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More of the same; background info on Bunyaviruses
https://www.ncbi.nlm.nih.gov/books/NBK8004/
From the Update: Brilacidin has now been evaluated in vitro in 10 separate human cell lines, showing consistent and potent inhibition against coronaviruses, alphaviruses and, most recently, bunyaviruses.
Comment: The sentence above and inclusion of news regarding an ongoing study of an additional class of virus, bunyaviruses, should be recognized as excellent news. As I read it, GMU has studied and collected data on Corona and Alphaviruses. The result of those studies comprise the finding to be presented at the annual American Society for Virology in July. GMU, having collected sufficient positive data on Corona and Alphavirus and has begun to collect positive efficacy data on to a new class of virus, bunyaviruses.
Brilacidin, a broad-spectrum antiviral is poised to rock the world.
Thanks. Good info to have and appreciate.
Link follows excerpt.
It’s a pretty ballsy statement in an otherwise typical academic article. Not a position an academic is typically willing to stake.
Excerpt: Bio-computational designed Brilacidin is a synthetic non-peptide defensin mimic drug that destabilises the viral membrane by its amphipathic & hydrophobic nature, and its immunomodulatory property influence the expression of IL-1ß, IL-6, TNF-a cytokines, and cAMP& PDE4/PDE3 pathways which are associated with bronchodilator and anti-inflammatory effects of COVID-19 disease. The smaller size, more effective antimicrobial activity, bioavailability, low enzymatic degradation and toxicity, natural and low-cost production make the Brilacidin a most potent drug against SARS-CoV-2 than the known antiviral drugs.
https://www.sciencedirect.com/science/article/pii/S0882401021002023
The number was 106. Remained at 106 since first posted (I have a screen image from 2/28), until yesterday. Yesterday the Quantity of Patients was increased to 138.
To avoid confusion, the referenced increase from 106 to 138 reflects participants in Russia only. The information is from the Russian State Registry of Medicine.
Update: Increase participant count posted for Brilacidin Phase II on Russian State Register of Medicines.
The Quantity of Patients has been increased from 106 to 138.
http://grls.rosminzdrav.ru/CiPermitionReg.aspx?PermYear=0&DateInc=&NumInc=&DateBeg=&DateEnd=&Protocol=IPI-BRIc-201&RegNm=&Statement=&ProtoId=&idCIStatementCh=&Qualifier=&CiPhase=&RangeOfApp=&Torg=&LFDos=&Producer=&Recearcher=&sponsorCountry=&MedBaseCount=&CiType=&PatientCount=&OrgDocOut=2&Status=1%2c2%2c3%2c4&NotInReg=0&All=0&PageSize=8&order=dateperm&orderType=desc&pagenum=1
A perspective on the challenges of Clinical Trials (recruiting being among the greatest challenges) and the hope that AI and new methodologies might improve the process.
https://www.nature.com/articles/d41586-019-02871-3
"Hey everybody, I have an idea to stop this pandemic thingy. Let's develop an at home cure by...say...September." Press conference over.
WTF do these noobs think has been going on in pharma labs since (plug in your favorite date from the past here. And please, feel free to go as far back as 1994@UPENN)?
Call Innovation Pharmaceuticals or GMU, please.
Some days I just want to pull my own head right the f#ck off!
Reminder; the US represents only 4.25% of the world's population.
https://www.cnn.com/2021/04/20/europe/who-global-covid-cases-rise-intl/index.html
Terrific, content-rich, post. Thanks for the contribution to advancing Innovation Pharmaceuticals visibility.
He. eliedolgin.com
He has been notified.
How an 8am trade, .05 below prior close, can be transacted is beyond me. Perhaps the SEC will be able to explain if/when they respond to my complaint.
GLTA(Longs)
Interesting smattering of semi-large purchases today, beginning in pre-market and spaced nonchalantly thru end of day. No whale by any stretch but a retail buyer with a sniff of something?
Link please.
If "Teams" are offering Bryant Reeves-worthy contracts and you're Michael Jordan maybe you go and play minor league baseball for a bit. Or maybe you continue to demonstrate the value of your game until an offer that meets your "known" value is placed on the table.
