC Administrative Proceeding regarding delinquent filings which were cured July 15, 2018. The Company intends to move ahead thereafter to the scaled, growth plan in multiple geographies to benefit all stakeholders, once the 2Q identified global pandemic’s effect is quantified and considered in business development. DBMM’s brand, Digital Clarity, has competitive advantage and intends to meet the challenge as it has in the past.
Correct so News sends it up fast. 5G news sounds good to me.
Big Spread on this Ticker at this PPS shows illiquidity.
Don't know what to make of all the 4 share trades. Never seen so many like yesterday and seems like it is continuing today. Strange and not sure why they want to keep it right here. Just need to wait for it to break. Was in another that traded similarly for a few days but not dozens of 4 share trades and once it broke it ran hard.
Either way got to wait it out.
LP was this updated today i was on a site over the weekend and this wasn't it?
I do notice it is a 2020 Site.
Not available for Grey or Expert market. Just throw up a big for what you want current price is shown on Time and sales. Or should be on watchlist.
People are buying based on possible Pink Reinstatement.
$SSOK MM's playing games today with 4 share trades. Lots of them. Not retail.
$DBMM LOL the gangs all here.
$DBMM took a bit of 45's potential Lotto nothing more nothing less Reinstatement and lights out.
$SSOK took a starter.
There he is. $WOGI agreed Filings and PR's going to come.