I'd like a deal. I'd like a deal that approximates the value of the Brilacidin platform. I'd like to wait until we're not low balled, until low balling places more risk on the BP than on IPIX.
Champions like Michael Jordan know, sometimes, you have to risk losing to win competitive games.
BTW, the Russian Ministry of Medicines site is reporting the trial in active status. See an earlier post of mine for detail and link.
Up Date: After adjusting my search criteria I have been able to document that the Brilacidin COVID-19 Clinical Trial is still in HELD (HELD=Current), status on the Russian State Register of Medicines Site: http://grls.rosminzdrav.ru/CiPermitionReg.aspx?PermYear=0&DateInc=&NumInc=&DateBeg=&DateEnd=&Protocol=%d0%ad%d0%9f-%d0%9a%d0%b8%d1%80%d0%bf%d0%b8%d1%87-%d0%9a+1&RegNm=&Statement=&ProtoNum=&idCIStatementCh=&Qualifier=&CiPhase=&RangeOfApp=&Torg=%d0%91%d1%80%d0%b8%d0%bb%d0%b0%d1%86%d0%b8%d0%b4%d0%b8%d0%bd&LFDos=&Producer=Epharma&Recearcher=%d0%98%d0%bd%d0%bd%d0%be%d0%b2%d0%b0%d1%86%d0%b8%d0%be%d0%bd%d0%bd%d0%b0%d1%8f+%d1%84%d0%b0%d1%80%d0%bc%d0%b0%d1%86%d0%b5%d0%b2%d1%82%d0%b8%d0%ba%d0%b0&sponsorCountry=&MedBaseCount=&CiType=&PatientCount=&OrgDocOut=2&Status=1&NotInReg=0&All=0&PageSize=10&order=phase&orderType=asc&pageNum=1
Start and end dates still reported as 12/17/20-9/30/21
I agree. And the Ignore button saves me from all that BS. In fact, I only ever see about 10 posts per day on this board I've used my Ignore so generously.
GLTA(Longs)
This site never updated information to reflect the September end date. It has only ever reflected the March end date. I reached out to them a while back for clarification but never received a response.
Also, the Russian State Register of Medicines no longer lists the Brilacidin trial. I'm not confident that either of these sites is actually a state-run reporting registry.
http://grls.rosminzdrav.ru/CiPermitionReg.aspx?PermYear=0&DateInc=&NumInc=&DateBeg=&DateEnd=&Protocol=IPI-BRIc-201&RegNm=&Statement=&ProtoNum=&idCIStatementCh=&Qualifier=&CiPhase=&RangeOfApp=&Torg=&LFDos=&Producer=&Recearcher=&sponsorCountry=&MedBaseCount=&CiType=&PatientCount=&OrgDocOut=2&Status=&NotInReg=0&All=0&PageSize=8&order=date_perm&orderType=desc&pagenum=1
https://www.fda.gov/about-fda/ethics/monthly-added-removed-significantly-regulated-organizations-sro
In recent history; 2019-2021 Innovation Pharmaceuticals has never been listed on the Add or Remove From SRO list.
I would love to get an announcement, tomorrow, of the additional site and an updated count of treated participants
If you haven't done it before (no insult intended), view the selected project in tabular-view and select:
Change History Complete list of historical versions of study NCT04784897 on ClinicalTrials.gov Archive Site (about a third of the way down the page)
There you will be provided a comprehensive history of all changes and have the ability to compare side by side or merged.
Agreed, a misread.
Billy: Do a side by side comparison and you will clearly see only two of the three are recruiting
From clinicaltrials.gov
Last change March 17th. 2021
Locations:
Winfield, Illinois, United States, 60190
IPI Investigator Site
[Recruiting]
Metairie, Louisiana, United States, 70006
[Not yet recruiting]
Toledo, Ohio, United States, 43608
IPI Investigator Site
[Recruiting]
I want to be wrong.. Show me the mistake please.
I've submitted a request for clarification from the site you provided. Let's see if they provide any interesting info.
FWIW, The site I linked doesn’t seem to track (or report) changes. At least, not like clinical trials.gov.
Still reported as 9/30/2021 on State Register of Medicines site.
http://grls.rosminzdrav.ru/CiPermitionReg.aspx?PermYear=0&DateInc=&NumInc=&DateBeg=&DateEnd=&Protocol=IPI-BRIc-201&RegNm=&Statement=&ProtoNum=&idCIStatementCh=&Qualifier=&CiPhase=&RangeOfApp=&Torg=&LFDos=&Producer=&Recearcher=&sponsorCountry=&MedBaseCount=&CiType=&PatientCount=&OrgDocOut=2&Status=&NotInReg=0&All=0&PageSize=8&order=StatusName&orderType=asc&pageNum=1
(You will need to run translator.)
http://grls.rosminzdrav.ru/CiPermitionReg.aspx?PermYear=0&DateInc=&NumInc=&DateBeg=&DateEnd=&Protocol=IPI-BRIc-201&RegNm=&Statement=&ProtoNum=&idCIStatementCh=&Qualifier=&CiPhase=&RangeOfApp=&Torg=&LFDos=&Producer=&Recearcher=&sponsorCountry=&MedBaseCount=&CiType=&PatientCount=&OrgDocOut=2&Status=&NotInReg=0&All=0&PageSize=8&order=date_perm&orderType=desc&pagenum=1
Russian clinical trials site.
IPharma LLC, 143026, Moscow, the territory of the Skolkovo innovation center, st. Nobel, 7, Russia
If Brilacidin returns phase II results on par with 700 mg of bamlanivimab and 1400 mg of etesevimab (currently approved for limited EUA), I dare say most Brilacidin supporters would be very disappointed.
700 mg of bamlanivimab and 1400 mg of etesevimab- has not demonstrated efficacy against SARs-CoV-2 variants.
700 mg of bamlanivimab and 1400 mg of etesevimab has not been approved for severe hospitalized COVID-19 cases.
700 mg of bamlanivimab and 1400 mg of etesevimab has yet to receive approval, EUA or full, for use is multiple populations.
Brilacidin, by my reading of the current PhaseII trial, has grander ambitions.
https://www.covid19treatmentguidelines.nih.gov/statement-on-bamlanivimab-plus-etesevimab-eua/
Machine Learning Model: Where are candidates listed on clinicaltrials.gov?
Edit: Full list of 47 indications selected along with Brilacidin. AI selection of 14k indications, Brilacidin among the top 3% (47total)
clinicaltrial.gov Search criteria: Indication Name/COVID19. Not an exhaustive piece of research on my part but by quick search, not many of the indications are in registered clinical trials for COVID-19.
1 Study found for: Brilacidin | Covid19 https://clinicaltrials.gov/ct2/results?recrs=&cond=Covid19&term=Brilacidin&cntry=&state=&city=&dist=
No Studies found for: Zanamivir | COVID19
No Studies found for: Tipranavir | Covid19
Trial record 2 of 88 for: Lopinavir | COVID19https://clinicaltrials.gov/ct2/results?recrs=&cond=COVID19&term=Lopinavir&cntry=&state=&city=&dist=
93 Studies found for: Ritonavir | Covid19 https://clinicaltrials.gov/ct2/results?recrs=&cond=Covid19&term=Ritonavir&cntry=&state=&city=&dist=
No Studies found for: Palinavir | Covid19
No Studies found for: Simeprevir | Covid19
No Studies found for: Cabotegravir | Covid19
No Studies found for: L-870812 | Covid19
No Studies found for: MK-4965 | Covid19
No Studies found for: Tipranavir | Covid19
No Studies found for: Zanamivir | Covid19
No Studies found for: BMS-707035 | Covid19
No Studies found for: GSK-364735 | Covid19
No Studies found for: Paritaprevir | Covid19
No Studies found for: Filociclovir | Covid19
No Studies found for: TMC-647055 | Covid19
No Studies found for: Elvitegravir | Covid19
No Studies found for: Dapivirine | Covid19
No Studies found for: PLX-8394 | Covid19
1 (Phase I) Study found for: Triciribine POhttps://clinicaltrials.gov/ct2/results?recrs=&cond=&term=Triciribine+PO&cntry=&state=&city=&dist=
No Studies found for: Zidovudine | Covid19
No Studies found for: API-2 | Covid19
No Studies found for: Fluorouracil | Covid19
No Studies found for: Gossypol | Covid19
No Studies found for: LM565 | Covid19
No Studies found for: PF-03814735 | Covid19
No Studies found for: Barasertib | Covid19
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No Studies found for: Edoxudine | Covid19
No Studies found for: Cefozopran | Covid19
No Studies found for: Clemizol | Covid19
No Studies found for: VBY-825 | Covid19
No Studies found for: R-763
No Studies found for: Bietaserpine
No Studies found for: ACT-077825 | Covid19
No Studies found for: MP-412 | Covid19
92 Studies found for: Remdesivir Covid19 https://clinicaltrials.gov/ct2/results?recrs=&cond=Covid19&term=Remdesivir&cntry=&state=&city=&dist=
No Studies found for: ABT-263 | Covid19
No Studies found for: BMS-903452 | Covid19
No Studies found for: Taselisib | Covid19
No Studies found for: Goxalapladib | Covid19
No Studies found for: HKI-357 | Covid19
No Studies found for: Sitravatinib | Covid19
No Studies found for: Rifabutin | Covid19
No Studies found for: Omadacycline | Covid19
No Studies found for: Cefpiramide | Covid19
No Studies found for: VCH-286 | Covid19
No Studies found for: BMS-75807 | Covid19
It’s not exhaustive as I stated. Nor is it complete, I don’t have the time right now.
Many of the indications are in clinical trials/have been in clinical trials for other use cases.
clinicaltrial.gov Search criteria: Indication Name/COVID19.
Not an exhaustive piece of research on my part but by quick search, not many of the indications are in registered clinical trials for COVID-19.
1 Study found for: Brilacidin | Covid19 https://clinicaltrials.gov/ct2/results?recrs=&cond=Covid19&term=Brilacidin&cntry=&state=&city=&dist=
No Studies found for: Zanamivir | COVID19
No Studies found for: Tipranavir | Covid19
Trial record 2 of 88 for: Lopinavir | COVID19https://clinicaltrials.gov/ct2/results?recrs=&cond=COVID19&term=Lopinavir&cntry=&state=&city=&dist=
93 Studies found for: Ritonavir | Covid19 https://clinicaltrials.gov/ct2/results?recrs=&cond=Covid19&term=Ritonavir&cntry=&state=&city=&dist=
No Studies found for: Palinavir | Covid19
No Studies found for: Simeprevir | Covid19
No Studies found for: Cabotegravir | Covid19
No Studies found for: L-870812 | Covid19
No Studies found for: MK-4965 | Covid19
No Studies found for: Tipranavir | Covid19
No Studies found for: Zanamivir | Covid19
No Studies found for: BMS-707035 | Covid19
No Studies found for: GSK-364735 | Covid19
No Studies found for: Paritaprevir | Covid19
No Studies found for: Filociclovir | Covid19
No Studies found for: TMC-647055 | Covid19
No Studies found for: Elvitegravir | Covid19
No Studies found for: Dapivirine | Covid19
No Studies found for: PLX-8394 | Covid19
1 (Phase I) Study found for: Triciribine POhttps://clinicaltrials.gov/ct2/results?recrs=&cond=&term=Triciribine+PO&cntry=&state=&city=&dist=
No Studies found for: Zidovudine | Covid19
No Studies found for: API-2 | Covid19
No Studies found for: Fluorouracil | Covid19
No Studies found for: Gossypol | Covid19
No Studies found for: LM565 | Covid19
No Studies found for: PF-03814735 | Covid19
No Studies found for: Barasertib | Covid19
I did i quick review (this morning before work) of the top five on the list of 47. Only 1 of 5 had progressed to phII.
It’s a slow process checking on clinical trials.gov. If anyone might suggest a quicker method than looking up each indication separately, the suggestion would be welcome.
Thank you, I had difficulty this morning identifying the trial.
Can you provide a link to the associate clinical trial?
Keeping perspective.
Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating.
https://clinicaltrials.gov/ct2/show/NCT01606033